cyrilzakka/clinical-trials huggingface dataset:
PAI-1, tPA, TFPI and HEECs in Uterine Hemostasis

The purpose of the study is to learn more about the role of blood clotting factor proteins and cells in menstrual (period) bleeding. The investigators are hoping to identify differences in these proteins and cells in the menstrual blood of individuals with heavy periods compared to menstruating individuals who do not have heavy periods.

The purpose of this study is to learn if human endometrial endothelial cells (HEECs) regulate human uterine hemostasis through the up and down-regulation of pro- and anti-coagulant factors in menstrual blood including PAI-1, factor XI (FXI)-PAI-1 complex, tPA, and TFPI.

This study will enroll participants with heavy menstrual bleeding (HMB) and participants without HMB. Coagulation factors will be measured in menstrual blood and mRNA for these factors will be quantified from cultured HEECS from endometrial biopsies and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Regularly menstruating participants between 18-45 years of age

Exclusion Criteria:

* Pregnancy within 3 months of enrollment
* Lactating at the time of enrollment
* Hormonal contraceptive use or use of the copper intrauterine device (IUD)
* Antifibrinolytic use
* Inherited or acquired bleeding disorder or anticoagulant use
* Known structural cause of HMB
* Inability to complete PBACs
* Unwilling to refrain from sexual intercourse for the two weeks prior to endometrial biopsy
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* PS≤2
* Normal organ, electrolyte, and bone marrow function

Exclusion Criteria:

* Previous treatment with nilotinib or any other drug in this class or other targeted therapy
* Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
* Impaired cardiac function
* Use of coumarin derivatives (i.e. warfarin)
* Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply.
Subantimicrobial Doxycycline in Acne

Antibiotic resistance is a public health problem that worsens the more physicians prescribe standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most common dermatologic conditions among pediatric populations. As such, clinicians can make a large impact by practicing good antibiotic stewardship while still addressing the impact of acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its anti-inflammatory effects while eliminating antimicrobial properties and associated risks of drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial doxycycline is efficacious in treating acne from a physician standpoint. The investigators aim to investigate the patient experience of acne treatment with subantimicrobial dose doxycycline in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Documented moderate to severe facial acne

Exclusion Criteria:

* Other skin conditions on the face
* Previous antibiotic treatment for acne
* Use of antibiotics for any reason within the past month
* Use of new prescription regiment for acne within the last 3 months
* Positive pregnancy test in the clinic
* Cognitive impairments
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) recipients of a kidney-only transplant, including re-transplants
* Non-HLA identical Living or Deceased Donor Grafts
* Able to provide informed consent
* Absence of donor specific antigens
* Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)
* Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above)
* Patients who underwent kidney transplantation at least 9 months prior to study entry

Exclusion Criteria:

* Prior or concurrent non-kidney organ transplants
* Presence of BK nephropathy in current graft
* Recipient on any other investigational drug in the 12 weeks prior to inclusion
* Patient with history of recent (\<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Significant hepatic impairment
* Bilateral kidney transplantation
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

The purpose of this study is to evaluate the efficacy and safety of SHR-3167 compared with insulin glargine after treatment in insulin naïve subjects with type 2 diabetes treated with metformin alone or in combination with SGLT2 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening.
3. A stable dose of metformin alone or in combination with a stable dose of a SGLT2 inhibitor for 3 months prior to screening.
4. Body mass index (BMI): 18.5\~35.0 kg/m2.
5. HbA1c of 7.5%\~10.0% as assessed by the local laboratory.
6. Insulin naïve.
7. Female subjects and partners of male subjects who are of childbearing potential, have no fertility plan and agree to take highly effective contraceptive measures within 6 months after signing the informed consent form to the last dose, and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.

