cyrilzakka/clinical-trials huggingface dataset:
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds

Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.

In an attempt to explore the contribution of Adipose Derived Stem Cells (ASCs) to chronic wound healing, we will investigate the effects of injecting ASCs into the periphery and debrided surfaces of chronic wounds. Our goal is to achieve healing in two months, and for the wounds to stay healed for the following two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Female or male patient aged ≥ 18
* With diagnosis of diabetic or other chronic wound
* Grade 1 or 2 wound on the Wagner Scale
* Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
* For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
* Patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days)
* Patient has adequate (\>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
* Patient has activated platelet thromboplastin time (aPTT) of \< 1.6x the mean normal reference interval at the time of the lipoharvest procedure and no contraindication to lipoharvest

Exclusion Criteria:

* Typical Charcot's foot
* Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound \[bone erosion or disappearance of the cortical bone\]) as determined by MRI
* Clinical evidence of uncontrolled infection at the inclusion visit
* Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
* Subjects with cancerous or pre-cancerous lesions in the area to be treated
* Patient with working activity who cannot be on sick-leave during the study period
* Patient suffering from a psychiatric disorder not treated
* Clinical evidence of gangrene on any part of the affected foot
* Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
* Pregnant or nursing females
* Patient receiving dialysis for renal insufficiency or who have severe renal dysfunction
* Patient who cannot have an off-loading method
* Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this study
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Potential Effect of Dialyzer Leaching of BPA From the Fresenius Optiflux 160NR Compared to the Nipro ELISIO-15H

The aim of the study is to identify hepatic enzyme and estrogen-dependent biochemical changes that occur when dialysis patients are treated with dialyzers known to leach BPA (Bisphenol-A) into the blood, such as the commercially available Fresenius F160NR, as compared with the same chemical evaluations in patients being treated with the non BPA containing Nipro Elisio-15H dialyzer. Evaluations of patient's chemistries will be obtained prior to and after 2 months of standard dialysis treatments with each dialyzer.

The investigators propose to elucidate any eventual biochemical changes, and in particular, the in vivo estrogenic activity of BPA (Bisphenol-A), when BPA is being leached into the circulation by the Fresenius 160NR dialyzer as opposed to the same biochemical changes when there is no BPA being leached, as with the non-BPA containing Nipro Elisio-15H dialyzer. The estrogen dependent biochemical end points in humans include free testosterone, sex hormone binding globulin (SHBG) and thyroid binding globulin (TBG).

Eligibility Criteria:
Inclusion Criteria:

* Male ESRD patients 18 years or older
* Stable on hemodialysis for more than 3 months
* Stable hematocrit equal to or above 29 %
* Stable vascular access
* Stable anticoagulation
* No active infection
* Able to sign informed consent and able to participate in the study
* Medically stable

Exclusion Criteria:

* Participation in another study which may interfere with the planned study
* Active infection
* Medical conditions which may interfere with the study (unstable cardiac status, chronic liver disease, active hepatitis as defined by elevated liver enzymes)
* Females (It is expected that potential changes in estrogenic activity that might be seen in patients exposed to BPA will be modest and would be masked by naturally occurring variability of estrogen activity in women at varying stages of gonadal activity (pre, post-menopausal, different points in menstrual cycle, eventual pregnancy, etc). Thus, limiting study to adult males will maximize the possibility of detecting any changes in estrogenic activity.)
Laryngeal Manifestations of Connective Tissue Diseases

Connective tissue diseases represent a rather heterogeneous spectrum of overlapping pathologies, which have as a common feature the involvement of multiple organ systems. Though generally uncommon, they represent lifelong conditions, which are often coupled with various immunologic disorders, thus significantly affecting the overall health and quality of life of the affected individual. The classic connective tissue disorders include rheumatoid arthritis ,Juvenile idiopathic arthritis, systemic lupus erythematosus , scleroderma, Sjogren's syndrome, and the mixed connective tissue disease several studies have reported that up to fifty percent of connective tissue diseases' patients are having laryngeal involvement as the sole manifestation of this disease In acute phases, patients may complain of burning, foreign body sensation in the throat, and difficulty in swallowing. In chronic cases the cricoarytenoid joint is usually affected with resultant fixation. The laryngoscopic findings include mucosal edema, myositis of the intrinsic laryngeal muscles, hyperemia, inflammation and swelling of the arytenoids, interarytenoid mucosa, aryepiglottic folds and epiglottis, and impaired mobility or fixation of the cricoarytenoid joint. In the early stage of the disease, the laryngeal examination may be normal

