cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate a Specified Type of APGAR

It is of importance to predict the risk to develop problems after birth. Virginia Apgar developed a score more than 50 years ago that allows a description of the condition of newborns at 1, 5 and 10 minutes after birth. The Apgar score is used for every newborn, however, its applicability is restricted in preterm infants and resuscitated newborns. Thus, two scores have been suggested recently - the Specified Apgar and the Expanded-Apgar score. By combining both scores the Combined-Apgar has been developed as a new delivery room tool.

The purpose of this study is to determine whether the Combined-Apgar predicts poor outcome better than the Specified- or Expanded Apgar alone.

Since the conventional Apgar score has its limitations in preterm or resuscitated infants, specifications of the individual items of the original Apgar score were suggested (Specified Apgar). The Specified-Apgar will slightly change the Apgars' perspective, but will not alter the number of its components. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age. However, neither the conventional nor the Specified-Apgar score describes the condition of the infant. That problem has been taken up by the American Academy of pediatrics (AAP)and the American College of Obstetricians and Gynecologists (ACOG). They suggested to use an expanded Apgar Score reporting form (Expanded-Apgar)that accounts for concurrent resuscitative interventions. Whereas the Specified-Apgar score describes the condition of the infant, the Expanded-Apgar is a measure of interventions needed to achieve this condition. By combining both scores (Combined-Apgar) the postnatal condition is described in more detail than by a single score alone.

To validate the accuracy of these scores in a population of very preterm infants, the present prospective, observational, international multicenter study is planned. Until today there is no gold standard available to describe infant's conditions and interventions. For the evaluation of the scores it was therefore hypothesized that the Combined Apgar predicts poor outcome (defined as either death or any major morbidity) better than the Specified Apgar or Expanded Apgar alone. Prediction of poor outcome was used as a surrogate parameter to test the predictive value of the Combined-Apgar score in a clinical setting for preterm infants. In an attempt to determine how strong of an association there is between the Combined Apgar Score and neurologic impairment in early childhood, we are presently engaged in a long-term follow-up of all surviving infants at a corrected age of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* gestational age below 32 weeks
* born within the study centres

Exclusion Criteria:

* missing informed consent
* outborn
* major congenital abnormalities
* death in the delivery room
Piperacillin/Tazobactam for Bacteremia With Organisms Producing Chromosomally-Encoded AmpC Beta-Lactamase

Nosocomial bloodstream infections are important causes of morbidity and mortality caused by AmpC beta-lactamase-producing Enterobacteriaceae. The information collected will optimize the management of patients with nosocomial bloodstream infections.

The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical information is collected by chart review of "case" and "control" patients. A "case" patient is defined as follows:

  * One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii.
  * The patient received piperacillin/tazobactam as the initial empiric therapy.
  * The organism was susceptible to piperacillin/tazobactam.
* A "control" patient is defined as follows:

  * One or more blood cultures are positive for E. cloacae, E. aerogenes, C. freundii, S. marcescens or M. morganii.
  * The patient received a carbapenem or fluoroquinolone antimicrobial as the initial empiric therapy.
  * The organism was susceptible to the empiric regimen.
Evaluation of Wound Dressings in the Reduction of Shear- Force

The purpose of this study is to investigate if wound dressings are capable in reducing the effects of shear- force at the skin. With our own shear- force model we are able to apply 19 Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm. After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of shear- force application at the skin.

Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant fore-arm but this time we put a wound dressing between the skin and shear- force model. After half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the erythema index.

This research consists of three research day, each day we are going to investigate a different wound dressing


Eligibility Criteria:
Inclusion Criteria:

* healhty volunteer
* age 18- 30
* BMI 20- 30

Exclusion Criteria:

* Trauma fore-arms
* Diabetes mellitus type I or type II
* The use of NSAID's in the last 7 days
* Vascular diseases
* Muscular dystrophy
* Malignancy
* Participant is unable to give informed consent
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range

The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria

Main Exclusion Criteria:

* Female subject who is pregnant, nursing or planning a pregnancy during the study
* Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
* Subject with any contraindications to the injection of botulinum toxin (see package insert)
* Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
* Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments
* Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
* Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit
International Electrical Storm Registry

Organized ventricular arrhythmias (ventricular tachycardia (VT), torsades de pointes (TdP) and ventricular fibrillation (VF)) represent a major event in the clinical history of a patient and they can lead to hemodynamic instability and sudden cardiac death (SCD). Recurrences of ventricular arrhythmias and electrical instability have exponentially increased in the last decades and a new clinical entity called "electrical storm" (ES) has emerged as major morbidity and mortality factor. The ES is defined as a cluster of 3 or more sustained ventricular arrhythmias within 24 hours, or a sustained ventricular tachycardia lasting 12 hours or more and that does not respond to treatments.

