cyrilzakka/clinical-trials huggingface dataset:
Effect of Autologous Fat Grafting on Acute Burn Wound Healing

the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring, in comparison with control group that were treated with traditional methods, so as to find out new method of treating burn injuries and decreasing its morbidity.

as the patient is admitted, full evaluation locally ( as regard the wound itself and the areas of fat harvesting) and generally (assessment of the general condition) is done, fluid resuscitation is started as the unit protocol hand in hand with the analgesia and other medications prescribed according to the unit protocol.

the patient's general condition is optimized for surgery of the fat extraction and grafting which typically should be within the first 6 days of admission.

then under anesthesia (any possible type from local and regional up to general anesthesia) liposuction procedure is performed, then fat is processed then grafted at the wound site with other portion prepared as nanofat for topical use and wound coverage, then sterile dressing is applied.

typically follow up is held daily with the dressing change day after another with the use of the nanofat only and sterile dressing

Eligibility Criteria:
Inclusion Criteria:

* both males and females within the age frame are candidates.
* previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic, diabetic, vascular or renal disease.
* with TBSA of 10 to 30% affected and of deep dermal to full thickness wound depth, at any part of the body except the genitalia, perineum or the perianal region or those with inhalational injury.

Exclusion Criteria:

* other patients aged younger or older than the specified age group.
* patients with co-morbid conditions.
* patients with smaller or larger BSA than the specified BSA.
* burns involving the genitalia, perineum or the perianal region and patients with inhalational injury.
Intracranial Hydatid Cyst

Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the treatment of choice, resulting in most cases to a complete recovery.

Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon, Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less commonly, Egypt)

Eligibility Criteria:
Inclusion Criteria:

* intracranial hydatid cyst

Exclusion Criteria:

* Arachnoid cysts
* conservative treatment
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
* HbA1c in the range of 7.0-10.0%
* Body mass index in the range 20-35 kg/m2

Exclusion Criteria:

* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria

Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT.

Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.


Eligibility Criteria:
Inclusion Criteria:

* Presentation to a healthcare facility with probable uncomplicated clinical malaria
* Adults aged between 18 and 60 years , or children aged between 12 and 120 months
* Weight between 5 and 85kg
* Pure \[on microscopic grounds\] screening P. falciparum parasitaemia in children from 25,000 to 100,000ul-1, or in adults from 10,000 to 100,000ul-1. \[The parasitaemia range for adults was originally set at 25,000 to 100,000µl-1 and changed to 10,000 to 100,000µl-1 in protocol amendment 3 dated 05 May 2004\]
* Written or oral witnessed consent obtained from subject, parent or guardian
* Compliance with the requirements of the protocol which include a hospital stay of 4 days and 3 nights and regular blood samples by finger-prick (children) or via a cannula (adults)
* A negative pregnancy test for women of child-bearing age on enrolment

Exclusion Criteria:

* Features of severe/complicated falciparum malaria
* Known allergy to sulphonamides
* Evidence of any concomitant infection at the time of presentation (including P. ovale and P. malaria)
* Any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis and bacterial infection)
* Treatment in the 28-days prior to screening with sulfadoxine/pyrimethamine (FANSIDAR, CELOXINE), sulfalene/pyrimethamine (METAKELFIN), mefloquine-sulfadoxinepyrimethamine (FANSIMET), chloroquine\* (NIVAQUINE); treatment in the 21-days prior to screening with mefloquine, or 7-days prior to screening with amodiaquine, halofantrine, quinine (full course), atovaquone - proguanil, artemisinins, co-artemether, tetracycline or clindamycin, or treatment for 5 half-lives prior to screening with drugs that have a potential anti-malarial activity (e.g. co-trimoxazole in the previous 60 hours)
* Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
* Previous participation in this study
* A positive pregnancy test at enrolment, women of child-bearing age who do not take a pregnancy test or female subjects who are breast-feeding an infant for the duration of the study
Carfilzomib for the Prevention of Graft Versus Host Disease

The aim of this study is to evaluate the safety and efficacy of Carfilzumib, which is a novel biological agent used in the treatment of multiple myeloma in preventing graft-versus-host disease, after stem cells transplantation from unrelated donors.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with MDS/AML
2. 18 years or older and willing and able to comply with the protocol requirements.
3. LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
4. Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation
5. Patients conditioned with reduced intensity or reduced toxicity conditioning i.e. Fludarabine combine with Treosulfan or 2-4 days of I.V Busulfan.
6. Patients must sign written informed consent.
7. Adequate birth control in fertile patients.

