cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation

The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.

The investigators propose a pilot single-center study, randomized with crossover design to compare the intuitive control strategy with the standard-in-care direct control strategy.

Primary Objectives The primary objective is to validate a non-invasive, transradial prosthesis that integrates the latest advancements for intuitive, bidirectional and multi-articulated control. This validation is intended to be conducted in unsupervised environments (i.e., home-use). The prosthesis under validation combines intuitive movement control through pattern recognition applied to myoelectric signals, and vibrotactile sensory feedback in response to touch and object release events.

The validation is conducted through well-established functional tests in the field designed to measure dexterity and motor coordination, and through data on daily usage.

Secondary Objectives The secondary objective is to validate the proposed prosthesis based on subjective assessments regarding user satisfaction, perceived capacity to control the device, and perceived level of disability.

Additionally, the study aims to assess whether participation in this research has any impact on the control of the clinically used prosthesis. To this end, both functional tests and self-assessment questionnaires will be used to evaluate the clinical prosthesis before and after the trial protocol.

Eligibility Criteria:
Inclusion Criteria:

* subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis;
* subjects who have expressed informed consent to participate in the study and consent to data processing.

Exclusion Criteria:

* subjects with obvious visual and oculomotor defects;
* concomitant comorbidities/disabilities/chronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study;
* pregnancy or breastfeeding;
* declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24);
* difficulty in understanding the Italian language.
A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer

This Phase 2 study evaluates HBI-8000, a histone deacetylase inhibitor (HDACi) in combination with pembrolizumab for the treatment of patients with advanced or metastatic non-small cell lung cancer who possess programmed death ligand 1 (PD-L1) expression Tumor Proportion Score (TPS) of 1% or greater.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of NSCLC with PD-L1 expression of ≥1% based on FDA-approved test
* No prior treatment with checkpoint inhibitors or more than one regimen of chemotherapy including epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation directed therapy for advanced or metastatic disease
* Disease must have at least 1 measurable target lesion by RECIST 1.1
* Adequate major organ functions as evidenced by laboratory findings within 14 days prior to first dose
* Eastern Cooperative Oncology Group (ECOG) ≤2 and must have a life expectancy of ≥12 weeks

Exclusion Criteria:

* History of grade ≥3 hypersensitivity reactions to monoclonal antibodies
* Participation in another interventional clinical trial within 28 days or less than 5 half-lives of investigational agent before the first dose
* Recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry (except patients with a PleurX™ port)
* Active, known or suspected autoimmune disease or history of immune-mediated toxicity leading to discontinuation of previous checkpoint inhibitor treatment should be administered in (neo)adjuvant setting. Exceptions are for type I diabetes mellitus, hyperthyroidism requiring hormone-replacement or skin only disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy
* Active pneumonitis, history of non-infectious pneumonitis that required treatment with steroids, or history of interstitial lung disease
* Received approved live vaccines within 30 days of planned first dose. Intranasal influenza vaccines (e.g. Flu-Mist) are not allowed, however inactivated viral vaccines or vaccines based on subviral component are allowed
* Any condition requiring chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications. And any steroids use within 14 days of first dose except for inhaled or topical steroids.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply
C. Difficile and Ursodiol

In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.

The non-investigational reference therapies, Metronidazole, Vancomycin and fidaxomicin , are FDA-approved antibiotics currently in use today because of their effectiveness in suppressing the growth of C. difficile and therefore quickly eliminating the colitis and diarrhea. However, they do not promote the restoration of the normal bacterial flora. Therefore, when medication is stopped, the C. difficile colitis returns. In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with recurrent C. difficile colitis
* 18 years of age and older
* Capable of giving informed consent

Exclusion Criteria:

* Patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. Lactose intolerance or gluten enteropathy are not an exclusion provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen.
* Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations.
* Patients not available for long-term follow-up (2 months) by their physician will be excluded from the study.
AMG 151 Amgen Protocol Number 20100761

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 years, inclusive
* Diagnosis of type 2 diabetes mellitus
* HbA1c levels 7.5% to 11.0%, inclusive, at screening
* Fasting C-peptide levels ≥ 0.2 nmol/L at screening
* BMI ≥ 25 to \< 45 kg/m2 at screening
* Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
* If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
* Subject has provided informed consent.