Most of the patients presenting ES are already implanted with an ICD. This is due to 3 factors: first, patients with ICD implant are at higher risk to develop ventricular arrhythmias for the cardiac disease that led to the ICD implant. Second, the device records and treats also asymptomatic or poor symptomatic arrhythmic episodes that otherwise would not be detected. Third, and more important, the device gives the possibility to survive to an arrhythmic episode, making it possible for the patient to experience an ES. The incidence of ES is debated in different studies and ranges from 10 to 60% in patients with ICD for secondary prevention and from 4 to 7% in patients with ICD for primary prevention.

The aim of the ELECTRA registry is twofold:

1. To create an international registry on clinical features, optimal therapy, ablation strategy, prognosis and the effect of ICD programming on patients with ES.
2. To use the data derived from the registry for a prospective, observational study on mortality and rehospitalization rate in patients with ES.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ES (documentation of 3 or more episodes of sustained ventricular arrhythmia within 24h or documentation of sustained ventricular tachycardia lasted at least 12h).In order to fulfill this criterion, a patient with a previous episode of ES could also be enrolled during routine screening.
* Age ≥18
* Written informed consent

Exclusion Criteria:

* patient without ICD
* Confirmed or suspected use of drugs or narcotics with known direct pro-arrhythmic effect
* Inability to express an informed consent for the study
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age (at least 15 years of age in Japan)
* Clinical diagnosis of TAK and fulfilling the Japanese Guidelines for Management of Vasculitis Syndrome 2017 criteria.
* Participant must have experienced a relapse of TAK within 12 weeks of Baseline despite being on treatment with oral corticosteroid.
* Participants must be in remission and on a stable corticosteroid dose prior to Baseline.

Exclusion Criteria:

* Treatment with an interleukin-6 (IL-6) inhibitor or Janus Kinase (JAK) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib) within 4 weeks of Baseline.
* Current use of immunomodulators other than corticosteroids.
N-acetylcysteine in Bulimia Nervosa

This study tests NAC in the treatment of Bulimia Nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Bulimia Nervosa
* 18-65 years of age
Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study

The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.

There is currently no universal consensus on all aspects of management of pelvic injuries.

Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) \< 13; systolic blood pressure \< 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. -

Exclusion Criteria:

* Not meet the criteria and loss follow up (transfer to other hospital or data not available) -
Calcium-protein Co-ingestion and Gut Hormones

Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2 diabetes (T2D). Rodent evidence suggests that calcium may potentiate the effects of protein ingestion on gut hormone secretion. Evidence in humans however, is lacking. This study aims to assess whether the addition of calcium to protein ingestion augments postprandial gut hormone availability in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women age between 18-65 yrs.
* Able to consume provided supplement.
* Weight stable for the past 3 month (no change within 3%)

Exclusion Criteria:

* Any previous or current metabolic, cardio-pulmonary or musculoskeletal disease
* Not between the ages of 18-65 years
* A body mass index below 18.5 kg/m2 or above 30 kg/m2 (body mass (kg) divided by your height (m) squared)
* Taking medications that may influence your metabolism
* Plans to change your lifestyle (diet and/or physical activity) during the study period
* Not willing to refrain from alcohol containing drinks or unaccustomed exercise one day before the laboratory sessions.
* Current smoker
Back to Basics: Addressing Childhood Obesity Through Traditional Foods in Alaska

Back to Basics is a mixed-methods intervention trial to reduce the prevalence of obese Alaska Native children by increasing the proportion of nutrient-dense traditional and non-traditional foods consumed, and decreasing consumption of sugar-sweetened beverages (SSBs). This 5-year intervention trial targeting 0-5 year olds is conducted in partnership with Rural Community Action Program, Inc. (RCAP) Head Start (HS), Early Head Start (EHS), and Parents as Teachers (PAT) programs in 12 rural Alaskan communities in the Yukon-Kuskokwim (YK) region, where each site is assigned to either a 9-month nutritional education and meal program intervention or a standard education and meal program repeating annually.

This intervention trial aims to increase consumption of local traditional foods and nutrient-dense non-traditional foods, decrease SSB consumption, and decrease prevalence of obesity in children 3-5 years old by: (1) adjusting the nutritional content of existing meal services provided by RCAP to children ages 3-5 years; (2) providing culturally relevant nutrition education to families of children 0-5 years; (3) developing local and community driven initiatives that provide knowledge and skills and engage families in the gathering and preparing of local traditional foods; and (4) incorporating available and emerging resources (e.g. Fish/Farm-to- Schools) to increase integration of traditional foods into the diet.

Phase 1 involves the collection and analysis of formative and baseline data to help guide the intervention in Phase 2.

Phase 1 includes:

1. Gathering baseline height/weight and food/SSB consumption data previously collected on children ages 0-5 years enrolled in YK RCAP programs.
2. Conducting formative studies in the 12 YK communities to better understand attitudes towards childhood obesity and barriers/enablers to traditional foods consumption
3. Creating/integrating a traditional foods-focused nutrition curriculum into RCAP menu programs in YK communities.

