cyrilzakka/clinical-trials huggingface dataset:
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of diabetes mellitus type 2
* Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
* HbA1c \>/=7% and \</=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
* Fasting plasma glucose \</=240 mg/dL at pre-randomization visit
* Agreement to maintain diet and exercise habits during the study

Exclusion Criteria:

* Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
* Any previous treatment with thiazolidinedione or a dual PPAR agonist
* Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
* Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
CV Disease in Adolescents With Type 2 Diabetes

To study cardiac and vascular structure and function in a population of adolescents with type 2 diabetes mellitus (T2DM) compared to a similar group with obesity alone and a similar non-obese group.

BACKGROUND:

The prevalence of type 2 diabetes mellitus has increased dramatically in adolescents. This appears to be a direct result of the increase in prevalence and severity of obesity in the pediatric population. In adults with type 2 diabetes, it is well known that the risk for cardiovascular disease (CVD) is quite high. This has led to current clinical recommendation that adults with diabetes be considered equivalent in risk to those adults who already have existing coronary artery disease. It is not known if adolescents with type 2 diabetes have an equivalent high level of risk of CVD as the adult population. If they do then it would be expected that they would develop clinical CVD in their late 20's or 30's. This would have important clinical implications and would suggest the need for very aggressive management of CVD risk factors and diabetes.

DESIGN NARRATIVE:

The study is a cross-sectional evaluation of cardiac and vascular structure and function in a population of adolescents with type 2 diabetes compared to a group with similar age, sex, race and BMI with obesity alone and a non obese group with similar age, sex and race. 300 subjects with type 2 diabetes, 300 subjects with obesity and 300 non obese subjects will be studied. Assessment of CVD development will be accomplished using novel non invasive imaging methods for subclinical atherosclerosis including echocardiographic measurement of cardiac structure and function, ultrasound evaluation of carotid intimal medial thickness, and evaluation of endothelial function by brachial artery reactivity. The primary hypothesis is that adolescents with type 2 diabetes will have greater abnormality in cardiac and vascular structure and function compared to controls with obesity. Subjects with obesity alone will have greater abnormality in cardiac and vascular structure and function compared to controls who are not obese. Correlates of cardiac and vascular abnormalities including markers of inflammation, adiponectin, diet and physical activity will also be evaluated.

Eligibility Criteria:
An estimated 300 subjects, ages 10 to 23, with type 2 diabetes, 300 subjects with obesity and 300 non-obese subjects will be studied.

Inclusion Criteria:

* Diabetes, type 2
* Obese

Exclusion Criteria:

* Diabetes, type 1
The Identification of Novel Prognostic Markers in Melanoma

The purpose of this project is to analyze tumour tissue from a group of subjects with malignant melanoma, who have been treated at the Royal Marsden Hospital.

Background - The Royal Marsden Hospital and the Institute of Cancer Research constitute the largest comprehensive cancer centre in Europe. In addition to an in-house drug development program, phase I - phase III clinical trials of novel anti-cancer agents are hosted. In order to investigate the optimal use of novel molecularly targeted agents, access to clinical tumour samples is needed in order to determine which particular cancer type expresses a molecular "signature" that may indicate potential therapeutic utility. Understanding such signatures should accelerate the registration of new drugs for routine cancer therapy; offering the potential of selecting those patients with tumour types most likely to benefit from therapy. Furthermore, new insights into disease biology may be gained.

Main research question/ objective - Are there features of primary melanoma or lymph node metastases that predict subsequent clinical outcome better than existing markers?

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of melanoma
* Adequate paraffin-embedded material available for analysis.
* Adequate clinical follow-up information
* Written informed consent where applicable

Exclusion Criteria:

* Inadequate paraffin-embedded material available
* Inadequate clinical follow-up information.
Telehealth Intervention Strategies for WIC (THIS-WIC)- Michigan

With funding through the United States Department of Agriculture (USDA) and Tufts University's Telehealth Intervention Strategies for WIC (THIS-WIC), Michigan's (MI) WIC department will pilot telehealth opportunities as a means of delivering services to WIC Clients. This video conferencing pilot looks to improve and/or remove barriers. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations.