Exclusion Criteria:

* History of type 1 diabetes
* History of significant weight gain or loss (\> 10%) during the 4 weeks before randomization
* Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
* Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
* Use of chronic and/or continuous insulin administration for \> 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
* Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
* Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
* Evidence of active infections that can interfere with the study
* Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
* Currently receiving immunosuppressive therapy
* History of positive HIV, chronic hepatitis B or C, or cirrhosis
* Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
* History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
* Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
* Poorly controlled hypertension defined as diastolic pressure \> 100 mm Hg or systolic pressure \> 160 mm Hg (assessed on two separate occasions during the screening period)
* Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred \> 5 years ago, subject is eligible with documentation of disease-free state since treatment)
* Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization
Effects of Foot Strengthening on the Incidence of Injuries in Long Distance Runners

The main objective of this trial is to investigate the effects of a training protocol for the foot and ankle complex on the prevalence of running related injuries on long distance runners.

Using a web software as a follow up tool, subjects can be scanned for injuries and have them confirmed by a physician, determining the injuries prevalence in one year.

Through force platform and infrared cameras, the kinematics and kinetics during gait will allow assessment of joint moments, power during propulsion, ankle and knee range of motion.

The hypothesis is that a strengthening program for foot and ankle muscles can alter the prevalence of lower limbs injuries on long distance runners, lowering the harmful forces that these segments receive. The participants will be randomly assigned into control group (placebo intervention) or into intervention group, that will receive an 8 weeks strengthening intervention, twice a week with the supervision of a physiotherapist and three times a week being remotely supervised by a software at home, for 30 minutes each session. This will aim for increasing foot and ankle range of movement and muscle strength.

Every exercise has its own progression depending on the subjects execution, increasing in intensity and difficulty.

Eligibility Criteria:
Inclusion Criteria:

* practice long distance (more than 5 km) running for at least one year;
* run at least 20 km a week;

Exclusion Criteria:

* run using minimalist shoes or barefoot;
* having prior experience in isolated foot and ankle strength training within the last year;
* have any health condition that affect gait and running;
* being receiving any physical therapy intervention;
* having any running related injuries during the last two months.
Plaquenil for Alopecia Areata, Alopecia Totalis

Alopecia areata is an autoimmune condition resulting in hair loss and complete baldness (alopecia totalis). Published evidence says that it is mediated by T-lymphocytes. Plaquenil is an anti-inflammatory drug approved by the FDA for malaria, lupus erythematosus, and rheumatoid arthritis. It has an effect on T-lymphocyte mediated inflammation, making it a logical choice for a treatment trail for alopecia areata.

Alopecia areata is a high prevalence autoimmune disease with significant consequences. Alopecia areata is a tissue restricted autoimmune disease directed at the hair follicle, resulting in hair loss. Patients frequently suffer severe psychiatric consequences. This is especially true of girls and young women who become bald. The incidence of alopecia areata in the USA (Minnesota is 20.2 per 100,000 person-years with a lifetime risk of approximately 1.7%. There is no significant gender difference. The disease is often chronic with a remitting, relapsing course. Although it responds to immunosuppression, generalized immunosuppression has significant morbidity and treatment is frequently frustrating and not successful. New treatment options are essential. With evidence that alopecia areata is a T-lymphocyte mediated autoimmune condition it has become a model system for the study of pathogenesis and treatment of T-cell mediated autoimmunity and as such is a model for a host of additional T-cell mediated autoimmune conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Severe alopecia areata: \>75% loss of scalp hair or alopecia areata totalis: 100% loss of scalp hair above with or without loss of body hair (alopecia universalis) 2. Group I (8 subjects): Duration of disease less than 1 year 3. Group II (8 subjects): Duration of disease greater than 1 year 4. At least 18 years old 5. Able to give consent.

Exclusion Criteria:

1. Coexisting significant systemic disease that would increase risk of hydroxychloroquine (e.g. renal disease, liver disease, alcoholism, anemia, blood dyscrasia, psoriasis, porphyria) 2. Systemic immunosuppressive therapy within 3 weeks (e.g. prednisone, cyclosporin, azathioprine) 3. Immunosuppressive conditions (e.g. HIV infection, cancer immunotherapy genetic immunodeficiency 4. Medications with potential interaction to hydroxychloroquine (e.g. liver toxins, bone marrow toxins) 5. Pregnancy, or breast feeding 6. Women of child bearing potential not able or willing to use two methods of contraception at least one of which is not a hypersensitivity to 4-aminoquinolone compounds (chloroquine and hydroxychloroquine) 9. Glucose-6-phosphate deficiency.
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle

This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.

This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
* International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.
* Medically stable to undergo sedation for EUS.
* Signed informed consent

Exclusion Criteria:

* Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
* Pregnant patients
Osteopathic Treatment in Adult Patients With Cystic Fibrosis

To study the contribution of osteopathy on the reduction of pain in adult patients with cystic fibrosis

To compare the impact of osteopathic treatment to a placebo of osteopathic treatment and to usual care on pain at 6 months in adult patient with cystic fibrosis localized to chest, cervical, dorsal neck or back.

