cyrilzakka/clinical-trials huggingface dataset:
Tolerability of Acthar for the Treatment of Multiple Sclerosis in Relapses (TAMS)

Tolerability of Acthar for the Treatment of Multiple Sclerosis Relapses (TAMS)

We propose to conduct a prospective, single-center, open-label, single-arm study comparing tolerability of Acthar versus oral prednisone in the treatment of MS relapses. Potential subjects will be identified during routine clinical evaluations. If patient is determined to be having a study-defined MS relapse, they will be invited to participate in this study. After consent is obtained, the patient will complete the first page of the ARMS survey. If prior steroid use was deemed tolerable then only the first page of the ARMS will be collected and analyzed and these patients will complete their participation in the trial. Their data from the ARMS will provide an estimate as to the number of patients who self-report tolerability and efficacy issues with steroids. However, if patients self-report prior steroid intolerability, then they will advance into the Acthar treatment arm of the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have volunteered and consented to participate in the study.
2. Subjects who have no contraindication to taking high dose, oral prednisone or Acthar.
3. Male or Female subjects age 18 or greater years of age.
4. Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) based on 2010 McDonald Criteria.
5. Subjects without an active infection (Note: If a patient is found to have an uncomplicated UTI and agrees to start on appropriate antibiotic treatment, they can continue in the study).
6. Subjects who are experiencing a protocol defined MS relapse within two weeks of relapse onset.
7. Subjects who are able and willing to sign a consent form.

Exclusion Criteria:

1. Subjects who are less than 18 years of age.
2. Subjects with any contraindication to taking Acthar.
3. Subjects with an active infection other than an uncomplicated urinary tract infection (UTI) (subjects determined to have a UTI who agree to be treated with appropriate antibiotics will not be excluded).
4. Subjects with an immune deficiency.
5. Subjects with a history of any of the following conditions: gastrointestinal ulcers, diabetes mellitus, gestational diabetes, malignant hypertension or steroid induced psychosis.
6. Subjects who are pregnant or breastfeeding.
7. Subjects who are unable or unwilling to sign consent form.
8. Patient is unable or unwilling to participate in phone and clinic follow up.
9. Other factors that in the opinion of the Principal Investigator would exclude the subject from participation in the study.
Vibration Analgesia in Propofol Infusion During Anesthesia Induction

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Background and Significance Infusion of propofol during the process of inducing anesthesia can cause a fair amount of transient discomfort to patients while the are on the operating table and of intact faculties. It is not uncommon for patients to cry out in pain. The investigators have noticed this first hand on numerous occasions and have wondered if there is a risk-free way to lesson the pain associated with propofol infusion.

This study will focus on the use of vibration analgesia to potentially reduce the pain associated with propofol infusion. Vibration is proposed to stimulate A-beta nerve fibers, which transmit information from vibration and touch which, according to the Gate Control Theory of Pain (Melzack and Wall 1965), inhibits signal transduction by A-delta and C fibers (Kakigi and Shibasaki 1992). Vibration has been demonstrated to be effective to decrease pain during vaccinations, phlebotomy, and dental anesthesia (Baxter et al. 2011; Nanitsos et al. 2009).

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Study Design

The objective of this study is to evaluate the effectiveness of vibration as a analgesic during induction of anesthesia. It is the investigators hypothesis that both vibration will lessen the pain of propofol infusion.

Patients set to receive a propofol infusion as part of induction of anesthesia during surgery will be recruited to participate in this study. All participating patients will be randomized following acquisition of consent for study participation to one of two intervention groups: 1) normal standard of care infusion of propofol without analgesia 2) infusion of propofol with application of vibration analgesia. Patients will then be asked to place a mark on a 100-mm visual analogue scale corresponding to the level of pain that they experienced during the digital block. Additionally, Please see the next section for specific details regarding the intervention.

Due to constraints regarding the validity of the linear visual analogue scale in very young patients (Stinson et al. 2006), only those aged 18 years or older will be eligible for participation in the study. Parents or guardians will provide consent for minors or for individuals who are otherwise unable to provide consent themselves.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery

Exclusion Criteria:

* Those below the age of 18
Study of the Contribution of Mutant p53/YAP Proteins to Therapy Resistance in Recurrent Head and Neck Cancer

Multicenter, non-interventional, retrospective/prospective study of a biological nature, on patients affected by head and neck tumors, for which the collection and use of tissue samples is planned for the study of the mutational profile, the transcriptional profile and the proteomic profile.

The study aims to characterize molecular networks governed by the mutated protein p53 with a relevant role in the development of local recurrence in head and neck tumors HNSCC, in order to identify the main actors involved in resistance to current therapy and try to develop new more effective therapeutic strategies for head and neck tumors.