Exclusion Criteria:

1. Electrocardiogram (ECG) results show clinically significant abnormalities that may affect the safety of the subject.
2. Poor blood pressure control at screening.
3. Diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (LADA)，other special types of diabetes or secondary diabetes mellitus.
4. ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.
5. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state due to hyperglycemia within 6 months prior to screening.
6. Presence of acute or chronic hepatitis, cirrhosis, or other serious liver disease other than non-alcoholic fatty liver disease.
7. Those who have a history of severe cardiovascular and cerebrovascular diseases within 6 months before screening.
8. Malignancy or history of malignancy within 5 years prior to screening.
9. Received any diabetes mellitus or weight-loss medication outside the inclusion criteria within 3 months prior to screening.
10. Participation in a clinical trial of any drug or medical device within 3 months prior to screening.
11. Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.

Eligibility Criteria:
Inclusion Criteria:

* CAC score \> 300
* Life expectancy \> 6 months
* Dialysis vintage \> 6 months

Exclusion Criteria:

* Non-compliance to hemodialysis
A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care

The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:

i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.

Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across time and situations. ADHD in adulthood, with estimated prevalence of 2-3%, is associated with challenges that may have severe consequences on daily life functioning. Treatments delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions for a larger group of adults with ADHD. The overall aim of this study is to investigate 1) predictors of effect; 2) implementation outcomes; and the 3) cost-benefit of a therapist guided Internet-delivered treatment for adults with an ADHD diagnosis. The study is an open longitudinal cohort trial in routine care. A total of 200 participants with an ADHD diagnosis will be included in the trial, and 15 participants will be interviewed about their experiences with guided Internet-delivered treatment. The outcomes are change in primary and secondary symptoms and quality of life, cost-benefit and implementation outcomes of guided internet-delivered treatment for adults with ADHD. The investigators will use quantitative statistical procedures and qualitative methods to analyze the data. The results from the study will contribute to the growing research on Internet-delivered treatments. The expected results may have a major impact on treatment provision and the further development of treatment options for adults with ADHD. Moreover, investigating ways to increase adoption, adherence and fidelity in Internet-delivered treatment could be of great value when implementing such treatment into routine care.

Eligibility Criteria:
Inclusion criteria: \|

* Age ≥18
* A self-reported diagnosis of ADHD
* Access to and ability to use a computer, smartphone and the Internet.
* Speaks, writes and reads Norwegian

Exclusion criteria:

* In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis.
* Ongoing psychological treatment for ADHD or other psychiatric illnesses.
Envarsus in Delayed Graft Function (E-DGF)

Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.

This is a single center randomized phase IV trial of comparing extended release Envarsus XR (study drug) once a day vs immediate release tacrolimus twice a day in a new kidney transplant recipients with delayed graft function (DGF). The primary study endpoint is the interval between first dialysis and last dialysis after kidney transplant (duration of DGF). The second end point is the number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Willing to comply with all study procedures and be available for the duration of the study
3. Male or female, at least 18 years of age
4. Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
5. Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
6. Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.

   * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

     * Has not undergone a hysterectomy or bilateral oophorectomy; or
     * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion Criteria:

1. History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
2. Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen
3. Women who are or plan to become pregnant or breast-feeding during the study period
4. Not suitable for study participation due to other reasons at the discretion of the investigator
5. Major post-surgical complications requiring allograft nephrectomy
6. Multi-organ transplant recipients
7. Non kidney transplant recipients
A Case-Control Study of Negative Pressure Platform Wound Devices (NP-PWD) for Skin and Soft Tissue Defects

This study will demonstrate the effectiveness of the NP-PWD therapy in managing complex wounds and improving wound healing parameters as compared to standard of care.

A study of 24 completed subjects will be conducted by enrolling patients who are requiring treatment for open skin and soft tissue defects. Patients will be screened for inclusion criteria and asked to consent to participate in the study. Following consent subjects will be randomized to receive treatment of one of the two study arms. Arm 1, the standard of care arm, will receive KCI Wound VAC Granulofoam. Arm 2, the study arm, will receive treatment with NP-PWD. Prior to the initial application, wound evaluations and photography will be completed to include assessment of infection with wound swabs. The wound dressing will be assessed for the need for change every 2-3 days and changed if clinically indicated (following each device IFU). Subjects will be followed for up to nine days post initial application. At minimum, the randomized treatment will be applied for 2 days after initial application for a subject to be considered completed. Subject who do not complete the treatment course (minimum of 2 days of treatment), may be replaced per investigators discretion. Follow up data will be gathered at each change/removal of the NP-PWD or Wound VAC. The data collected will include indications for dressing change, dressing change process, photographs and assessments for wound healing, infection, and adverse events. Gathered clinical data of the enrolled subjects will be used to evaluate the feasibility in using the NP-PWD device for wound healing management.

