cyrilzakka/clinical-trials huggingface dataset:
Treatment of Wounds Using Oasis® ECM

The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for different types of chronic wounds in the community setting in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting

Exclusion Criteria:

1. Age \< 18 years
2. Unable or unwilling to provide informed consent
3. Unable or unwilling to comply with the study follow-up schedule, and procedures
4. Simultaneously participating in another investigational drug or device study
5. Target wound area is \< 2 cm2 or \> 140 cm2 after baseline debridement
6. Target wound has reduced in area by \> 40% with 4 weeks of documented standard of care therapy
7. Known allergy to pig or porcine products
8. Systemic infection
9. Infection of the target wound as determined by the collection of pus
10. Osteomyelitis
11. ABI/TBI \< 0.6 obtained within 3 months prior to the screening visit
12. Other exclusions may apply
Observation on the Correlation Between Serum/Fecal Isoflavones, Abundance of TMA-producing Bacteria and Serum TMAO in Hyperlipidemia and Healthy Subjects

Previous studies have shown that trimethylamine N-oxide (TMAO), a gut microbiota-related metabolite, plays a significant role in the development and progression of cardiovascular disease (CVD). How to regulate the structure of gut microbiota to reduce circulating TMAO levels in the host is currently one of the hot topics in research. Diet is a major factor shaping the structure of gut microbiota. Through the exploration of dietary elements, we have found that multiple epidemiological studies suggest an inverse correlation between the intake of isoflavones and CVD, indicating that isoflavones are potential agents for the prevention and treatment of CVD. Interestingly, isoflavones have poor water solubility and low bioavailability. Several studies have confirmed interactions between isoflavones and gut microbiota, suggesting that the gut and gut microbiota are likely important therapeutic targets for isoflavones in preventing and treating CVD. Furthermore, a high-fat diet (HFD) is also an independent risk factor for CVD. Research literature indicates that HFD can disrupt both the gut and gut microbiota. As a biomarker for CVD risk, TMAO has been reported in some studies to increase in circulation following HFD intake, but the mechanisms behind this phenomenon require further exploration.

Based on the above literature, we propose a scientific hypothesis: Can isoflavones regulate gut microbiota and subsequently reduce serum TMAO levels in HFD-fed mice? This hypothesis can be further divided into three specific scientific questions:

Which isoflavones can reduce serum TMAO levels in HFD-fed mice?

Is gut microbiota the key factor through which isoflavones reduce serum TMAO levels in HFD-fed mice?

What mechanisms do these substances use to modulate gut microbiota?


Eligibility Criteria:
* Inclusion Criteria:
* Hyperlipidemia inclusion criteria:
* 18-70 years old；
* patients diagnosed with hyperlipidemia；
* Healthy people inclusion criteria:
* 18-70 years old；
* male weight ≥50.0kg, female weight ≥45.0kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including critical values);
* volunteers have no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal system within three years, and are in good overall health.
* Exclusion Criteria:
* Consuming dietary supplements (ω-3 fatty acids, probiotics, prebiotics, plant stanols/sterols) 1 month before the study;
* Using antibiotics, antidiarrheal drugs, statins, fibrates and other drugs within 2 months before the study;
* Drinking alcohol (\> 2 cups per day);
* Hyperlipidemia patients with inflammatory bowel disease or irritable bowel syndrome and healthy people.
Study of the Relationship Between Clinical and Paraclinical Markers During Situations of Cachexia and Pre-cachexia in Patients Over 70 Years With Colorectal Surgery

Cachexia associated with cancer is a grave and most of the time irreversible common situation. It seems independent from the size of the tumor or from its metastatic character. The consequences for the management of the patient are major and exceed widely the frame of the nutrition.

Undernutrition of patients with cancer is described by a decrease of the energy contributions and a loss of muscular and fat mass, leading to a progressive functional deficiency which can go to the cachectic state.

Actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia but it remain too indistinct to allow an early and efficient screening and set up effective measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast iron of the energy reserves.

It is necessary to have clinical and biological markers with diagnostic aim and forecasts during the situations precedents the appearance of cachexia.

