cyrilzakka/clinical-trials huggingface dataset:
Lapelga vs Gastrofil

This study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. Study aims to compare biosimilar pegfilgrastim - LaPelga and biosimilar filgrastim -Gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.

This will be a prospective open randomized controlled study. The study will be conducted in the inpatient setting at the London Health Sciences Centre (LHSC) in London, ON, and Windsor Metropolitan Hospital (WMH) in Windsor, ON. The objective of the study is to assess if biosimilar Peg-filgrastim similar is non-inferior to biosimilar filgrastim (LaPelga versus gastrofil) in terms of neutrophil engraftment in autologous transplant patients with lymphoma and multiple myeloma.

Current clinical practice uses a risk-adapted approach where we use originator filgrastim - Neupogen starting on day 5 for patients who are aged 60 or greater, infusion of stem cells with a CD34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the provider's clinical discretion. For the purposes of the trial, patients will be randomized to LaPelga versus gastrofil arm directly and will initiate assigned treatment at day+5 of autologous transplant.

Both LHSC and WMH have qualified investigators (hematologists or other qualified clinicians. The study will start only after receipt of regulatory and ethics approval. Screening investigations on patients will be done only after the signing of written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able and willing to give written informed consent prior to any study related procedures
* Patients with a diagnosis of multiple myeloma or lymphoma who are eligible for autologous stem cell transplant
* All adult patients aged 18 to 75 years
* All patients admitted to LHSC for autologous peripheral blood stem cell transplant receiving peripheral blood stem cell infusions at LHSC and post-transplant care at either LHSC or WMH.
* Of the patients who are admitted for autologous stem cell transplant, the patients that meet the risk adapted approach for GSCF will be included in the study. The risk adapted criteria are aged 60 or greater, infusion of stem cells with a CD34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the providers clinical discretion
* Conditioning chemotherapy as per usual clinical practice

Exclusion Criteria:Patients satisfying the above inclusion criteria but with the following contraindications (prior to randomization) will be excluded from the study:

* Any clinical contraindications to filgrastim, e.g. hypersensitivity to G-CSF or E. coli-derived proteins
* Pain requiring opioids with use of filgrastim during mobilization of autologous stem cells.
* Unable or not willing to provide written consent
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of MYK-461 in Healthy Volunteers

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.


Eligibility Criteria:
Inclusion Criteria:

* Normal body mass index (BMI)
* Normal LVEF
* Normal electrocardiogram (ECG)
* Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug

Exclusion Criteria:

* Any structural abnormalities on echocardiography
* Positive results of HIV test and/or seropositive for HCV or HBV
Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation

The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.

It is hypothesized that described features will reduce the median radiation exposure during the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred for a first radiofrequency ablation procedure for treatment of paroxysmal atrial fibrillation (AF episodes that last less than 30 days and are not terminated via cardioversion) and who are considered eligible for treatment by the physician.

Exclusion Criteria:

* There are no study specific exclusion criteria for this observational study. The exclusion criteria will be conditions that, in the physicians opinion, preclude an RF ablation procedure because the procedure risks outweigh any potential benefits for the subject.
Functionality and Clinical Correlates in TMD

Temporomandibular disorders (TMD) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (TMJ). They negatively affect individuals physically, psychologically, and socially. The structural and functional impairments observed in TMD typically manifest as pain, restricted jaw movement, joint sounds, and muscle tension. In addition to these core symptoms, secondary issues such as chewing difficulties may also occur. Pain in TMD can negatively impact many orofacial functions, especially chewing. Functional impairment in individuals with TMD may result from pain, restricted jaw mobility, muscle tension, alterations in muscle activation, mandibular asymmetry, and morphological changes in the joint. These findings highlight the importance of addressing factors associated with functional impairment in individuals with TMD.

Pain severity is strongly associated with functional limitations of the TMJ and neck disability. Particularly in cases of muscular-origin TMD, significant impairments in neck muscle function and joint mobility have been observed. This condition directly affects jaw function and leads to a decrease in quality of life. The impact of TMD on quality of life is directly related to pain severity and functional limitations. As pain severity increases, limitations in daily activities and reductions in overall quality of life also increase. Therefore, a multidisciplinary approach to TMD is essential for pain management, functional rehabilitation, and improving quality of life.

The aim of this study is to investigate the relationships between functionality and pain, range of motion, neck disability, and quality of life in individuals with TMD. Understanding these relationships will form a basis for the effective management of TMD and improving individuals' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation in the study
* Aged between 18 and 55 years
* Diagnosed with temporomandibular disorders (TMD) and exhibiting at least one of the three main symptoms (jaw pain, limited mouth opening, and/or temporomandibular joint sound)
* A Mini-Mental State Examination (MMSE) score of 24 or higher
* Pain score of 3 or above on the Visual Analog Scale (VAS)

Exclusion Criteria:

* History of complex surgery, trauma, chemoradiotherapy, and/or tumors involving the head and neck region
* Ongoing use of analgesics, anti-inflammatory or psychiatric medications, and/or substance abuse
* Significant tooth loss that interferes with chewing function
* Use of dental prosthesis
* Ongoing tooth pain
* Receiving any TMD-specific treatment prior to or during the evaluation period
* History of orthodontic treatment
* Diagnosis of disc displacement without reduction
Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years at the time of influenza vaccination
* KPNC member at the time of vaccination
* Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25 influenza seasons

Exclusion Criteria:

* Age \<65 years at the time of influenza vaccination
* Received either aIIV4 or HD-IIV4 in the inpatient setting
* Receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons)
* Receive an influenza vaccination outside of KPNC
Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse

The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.

54 subjects were recruited and divided into two groups by random allocation. Consents were obtained . Group 1 received fiber reinforced composite retainer and group 2 received multistranded stainless steel wire retainer. The patients were recalled at every three months interval for a period of 12 months. They were evaluated for number of fractures, failure pattern based on adhesive remnant index and relapse tendency by measuring little's irregularity index.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed fixed appliance orthodontic treatment.
* Subjects who have signed the consent forms.
* Subjects who have accepted the terms and conditions of visiting after every three months for one year.
* Non extraction cases in the mandibular arch with no IPR.
* Patients without caries/ restoration/ fracture on the lower anterior teeth.
* Patients with healthy periodontium with no periodontal disease at that time.

Exclusion Criteria:

* Presence of syndrome or systemic disease.
* Patients taking medications/ drugs.
* Patients with poor oral hygiene.
* Patients with congenitally absent/ missing anterior teeth in the mandibular arch.
* Patients with habit of clenching/ bruxism.
* Patients with history of betel nut chewing.
* Presence of occlusal interferences.
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed prior to the performance of any study procedures
* Male or female volunteers, age 18 to 65 years, inclusive
* Overweight to obese (greater than or equal to BMI 28.0
* Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
* If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
* History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
The Intensively Follow-up Examinations for Asymptomatic MPS I Infants in Taiwan

MPS I newborn screening has been executed in Taiwan nationwide since August 2015. Infants who failed the recheck at recall were referred to MacKay Memorial Hospital for a detailed confirmatory diagnosis. Urinary first-line biochemistry examinations including urinary GAG quantification (DMB/Cre. ratio), two-dimensional electrophoresis (2-D EP), and tandem mass spectrometry assay for predominant disaccharides derived from GAGs (i.e. CS, DS, HS, and KS) were performed. If the results were positive, a confirmative diagnosis was made according to the results of leukocyte enzymatic assay and molecular DNA analysis. Up to January 31, 2019, a total of 390,793 infants had been analyzed for MPS I, in those 11 suspicious cases were referred to MacKay Memorial Hospital for confirmation. The recall rates of MPS I was 0.0028%. Four of the 11 infants were confirmed to have MPS I. The prevalence rates of MPS I was 1.02 per 100,000 live births, respectively. Infants suspected of having MPS with a positive laboratory diagnosis but without any typical, clinical manifestations are not conformed to receive ERT under the treatment guideline of ERT for MPS in Taiwan. Distinctly, the clinical manifestations of MPS are irreversible and would be worse progressively while the symptoms have shown up. Receiving ERT at this time would effectively prevent the progression of illness, but, cannot rescue or reform the irreversible physical problems. By proceeding and undergoing an intensively long-term regular physical and laboratory examinations for asymptomatic infants with MPS I can effectively control the possibility of giving an ERT in a timely fashion.

The study hypothesis is to proceed and to undergo an intensively long-term clinical management and laboratory examinations for asymptomatic infants with MPS I in order to be able to give an enzyme replacement therapy (ERT) in a timely fashion. The overall objectives of this study are summarized as follows, including: 1. To plan a three-month or six-month interval of recall process depending on the judgment of individual case by pediatric geneticist. 2. To recall the asymptomatic MPS I infants back to MacKay Memorial Hospital for MPS follow-up examinations, including regular physical examinations for the earliest presenting symptoms such as otitis media, abdominal or inguinal hernia, and coarse facial features, as well as the urinary biochemistry glycosaminoglycan (GAG) tests. 3. To give ERT in time whenever the typical MPS signs or symptoms showed up. 4. To achieve the aim of newborn screening for MPS, "Early detection, making early diagnosis, and providing early therapy can effectively prevent the development of severe clinical manifestations".

