cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Copaxone Administered in Combination With N-Acetylcysteine

This study evaluates the effect of the therapy combining GA and NAC on disease activity as reflected by MRI parameters while assessing tolerability and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically Definite Multiple Sclerosis (CDMS) as defined by Poser et al (Ann Neurol 1983).
2. Subjects must have at least one T1 Gd-enhancing lesion in one of the pre-treatment MRI scans.
3. Subjects must have a relapsing-remitting disease course.
4. Subjects must have had at least one documented relapse within the last year prior to the screening visit (week -10).
5. Subjects must be relapse-free and not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the screening visit.
6. Subjects may be male or female. Women of child- bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive or double-barrier method (condom or IUD with spermicide).
7. Subjects must be between the ages of 18 and 50 years inclusive.
8. Subjects must be ambulatory, with a Kurtzke EDSS score of between 0 and 5.0 inclusive.
9. Subjects must be willing and able to give written informed consent prior to entering the study.

Exclusion Criteria:

1. Previous use of injected glatiramer acetate.
2. Previous use of cladribine within 2 years prior to screening visit (week -10).
3. Previous use of immunosuppressive agents in the last 6 months.
4. Use of experimental or investigational drugs, including I.V. immunoglobulin, within 6 months prior to study entry.
5. Use of interferon agents within 60 days prior to the screening visit.
6. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
7. Chronic use of antioxidant substance(s), including NAC, (more than 30 consecutive days) within 60 days prior to the screening visit.
8. Previous total body irradiation or total lymphoid irradiation (TLI).
9. Pregnancy or breastfeeding.
10. Significant medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or any condition which the investigator feels may interfere with participation in the study (e.g. alcohol or drug abuse).
11. A known history of uncontrolled asthma.
12. A known history of sensitivity to mannitol or acetylcysteine.
13. Inability to successfully undergo MRI scanning.
The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale

Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making.

MyLungHealth is a multi-site pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. The intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused clinical decision support and shared decision-making intervention) against DecisionPrecision+ alone.

Eligibility Criteria:
Inclusion criteria for both study 1 and study 2:

* aged 50-79
* a history of smoking (e.g., current or former tobacco use)
* seen in a study primary care clinic in the 12 months preceding the start of the trial

Exclusion criteria for both study 1 and study 2:

* \>0 but \< 10 pack-year smoking history or quit more than 15 years ago
* No use of the patient portal at least once in the year preceding the start of the study
* A lung cancer diagnosis at the start of the study
* LDCT completed in the past 3 years
* Another chest CT completed in the past year
* Structured EHR data indicating LCS SDM was provided in the past 3 years
* Exposed to the intervention during the pilot phase

Inclusion criteria for study 1:

* a 10-19 pack-year smoking history, an unknown pack-year history, unknown quit date for patients who quit smoking, or a 0 pack-year smoking history

Inclusion criteria for study 2:

* at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years
Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.


Eligibility Criteria:
Inclusion Criteria:

* Positive bilateral conjunctival allergen challenge(CAC) reaction

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
PAIN (Pain AI iNtervention) Platform for Patients at Home

The purpose of this research is to identify physiological markers to determine pain intensity and build an Artificial Intelligence (AI) enabled system to objectively measure pain intensity. Researchers hope to personalize pain medication regimens to help prevent medication over-use.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing low-risk outpatient plastic surgery procedures with expected pain intensities ranging from mild to severe.

Exclusion Criteria:

* Patients with treated or untreated cardiopulmonary syndromes.
* Patients with treated or untreated ophthalmologic pathologies.
* Patients with skin pathologies that prevent us from using the TENS device.
* Patients with pathologies or conditions preventing them from appropriately using their voice.
* Patients with barriers to effective communication.
* Patients with poor digital literacy.
* Patients incapable of taking oral medication.
* Patients who are currently taking medical therapy for chronic pain.
* Patients with a previous diagnosis of severe anxiety disorders.
* Patients who are immobile at baseline.
Treating Depression With Physical Exercise

The purpose of the study is to investigate the effects of an internet-administered, therapist-assisted physical exercise program for the treatment of depression.

Previous research has found promising results regarding physical exercise as treatment of depression. This study will test a 9 week, internet-administered, therapist-assisted physical exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy DSM-IV criteria for depression
* Living in Sweden and being able to read Swedish
* Access to computer with internet connection

Exclusion Criteria:

* Currently receiving other psychological treatment
* Non-stable use of psychoactive medication
* Deemed to suffer from a too severe depression, or being suicidal
* Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU

The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.