The present study will allow calibrating a longitudinal study, which could confirm the value of measures made for the diagnosis of pre-cachexia.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 70 years
* Colorectal tumor resection with/without synchronous metastases

Exclusion Criteria:

* Emergency resection of colorectal tumor
* Unresectable colorectal tumor with/without synchronous metastases
Effects of Diacutaneous Fibrolysis on Flexibility and Active Neuromuscular Response

Diacutaneous fibrolysis is a physiotherapeutic instrumental technique, used to treat musculoskeletal conditions causing pain and/or movement restriction. It is applied by means of metallic hooks, ending in a spatula with beveled edges, that seems to allow a better pressure distribution on the skin and a deeper and more precise application, compared to the manual approach. Recent studies indicate positive responses regrading pain intensity decrease in sports people suffering anterior knee pain, improving range of motion in subacromial impingement syndrome, improving sensory conductivity in symptomatic patients with carpal tunnel syndrome, decreased pain in patients with chronic epicondialgia or improveing function athletes with anterior knee pain. However, the specific action mechanism, have not been investigated in depth yet. There are no studies evaluating its effects on posterior muscular chain of lower extremity in athletes, where FD effects on neuromuscular response could be more evident due to the overload involved on this area. The aim of this study is to evaluate the immediate, and after 30 minutes, effects of a single diacutaneous fibrolysis session on flexibility, strength and neuromuscular activity on hamstring in athletes. A randomized controlled trial with blind evaluator. Randomization will be done between lower extremities of each subject (Random.org). Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maixmus, biceps femoris and semitendinosus to de lower experimental limb. The other extremity will not be treat (control limb).

Sample recruitment. Athletes from UIC university community, who compete officially or institutionally, whether they are federated or recorded in a sport official register where the predominant activity focuses on the lower train (athletics, cycling, football, rugby...). Procedure. The anthropometric data will be collected at the beginning of the study. Each outcome assessment will be performed by a blinded evaluator at the baseline, immediately after the technique application and 30 minutes after.


Eligibility Criteria:
Inclusion Criteria:

* Athletes
* \<160º in the Passive Knee Extension test
* Participants must sign and have informed consent.

Exclusion Criteria:

* Poor skin
* Trophic condition
* Taking anticoagulants
* Inflammatory process
* Recent musculoskeletal lower limb injury (\< 6 month)
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors

The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.

Patients receive a treatment regimen consisting of didanosine, stavudine, delavirdine, and MKC-442 for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Samples for population pharmacokinetics are collected from all patients every 4 weeks. Patients who experience virologic failure may add hydroxyurea to their treatment regimen or be discontinued from the study. Patients who add hydroxyurea to their regimen and subsequently experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving study treatment until their plasma HIV-1 RNA levels return to baseline levels. For patients receiving hydroxyurea beginning at Week 24, visits are conducted at Weeks 28, 32, 36, and every 12 weeks thereafter. For patients who continue taking didanosine, stavudine, delavirdine, and MKC-442 or who have started hydroxyurea treatment between Weeks 12 and 20, follow-up visits are conducted every 12 weeks, or sooner if needed, until the patient permanently discontinues study treatment.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.
* Agree to use a barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

* Have a history of certain medical conditions, such as pancreatitis, peripheral neuropathy, seizure disorder, or AIDS-related cancer (except for Kaposi's sarcoma).
* Are allergic to any of the study drugs.
* Have ever taken certain anti-HIV medications including non-nucleoside reverse transcriptase inhibitors (NNRTIs), ddI, or d4T.
* Have taken certain other medications including interleukin-2, interferon or a vaccine within 30 days of study entry.
* Have received radiation therapy or chemotherapy within 30 days of study entry. (Local radiation therapy is allowed.)
* Abuse alcohol or drugs.
* Are pregnant or breast-feeding.
Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.


Eligibility Criteria:
Inclusion Criteria:

* allogeneic and autologous HSCT recipients
* ≥ 18 year-old
* patients having been informed of the conditions of the study (24-month follow-up) and having signed the informed consent form
* Person with social security insurance

  • Additional inclusion criteria for healthy volunteers enrolled (10 volunteers)in the ancillary study of influenza vaccine response:
* health-care workers recruited from the hospital staff

Exclusion Criteria:

* Patient with innate or acquired immune deficiency (severe combined immunodeficiency, Hepatitis C virus (HCV), HBV, HIV infections at any stage)
* Pregnant or breastfeeding women
* History of previous severe allergic reaction to vaccine components
* Patient with no social security coverage, with restricted liberty or under legal protection.
Stem Cell Therapy in Traumatic Brain Injury

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of chronic traumatic brain injury
* Age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B - Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
* pregnancy
* lactation
Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore

Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). There is also increasing evidence to show that these abnormalities increase cardiovascular morbidity and mortality in CKD patients. There is a need for early identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term complications. However, the vitamin D status of CKD patients in Singapore has not been well described. The purpose of this study is to assess the vitamin D status of predialysis CKD patients in a tertiary academic teaching hospital in Singapore, and its association with parameters for MBD. Predialysis patients from the outpatient renal clinic at the National University Hospital (NUH) will be recruited into this study. Blood samples from the patients will be collected after an overnight fast to determine their serum 25(OH)D, creatinine, phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared among patients in various stages of CKD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 21 years of age or older
* CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR \<15 ml/min/1.73m2)
* Not receiving over-the-counter or prescription vitamin D therapy
* On a stable dose of phosphate binder (if any) for at least 1 month prior to the study

Exclusion Criteria:

* History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies
* Use of corticosteroids, anticonvulsants or vitamin D compounds
* Use of an investigational agent within 30 days of study entry
Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder

The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.

The aims of this study are to explore the various cognitive impairments of ADHD children, to differentiate various subtypes of ADHD children, and to investigate the efficacy of anti-ADHD drugs on various cognitive performance of ADHD children by event-related potentials(ERP).

Children, aged six to 18 years old, are enrolled and assigned to three groups (normal control, pure ADHD, and ADHD with comorbidities). ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively.

Methylphenidate (either immediate-release or extended-release formulations) or atomoxetine Hydrochloride is given to ADHD participants.Continuous performance task (CPT) and ERP tasks are applied.

Eligibility Criteria:
Inclusion Criteria:

* health children
* or clinical diagnosis of attention-deficit hyperactivity disorder

Exclusion Criteria:

* hearing impairment
* uncorrectable visual impairment
* epilepsy
CongenItal Naevus Cohort for Longitudinal Evaluation

Congenital Nevus (CN) is a pigmented skin lesion present at birth, which grows in size as the child grows. It can vary in appearance and is classified by its size, from small (less than 1.5 cm) to giant (greater than 40 cm). CN is associated with genetic mutations, mainly in the NRAS/BRAF genes.

A large CN can lead to several clinical issues, including:

Risk of neurological disorders: Large CN can be associated with neurological abnormalities such as neuro-meningeal melanosis, hydrocephalus, or brain malformations. These conditions may cause early neuro-developmental delays. The risk is not well understood and requires further studies.

Risk of melanoma: The risk of developing melanoma is higher for a large CN but remains low for smaller ones. Increased monitoring is necessary during the early years for large and giant CN.

Psycho-social impact: Parents often experience significant anxiety at birth due to the cancer risk and social stigma. As the child grows, a visible CN may impact their quality of life, particularly socially at school.

Management of CN remains controversial, especially for those of medium to giant size or with multiple satellites. There is an urgent need for further research to clarify best practices in monitoring and treatment, including the need for routine brain imaging and criteria for surgical intervention.

Ultimately, this study aims to deepen our understanding of CN, its associated neurological and melanoma risks, and the psycho-social challenges it poses, while striving to establish clear, evidence-based guidelines for monitoring and treatment to enhance patient outcomes and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient under 2 years old.
* Patient with a medium, large, or giant congenital nevus (CN) according to the Krengel classification, either single or multiple.
* Patient affiliated with social security.
* Patient whose legal representatives consent to their child's participation in the project.

Exclusion Criteria:

* Patient with light brown spots or pigmented lesions not classified as nevi.
* Patient for whom It is impossible to establish annual follow-up.
* Patient whose parents do not speak French.
Phase 1, Dose-Escalation Study of IGN002 in NHL Subjects

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)

This open-label, non-randomized, first-in-human Phase 1 study involves two stages:

In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
* Refractory disease, having failed available therapies
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy \> 3 months
* Adequate organ function

Exclusion Criteria:

* Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
* Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
* Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
* Radiation therapy within 4 weeks of Day 1
Multimodal Assessment of Knee Conditions in Rehabilitation

The purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* ACL injury
* Ages 18-40
* Female

Exclusion Criteria:

* BMI under 18
* BMI over 40
* Contraindications to MRI
Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypercholesterolemia
* Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion Criteria:

* Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).

Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* On daily PPIs for \> 6 months
* Documented PPI dependency
* Persistent GERD symptoms without PPI therapy during the titration phase of the study
* Evidence of two or more of the following while off PPI therapy (\> 10 days):
* Erosive esophagitis (Los Angeles grade A-C)
* Abnormal ambulatory pH study
* Moderate to severe GERD symptoms
* Normal or near normal esophageal motility (by manometry)
* Patient willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent

Exclusion Criteria:

* BMI \> 35
* Hiatal hernia \> 3 cm
* Esophagitis LA grade D
* Esophageal ulcer
* Esophageal stricture
* Barretts esophagus (Prague: C\>1, M\>2)
* Esophageal motility disorder
* Severe gastric paralysis
* Pregnancy or plans for pregnancy in the next 12 months
* Immunosuppression
* ASA \> 2
* Portal hypertension and/or varices
* History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
* Active gastro-duodenal ulcer disease
* Gastric outlet obstruction or stenosis
* Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
* Coagulation disorders