Furthermore, the existence of a significant relationship between the time of onset of recurrence and the deregulation of the identified molecular networks will be studied.

This study will therefore allow to:

1. Identify networks associated with the presence of mutation in the TP53 gene relevant in the development of relapse, comparing the tissues of the primary tumor to the respective tissue of the relapse of patients affected by head and neck cancer, by:

   1. expression profiles of coding and non-coding RNAs (retrospective cohort)
   2. mutational profile by NGS (retrospective cohort)
   3. Single cell RNA-sequencing (SC-RNAseq) on samples belonging to the prospective cohort
2. Characterize the molecular mechanisms underlying TP53-dependent networks with a key role in resistance to therapy, using resistance cell systems and in organoid cultures derived from head and neck tumors HNSCC (PDO) (prospective cohort).
3. Identify the best treatment combinations able to target the networks identified as associated with resistance (prospective cohort).
4. To evaluate the response of treatments in vivo using a syngeneic model of head and neck tumors HNSCC (MOC model).

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patients with squamous cell tumors of the oral cavity, pharynx or larynx
* Surgical patients with primary HNSCC tumors, who have not had previous tumors in other sites or adjuvant treatments prior to surgery.
* Availability of adequate material (tissue) for the planned analyses
* Availability of follow-up data for at least one year (retrospective part)
* Written informed consent (prospective part and/or, for the retrospective part, traceable patients and/or patients in follow-up and/or if necessary for the legal nature/institutional purposes of the participating centers).

Exclusion Criteria:

* Presence of distant metastases at the time of diagnosis
* Previous head and neck cancer
* Second cancer undergoing treatment or follow-up for less than 5 years
Toric Intraocular Lens Following Cataract Surgery

The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract
* Subjects must require a lens power from 16 to 27 diopters
* Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
* Subjects with diagnoses of degenerative visual disorders.
* Subjects with conditions associated with increased risk of zonular rupture.
* Subjects who have had previous corneal surgery in the planned operative eye.
* Subjects with irregular corneal astigmatism.
* Subjects with clinically significant retinal pigment or epithelium/macular changes.
* Subjects with chronic use of systemic steroids or immunosuppressive medications.
* Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
* Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.
Heart Failure and Anemia

The purpose of this study is to determine whether increasing hemoglobin concentration in patients with heart failure and anemia will improve the patients' functional status, including exercise tolerance and New York Heart Association (NYHA) classification.


Eligibility Criteria:
Inclusion Criteria: - At least 21 years of age - Symptomatic CHF for at least 3 months - Limited exercise tolerance on a treadmill - Reduced left ventricular ejection fraction - Stable heart failure medication - Hemoglobin concentration between 9.0 and 12.5 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or in renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent epogen or darbepoetin alfa therapy - Recent blood transfusion
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.

This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);
2. At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical;
3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and
4. Subjects or parent or legal guardian of the subject who are willing and able to sign consent.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation;
2. Indications for emergency surgery;
3. Pre-operative laboratory findings of a hematologic disorder;
4. Subjects with history of moderate to severe allergies;
5. Subjects undergoing minimally invasive laparoscopic surgery;
6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery;
7. Subjects who are pregnant or breast-feeding at the time of surgery; or
8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.
Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign an Informed Consent form.
* Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
* Be on a stable IOP lowering regimen within 30 days of Screening Visit.
* IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
* IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
* Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
* Willing to follow instructions and able to attend required study visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known history of hypersensitivity to any component of the preparations used in this study.
* Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
* History of ocular herpes simplex.
* Abnormality preventing reliable applanation tonometry.
* Corneal dystrophies.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
* Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
* Pregnant or lactating.
* Other protocol-defined exclusion criteria may apply.
Nocturnal Parkinson's Disease Symptoms Study Group

To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers.


Eligibility Criteria:
Inclusion Criteria:

Idiopathic Parkinson's disease patient

Exclusion Criteria:

1. Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis
2. Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD)
3. Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington's disease
Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy

This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function

At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.

All will be enrolled at Samsung Medical Center

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of prostate adenocarcinoma
* Clinical stage: AJCC (VI) stage T1-T2 N0M0
* Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy

Exclusion Criteria:

* Clinical Stage: T3, T4, nodal or distant metastasis
* All kind of neoadjuvant, concurrent and adjuvant treatment
* poor health forced a patient into dropout
Prevalence of Thrombosis in COVID-Patients

Examination of the prevalence of thrombosis in COVID-patients, especially in an out-patient setting. Assessment by duplex sonography. If thrombosis is detected, we will correlate it with immunity status. Assessment of health issues and cognitive function as late complication after infection.