The purpose of this study will be to evaluate the effectiveness of this telehealth solution.

Michigan WIC Agency will pilot telehealth opportunities as a means of delivering services to WIC Clients.This video conferencing pilot looks to improve and/or remove barriers such as negative clinic experiences (long wait times or poor customer service), lost time from work (creating job risk and lost wages), inconvenient WIC clinic locations and appointment times, and lack of transportation. Implementing a pilot program in select local agencies to utilize technology would allow clients to connect with a WIC Registered Dietitian (RD) or an International Board-Certified Lactation Consultant (IBCLC). Videoconferencing could open new opportunities for leveraging the extensive expertise of the nutrition and lactation workforce in WIC agencies to address rural and remote locations and travel considerations. Additional urban locations, where clients lack transportation or use of public transportation presents a barrier to traveling to subsequent WIC appointments, will also be included in the pilot. Local agencies in rural and urban areas with similar caseloads will serve as controls to compare outcomes between offering telehealth and conducting IBCLC and RD appointments in person.

The purpose of this study is to evaluate the effectiveness of this telehealth solution by having clients complete surveys on their comfortability using telehealth and their satisfaction with the telehealth appointment. Additionally, secondary demographic and other nutrition-related information about study participants is already collected in the MIS and will be utilized.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Breastfeeding women
* postpartum women with children in the age range of 0 to 5 years

Exclusion Criteria:

-
A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy

The goal of this clinical trial is to learn how safe and tolerable EPI-321 is and whether there may be early signs it is working in male or female adult (18 to 75 years) participants with facioscapulohumeral muscular dystrophy (FSHD) Type 1 condition. The main questions it aims to answer are:

How safe is EPI-321 and how well can people handle it over time? How does EPI-321 interact with its target and does it show early signs of working?

Participants will receive a single dose of EPI-321 through a vein while being closely watched in a hospital and visit the clinic regularly for tests and checkups for about 5 years after getting EPI-321.

EPI-321 is an investigational drug product comprising a recombinant adeno-associated viral vector, serotype rh74 (AAVrh74), for the delivery of genetic material encoding an epigenetic editor designed to address the root case of FSHD. AAVrh74 has been shown to transduce human skeletal muscle efficiently in the clinical experience. EPI-321's transgene product, a non-cutting, nuclease-dead mini, clustered regularly interspaced short palindromic repeat (CRISPR)-associated protein (dCasONYX) with fuse epigenetic modulators, is designed to selectively bind the D4Z4 repeat region via the accompanying guide RNA, methylate CpG groups within the region near the DUX4 gene on chromosome 4q35, and thus repress the expression of toxic DUX4 protein, ameliorating the downstream pathology that drives FSHD. As it is under a muscle-specific promoter, the dCasONYX-fused protein is expected to be preferentially and actively expressed in muscle tissue following a single intravenous (IV) dose.

EPI-321-02 clinical trial is an open label dose ascending study of EPI-321 for safety and tolerability to determine the best dose for a future trial of drug activity. Two dose levels will be evaluated. In addition, this study will collect secondary outcome data on muscle function, imaging characteristics, and other markers of disease activity at the baseline and throughout the study to assess their utility as measures of drug activity in a future clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide informed consent
* Male or female 18 to 75 years of age
* Clinical diagnosis of FSHD with genetic Type 1
* FSHD Ricci clinical severity score 2 to 4 (on 5-point scale)
* Has adequate liver function
* Has adequate kidney function

Exclusion Criteria:

* Has an anti-AAVrh74 total binding antibody titer \> 1:400
* Requires a walker or wheelchair for ambulation
* Pregnant and/or breastfeeding at baseline or is planning to become pregnant during the first 12 months following EPI-321 administration
* Has FSHD Type 2
* Has a body mass \>90 kg
* Has a concurrent or past medical conditions could jeopardize the safety of the participant
Rehabilitation After Rotator Cuff Repair

A new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

A new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. Function is measured by Constant score, pain with VAS and quality of life with EQ5D, 3 and 12 months after surgery. The two treatment groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* planned shoulder surgery, rotator cuff repair

Exclusion Criteria:

* not swedish speaking
* reoperation
MSB11022 in Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult participants with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis based on 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria
* At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Evidence of untreated or inadequately treated latent or active Tuberculosis
* Evidence of uncontrolled, clinically significant diseases
* Any second disease-modifying antirheumatic drugs must be washed out prior to the first study dose
* Other protocol defined exclusion criteria could apply
Effects of Mindfulness Practice on Healthcare Workers

This study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in Singapore.

Research has shown that health workers are particularly at risk of experiencing heightened risks of burnout and psychological symptoms when dealing with a health pandemic, including the current COVID-19 pandemic (Lai et al., 2020; Tan et al., 2020; Wu et al., 2009). The increased risk reflects an urgent need to develop feasible psychological interventions to mitigate burnout and psychological symptoms among health workers. The present study aims to examine the effects of a brief mindfulness intervention delivered using a mobile application (HeadSpace) on psychological functioning in the context of coping with the COVID-19 pandemic in a sample of health workers in Singapore. A total of 80 health workers will be recruited and randomly assigned to using a mindfulness practice app or a cognitive games app daily over a period of 21 days. They will be assessed at baseline, post-intervention, and at one-month follow-up on depressive symptoms, anxiety, stress, burnout, compassion fatigue, compassion satisfaction, post-traumatic stress symptoms, trait mindfulness, self-compassion, sleep quality, working memory, and fear of COVID-19 infection. Results of the study will have implications on developing cost-effective interventions to mitigate psychological symptoms among health workers in the context of heightened pandemic-related stress.

Eligibility Criteria:
Inclusion Criteria:

* aged between 21 and 60
* being a health care worker based in Singapore
* proficient in English
* owns a smartphone (iOS or Android) with Wi-Fi or data access.

Exclusion Criteria:

-Regular mindfulness practice, defined by practicing a minimum of two to three times a week for 10 to 15 minutes each time within the past six months.
Lactate Level and Gastrointestinal Bleeding

Acute gastrointestinal bleeding is a common emergency with significant morbidity, mortality, and cost. Appropriate risk stratification of patients presenting with acute gastrointestinal bleeding aids in the triage of patients to determine need for hospital admission and the need for emergency endoscopic intervention. Increased blood lactate levels are common in critically ill patients. Our study will evaluate the usefulness of lactate measurements on resources utilisation ( intensive care unit admission, length of hospital stay) and other patient-oriented outcomes ( need for transfusion and endoscopy) in patients with acute gastrointestinal bleeding.

The present study is a prospective cross sectional study aimed to assess whether venous blood lactate on hospital presentation is predictive of need for interventions and short term outcomes (eg PRBC transfusion, ICU admission ) in patients with acute GIB who presented to ED of Assuit University hospital between September 2019 and June 2022. The study included 300 patients with acute GIB. Out of those patients; 200 patients had elevated blood lactate and 100 patients had normal blood lactate.

It was found that mean age of patients with elevated lactate was significantly higher in comparison to those with normal lactate. There were no significant differences between both groups as regard risk factors for bleeding (use of anti-coagulants, aspirin), use of NSAIDs was higher among patients with normal lactate while history of prior UGIB was higher among patients with elevated lactate. The most frequent presentations among the studied patients were hematemesis and melena.

Both groups had insignificant differences as regard laboratory data, endoscopic findings and interventions.

Patients with elevated lactate had prolonged hospital stay, higher frequency of blood transfusion, ICU admission and mortality in comparison to those with normal blood lactate.