In acute involvement of the cricoarytenoid joints, signs of inflammation such as edema and redness may be present with or without impaired mobility chronic cases where ankylosis of the connective tissue disease cricoarytenoid joint is present, one or both vocal folds may be fixed in the median, paramedian, or lateral positions. Other laryngoscopic findings include the presence of inflammatory masses or rheumatoid nodules in the larynx and pharynx. In 1987, the American Rheumatism Association has included submucosal nodules in the laryngeal tissue in her revised criteria for the classification of Rheumatoid arthritis there was a description of small submucous rheumatoid nodule in the larynx, were later confirmed by multiple studies . Rheumatoid deposits in the form of bamboo nodes which are white- yellow bands in the middle of the membranous portion of the vocal folds had been described Cricoarytenoiditis has been reported to occur in Juvenile rheumatoid arthritis, and sometimes, it may be the first presentation of the disease ,Vocal cord lesions that have been reported in connective tissue diseases diseases include cricoarytenoid arthritis, rheumatoid nodules, and bamboo nodes .

Eligibility Criteria:
Inclusion Criteria:

1. Age: any age group may be included in this study.
2. Gender: both sexes will be included in the study.
3. 'previously established diagnosis of connective tissue diseases:

Exclusion Criteria:

1. history of neurological diseases .
2. previous history of neck radiation
3. presence of any other systemic diseases
4. professional voice users
5. chronic nonspecific laryngitis like laryngeal scleroma,Tuberculous laryngitis
6. presence of laryngeal masses
7. history of neurological diseases .
8. previous history of neck surgery,intubation.
JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases

This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.

This is a multicenter, single-arm, phase 2 study to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.

Patients will receive JK-1201I until disease progression. The primary objective of this study is to assess whether treatment with JK-1201I prolongs progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM in triple negative breast cancer patients with brain metastases.

The secondary objectives of the study are to further evaluate the efficacy, safety and pharmacokinetics of JK-1201I.

Eligibility Criteria:
Inclusion

Participants must meet all the following criteria to be eligible for randomization into the study:

1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
2. Female aged ≥18 years.
3. Has ECOG PS of ≤1.
4. Life expectancy ≥ 3months.
5. Histological or cytological confirmation of triple-negative breast cancer (TNBC).
6. At least one prior chemotherapy regimen with anthracyclines and taxanes for advanced disease.
7. Has at least 1 measurable brain metastatic lesion according to RANO-BM.
8. Adequate biological function.
9. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.

Exclusion

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Patients who have received prior anti-cancer treatment within 4 weeks.
2. . Patients must not have previously received JK-1201I or any other form of irinotecan, SN38.
3. Hypersensitivity to any ingredient of JK-1201I and Topotecan.
4. Current use or any use in the last two weeks of strong CYP3A-enzyme inducers / in the last two weeks of strong CYP3A-enzyme inhibitors and / or strong UGT1A inhibitors.
5. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
6. History of other malignancies within last 5 years.
7. History of immunodeficiency disease, or positive human immunodeficiency virus antibody.
8. Severe infections within 4 weeks before the first use of the study drug.
9. Active hepatitis B virus infection, or active hepatitis C virus infection.
10. Patients who received surgery within last 4 weeks before the initiation of study treatment.
11. Patients with brain stem, meningeal or spinal cord metastasis.
12. Severe symptoms by tumor aggressive important organ.
13. Uncontrolled hydrothorax and ascites.
14. Uncontrolled concomitant systemic disorder as defined in the protocol.
15. Serious cardiac condition or uncontrolled high blood pressure.
16. History of mental illness, drug abuse, alcoholism.
17. Pregnant or breast-feeding.
18. Other conditions that the investigator considers unsuitable to participate in this clinical trial.
Long-term Follow-up of Children Born in the PETN Studies

In every 10th pregnancy, the child in the uterus is insufficiently nourished, a so-called growth retardation. This occurs when the child cannot reach its growth potential due to an undersupply in the uterus. This inadequate supply is considered a developmental cause for the later development of physical diseases like cardiovascular diseases, sugar metabolism disorders and obesity as well as mental developmental problems (for example problems in cognitive skills, deficits in language development, concentration and attention).

From 2002 to 2008, 111 patients with impaired placental blood flow were included in a small study and treated with Pentalong or placebo. From 2017 to 2022, the positive effects of the study treatment were tested on a larger number of patients. A total of 317 pregnant women were included at 14 participating study centers in Germany.

In this follow-up study, the development of the children born in the two studies will be examined. The study consists of two independent parts: firstly, questionnaires are answered by the former participants and secondly, an on-site visit is carried out to check the physical and mental health of the child.