Eligibility Criteria:
Inclusion Criteria

All subjects enrolled must meet ALL the following criteria:

1. Patients 18 years of age or older of either gender
2. Have an open skin or soft tissue defect requiring treatment

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study:

1. Active malignant disease at the study site
2. Any concomitant medications or co-morbidities that, in the opinion of the investigator, may interfere with device use
3. On any investigational drug(s) or therapeutic device(s) to the study site in the last 30 days or any previous enrollment in this study
4. Pregnant at enrollment
Intestinal Microbiota, Tryptophan and Autism

Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.

The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.

The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.

Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. In France, Autism Spectrum Disorderaffects about 1 in 100 people according to international criteria and is diagnosed in early childhood. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.

The overall goal of this project is the identification of metabolic biomarkers based on clinical profile (based on behavioral and cognitive markers). The best characterization of physiopathological pathways (from the molecular scale to the phenotypic scale) will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.

The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.

Eligibility Criteria:
Inclusion Criteria (patient):

* 3-12 year old child
* Diagnosis of Autism Spectrum Disorders according to the DSM-5 (2013), invasive developmental disorder according to the ICD-10 (1993) or Autism Spectrum Disorders according to ICD-11 (2018)
* Affiliate or beneficiary of a social security scheme
* Consent signed by at least one of the parents

Exclusion Criteria (patient):

* Chronic inflammatory pathology
* Probiotic intake
* Taking medication (except melatonin) within 6 days before inclusion and until biological samples are collected

Inclusion Criteria (healthy volunteer):

* 3-12 year old child
* Affiliate or beneficiary of a social security scheme
* Consent signed by both parents

Exclusion Criteria (healthy volunteer):

* Chronic inflammatory pathology
* Digestive pathology
* Probiotic intake
* Taking medication within 6 days before inclusion and until biological samples are collected
* Personal and / or family history of neurological disease, epilepsy, psychiatric disorder, neurodevelopmental disorder, language disorder, overdrive, intellectual disability
Temozolomide Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost for Non Small Cell Lung Cancer Brain Metastases

With the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. Conventional Whole Brain radiotherapy(WBRT) was less effective, the stereotactic radiosurgery(SRS) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost(SIB-IMRT) is a new radiotherapy technology, Giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, So that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. In the aspect of normal tissue protecting, SIB was better than WBRT plus SRS sequential treatment pattern. 30Gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25Gy to the whole brain while the tumor bed Simultaneous push to 50Gy was safe and effective, while reducing the impact on cognitive function. Hippocampus is a part of the brain located in the temporal lobe, Mainly responsible for long-term memory storage conversion and orientation. Many investigators point out that hippocampus is the main commander of neurocognitive function, Reduce the dose of hippocampus can significant improve the neurocognitive function. Temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. In recent years, some researchers find that Temozolomide capsules combine with radiotherapy such as SRS, WBRT or The two combined, can improve Objective response(OR) and prolong the Progress Free Survival(PFS),while with tolerable therapeutic toxicity. In order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the SIB-IMRT technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have an estimated survival of at least 4 weeks
2. Karnofsky Performance Status Scale (KPS) of 60-100.
3. Patients' laboratory values had to meet these restrictions: hemoglobin\>8 g/dL, platelets\>70\*109/L, white blood cells\>4\*109/L.
4. Patients must sign a study specific informed consent form prior to study entry

Exclusion Criteria:

1. Patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy
2. had received previous brain irradiation
3. could not be regularly followed
4. with leptomeningeal involvement