Eligibility Criteria:
Inclusion Criteria:

* SARS CoV 2 positive swap, at least 4 weeks after infection

Exclusion Criteria:

* under 18 years old no consent anemia
Evaluation of Nucleus 6 Sound Coding Algorithms

The purpose of the study was to evaluate the features of the Nucleus 6 Sound Processor (CP900 series) on existing Nucleus recipients who currently use the previous generation sound processor, the Cochlear Nucleus CP810 (also commonly known as the Nucleus 5), with a Cochlear Nucleus CI24RE, CI512 or CI422 cochlear implant. The features evaluated included an enhanced Automatic Gain Control (eAGC), the option to provide acoustic amplification in combination with traditional electric stimulation through an acoustic component, and three input processing algorithms: Signal to Noise Ratio - Noise Canceller (SNR-NC), Wind Noise Reduction (WNR) and Automatic Scene Analyzer (SCAN).

As is customary for a single-subject research design, study results will be analyzed for each subject individually. For evaluations where testing took place under two conditions (i.e. Endpoint 2, 3, 4, and 5) a non-inferiority hypothesis test based on the paired comparisons of the % of words correct will be performed. For each subject, the paired difference (P1 minus P2) will be calculated and the mean difference will be tested statistically against a non-inferiority null hypothesis of 10%. Successful rejection of the null hypothesis allows for a conclusion that the performance under the test condition 2 (based on the Nucleus 6 sound processor) will be non-inferior to the test condition 1 (based on the Nucleus 5 sound processor).

Ho: P1 - P2 ≥ 10% Ha: P1 - P2 \< 10%

We hypothesize acceptance of the null hypothesis for the Nucleus 6 features.

Testing will be based on a paired t-test with a one-sided 0.05 alpha level. The value of 10% was selected as the non-inferiority margin as one that can be tested with reasonable power and was clinically meaningful.


Eligibility Criteria:
Inclusion Criteria:

1. Eight years of age or older
2. CI24RE, CI500 or CI422 series Nucleus cochlear implant types (commercially approved)
3. At least 3 months experience with the cochlear implant
4. Post-linguistic onset of bilateral sensorineural hearing loss, with no congenital component to the hearing loss
5. Native speaker of English, the language used to assess speech perception performance
6. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the prosthetic device 2. Unwillingness or inability of the candidate to comply with all investigational requirements 3. Additional handicaps that would prevent or restrict participation in the audiological evaluations

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Magnesium Therapy in Children With Cerebral Palsy

This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.

The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.

Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.

Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.

The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.

Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age below12 years.
* Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.
* Acceptance of caregivers to participate in the study and signing the written consent.
* Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).

Exclusion Criteria:

* Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).
* Gastrostomy tube feeding.
* Joint contractures.
* Congenital malformations.
* Suspected inborn error of metabolism.
* Suspected inherited neurologic disease.
* Care giver's refusal to participate in the study.
* Occurrence of side effects of oral magnesium sulfate.
* Patients with cardiac, renal, GIT problem or chronic diarrhea.
The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms

Chronic sinonasal symptoms (CSNS), such as coughing, throat clearing, nasal obstruction, crusting, dryness and discharge are extremely common in the general population. Although the physical symptoms are readily apparent, the psychosocial impact is often overlooked. Depression, anxiety, fear of social interaction, impaired personal relationships and decreased performance at work have all been associated with CSNS, often leading to multiple, frequent visits to the patient's primary care physician. A variety of clinical studies have shown that health-related quality of life (HRQoL) is significantly impaired in people with CSNS, with depressive symptoms being particularly common.

CSNS may be due, in part, to tenacious nasal and paranasal secretions. It is therefore conceivable that a mucolytic may thin these secretions and improve mucociliary clearance, thereby reducing CSNS. N-acetylcysteine (NAC) is the most widely used mucolytic agent, particularly in patients with cystic fibrosis (CF), and has been documented as the most effective of the mucokinetic agents. Our group wishes to examine the use of NAC as a treatment for CSNS by testing the hypothesis that oral NAC reduces symptoms of CSNS compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* one or more the following symptoms: nasal stuffiness, nasal dryness or crusting, nasal congestion, discolored nasal discharge, or thick nasal discharge, for four or more days a week in the preceding two weeks

Exclusion Criteria:

* poorly controlled asthma
* cystic fibrosis
* chronic obstructive pulmonary disease (COPD)
* severe coronary artery disease
* vasculopathy
* poorly controlled diabetes
* poorly controlled hypertension
* women who are breastfeeding