Eligibility Criteria:
Inclusion criteria :

* Diagnosis of cystic fibrosis ( positive sweat test and / or presence of 2 disease causing mutations in the CFTR gene
* Age \> 18 years
* Patient with chronic chest , neck or back pain
* Written Informed Consent
* with health insurance

Exclusion criteria :

* regular follow-up by an osteopathic physician in the previous 3 months
* patients awaiting lung transplantation
* history of lung transplantation
* pregnancy
* understanding disorders preventing the patient to apply the study
* participation in another clinical interventional study protocol
The SIR-POBA Shunt Trial

The goal of this clinical trial is to compare plain old balloon angioplasty with sirolimus-coated balloon angioplasty in patients with an arteriovenous shunt stenosis. The main question we aim to answer is, how patency is affected by each of the randomised treatment modality.

This clinical trial will be conducted at our Division of Vascular Surgery and Endovascular Surgery at the University Hospital of Salzburg. Patients will be randomized into one of the two treatment options (plain old ballon angioplasty versus sirolimus coated balloon angioplasty). The recruitment phase is calculated for two years with a planned follow-up of 2 years. Follow-up data will be collected to answer the endpoints and will include all available follow-ups to monitor the shunt up to 2 years after the procedure. Typically, follow-up visits will be conducted at 6 weeks, 3 months, 6 months, 12 months, and 24 months after the procedure.

The shunts are checked for functionality as part of the dialysis required three times a week and presented to our department beforehand in need. This saves chronically ill patients the additional waiting time in hospital outpatient departments.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Informed consent with signature
* Maturated shunt, defined as already in use for two weeks
* Shunt stenosis in need of intervention

Exclusion Criteria

* Pregnant or breastfeeding women
* Active infection or sepsis
* Incapacitated patients
* Lesions in the affected stenosis already pretreated by stenting in the same area shunt.
* Patients currently participating in another study
* Central venous stenosis worthy of treatment
* intolerance to sirolimus
* coagulopathy
* radiotherapy
* patients on immunosuppressive therapy
* use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).
Long-Term Effects of Treatment in Patients Previously Treated for Childhood Hodgkin's Lymphoma

RATIONALE: Assessing the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.

PURPOSE: This clinical trial is studying the long-term effects of treatment in patients who were previously treated for childhood Hodgkin's lymphoma.

OBJECTIVES:

* Determine the cumulative incidence and characterize the spectrum of selected adverse physiologic and psychosocial outcomes, using self-report and clinical evaluation, in patients previously treated for childhood Hodgkin's lymphoma.
* Compare the cumulative incidence and spectrum of self-reported adverse outcomes of these patients, using data collected at a comparable time period after diagnosis, with Hodgkin's lymphoma survivors from the Childhood Cancer Survivor Study (CCSS).
* Compare self-reported health-related outcomes with outcomes detected by clinical evaluation and medical record review of each group of patients.

OUTLINE: This is a cohort, cross-sectional, multicenter study.

* Contemporary group: Patients complete a self-report of long-term outcomes questionnaire and a comprehensive psychosocial questionnaire. A medical record review is then performed. Patients then undergo a comprehensive risk-based clinical evaluation with specific examinations and studies based upon the Children's Oncology Group Late Effects Screening Guidelines and the patients' specific therapeutic exposures.
* Childhood Cancer Survivor Study (CCSS) group: Patients undergo a telephone interview and have medical records reviewed to validate select self-reported long-term outcomes. Patient replies from the baseline CCSS questionnaire (which was completed at certain timepoints after diagnosis) are reviewed for targeted long-term outcomes.

PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Contemporary cohort

  * At least 5 years since diagnosis of Hodgkin's lymphoma

    * Diagnosed between the years 1987-2001
    * 21 and under at diagnosis
    * No evidence of disease
  * Prior treatment on 1 of the following protocols during the years 1987-2001:

    * Children's Cancer Group (CCG) CCG-5942, CCG-59704
    * Pediatric Oncology Group (POG) POG-8625, POG-8725, POG-9425, POG-9426
    * Pediatric Hodgkin's Consortium: VAMP, VEPA, VAMP/COP
    * Institutional protocols COPP/ABV, MOPP/ABVD, ABVD
* Childhood Cancer Survivor Study (CCSS) Hodgkin's lymphoma cohort

  * Current enrollment in the CCSS
  * Diagnosed between the years 1976-1986
  * Completed baseline questionnaire at comparable timepoints (as the contemporary cohort) after diagnosis

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified