cyrilzakka/clinical-trials huggingface dataset:
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.

The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.

This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.

Eligibility Criteria:
Inclusion Criteria:

* Baseline fasting serum TG level \> 200mg/dL and \<1000mg/dL, in subjects treated for HTG.
* If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study.
* Able and willing to give written informed consent.

Exclusion Criteria:

* Subjects taking fish oil capsules 8 weeks prior to inclusion in this study.
* Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos).
* Pregnant of lactating females.
* Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease.
* Significant hepatic disease.
* Significantly reduced renal function.
* Alcohol consumption \>30g for male and 20g for female daily.
* Concomitant use of other investigational drugs.
* Subject related to the investigator.
* Subject expected to be not compliant.
Nourish Clinical Trial

The purpose of the research study is to learn more about the best ways to teach cooking and food skills to adults, and how cooking classes may help reduce one's stress and food waste, as well as improve their diet.

Currently, 12.8% of Americans experience food insecurity, and food insecurity is associated with elevated perceived stress. Food literacy is proficiency in food-related skills and knowledge, including food preparation and cooking skills, basic nutrition knowledge, and the ability to prevent food waste. Recent research conducted in Australia suggests that food literacy interventions are associated with improved food security. Traditionally food literacy interventions take a recipe-based approach to culinary nutrition and lack information about key components of food literacy, such as food storage and food waste reduction techniques. However, recent research by the PI contends that recipes may be difficult for food insecure individuals to implement at home, given the challenge of procuring ingredients, suggesting the need for a new approach. In addition, food insecure households face additional environmental challenges, such as owning fewer cooking utensils, compared to food secure households. Based on the Social Cognitive Theory, the Nourish intervention addresses these limitations by incorporating food waste reduction, food storage knowledge, and improvisational cooking skills (cooking with what you have on hand) into food literacy and culinary nutrition education, as well as providing key cooking utensils. Eventually, the study team plans to test the impact of the Nourish intervention on food literacy, perceived stress, diet quality and food security to determine if food literacy interventions can positively impact perceived stress, diet, and food security. The present clinical trial will test the effectiveness of the Nourish intervention on household food waste, diet quality, and food and cooking skills and behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Ability to attend classes in person

Exclusion Criteria:

* Non-English speaking
New Psychoactive Substances in Intoxicated Patients During the Winter Activities

The purpose of this research is to identify the New Psychoactive Substances (NPS) that are responsible for intoxicating patients in ski resort during winter activities.

The New Psychoactive Substances expose to an additional risk of overdose or death due to their potency. These New Psychoactive Substances are used voluntarily by users wishing to test new substances, but also involuntarily because of association (unknowingly users) with more "conventional" drugs such as cocaine or heroin in the self-administered powder. These intoxications are still poorly known and the investigators believe that the identification of New Psychoactive Substances among the drugs consumed, and the association of their consumption with the appearance of a particular symptomatology allow the physician to guide the diagnosis and facilitate the care of future patients.

Eligibility Criteria:
Inclusion Criteria:

* Admission to emergency, resuscitation or intensive care departments involved in the study
* Anamnestic and / or clinical suspicion of acute drug poisoning according to International Classification of Diseases-10 criteria
* Patient coming from a ski resort from the pre-established list
* urine sample available as part of the treatment
* person understanding French or English
* Non-opposition to the study

Exclusion Criteria:

* Suspicion of alcohol intoxication alone
* Suspicion of voluntary drug poisoning
* Suspicion of intentional intoxication by others
* Pregnant or breastfeeding women
* Major mentioned in Articles L1121-6 and 1121-8 of french public health code
* Patients in the exclusion period of another research involving the human person type 1 or 2
Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Conditioning therapy

* Busulfan 3.2 mg/kg/d on d-7 to -6
* Fludarabine 30 mg/m2 on d-7 to -2
* ATG 1.5-3.0 mg/kg/d on d-3 to -1
* Methylpred 2 mg/kg/d on d-4 to -1

Mobilization and harvest

* Donor
* G-CSF 10 mcg/kg/d s.c. on d-3 to 0
* Harvest of PBMCs on d 0 to +1

Infuse G-PBMCs on d 0 to d+1.

* Donor G-PBMC infusion

GVHD prophylaxis

* Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
* Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Prophylactic dose-escalating DLIs

* Begin at d+120 or at least 2 wks after IST discontinuation.
* No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Eligibility Criteria:
Inclusion Criteria:

1. Patients with higher risk MDS including chronic myelomonocytic leukemia

   * RAEB-1 or RAEB-2
   * IPSS Intermediate-2 or High risk category
   * Chronic myelomonocytic leukemia
2. Patients with appropriate hematopoietic cell donor

   * HLA-matched sibling
   * HLA-matched unrelated donor
   * HLA-mismatched familial donor 3.16 years old or older

Exclusion Criteria:

* • Presence of significant active infection

  * Presence of uncontrolled bleeding
  * Any coexisting major illness or organ failure
  * Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
Family Intervention for Chinese Americans With Type 2 Diabetes

The goal of this pilot study is to examine the feasibility and acceptability of a family-oriented SMS intervention in 30 Chinese Americans with T2D and their family members. Participants will be randomized to one of 2 arms (n=15 each): 1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard of care treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the counseling videos.

Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Given the high economic and societal burden of T2D and rapid population growth in Chinese Americans, there is an urgent need for research to develop effective interventions to address T2D burden in this population. Recent evidence suggests the importance of involving and empowering family members in diabetes intervention and calls for family intervention. A mobile health approach such as short message service (SMS) might be a promising way to deliver such family-oriented interventions to the target population given prior studies suggests that Chinese Americans often report challenges to attend in-person lifestyle counseling because of long working hours and lack of sick time from work. A SMS-based intervention provides the flexibility of allowing them to view the intervention at a time and place convenient to them. This study will serve as the first step to explore an alternative approach for managing T2D in this group.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patient participants:

* self-identify as Chinese or Chinese American;
* be between the ages of 18 and 70,
* self-report a diagnosis of T2D;
* be willing to receive WeChat messages regarding T2D management,
* possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them
* has a family member or friend be willing to participate in the study to learn about T2D to better support them

Inclusion criteria for family/friend participants: family/friend participants must

* be between 18-70 years old,
* be willing to receive WeChat messages regarding T2D management
* possess a smartphone or be willing and able to use a study smartphone. If participants have their own smartphones, they are encouraged to use their own phones. For participants who do not have smartphones, the study will provide them

Exclusion Criteria:

Exclusion criteria for both patient and family/friend participants:

* unable or unwilling to provide informed consent;
* unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
* unwilling to accept randomization assignment;
* pregnant, plans to becomes pregnant in the next 6 months, or who become pregnant during the study, or
* breastfeeding.
Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients

The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of type 1 diabetes incidence in younger patients. Adjuvant treatments to scaling and root planing as antimicrobial photodynamic therapy show improved clinical outcomes. Thus, the aim of this randomized clinical trial is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose of Type 1 diabetes mellitus
* Age between 18 to 65 years old
* Presence of at least one tooth for hemiarch
* Moderate and severe periodontal disease

Exclusion Criteria:

* Type 2 diabetes mellitus
* Total edentulism
* Smokers
* Pregnancy
* Systemic diseases as other endocrine diseases and blood diseases
* Use of drugs that alter periodontal tissue as phenytoin and cyclosporine
Functional and Neuroplastic Effects of HABIT-ILE in Children With Bilateral Cerebral Palsy

This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.

This study aims to compare, for the first time, the effects of a double period of HABIT-ILE therapy on functional and neuroplastic changes against a single period, in people with bilateral cerebral palsy (CP). Previous HABIT-ILE protocols have only assessed the effects of a single intervention period. Still, the literature suggests a possible dose-response relationship between the number of intensive therapy periods and progress in motor function.

A randomized controlled trial will be conducted, comparing the effects of a double period of HABIT-ILE; (2HG; n=24) versus a single period (1HG; n=24) in children and youth with bilateral CP. Each HABIT-ILE period will consider 6.5 hours of intervention during 10 consecutive working days. Children will be assessed at 6-time points: baseline, three weeks after, at 3 months, at 6 months, at 7 months, and at 9 months, to evaluate the long-term effect of HABIT-ILE and the summative effects of the double period in functional and neuroplastic variables. The 1HG will receive only 65 hours of HABIT-ILE after baseline; the 2HG will perform 130 hours over two intervention periods, after baseline and again at 6 months.

Overall, this study aims to provide evidence for the effectiveness of HABIT-ILE in producing functional and neuroplastic changes in children with bilateral CP. It will allow us to approach the possible mechanisms underlying the effect of HABIT-ILE.

Eligibility Criteria:
Inclusion Criteria:

* Children with medical diagnosis of bilateral cerebral palsy
* Cognitive capacity and language that allows understanding and following the therapist's instructions.
* Manual Ability Classification System (MACS) levels I to III
* Bimanual Fine Motor Function (BFMF) levels I to III
* Gross Motor Function Classification System (GMFCS) levels I to III

Exclusion Criteria:

* Severe visual problems
* Movement restriction due to orthopedic surgery in less than a year
* Treatment with botulinum toxin and/or baclofen pump in the last 6 months
* Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)
Prolonged Sitting on Responses to Short-Term Exercise Training

Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years

Exclusion Criteria:

* cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
* respiratory problems
* musculoskeletal problems that prevent prolonged sitting or exercise
* obesity
* susceptibility to fainting
* pregnancy
Creation of a Vascular Access Specialist Teams Within an Interventional Vascular Radiology Service: a Retrospective Observational Study

A study will be carried out to observe catheters (polyurethane tubes inserted into veins) over a period of five years. The study will look at any problems related to these devices, especially those put in at a specific hospital unit (vascular interventional radiology service) of the Arnau de Vilanova hospital in Lleida (Catalonia, Spain).

Introduction: Vascular Access Specialist Teams (VAST) have been implemented in numerous hospitals worldwide with excellent results. Although these vary in structure and function the purpose is the same in all of them, the improvement in cannulation and comprehensive cures of vascular access devices (VADs) based on the best scientific evidence.

Hypothesis: The creation of a VAST within an Interventional Vascular Radiology (IVR) service reduces the main complications related to VADs and contributes to improving the quality and safety standards necessary in the implantation and treatment of these devices Objective: To describe the creation of a VAST within an IVR service in a second level hospital. In addition, it is expected to analyze the prevalence of VADs placement and success rate, to determine the number of catheter-related bacteremia's and to know the number of failures of VADs cannulated in the EIAV in acute hospitalized patients.

Methodology: Retrospective observational study. A description will be made of the characteristics of the VAST, the implanted VADs and the main associated complications.

Expected results: We expect to describe the structure of a VAST within an IVR service and to analyze the prevalence of VADs placement and success rate, to determine the number of catheter-related bacteremia's and to know the number of failures of VADs cannulated in the VAST in acute hospitalized patients.

Clinical implication: The study will help to improve current VAST and to reduce the difficulties in the creation of future VAST, as well as to clarify the need for these specialized teams, which aim to improve the quality and safety standards necessary for VADs implantation and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Admitted to a hospitalisation unit
* Requiring VAD cannulation for intravenous treatment or due to poor venous access, in accordance with the protocol of insertion criteria of the hospital.

Exclusion Criteria:

- Patients who underwent initial evaluation and cannulation was not attempted are excluded.
Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Eligibility Criteria:
Inclusion Criteria:

* Male/female aged from 18 to 45 years;
* Written informed consent;
* Healthy volunteers without any subjective ocular symptom;
* Corrected visual acuity \>= 6/10;
* Registered in the national register of healthy volunteers

Exclusion Criteria:

* Ocular trauma, infection or inflammation within the last 3 months;
* Conjunctival hyperaemia (score \>= 2);
* Folliculo-papillary conjunctivitis (score \>= 2);
* Topical ocular treatment within the last month;
* Ocular surgery, including LASIK and PRK, within the last 12 months;
* Other ocular laser within the last 3 months;
* Zithromax® and Azadose® within the last 3 months;
* Medication during the study (except: paracetamol, contraceptives
Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer

Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are relatively common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

The investigators research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone upper gastrointestinal surgery. These chemical messengers play a role in signalling the feeling of fullness during and after a meal (satiety). Understanding the mechanisms involved in increased gut hormone secretion after these operations may allow us to use certain medications to block gut hormone release and hence reduce satiety allowing patients to eat more, regain weight and prevent nutritional complications after surgery.

Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have, however, only been established cross-sectionally and therefore the time course for development of increased gut hormone secretion is unknown. Data collected from this study will provide important information about optimal timing of therapeutic intervention in this patient group, while offering mechanistic insights with regard to the pathophysiologic process underlying post-operative early satiety.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo two-stage, three-stage or transhiatal oesophagectomy with gastric conduit reconstruction OR total gastrectomy with Roux-en-Y reconstruction

Exclusion Criteria:

1. Significant and persistent chemoradiotherapy complication
2. Other previous upper gastrointestinal surgery
3. Unwell or unable to eat
4. Other disease or medications which may affect satiety gut hormone responses
5. Active and significant psychiatric illness including substance misuse
6. Cognitive or communication issues or any factors affecting capacity to consent to participation
7. History of significant food allergy, certain dietary restrictions
8. Confirmed or suspected residual or recurrent disease after surgery, synchronous or metachronous malignancy
9. Significant surgical complication, aspiration risk or deterioration in performance
Feasibility of At-Home Chair-Based Resistance Band Training to Improve Balance, Strength, and Bone Density in Older Adults

The purpose of this study is to determine the feasibility of implementing a 24-week at-home chair-based resistance band training intervention, to determine effectiveness of a the a 24-week at-home chair-based resistance band training intervention in improving body composition and to determine the effectiveness of a 24-week at-home chair-based resistance band training intervention in improving physical performance in adults 50 years and older, receiving care at the UT Physicians Center for Healthy Aging.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* receive care at the UT Physician Center for Healthy Aging

Exclusion Criteria:

* inability to provide informed consent on their own
* presence of obvious signs of cognitive decline
* a diagnosis of dementia and inability to come to the clinic for the scheduled study visits.