cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects

Some of the most common side effects of the multiple sclerosis drug Plegridy (pegylated interferon beta-1a) include flu-like symptoms and injection site reactions. Physicians often advise patients to take Tylenol or aspirin prior to injection, but in this study the investigators evaluated whether using a low dose of oral steroid in combination with Tylenol reduced flu-like symptoms and injection site reactions.

Multiple Sclerosis (MS) is a chronic neurological disease characterized by demyelination of the brain and spine. Currently, there are several treatments designed to decrease the frequency of attacks and delay disease progression. One of these treatments, interferon beta, has shown the potential to decrease relapse rates by approximately 30%, but because the body quickly clears these proteins, patients require more frequent dosing. Another interferon therapy called pegylated interferon beta-1a (Plegridy) was released and it was shown to last longer in the body than interferon beta-1a. This is why Plegridy can be take by an injection into tissue under the skin once every 14 days. However, some of the most common side effects of interferon beta therapy include flu-like symptoms and injection skin reactions, which can often cause patients to want to stop treatment. Clinical practitioners often advise patients to take acetaminophen (Tylenol) or aspirin before the injection in order to prevent the onset or decrease the severity of flu-like symptoms. A previous study with patients taking interferon beta-1a showed that taking a low dose oral steroid (prednisone) in addiction to a medication like Tylenol reduced flu-like symptoms compared to just taking Tylenol by itself. Because Plegridy lasts longer in the body and has more convenient dosing for patients, researchers in this study decided to investigate whether taking prednisone in addition to acetaminophen before the injection would help decrease or prevent the occurrence of flu-like symptoms and injection site reactions in patients taking the therapy.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed any form of MS (relapsing remitting, primary progressive, secondary progressive), any EDSS (expanded stability status scale) score

Exclusion Criteria:

* prior allergic reaction to interferon products, congestive heart failure, elevated liver enzymes
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients

This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with sporadic inclusion body myositis;
* Must be able to walk (assistive aids allowed, including intermittent use of wheelchair);

Key Exclusion Criteria:

* Must not have other conditions that significantly limit ability to move around;
* Must not be using corticosteroids. Must not have used systemic corticosteroid (at daily dose \>=10mg prednisone) for the past 3 months;
* Must meet cardiovascular requirements;
* Must not be pregnant or nursing;
* Must not have a chronic active infection (e.g., HIV, hepatitis B or C, tuberculosis, etc.);
Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient has paroxysmal or persistent atrial fibrillation
* The patient is available for 18 month follow-up

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding
* Sinus rhythm has not been able to be determined using external electric cardioversion
* Patient not susceptible to atrial fibrillation following wide antrum circle ablation
* The subject has already been included in the study (patients cannot be included more than once)
Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children

Burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. Thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. The epidermis is the only layer of skin affected by superficial burns (sometimes known as "first degree" burns). Blistering is a common symptom of partial thickness (second degree) burns, which damage both the epidermis and dermis.

This study will include patients with age 2-10 \& having burns on hands and develop scars will be recruited through Randomized Controlled trial in which convenience sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A which will be treated by low level laser therapy with pressure garment (8-10hrs a day) and group B which will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). Vancouver Scar Scale and PSOAS tool will be used. The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools. Results will be analyzed on SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-10 years
* Patient with 2nd degree of burns on hands and develop scar
* Patients after 3 months of burn on hand
* Only patients that were diagnosed with hypertrophic scars secondary to burn injuries were included
* Patients those with second degree burns or more or those with HS from burns
* Scar type (hypertrophic, flat or atrophic) and scar dyschromia (i.e. erythema) are the main factors that drive laser device selection

Exclusion Criteria:

* Participants who have certain medical problems that may impair scar healing or response to therapy interventions (such as uncontrolled diabetes, autoimmune disorders, or immunocompromised states).
* Those who have suffered burns recently (within the past few weeks) or who have had their scars for a long time (five years or more)
* Wounds that have open area and risk of bleeding occurs.
* Any spinal cord injuries.
* Patients with any other skin disease like skin cancer, inflammation,Allergic conditions etc
* Patients with under treatment like radiations etc
Outcome Evaluation of Solutions for Wellness and Team Solutions Program in Patients With Severe Mental Illness

Obesity is increasing at an alarming rate in patients with schizophrenia, possibly in association with the increased use of atypical antipsychotics. In order to address the weight and metabolic syndrome issues, Manhattan Psychiatric Center (MPC) has implemented the Solutions for Wellness and Team Solutions Program. This program is designed to create a supportive, educational and monitoring environment to stabilize both the psychiatric and medical conditions and to prepare patients for independent management of their psychiatric and physical health condition in the community.