Eligibility Criteria:
Inclusion Criteria:

* The confirmed MPS I infants

Exclusion Criteria:

* Not MPS I infants
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)

The aims of the current study are: 1) to pilot a manualized intervention (INSPIRE - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise) to determine feasibility and acceptability, and 2) to evaluate the preliminary effectiveness of INSPIRE on physical and psychological variables.

The purpose of the current study is to implement an evidence-based prevention program to promote positive health behaviors among young adult women. It will be one of the first to intentionally execute a prevention program targeting well-established risk factors for both obesity and eating disorders in this high-risk population. Intervention content focuses on promoting body size diversity and emphasizing positive health and behavior change in order to reduce stigmatization and remain sensitive to weight-related issues. The manual was developed by integrating two successful existing prevention programs and expanding on previous prevention efforts. Specifically, the diversity of beauty ideals were highlighted to enhance relevance among ethnic minority women, and distress tolerance and emotion regulation skills training were included to target the maladaptive coping mechanisms young adults use to manage the stress associated with transitioning to college.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in postsecondary education at Virginia Commonwealth University

Exclusion Criteria:

* BMI ≥ 30 kg/m2
* Meet criteria for eating disorder threshold risk
* Pregnancy
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis

This research study will be completed by enrolling a prospective, observational cohort study to evaluate medical versus surgical treatment outcomes for chronic sinus disease. This investigation will compare quality of life outcomes between each treatment type, as well as measure cellular and molecular markers of inflammation in the sinus mucosa, to create models that predict improvement in quality of life following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>= 18 years)
* Chronic rhinosinusitis as defined by the 2007 multi-disciplinary adult sinusitis guidelines
* Able to complete all surveys/questionnaires in English
* Persistent symptoms following initial medical management
* Received at least 1 course of broad spectrum antibiotics or culture directed antibiotics for at least a total of 14 days
* Received at least a 3 week trial of topical steroid sprays OR at least a 5 day trial of systemic corticosteroid therapy.
* Counseled for subsequent treatment options including either medical management or endoscopic sinus surgery

Exclusion Criteria:

* Children (\<18 years)
* Unable to complete all surveys/questionnaires at baseline
Acupuncture for Prevention and Treatment of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

A study on the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

The goal of this clinical trial is to investigate the efficacy and safety of acupuncture for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main questions it aims to answer are:

* the efficacy of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors
* the safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Participants will:

* be treated with real acupuncture or sham acupuncture
* be evaluated to learn the efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors

Researchers will compare real acupuncture group with sham acupuncture group to see if acupuncture has good efficacy and safety of acupuncture for the prevention and treatment of oral-related complications caused by radiotherapy for head and neck malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with malignant tumors of the head and neck without metastasis
* Age ≥18, ≤80 years old
* ZPS score ≤2
* Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of \>50 Gy, including at least one parotid gland
* Judged to be able to receive acupuncture treatment, with all needle positions identified as accessible
* Signed informed consent form

Exclusion Criteria:

* History of dry mouth, Sjogren's syndrome, or other underlying systemic condition known to cause dry mouth
* Suspected or confirmed physical closure of both salivary gland ducts
* Have a phobia of needles or prohibit the use of acupuncture at any acupuncture points
* Have a history of head and neck radiotherapy
* Have contraindications to acupuncture, including but not limited to bleeding disorders, having skin infections, ulcers or frequent infections
* Have taken any medications or herbs within the past 30 days that may affect salivary function, plan to or eventually take such substances during the study period
* Poor oral hygiene or severe periodontitis
* Poor compliance
* Other patients who, in the opinion of the investigator, are not suitable for participation in this study
A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.

A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

* pregnant/lactating women
* patients who previously received permanent facial implants or using ovet-the-counter products
Auditory Sensory Attenuation in Anorexia Nervosa

The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women affected by anorexia nervosa and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):

i) is observed in anorexia nervosa ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.

Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.

The perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. This effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one\&#39;s intentional action). Recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals.

Participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions:

i) participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter\&#39;s signal (i.e., who touch the participants\&#39; arm) iv) the experimenter presses the button upon the participants\&#39; signal (i.e., who touch the experimenter\&#39;s arm).

However, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships.

To this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women affected by anorexia nervosa with healthy-weight women.

Indeed, relational difficulties and social withdrawal characterized this clinical condition.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of anorexia nervosa according to the DSM-V classification (experimental group)
* BMI ranged between 19 - 25 kg/m2 (controls)
* handedness: right

Exclusion Criteria:

* history of eating disorders (controls)
* major psychiatric conditions (e.g., psychosis, personality disorders)
* developmental disorders (e.g., autism spectrum disorders)
* neurological or brain injuries disorders
* motor impairments