5. Work to expand the "Fish to Schools" and "Farm to Preschool" programs into YK RCAP HS programs.

Phase 2 includes implementing:

1. A physical activity curriculum in HS programs in all communities
2. A traditional food in HS menu program in intervention communities
3. A home-based nutrition program in intervention communities
4. A mechanism to document traditional foods important to each community


Eligibility Criteria:
Inclusion Criteria:

* for the Focus Group Discussions: Consenting Alaska Native residents of the 12 communities involved in the study, aged 18 and over.
* for the intervention study: Upon parental or guardian consent, Alaska Native residents of the 12 communities involved in the study, aged 0-5 years and enrolled in the RurAL CAP Head start, Early Head start, or Parents as Teachers, programs

Exclusion Criteria:

* None
Physical Activity in the Treatment of Obesity

Although exercise is widely regarded as a key component in obesity treatment, few individuals seem able to adhere to exercise programs over time. In response, efforts have focused on developing new approaches to physical activity that may appeal to sedentary overweight persons. For instance, is has been shown that accumulating multiple short bouts of vigorous exercise may enhance both exercise adherence and weight loss in overweight persons. Accumulating moderate-intensity activity throughout the day may offer comparable health and weight benefits as a traditional exercise program. Public health recommendations now include the option of accumulating 30 minutes of moderate-intensity lifestyle activity for health and well-being. While these two options offer a viable alternative to those who dislike or cannot sustain continuous vigorous exercise programs, it is unclear whether the flexibility of accumulating physical activity or the vigorous intensity of the exercise is responsible for improved weight loss and long-term adherence.

The goal of this research is to extend our preliminary findings suggesting that moderate intensity lifestyle activity is an important and viable alternative to traditional structured vigorous exercise for obese dieting individuals. The primary specific aim of this project is to compare the effects of three modes of exercise on long-term weight regain. Participants will be 165 overweight men and women who are sedentary, but otherwise healthy. All participants will receive the same 16-week behavioral weight loss program and will be randomized to one of three exercise study conditions: 1) diet-plus-continuous bouts of vigorous aerobic exercise; 2) diet-plus-short bouts of vigorous aerobic exercise accumulated throughout the day; or 3) diet-plus-moderate intensity lifestyle activity accumulated throughout the day. By varying both the intensity and duration of exercise bouts, we can determine which type of exercise is associated with optimal outcomes one year later. Additional questions of interest include:

1. Does mode of exercise influence exercise adherence?
2. Does mode of exercise improve cardiovascular risk profiles similarly in all three conditions?
3. Does mode of exercise influence changes in body composition?
4. Does mode of exercise influence exercise enjoyment and exercise self-efficacy?


Eligibility Criteria:
Inclusion Criteria:Sedentary and \>30 pounds above healthy weight. No plans to move from area for next 1.5 years. No plans for excessive travel.

-

Exclusion Criteria: recent weight loss or regular exercise (≥2 bouts per week), serious medical or psychiatric condition (cardiovascular, metabolic or orthopedic) or history of clinical depression or eating disorder.

-
Nutritional Status and Body Composition of Adult Patients With Crohn's Disease

Patients with Crohn's disease generally have nutritional risks and malnutrition. The investigators will conduct a multicenter cross-sectional study to discover nutritional status and body composition of Chinese adult patients with CD.

Several studies have found that the body composition of CD patients is related to disease and therapies. Due to lack of a prospective multicenter cross-sectional observational study on the nutritional status and body composition of adult patients with CD in China. Evaluating the nutritional status and body composition of these patients can help formulate individualized nutritional support strategies for adult CD patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old;
* diagnosis of CD;
* Admission time \<48 hours;
* Subject has voluntarily signed and dated an informed consent form.

Exclusion Criteria:

* Emergency surgery for intestinal fistula or abdominal abscess;
* Unstable vital signs or unstable hemodynamics;
* Pregnant or lactating women;
* Admission to hospital due to other critical illnesses (such as tumor, HIV, severe infections requiring ventilator or CRRT treatment);
* Dying patients whose life expectancy does not exceed 24 hours;
* Severe liver insufficiency (liver function score 11-15 or total bilirubin\> 3mg/dL or tissue biopsy diagnosed as liver cirrhosis, hepatic encephalopathy, portal hypertension with history of gastrointestinal hemorrhage, etc.);
* Severe renal insufficiency (creatinine value is 2 times higher than the upper limit of normal);
* Severe metabolic diseases (such as metabolic syndrome, hyperthyroidism, etc.);
* Patients whose burn area exceeds 20% of the body surface area;
* Immunodeficiency, autoimmune disease, or receiving immunosuppressive treatment for diseases other than CD (such as organ transplantation, etc.);
* Those who are not suitable for body composition analysis
* Patients who have been selected for other clinical studies or have been selected for this study;
* Subjects are unwilling to participate in this study or refuse to sign informed consent.