Pregnancies in which impaired uterine blood flow is detected by Doppler measurements during routine examinations in the second trimester are at high risk of developing fetal growth restriction (FGR). FGR affects 10% of pregnancies and is the leading cause of perinatal mortality and morbidity. In addition, intrauterine growth restriction places a lifelong burden on the physical and mental health of affected children. Epidemiological studies have shown that children with FGR have an increased risk of developing type 2 diabetes mellitus, hypertension, dyslipidemia and a high BMI. In addition, the affected children show disorders in hormonal balance and pubertal development as well as specific impairments of various cognitive and neurocognitive functions. There is also a link between FGR and lower cognitive ability in preschool children, school-age children and young adults, as well as lower communication, language and reading skills in school-age children. Neuronal development (e.g. EEG frequency spectra, resting-state networks) and executive functions are also impaired by FGR.

In the follow-up study, the children will be examined from the age of 6. Here, the effects of PETN on the development of children of women with high-risk pregnancies can be further investigated and a comparative study of growth-retarded and normal-growth children can also be carried out.

Eligibility Criteria:
Inclusion Criteria:

* mothers participation in one of the PETN studies
* age above 5 years
* completion of questionnaires for self reported data
* written consent for physical examination

Exclusion Criteria - only physical examination:

* physical and mental states preventing physical examination
Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine

The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients treated with triple therapy who simplify to 3TC+DTG
* patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice

Exclusion Criteria:

* lack of willingness to provide informed consent
Evaluation of Different Colorectal Cancer Screening Strategies

A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies.


Eligibility Criteria:
Inclusion Criteria:

* 50-74 years old
* Informed consent is available

Exclusion Criteria:

* Previous colorectal cancer
* Previous colorectal resection
* Previous received cancer-related treatment (except non-melanoma skin cancer)
* Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
* Fecal occult blood or fecal DNA was performed within one year
* Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight)
* Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
Validation of a NICS Method Using the Culture Medium

This study aims to validate a non-invasive method of chromosomal screening (NICS), based on the Multiple Annealing and Looping Based Amplification Cycles- Next-generation Sequencing (MALBAC-NGS) technology, in order to determine the chromosomal endowment of a blastocyst from the DNA of the embryonic culture medium.

The chromosomal status of the embryo from an embryo biopsy of trophoectoderm will be established (usual clinical practice), the chromosomal endowment from the DNA of the embryonic culture medium will be determined, and the results using the NICS and the conventional invasive method (Preimplantation Genetic Testing for Aneuploidy \[PGT-A\]) will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Treatment by oocyte donation or own oocyte nd preimplantation genetic screening of aneuploidies (PGT-A).
* Embryonic cryopreservation.
* Informed consent signature

Exclusion Criteria:

* Embryo transfer without embryo freezing
* Embryonic block.
* Bad embryo quality.
The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis

The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians above 18 years of age
* Plaque psoriasis
* PASI score \>10
* No treatment or stable treatment of psoriasis during at least 3 months before inclusion
* Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
* Normal blood pressure
* Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (\~5 times the plasma half-life)

Exclusion Criteria:

* Psoriasis arthritis
* Fasting plasma glucose \> 7.5 mmol/L or HbA1c \> 7.5%
* Type 1 diabetes
* Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
* Heart failure, NYHA class III-IV
* Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \>150 µM and/or albuminuria
* Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \>2 x upper normal serum levels)
* Anaemia
* Acute or chronic pancreatitis
* Struma or thyroid cancer
* Pregnancy or breast feeding
* Inability to complete the study
CCTA Improves Clinical Management of Stable Chest Pain

The investigator aims to prospectively enroll patients who were referred for coronary computed tomography angiography (CCTA) for the assessment of stable chest pain (SCP) suspected of obstructive coronary artery disease (CAD). All patients underwent CCTA according to established guidelines and local institutional protocols. The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary. This study will determine if CCTA-based imaging evaluation can provide more informaton to improve clinical management for SCP, including fewer MACE and better decision-making of downstream investigations and therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients with SCP suspected of obstructive CAD.
* referred for CCTA for the assessment of SCP.
* ≥18 years of age.
* signed informed consent.

Exclusion Criteria:

* acute coronary syndromes
* previous CAD or coronary revascularization
* nonsinus rhythm
* cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka

This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka.


Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy
COVID-19 Vaccine Induced Adaptive Immune Responses

The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and aged between 18 to 59 years

Exclusion Criteria:

* High-risk epidemiology history within 14 days before enrollment
* SARS-CoV-2 specific IgG or IgM positive in serum
* Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples
* Axillary temperature of more than 37·0°C
* Known allergy to any vaccine component
* Thyroid disease
Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.

At present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.

Several authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.

The purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.


Eligibility Criteria:
Inclusion Criteria:

Patients under 49 years undergoing IVF cycles with PGS for one of the following reasons:

* Advanced maternal age
* Recurrent implantation failure
* Recurrent abortion
* Severe male-factor infertility

Exclusion Criteria:

* Not being able to sign the informed consent to participate in the study
* Patients undergoing preimplantation genetic diagnosis