cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial

The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)
* Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure
* Wound treated with only one layer of a maximum size 10cm\*12.5cm

Exclusion Criteria:

* Immunosuppressed patient
* Chronic wound (with no healing since 6 months)
* Addition of any substances (growth factor, stem cells,...) in the IDRT SL during the surgery
* Patient with a corticoid treatment with a daily dose greater than 5 mg
* Patients whose life expectancy is less than 12 months
* Patients whose mental health or health condition (Visual deficiency, Alzheimers...) would compromise completion of the self-evaluation questionnaires
* Patient with an hypersensitivity to bovine collagen, chondroitin
* Patient with clinical signs of infection (fever, pain, colour, swelling,...) and for whom the investigator diagnosed infection
Effect of Red Beetroot Juice Intake in Adults With Long COVID-19

Red beetroot juice may have positive effects on multiple pathways involved in long COVID. The aim of this pilot study was to explore the impact of beetroot juice supplementation on physical function, gut microbiota, and systemic inflammation in adults with long-COVID

A single-center, double-blind, placebo-controlled randomized trial to test the effects of 14 days of beetroot juice supplementation on functional and biological outcomes in adults with long-COVID.

Participants were randomized 1:1 to receive either daily oral supplementation with 200 mL beetroot juice or placebo for 14 days. The primary endpoint was the change from baseline to day 14 in the fatigue resistance test. Secondary outcomes included the distance walked on the 6-min walk test, handgrip strength, and flow-mediated dilation. Secondary endpoints also included changes from baseline in circulating inflammatory mediators, metagenomic and fecal water metabolomic profiles. Partial least squares discriminant analysis (PLS-DA) models were built to evaluate the differences in biological variables associated with the interventions.

Eligibility Criteria:
Inclusion Criteria:

* a certification of a previous SARS-CoV-2 infection
* a negative COVID-19 swab test at least four weeks prior to the screening visit
* meet the criteria for long-COVID diagnosis according to the World Health Organization criteria
* report persistent fatigue

Exclusion Criteria:

* intolerance to beetroot juice or its derivatives
* clinical conditions and/or use of medications that may interfere with trial outcomes (e.g., pregnancy or breastfeeding, diabetes, use of steroids or non-steroidal anti-inflammatory drugs, immunosuppressants, nitrates)
* participation in other intervention trials for long-COVID
Trident® X3 Polyethylene Insert Study

The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has signed an IRB-approved, study specific Patient Informed Consent Form.
2. The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.
3. The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.
4. The patient is a male or non-pregnant female patient ages 21 to 75.
5. The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. The patient has an active infection with the affected hip joint.
2. The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. The patient has a BMI \>45.
4. The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
6. The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
7. The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
8. The patient is a prisoner.
Treatment for Cubital Tunnel Syndrome

The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments.

The study is performed at 5 different hospitals in Norway.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cubital tunnel syndrome

Exclusion Criteria:

* Rheumatoid arthritis (RA)
* Osteoarthrosis
* Varus or valgus deformities at elbow
Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)

The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.

Eligibility Criteria:
Inclusion Criteria:

* Participants of ASA class 1 - 3, above or equal to the age of 18 years;
* Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;
* Participants scheduled for surgical procedures in supine position;
* Participants who had given written informed consent.

Exclusion Criteria:

* Participants in whom a difficult intubation because of anatomical malformations was expected;
* Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;
* Participants known or suspected to have a (family) history of malignant hyperthermia;
* Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg\^2+;
* Participants who had already participated in this trial;
* Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;
* Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;
* Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (\>6 months), intrauterine device (IUD), abstinence;
* Female participants who were breast-feeding.
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

This is a follow-up of Study A3L10 (NCT00315055)

Immunogenicity

* To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B®.
* To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP\~T.

Safety

- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP\~T.


Eligibility Criteria:
Inclusion Criteria:

* Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
* Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
* Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the last 3 months.
* Any vaccination in the 4 weeks preceding the booster vaccination.
* Any vaccination planned until second Visit.
* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
* Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
* Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).
* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
* Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature \> 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \> 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis

Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of life, functional outcome, cosmetic result, and the correction of spinal deformity of two instrumentation systems for the treatment of adolescent idiopathic scoliosis.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-18 years
* Diagnosis of idiopathic scoliosis requiring posterior instrumentation and fusion(including those also requiring anterior release with or without anterior instrumentation) who could receive either the USS or the Moss Miami system
* Patients with scoliosis and an incidental finding of conus \< L1-2 disc level, provided they have no symptoms or signs
* Patients with scoliosis and an incidental finding of a small syrinx (provided the syrinx is non-progressive and does not require neurosurgical treatment)
* Patients with non-progressive spondylolysis

Exclusion Criteria:

* Spinal cord abnormalities with any neurologic symptoms or signs
* Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
* Primary muscle diseases, such as muscular dystrophy
* Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, etc.)
* Primary abnormalities of bones(e.g. osteogenesis imperfecta)
* Congenital scoliosis
e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)

The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan.

The general objective of the e-VITA project is to improve well-being for older adults and thereby promote active and healthy ageing, contribute to independent living, and reduce risks of social exclusion of older adults by making use a virtual coach by 240 healthy older adults recruited from Europe (France, Germany and Italy) and Japan. The study is a multicenter Proof-of-Concept study with a duration of the intervention of six months.

The multidisciplinary consortium collaborating in this project will develop an innovative ICT-based virtual coaching system to detect subtle changes in physical, cognitive, psychological and social domains of older adult's daily life. The e-VITA virtual coach will thus provide personalized recommendations and interventions, for sustainable wellbeing in a smart living environment at home.

The different components of the system are:

* Coaches, consisting of social robots, that will interact with the users and are guided by apps;
* Sensors (both wearable and domestic) to detect physiological parameters, physical activities, and behavior of the users; these sensors are: the Huawei smart band (wearable), the NeU device (wearable), and the DeltaDore system (domestic).
* Smartphones (the chatbot to provide insights, suggestion, and stimulation about healthy nutrition and physical exercise; the social platform to encourage users to share their interests).

These components (coaches, sensors, chatbot and social platform) together with a main software named Use Cases Configurator (UCC) constitute the Virtual Coach.

Eligibility Criteria:
Inclusion Criteria:

* Able to stand and walk unaided;
* No acute or untreated medical problems;
* Montreal Cognitive Assessement test (MOCA) ≥ 22;
* Geriatric Depression Scale (GDS) \< 9;
* Short performance physical battery (SPPB) ≥ 7
* Clinical Frailty Scale score between 2 and 4.

Exclusion Criteria:

* Use of active implant or not-implant medical devices;
* Allergy to nichel;
* A myocardial infarction or stroke within 6 months;
* Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
* Uncontrolled hypertension;
* Pacemaker or implantable cardioverter defibrillator;
Fatty Acids During Pregnancy and Lactation and Body Fat Mass in Newborns

Pregnant and lactating women receive n-3 fatty acids starting from week 15 of gestation until 4 months post-partum (pp) in comparison to a control group, who only gets information about adequately healthy nutrition during pregnancy and lactation.

The amount of fat in newborns is measured through skinfold thickness, ultrasound, and magnetic resonance imaging (MRI).

It is hypothesised that a reduction in arachidonic acid intake and an increase of n-3 LC PUFAs (long chain polyunsaturated fatty acids) via supplements containing docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) could lead to less expansive fat tissue development in the first year of life.

The prevalence of overweight and obese children and adolescents dramatically increased during the last two decades. In Germany every 5th school child is overweight and 4 - 8% of all children are obese.

Recent studies suggest that fatty acids in maternal nutrition may have an impact on the fat tissue development during the fetal period.

Animal studies showed that a reduction in the arachidonic acid intake, a higher intake of n-3 LC PUFAs (i.e. DHA and EPA) and a resulting lower n-6/n-3 fatty acid ratio in food will cause less expansive fat tissue development in the first year of life.

In vitro studies and personal observations in animal studies also showed that n-6 fatty acids (i.e. arachidonic acid) stimulate the differentiation of preadipocytes to adipocytes whereas n-3 fatty acids (i.e. DHA and EPA) have the contrary effect.

The impact of the maternal fatty acid pattern on the early fat tissue development can only be clarified in an intervention study.

Therefore it is planned to recruit 204 pregnant women in the 14th week of gestation. They will be randomly assigned to the intervention or control group.

The intervention group will receive n-3 LC-PUFAs (DHA and EPA) as fish oil capsules from the 15th week of gestation until 4 months pp, the control group will get nutrition counselling according to the recommendations of the German Society for Nutrition during the same time period. Blood samples of the pregnant and lactating women, umbilical cord blood, placental tissue and blood of the newborns will be collected for fatty acid analysis.

Body fat mass in newborns will be determined from delivery until 4 months pp via skinfold measurement, ultrasound, and MRI.

The hypothesis is that newborns in the group of the "supplemented" mothers will have less expansive fat tissue development than children from mothers in the control group.

This would be an innovative primary preventive approach in a period of increasing prevalence of overweight and obese children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<= 15th week of gestation
* Age: 18-43 years
* Written informed consent
* Body mass index (BMI) before pregnancy between 18 and 30 km/m2

Exclusion Criteria:

* High risk pregnancy
* Hypertonus
* Chronic diseases (i.e. diabetes mellitus)
* Psychiatric diseases
* Former supplementation with LC-PUFA
Characterization of Subjective Discomfort in Patients With Tear Dysfunction

Characterization of subjective discomfort/pain in patients with ocular surface dysfunction in association with clinical and laboratory parameters, for a better understanding of the underlying pathogenic mechanisms.

Dry Eye Disease (DED) is a multifactorial chronic disease impairing the ocular surface.

DED can be associated with conditions of inflammation and neurosensory dysfunction.

The aim of this study is to characterize the discomfort/pain in subjects affected by DED with the administration of scales, questionnaires, and analysis of corneal sensitivity by keratoesthesiometry, in association with clinical laboratory parameters.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with suspected or diagnosed DED

Exclusion Criteria:

* nothing
mNGS vs Culture Critically Ill Patients

mNGS is popular in research and recently it has been used clinically to detect microbes in the blood or other secretion in infected patients for quicker ,broad and accurate detection of microbes. In ICU ,patients are critically ill and need quicker and accurate antibiotics use to stop the pathologic process. The purpose of this study was to determine whether the positive detection rate of pathogens in patients with sepsis by metagenomic full-targeted detection technology was higher than that in blood culture, and to determine whether the pathogens found in patients with sepsis by metagenomic full-targeted detection technology were important for clinical development. Anti-infective regimens can help.

Sepsis patients in ICU were took blood culture sample and blood sample for mNGS test (IDSeqTM Ultra, Combing with Metagenomics and Pathogen/AMR/VF Probe Enrichment). Clinicians use their knowledge and experience to decide antibiotics use with the guide of Culture results or mNGS results. Validation with digital droplet PCR assays when metagenomic full-targeted assays identify pathogens not identified in conventional blood cultures The difference between the positive rate of mNGS and the positive rate of blood culture were recorded. Patient were followed at least 28 days after enrollment or an outcome indicator. Possible scenarios for detecting clinical impact were detected. Etiology, biochemical indicators, immune function, infection indicator, secondary infection, SOFA score and length of stay，outcome were recorded.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18years admit to ICU Meet the Sepsis 3.0 diagnostic criteria and suspected bloodstream infection, and the diagnosis of Sepsis ≤ 24 hours; Estimated ICU stay ≥ 24 hours; Informed consent;

Exclusion Criteria:

Severe organ dysfunction, expected death within 72 hours; Receive palliative care; Refuse to participate;