The present program is divided into five detailed segments with three progressive levels, that provide a manualized lesson-by-lesson curriculum for implementation on the treatment mall.

* Medication Education
* Symptom recognition and management
* Living Healthy
* Interpersonal Skills
* Discharge Preparation

The program comprised of detailed instructor and patient manuals, specific curriculums and pre- and post-tests to determine acquisition of the learned materials. All modules are imbedded in weekly small group sessions.

* Each of the 5 modules are discussed in groups in weekly morning or afternoon session, Monday through Friday.
* Each module is divided into three 12-week periods for a total of 36 sessions.
* Upon completing 12 weeks at Level 1, each patient moves to Level 2 and then Level 3 for 12 weeks each.
* Each group has two trained instructors.
* Number of patients per group: ≤ 15.
* Sessions are interspersed within the patient's regular treatment mall classes

Eligibility Criteria:
Inclusion Criteria:

1. Are at lease 18 years of age; ≤ 65 years.
2. Are male or female
3. Are currently hospitalized at Manhattan Psychiatric Center and attend daily treatment mall programs.
4. Are fluent in the language of the investigator, and study staff (including testing administrators, group leaders and supervisors)
5. Have a documented current psychiatric diagnosis as obtained from patient's medical charts and recorded by a qualified psychiatrist.
6. Recently admitted patients will be included if their clinical state permits it.

Exclusion Criteria:

1. Are \> 65 years of age;
2. Are currently enrolled in the Intensive Psychiatric Services (IPS) program at Manhattan Psychiatric Center;
Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.

XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years of age (male and female)
* Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
* Signed Informed Consent Form
* The patient is able to understand the nature of the study

Exclusion Criteria:

* Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
* Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
* Significant abnormal laboratory tests that contraindicates patient's participation in the study.
* Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
* Smoker of more than 15 cigarettes a day
* Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
* Badly managed diabetes mellitus.
* Patients diagnosed with peripheral arterial disorders
* Previous therapeutic radiation (5 previous years) of the affected bone.
* Neoplasia within the previous 5 years, or without remission
* The patient is legally dependent
* Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
* The patient does not accept to be followed-up for a period that could exceed the clinical trial length
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis

Sepsis is a clinical syndrome with high morbidity and high fatality rate in emergency department. Patients with acute liver or kidney injury are more likely to develop Multiple Organ Dysfunction Syndrome(MODS) secondary to the non-hepatic injury group, and the prognosis deteriorates significantly. At present, there is no unified diagnostic criteria for acute liver injury associated with sepsis, and the commonly used prognostic evaluation system is rarely included in liver injury indicators, which is not good for practicality.

The project intends to collect the peripheral blood of the normal population, 24 hours after the onset of sepsis and patients in the recovery period. We will separate and extract plasma, Peripheral Blood Mononuclear Cell(PBMC), and plasma exosomal miRNA, and sequence to find indicators related to disease deterioration and prognosis. And then, we will construct and verify the early warning and prognosis evaluation system.

On this basis, the researcher explore cellular and molecular mediated pathological mechanisms of sepsis, and then clarify the treatment target of sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. The patient who voluntarily signs an informed consent form;
2. Adult patients who meet the criteria for sepsis, who is registration to the hospital within 24 hours of onset;
3. SEPSIS is defined as the sequential organ failure assessment (SOFA) score ≥ 2 within 24 hours after admission, accompanied by at least one site of infection;
4. Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain mean arterial pressure(MAP) 65 mm Hg and having a serum lactate level \>2 mmol/L (18 mg/dL) despite adequate volume resuscitation.

Exclusion Criteria:

1. Age \<18 years old or \>90 years old;
2. Patients with advanced tumors, Pregnancy or lactation;
3. Patients who missed out during treatment and whose data are incomplete.
Comparison of PRISM III, PIM2 and PELOD Scoring Systems

PRISMIII(Pediatric Risk of Mortality III), PIM2(Pediatric Index of Mortality 2) and PELOD(Pediatric Logistic Organ Dysfunction) are frequently used for predicting mortality and morbidity in general pediatric ICUs(Intensive Care Units). However, the effectiveness of these scoring sistems in a specific group patients undergoing congenital heart surgery(CHS) is unknown. In this study, the investigators aimed primarily to evaluate the success of these scoring systems in predicting mortality and morbiditiy in this specific group and to compare the scoring systems with eachother, and secondly to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category


Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 18 years of age who had undergone congenital heart surgery

Exclusion Criteria:

* emergency operations Patients staying in intensive care unit for less than 24 hours
Safety and Efficacy of the ToothWave Powered Toothbrush for Extrinsic Stain Reduction (Texas)

This study is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n ToothWave Powered Toothbrush for stains reduction and improvement of teeth shade.