Based on the current study, predictors of mortality among patients with UGIB were old age , LC, elevated lactate and variceal bleeding.

So we could say that elevated blood lactate can be predictive for interventions and short term outcomes in patients with acute GIB ,however, further and similar studies with multi-center settings would be more reliable and accurate.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with acute gastrointestinal bleeding, inclusive of both upper and lower sources
* Patients ≥18 years old

Exclusion Criteria:

* Patients with tumor bleeding
* patients with post procedure or surgical site bleeding
* patients with active systemic infection
* patients wit post-cardiopulmonary resuscitation state
A Safety and Tolerability Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

The objective of this study is to evaluate the long-term safety and tolerability of ABT-089 in children with ADHD.


Eligibility Criteria:
Inclusion Criteria:

* The subject was randomized into Base Study (M06-888 or M10-345) and completed the Treatment Period.
* If female, subject must be practicing at least one method of birth control throughout the study.
* If female, the result of a pregnancy test is negative.
* The subject is judged to be in generally good health.

Exclusion Criteria:

* The subject experienced a serious adverse event in Base Study (M06-888 or M10-345) that the investigator considered "possibly" or "probably related" to study drug.
* The subject has taken any ADHD medication between the last dose of study drug in Study M06-888 or M10-345 and the first dose of study drug in the current study.
* The subject has a positive urine drug screen for alcohol or drugs of abuse.
* The subject anticipates a move outside the geographic area.
The Effect of Cryostimulation on Inflammation and Motor Functions. The Study Was Conducted to Determine the Effect of Five Days of Whole-body Cryostimulation (PBC) on Reducing Inflammation and Improving Motor Skills in Soccer Players

The aim of the study was to determine the effect of a 5-day PBC on reducing inflammation and improving motor skills in soccer players during the initial phase of the training period.

The five-day cryostimulation applied did not significantly affect the profile of inflammatory markers in soccer players. However, a reduction in visuo-motor reaction time (RT) was registered in PBC-treated soccer players, suggesting the potential benefits of this method in improving motor skills.

Cryostimulation is one of the methods of post-exercise recovery, involving short-term (3 min) exposure of the body to extremely low temperatures, oscillating between -100°C and -190°C. The purpose of this therapy is to reduce inflammation, reduce physical and mental fatigue and use it as a passive form of preparing the body for further exercise as part of the training process.

The study was conducted to determine the effect of five days of whole-body cryostimulation (PBC) on reducing inflammation and improving motor skills in soccer players. A group of 24 football players was randomly divided into a test group (PBC; -140°C ± 20°C, 3 min, 5 days) and a control group (CON). Before the cryostimulation session, both groups were subjected to visual-motor ability tests, which were repeated on the last day of the study. Blood samples were collected at four time points (P0-1 day, P1-3 day, P2-5 day, P3-2 days after the test). Levels of creatine kinase (CK), tumor necrosis factor (TNFα), interleukins (IL-6, IL-10), testosterone (T) and cortisol (C) were determined in the samples.

Eligibility Criteria:
Inclusion Criteria:

* athletes
* no previous experience with systemic cryotherapy
* any other forms of recovery or cosmetic treatments

Exclusion Criteria:

* alcohol or any other stimulants
* anti-inflammation drugs
* injuries
EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management

Multi-center, prospective, interventional, uncontrolled open-label study evaluating the real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg ulcers, diabetic foot ulcers, pressure ulcers).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written informed consent form;
* Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer, diabetic foot ulcer or pressure ulcer by the Investigator;
* The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System would be an appropriate option;
* Both male and female patients must be willing to adhere to a medically-accepted birth control method during the course of the study;
* Willingness to comply with study requirements (visits, treatments, etc.).

Exclusion Criteria:

* Female pregnant patient (by medical history or as ascertained by a pregnancy test);
* Breast-feeding female patient;
* Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with conditions (e.g., porphyria) known to induce severe photosensitivity reactions;
* Patients with known skin hypersensitivity.