Exclusion Criteria:

1. Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.
2. Patients with respiratory failure (DLCO \< 30%).
3. Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
4. Patients with \> grade II liver renal toxicity.
5. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
6. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
7. Creatinine \> 2.0 mg/dl
8. ECOG-Performance status \> 2
9. Uncontrolled infection
10. Pregnancy or lactation
11. CNS disease involvement
12. Pleural effusion or ascites \> 1 liter.
Prospective Evaluation of Disparities in Provision of Allogeneic Transplantation

To look at the effect of a recipient's ancestry and socio-economic status on their choice of bone marrow transplantation donor cells and their chance of receiving genetically similar (allogeneic) bone marrow cells versus cells that are not genetically similar (allograft).

Primary Objectives To prospectively evaluate graft options and choice of donor by patient ancestry and SES for allograft candidates at MDACC.

Secondary Objectives

* To prospectively evaluate time to transplant for allograft candidates at MDACC.
* To evaluate treatment-related mortality for allograft candidates at MDACC.
* To assess overall survival for allograft candidates at MDACC.
* To prospectively evaluate receipt of preferred unrelated donor for allograft recipients at MDACC.
* To evaluate receipt of an optimal graft for allograft recipients at MDACC.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age.
2. Candidate for allogeneic transplantation

Exclusion Criteria:

1) Allogeneic stem cell transplantation not medically indicated.
Weight Loss in Adults Over 50 with Obesity

The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men \>50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age ≥50 years
* Post-menopausal if Female
* BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
* BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
* Ambulatory with or without a walking device or use of a manual wheelchair for mobility.

Exclusion Criteria:

* Untreated hyper or hypothyroidism.
* Cancer (except basal cell).
* Gastrointestinal disorders affecting food intake.
* \<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
* Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
* Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
* Uses a powered wheelchair for mobility.
* Has a pacemaker or any other life-sustaining medical implant.
Accuracy of Blood Glucose Detection by Diabetes Alert Dogs

Even though there is growing interest in and use of trained Diabetes Alert Dogs (DADs) as a way to monitor blood glucose in type 1 diabetes (T1D), no scientific studies have confirmed the ability of DADs to accurately detect extreme high and low blood sugar. The current project is the first preliminary investigation into the accuracy of DADs, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. The primary aim of the project is to test the hypotheses that DADs are accurate at detecting extreme blood sugar levels in adults and children with T1D. The proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic DAD alerts, 2) the degree to which alert accuracy is consistent across different DADs, and 3) whether or not DAD owners appear to experience better psychosocial status and quality of life compared to other individuals with T1D.

In the proposed project, DAD alerts will be compared to blood glucose (BG) readings from a continuous glucose monitoring (CGM) device, as well as a BG meter. CGM, BG meter, and DAD alert data will be collected over a 4-wk period. CGM devices will be "blinded" so that BG readings will not be shown. This will allow for a direct comparison between objective glucose readings generated by approved BG monitoring devices and DAD alerts. This study will also utilize two methods for measuring DAD alerts: (1) use of the event recorder mechanism of the CGM device, and (2) collection of more detailed and qualitative data on DAD alerts using diaries (Daily DAD Diaries) to collect information concerning the occurrence, timing, and type of DAD alerts.

Eligibility Criteria:
Inclusion Criteria:

* The participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis
* The participant must have a DAD placed in their home for a minimum of 6 months.
* Participants must not currently be using a continuous glucose monitor (CGM) in their diabetes management.
* Participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in English.
* Participants must have an internet-connected computer compatible with study software.
* Willingness to avoid consumption of acetaminophen-containing products for the duration of the study.

Exclusion Criteria:

* Pregnant women-self reported
* Current use of a CGM
* History of a systemic deep tissue infection with methicillin-resistant staph aureus or Candida albicans
Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay

This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

This is a non-significant risk multicenter, longitudinal specimen collection study. At the Baseline Visit, whole blood will be collected to be paired with either a previously collected tumor biopsy tissue sample or a prospectively collected tumor tissue sample. Whole blood samples will also be collected longitudinally at Interim visits for up to 5 years. Interim visits will be on a schedule dictated by their physician's standard-of-care management protocol. No more than 100mL of blood will be collected per month. Tumor tissue from recurrences will be collected for the duration of subject participation (after the Baseline Visit).

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older;
* Subject is willing to provide written informed consent;
* Subject has a diagnosis of a non-hematologic cancer, has tumor in the body, and has either;

  1. residual tumor tissue available for testing by the Sponsor; or
  2. genomic profiling results from an IVD or LDT assay performed on tumor biopsy tissue; or
  3. an invasive procedure (biopsy, surgery) scheduled following the Baseline Visit from which residual tumor tissue can be available for testing by the Sponsor.
* Subject is able, in the professional opinion of the investigator, to provide whole blood at the Baseline Visit and at the Interim Visits.

Exclusion Criteria:

* Underwent curative-intent surgery for management of the presently diagnosed tumor, at any time prior to the Baseline Visit.
* Underwent targeted or non-targeted chemotherapy, hormone receptor blocking therapy, or radiation therapy prior to the Baseline Visit.
* Underwent an invasive procedure (biopsy, surgery, thermal ablation) in the 7 days prior to any blood collection (baseline or follow-up).
* Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent.
Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing

The goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. The main questions it aims to answer are:

Question 1: To understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess.

Question 2: Understand the structure of rectal microbial community composition in healthy people.

Participants will be collected with rectal secretions and stool specimens.In addition, patients with perianal abscess should also collect pus samples.


Eligibility Criteria:
Inclusion Criteria:

* Observation group: ① Age between 18-60 years, local resident of Xi'an; ② met the diagnostic criteria for perianal abscess and underwent surgical treatment in our hospital; ③ did not use antibiotics before treatment; ④ himself and his family members were willing to participate in this study and signed informed consent.

Control group: ① Age between 18-60 years, permanent residents in Xi'an; ② had no serious chronic disease, no abnormality in physical examination in the last 1 week; ③ did not use drugs that may affect intestinal flora in the last one month; ④ himself and his family members are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Failing to retain the specimens as required
5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial

A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.

All patients (n=236) included in the DIRECTAVI randomized trial conducted between May 2016 to May 2018 will be prospectively assessed for up to 5 years follow-up . The DIRECTAVI prospective, randomized, single-center, open-label trial, demonstrated the non-inferiority of a "direct TAVR" strategy using the third-generation balloon-expandable Edwards SAPIEN 3 device (Edwards Lifesciences, Irvine, CA, USA)

A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.

Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.

Eligibility Criteria:
Inclusion criteria:

* Older than 18 years old.
* patients included in the DIRECTAVI trial

Exclusion criteria:

- Patients not living in France
Barts-MINOCA Registry

The last 15 years the introduction of primary angioplasty has radically improved outcomes for acute myocardial infarction (AMI). However, the system wide availability of prompt investigation has revealed an important group of patients where progress has stalled, the diagnosis is unclear and therapeutic approaches are uncertain. Myocardial infarction with non-obstructive coronary arteries (MINOCA) is found in 1 - 13% of all patients with a clinical diagnosis of AMI.

These patients present a therapeutic predicament since coronary revascularization is not appropriate. Guidelines do not exist for their management - yet the condition is not benign - the 12-month prognosis, although better than obstructive coronary artery disease patients is still guarded with recent data suggesting many questions remain unanswered.

This study utilises a prospectively collected clinical database. All patients referred to the Interventional Cardiology team are included onto this database. No patients will be contacted solely for research purposes. Patients will not have any investigations/procedures performed for research purposes. All data will only be available for access by named members of the Interventional Cardiology team. Data will be anonymised by the clinical care team and passed onto the research team before it is used and no patient identifiable information will be used in the analysis of the study or the publications of its results.

The database started in April 2015 and has collected data on all patients so far and will continue to do so for the duration of clinical work by the Interventional Cardiology team. As a result this study will continue indefinitely.

This study will include all patients admitted to or reviewed in clinic at Barts Health NHS Trust with either a diagnosis of MINOCA or who do not have a clear cause of a troponin rise. These patients range from young adults to the elderly and will include any patient ≥16 years of age. Patients who are followed up with and without any intervention (i.e. both medically managed patients as well as patients undergoing intervention) are equally as important and therefore the investigators shall include both groups of patients.

Patients will be included from referrals made by other clinicians either as in or outpatients. All these patients have their clinical data captured on a database or hospital based clinical programme.

This study aims to assess, in a real-world setting, the safety, efficacy and feasibility of further investigations in patients diagnosed with MINOCA among all patients with coronary artery disease.

The study will test various hypothesis including but not limited to:

1. The efficacy of diagnosis rates of CMR in patients diagnosed with MINOCA
2. Outcomes in patients diagnosed with MINOCA treated medically
3. Long-term outcome of patients diagnosed with MINOCA

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients ≥16 years of age will be included
* All patients will have a diagnosis MINOCA. Any patient who does not have a clear cause of troponin rise

Exclusion Criteria:

* Patients \<16 years will not be included in this study.
Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients:Correlation With Disease Activity and Chronic Organ Damage in These Patients

The study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index

We calculate important hematologic indices in children diagnosed as SLE as systemic inflamatory index ,systemic inflamatory response index and aggregate index of systemic inflamation in these patients ,and correlate these indices with SLE disease activity index and chronic damage index in these patients.

Eligibility Criteria:
Inclusion Criteria:

* patients who fillful 2012 SLICC criteria or 2019 ACR/EULAR criteria of systemic lupus erythematosus
* Age of patients at disease onset before 18 years

Exclusion Criteria:

* Adult onset disease ( age at disease onset after 18 years
* Any other chronic inflamatory disorders or other autoimmune diseases