cyrilzakka/clinical-trials huggingface dataset:
Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.

* On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI.
* All MRI scans will be done at Massachusetts General Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Locally resectable pancreatic mass present on one or more pre-operative imaging modalities
* Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan
* Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study
* 18 years of age or older
* No uncontrolled serious medical or psychiatric illness
* Women of childbearing potential must not be pregnant or lactating

Exclusion Criteria:

* Known allergy to iron or dextran
* Pregnant or lactating
* Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device
* Sickle cell disease or hemoglobinopathy
CEFID-II (CEra Flow Improves DVT-II)

For Deep Vein Thrombosis (DVT) risk groups, the effect and safety of blood circulation improvement before and after application are evaluated using an investigational device (model name CGM MB-1701).

The investigator applies the test device to the appropriate subjects for a total of 10 days (+1 days) at the institution and nursing hospital, and upon discharge for long-term follow-up investigation, the investigational device is applied at subjects' home according to the subject's consent for about 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women over 19 years of age
2. Subjects who have not been diagnosed with deep vein thrombosis in the lower extremities through the following test results prior to the application of medical devices.

(1) Subjects diagnosed by Doppler ultrasonography as having no blood clots in the femoral vein and the vena poplitea (2) D-dimer negative test result (Even if D-dimer is tested positive, it can be selected through additional tests at the discretion of investigator.)

3. Subjects have 2 or more points of venous thromboembolism (hereinafter referred to as VTE) clinical prediction score (Two-level wells score) at the time of screening.

4. Subjects who fully understand the purpose and procedure of the study and wish to participate in clinical trials with voluntary consent

Exclusion Criteria:

1. Subjects complain of a decrease in the sensation of the lower extremities or is unable to feel the sensation of pain
2. Subjects have inflammation or trauma on the skin that directly touches the device
Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.

Eligibility Criteria:
Inclusion criteria:

* Provided written informed consent.
* Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
* Have history of RLS symptoms at least 15 nights/month.
* Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

Exclusion criteria:

* Secondary RLS
* Primary sleep disorder
* Sleep apnea
* Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
* Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
* Use of any prohibited medication.
Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.

Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).

Eligibility Criteria:
Inclusion Criteria:

* B cell non-Hodgkin lymphoma based on WHO classification 2017
* incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection
* The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
* Those with a minimum life expectancy of 12 weeks or more
* In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
* Those who have agreed in writing to participate voluntarily in this trial

Exclusion Criteria:

* Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
* At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
* Those who cannot take autologous blood
* Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
* Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
* Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
* Those who have identified the following forces at the time of screening:

  1. Those who have been clinically aware of heart disease within 6 months prior to screening
  2. Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
  3. Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
  4. Those who have undergone major surgery within 4 weeks prior to screening
  5. Those who have undergone non-critical surgery within two weeks prior to screening
* Childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and AT101 administration or when AT101 in the body is not identified
* Those who have been administered or applied to other IP/ID within 4 weeks of screening
* Those who are addicted to alcohol and/or medication
* Those who are unfit or unable to participate in this trial when judged by PI
Side Effects of 4 Times Bone Marrow Mono Nuclear Transplantation in Patients With Ischemic Lower Limb

Critical limb ischemia (CLI) results from severe occlusive disease that impairs distal limb perfusion to the point where oxygen delivery is no longer adequate to meet the metabolic needs of the tissue, even under resting conditions. The limits of peripheral artery disease (PAD) compensatory mechanisms, such as distal vasodilatation and collateral formation, have been exceeded at this point. PAD is a widespread disease, affecting up to 15% of all adults older than 55 years. Formation of true new blood vessels, or angiogenesis, and development of collateral vessels from preexisting blood vessels, or arteriogenesis, is important in the pathophysiology of vascular disease. By stimulating these processes the investigators might be able to provide an alternative treatment strategy for patients with lower limb ischemia. In response to tissue injury and remodeling, neovascularization usually occurs via the proliferation and migration of progenitor endothelial cells (EPC) from preexisting vasculature. Indeed, recent studies have shown that bone-marrow mononuclear cell (BM-MNC) implantation increases collateral vessel formation in patients with limb ischemia. So the investigators determine to evaluate the efficacy of repeated MNC transplantation in patients with ischemic lower limb.