In recent years, acellular dermal matrix (ADM) products have increasingly been utilized in breast reconstruction in order to protect the implant from exposure under a thin mastectomy skin flap while also allowing better control of the inframammary fold and, therefore, a better cosmetic result. In current clinical practice, cost is a factor in considering procedures and adjunct products. AlloDerm RTU and SurgiMend PRS are dissimilar in cost, with AlloDerm RTU more costly by 30-50%, and it is unclear if they are similar in efficacy.

This study will be a prospective, randomized-to-test article (ADM), controlled, blinded-to-aesthetic/biopsy specimen evaluator trial. It will provide a way to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS product as well as the relative economics of these two treatment options. Study subjects will only be randomized to one of two surgical mesh products. Patient information including age, BMI, smoking history, tumor size and location, preoperative bra cup size, mastectomy specimen weight, mastectomy method, plastic surgeon, mastectomy surgeon, quality of skin, tissue expander type and maximal volume, intra-operative fill volume, gel/saline implant type and size, chemotherapy, and radiation therapy will be summarized.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's with ability to provide informed consent.
2. Subjects greater than 18 years old
3. Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
4. Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.

Exclusion Criteria:

1. Subjects less than 18 years of age
2. Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
3. Pregnancy
4. Bovine allergy
Suicide Classification System

The purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. Efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

In recent years, suicide prevention has received increased focus within the VA. This is in part related to concerns regarding the mental health and associated suicide risk of Operation Enduring Freedom/Operation Iraqi Freedom military personnel, and a recent study highlighting the increased risk of death by suicide for members of the veteran population. Suicide prevention initiatives could be greatly enhanced if a clinically feasible uniform language regarding suicidality and self-injury was readily available and adopted throughout the VA system. With this goal in mind, the Self-Directed Violence Classification System (SDVCS) and Clinical Tool were developed based upon the Centers for Disease Control and Prevention (CDC) nomenclature and VA VISN-19 MIRECC's work in this area. The purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. Efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

Eligibility Criteria:
Inclusion Criteria:

* Suicide Prevention Coordinator team members at Denver or Grand Junction VA Medical Center
* Mental Health leadership at Denver or Grand Junction VA Medical Center
* Mental Health professionals at Denver or Grand Junction VA Medical Center

Exclusion Criteria:

* Failure to sign appropriate informed consent
* MIRECC staff members
Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

The purpose of the protocol is to assess the efficacy and safety of BIM 23A760 on patient's overall satisfaction in terms of symptom relief (diarrhoea and/or flushes) in patients with carcinoid syndrome after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* The patient has a carcinoid syndrome defined as ≥3 stools/day and/or ≥3 flushes/week.
* The patient has elevated 5-Hydroxyindoleacetic acid (above upper limit normal).
* The patient has a well-differentiated mid-gut carcinoid tumour or serotonin secreting tumour of unknown localisation with hepatic metastasis.

Exclusion Criteria:

* The patient has undergone surgery related to a neuroendocrine tumour (NET) within 4 weeks prior to study entry or has surgery planned during the study.
* The patient has received short acting somatostatin analogues (SSAs) within 2 weeks before study entry or has received short acting SSAs for more than 3 months.
* The patient has received a radiolabelled SSA at any time before study entry.
* The patient has received long acting SSAs under certain circumstances.
* The patient has previously received any specific anti tumour treatment such as chemotherapy, (chemo)embolisation, radiotherapy or interferon in the last 6 months.
* The patient has signs or symptoms of cardiac insufficiency.
* The patient has an ejection fraction \<40% and/or clinically severe cardiac valvular regurgitation.
The Effect on Function of Increasing Activity for Nursing Home Residents

As designs of existing outcome studies are disparate and do not always relate well to a Swedish context, the need for further studies is obvious. Also, an empirical theory drawn from the best practice supporting autonomy and wellbeing for clients in a nursing home setting has not yet been fully depicted. The study described below intends to fill a gap in knowledge related to the effect of enhanced activities of daily living (ADL)-training, physical, and daily activities and staff education in a nursing home setting, based on a theory- and evidence-based intervention programme in a Swedish as well as a Nordic health care context. The aims of the study are to describe the impact of an individually tailored intervention program, in a nursing home setting, on:

* Physical capacity
* Degree of dependence in ADL
* Long-term participation in physical and/or daily activities
* Self-rated wellbeing

The Trondheim study has additional aims to assess the impact of intervention on:

* Urinary incontinence
* Falls

Eligibility Criteria:
Inclusion Criteria:

* \> 65 years of age
* Expected stay in the nursing home \> 3 months
* Able to take instruction

Exclusion Criteria:

* Persons in a terminal phase
SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory, post-menopausal women who would benefit from bisphosphonate treatment;
* \>55 years of age;
* naive to bisphosphonate therapy, or lapsed bisphosphonate users \>=6 months.