The study includes a total of 84 treatment sessions, twice a day, and 4 clinic visits over a period of 6 weeks.

One treatment group (Silk'n powered toothbrush - ToothWave) and 1 control group (an ADA approved powered toothbrush (PTB)) will participate in the study.

For each patient, efficacy assessment data will be collected at baseline, 4 weeks, and at 6 weeks. The average stain data will be calculated for each group.

Treatment is defined as a timed, 2 minute brushing of the teeth according to the manufacturer's instructions, twice daily (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use an ADA accepted PTB and standard fluoride toothpaste.

Eligibility Criteria:
Inclusion Criteria

1. Adult subjects aged 18-70, that are in good health.
2. Subjects should have notable extrinsic dental stains on the 6 maxillary labial front teeth, or on the 6 mandibular front teeth (lingual or labial), with a total extrinsic tooth stain score ≥14 according to the LSI.
3. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 as assessed by the Investigator.
4. Subject front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachedguide 3D-Master or the Vita EasyShade device.
5. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
6. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
7. The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.

Exclusion Criteria

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
2. Pregnant or nursing by subject report.
3. Any active condition in the oral cavity at the discretion of the investigator.
4. Any surgery in the treated area within 3 months prior to treatment, or before complete healing.
5. Subjects that do not brush regularly.
6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.

Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.

Outcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.

Eligibility Criteria:
Inclusion Criteria:

* Children with AD and their parents that provided an informed consent to participate in the study

Exclusion Criteria:

* previous experience with the Atopic App
* participation in affiliated online Atopic School program
* presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.)
* avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)
Oncostatin M in Ulcerative Colitis Patients

Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea, bloody stools, and abdominal pain with repeated relapses and remissions.

Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation can facilitate subsequent prognostication. On the basis of these considerations, achievement of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD using endoscopy is extremely important. However, endoscopic examinations are associated with problems such as physical burden to the patient, cost, and risk of complications.

Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal immunochemical occult blood test (FIT) are being widely used in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged \>18 years and \<80 years, of both gender who diagnosed to have UC and given the consent for participation in the study

Exclusion Criteria:

* 1- Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus erythematous
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.

This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.

This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Males with age 35-75 years inclusive.
* Evidence of hypogonadism: low free testosterone.
* Type 2 Diabetes
* People on stable doses of cholesterol lowering medications, blood pressure medications and multi-vitamins are allowed.
* If currently on testosterone replacement,testosterone treatment will be held for 8 weeks.
* BP under control even if on medication.

Exclusion Criteria:

* Coronary event or procedure in previous past 4 wks.
* High PSA
* H/O prostate cancer
* Hepatic or renal disease
* Participation in any other concurrent clinical trial
* Any other life- threatening , non cardiac disease.
* Uncontrolled BP
* Congestive heart failure
* High hemoglobin
* Use of investigational agent or therapeutic regimen within 30 days of study.
Treatment of Intrabony Defects With Simvastatin and Antimicrobial Photodynamic Therapy

Antimicrobial photodynamic therapy (aPDT) is characterized by the association of photosensitizing agents, promoting the generation of reactive oxygen species like free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Simvastatin (SMV) enhances alkaline phosphatase activity and increases the expression of bone sialoprotein, osteocalcin, and type I collagen and is shown to have an anti-inflammatory effect by decreasing the production of C-reactive protein (CRP), IL-6, and IL-8. SMV is also reported to stimulate VEGF release in a dose-dependent manner which promotes osteoblast differentiation and bone nodule formation. The aim of this study is to evaluate the adjunctive effects of SMV with and without aPDT in chronic periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients were all healthy and free from any systemic disease;
* no history of antibiotic therapy or periodontal treatment for at least 6 months preceding the study;
* patients were willing and able to return for multiple follow-up visits;
* good levels of oral hygiene

Exclusion Criteria:

* Pregnant and lactating female patients,
* smokers,
* alcoholics,
* those receiving any medication that could affect healing of soft or hard tissue