In this study we transparent bone marrow derived mononuclear stem cells 4 times to the ischemic limb of 11 patients with PAD.first of all all the patients evaluate by physical examination,PFWD,ABI and serologic tests.then underwent bone marrow aspiration to take sample.In our lab the MNC are separated and divided in to equal doses.one of them inject to the ischemic foot and the othr one are freezed and inject after 3weeks.3 weeks after second injection again patient underwent bone marrow aspiration and the same process repeat.then after 4times transplantation,patients are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.all the data are collected and analysed and the result will be shown.3 patients underwent cell transplantation just one time due to one time bone marrow aspiration.They are followed up after 1,3,6,9,12 months after injection and evaluate by physical examination,PFWD,ABI and serologic tests.at the end of the study patients with 4imes injection and 1time injection will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic lower limb based on TASK guide line
* Rutherford score:2,3
* ABI\<0.6
* Absolute ankle pressure \< 60 mmHg
* Both gender
* Age:20-62years

Exclusion Criteria:

* EF\<30%
* Cr\>2
* HbA1c\>8%
* Bone marrow disorders:leukemia
* Cognitive disorders
* Infections
* MI with ST elevation during last month
* Malignancy
* Immunologic or rheumatologic disorders
Luminopia One Pilot Study

A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.


Eligibility Criteria:
Major Eligibility Criteria:

* Age 4 to \<8 years (phase 1) or age 4 to \<13 years (phase 2)
* Monocular amblyopia associated with anisometropia, strabismus or both combined
* Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
* Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
* Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
* Visual acuity stability in current refractive correction (phase 2)
* Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).

The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)


Eligibility Criteria:
Inclusion Criteria:

* Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
* Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).

Exclusion Criteria:

* Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
* Subject has had any surgical treatment or any neurolytic injections for PHN
* Subject has clinically significant ECG and laboratory abnormalities.
* Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
* Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) \> 1,5 x ULN (upper limit of normal) at visit 1
* Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.
Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging

This experimental, randomized study aims at evaluating the preventative effect of a Sun Protection Factor (SPF) 50+ sunscreen (Anthelios UVMUNE 400 Fluid SPF 50+) with high Ultraviolet A (UVA) protection on clinical signs of skin aging.

The study will be conducted in compliance with the protocol, current internal procedures and in the spirit of the International Council on Harmonisation (ICH) Topic E6(R2)5 ref: EMA/CHMP/ICH/135/1995, ICH Good Clinical Practice (GCP) Addendum Nov 2016 and applicable regulatory requirement.

Statistical plan: Tx represents the values observed at Time x, for each parameter and by subgroup. Quantitative variables, or those that can reasonably be treated as such, will be summarized using the minimum, maximum, measures of central tendency such as the mean and median \& measures of dispersion such as the standard deviation (SD). Qualitative variables will be summarized in the form of counts and percentages.

For each parameter, a graphical representation of the means ±95% Confidence Interval (CI) will be produced to visually assess the evolution across time, by treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with signs of photo aging (Global score of at least 14)
* All skin types

Exclusion Criteria:

* Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site
* Pregnant or breastfeeding women
* Subject with known allergy to cosmetic products or to any ingredient of the sunscreen product
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome

This randomized pilot phase I trial studies the best way, either expressed prostatic secretion (EPS) or post massage urine (PMU) biomarkers, of predicting biopsy results in patients undergoing prostate biopsy. Studying samples of urine in the laboratory may help doctors detect prostate cancer. It is not yet known whether EPS or PMU biomarkers are more effective in predicting prostate biopsy results

OBJECTIVES:

I. To determine which non-invasive test for prostate cancer, EPS or PMU, is a better predictor of prostate cancer biopsy result. (Part I)

II. To determine whether standardized testing for transmembrane protease, serine 2 (TMPRSS2):ERG Types III and VI is superior to testing for TMPRSS2:ERG Type III in predicting prostate biopsy outcome. (Part I)

III. To expand the sample size utilizing the best TMPRSS2:ERG test and the best specimen type as determined in objective I and II in order to estimate with reasonable accuracy the positive predictive value (PPV) and negative predictive value (NPV) for each test. (Part II)

IV. To expand the biomarker set, to include Prostate Cancer Antigen 3 (PCA3)-ribonucleic acid (RNA), d-glyceraldehyde-3-phosphate dehydrogenase (GADPH)-RNA, prostate-specific antigen (PSA)-RNA, and deoxyribonucleic acid (DNA) methylation levels at glutathione s-transferase pi (GSTP1), adenomatous polyposis coli (APC), retinoic acid receptor beta (RARB), Mitochondrial DNA (MT-DNA) Deletions and ras association (RalGDS/AF-6) domain family 1 (RASSF1), so as to develop an extensive data set for use in multivariate analysis. (Part II)