Exclusion Criteria:

* inability to stand or sit in an upright position for at least 60 minutes;
* hypersensitivity to bisphosphonates;
* treatment with other drugs affecting bone metabolism;
* history of major upper gastrointestinal disease.
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.


Eligibility Criteria:
Inclusion criteria

* Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter
* Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
* Signed patient informed consent form (ICF) as applicable per local regulation

Exclusion criteria:

* Currently participating in an interventional (drug, device, biologic) clinical trial
* Life expectancy of less than 12-months
* Presenting any contraindication for the use of BWI commercially approved medical devices, as indicated in the respective user manuals
Early Provision of Enteral Microlipid and Fish Oil to Infants With Enterostomy

Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.

Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs.

The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.

It is an interventional randomized open-labeled controlled trial with two groups:

Treatment group: early supplementation of enteral lipid with ML and FO; Control group: routine care.

The primary goal of this study is to obtain pilot data that will inform the subsequent design and execution of a large, randomized trial which will test the hypothesis that infants with short bowel syndrome or ostomy will experience beneficial growth effects from enteral nutrition supplemented with balanced n6/n-3 PUFA, a simple, inexpensive and noninvasive intervention. This pilot study will confirm the safety of PUFA supplemented enteral nutrition, establish the length and amount of enteral versus parenteral nutrition required, and determine the impact on infant growth and intestinal adaptation by measuring expression of four key genes that play a crucial role in intestinal adaptation.

Eligibility Criteria:
Inclusion Criteria:

* infants (age range: newborn to 2-month-old) who are admitted to BCH NICU with a jejunostomy or ileostomy (from surgical intervention for NEC, bowel perforation, midgut volvulus (twisted bowel), atresia or other gastrointestinal surgery);
* who are expected to need full or partial PN for at least 21days from the day of enterostomy placement; and
* have received enteral feedings ≤ 4 days since enterostomy placement

Exclusion Criteria:

* infant with colostomy;
* infants with enterostomy but

  * unable to obtain written informed consent from parent;
  * presence of congenital liver or renal, or metabolic diseases; and
  * ostomy caused by gastroschisis, omphalocele, imperforate anus, and perinatal asphyxia
  * unable to initiate enteral feeds after 28 days of ostomy placement.
Evaluation of the Contamination of Ligatures

This crossover, in-vivo study was carried out with 10 patients who have been started to be treated at Orthodontics Department. 3 elastomeric ligatures were examined in terms of microbiological and surface roughness.

The development of dental plaque has been associated with several environmental and individual factors including diet composition, oral hygiene, the quality of saliva, the composition of the oral microflora and immune factors. Orthodontic fixed appliances also impede the maintenance of oral hygiene. Plaque accumulation surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque.

In patients with fixed orthodontic treatment, common pathological changes are gingivitis, bleeding and gingival growth; thus, gingival index and plaque index parameters have been used as indicators of periodontal disease in many studies. Enamel demineralization which results in white spot formation is observed due to the increase in the number and volume of acid-producing bacteria, and the decrease in pH level because of the glucose metabolized by these cariogenic bacteria . The most commonly investigated bacteria among those mentioned above is Streptococcus Mutans. In the literature, it has been the subject of many studies, including those investigating the correlation between the S. mutans count and the amount of adhesive left between brackets and the enamel, adhesion of S. mutans to nickel titanium and copper-nickel brackets, the difference in S. mutans colonization between self-ligation system and normal brackets, and the effect of elastomeric rings and ligature wires on S. mutans colonization.

Non-conventional elastomeric ligatures were produced in order to reduce the friction of orthodontic sliding mechanics. Manufacturers claim that non-conventional elastomeric ligatures reduced ligation friction by 60% compared to conventional modules. It was reported in another study that brackets combined via non-conventional elastomeric ligatures resulted in a reduced friction force compared to conventional elastomeric ligatures in any wires from 14-inch NITI to 19.25 SS.

To our current knowledge, bacterial colonization on non-conventional elastomeric ligatures was investigated in one study only, using microbial culture technique. In light of this information, present study was aimed to compare S. mutans colonization among different commercial types of non-conventional ligatures and ligature wires. The surface structures of these ligature types also will be investigated by atomic force microscope (AFM) and the results of this investigation will be associated with the results of bacterial colonization amount.

Eligibility Criteria:
Inclusion Criteria:

* permanent teeth in the mouth
* patients with good oral hygiene
* patients did not use antimicrobial drugs such as antibiotics and mouthwashes 3 weeks before the study period and within the 18-week period covering the study period.

Exclusion Criteria:

* smoker