V. Use multivariate analysis to determine which combination of molecular markers offers the greatest improvements in our ability to predict biopsy outcome over current baseline predictors (Serum PSA and digital rectal examination \[DRE\]). (Part II)

VI. Estimate PPV and NPVs from this analysis and compare them to the standard assay's performance. (Part II)

OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive digital rectal palpation and then void a spontaneous urine sample for PMU analysis. Patients then undergo a prostate biopsy.

ARM II: Patients receive DRE with prostatic massage for 30-60 seconds and are then milked at the urethra to provide a collection of EPS. Patients then undergo a prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* All men who will be undergoing transrectal ultrasound of the prostate (TRUSP) with biopsy in the department of Urology or participating urology clinics for the evaluation of prostate cancer

Exclusion Criteria:

* Men with a previous diagnosis of prostate cancer
* Men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious DRE or PSA
* Men with a prior diagnosis of cancer \< 5 years ago, excluding basal cell carcinoma and/or squamous cell carcinoma
Effect of Childhood Radioiodine Therapy on Salivary Function

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.

Radioiodine (I-131) therapy for thyroid disease is known to decrease salivary function in adult patients. The impact of pediatric I-131 exposure on salivary function is unknown. The investigators goals are to answer this question by measuring salivary gland function before and after I-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease. We will use a Modified Shirmer Test to measure saliva production and a questionnaire to evaluation symptoms of xerostomia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been treated with radioiodine therapy
* Patients who have never received radioiodine therapy (negative control group)

Exclusion Criteria:

* Non-English speaking subjects will be excluded due to our lack of translation support resources at this time. Of note, participation in our study cannot benefit participants in any way.
Evaluation of the Benefits for Overall Health Following Cochlear Implant Treatment in the Elderly Population

The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.

The study is designed as an observational prospective repeated measures study with each subject acting as his/her own control. Subjects are evaluated subjectively at pre- and post-operative intervals that coincide with their routine visits to the clinic. Outcomes from routine practice and application of cochlear implant intervention are recorded through observational measures using clinical standards scales used widely in geriatrics and audiology. The study is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear. Patients are approached for study participation prior to surgery by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral CI candidates with bilateral post-lingual deafness with intention to treat
* ≥ 60 years at first unilateral cochlear implant
* Implant ear: meets all local criteria for cochlear implant treatment
* Contralateral ear: average pure tone thresholds indicate a moderately-severe to profound hearing loss (4 freq. average: 0.5, 1, 2 and 3 or 4 kHz \> 56 dBHL).
* Willingness to participate in and to comply with all study procedures
* Fluency in languages used to assess clinical performance
* Appropriate expectations from routine cochlear implant treatment
* Able to decide on study participation personally and independently sign their consent

Exclusion Criteria:

* Significantly/severely dependent or fragile
* Unable to provide consent personally
* Unable to complete questionnaires for self-assessment independently
* Unilateral hearing loss
* Sequential and simultaneous bilateral cochlear implant recipients
* Ossification or other cochlear anomalies preventing full electrode insertion
* Retro cochlear or central origins of hearing impairment.
* Significant comorbidities preventing study participation (e.g. blindness, immobility or in a wheel chair, severe aphasia)
* Medical contraindications to surgery
* Clinic Standard fail criteria for cochlear implant candidacy in regards to chronic depression, dementia, and cognitive disorders.
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device.
Pilot Randomized Control Trial of Telehealth Group for Improving Peer Relationships (PEERS) in NF1

This is a pilot randomized control trial of the UCLA PEERS protocol delivered via Telehealth with teens with neurofibromatosis type 1 whose parents report that they have difficulty making and keeping friends.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of neurofibromatosis type 1
* Age 12-17
* Main language spoken in the home is English
* Reliable internet access
* Current functional impairment in peer relationships
* Teen is interested and motivated to participate

Exclusion Criteria:

* Main language spoken in the home is not English
* Cognitive or developmental difficulties that affect reading comprehension or understanding of treatment material
* Significant behavioral concerns
* Other comorbid medical conditions
* Major surgery in past 6 months
* Prior social skills group treatment within past 6 months
* Prior participation in PEERS