cyrilzakka/clinical-trials huggingface dataset:
Dissection of the Gastrointestinal-mediated Glucose Disposal and Incretin Defect in Patients With Type 2 Diabetes

In patients with type 2 diabetes, the incretin effect is markedly reduced contributing to the relative insulin deficiency that characterizes these patients. This defect is believed to be due to a decreased effect of GLP-1 and an almost ceased effect of GIP. Nevertheless, the impact of the defect on glucose tolerance is not fully understood. The so-called gastrointestinal-mediated glucose disposal (GIGD) is a measure of glucose handling, which includes the incretin effect, but also other factors affecting glucose disposal (e.g. glucagon secretion). Interestingly, patients with type 2 diabetes exhibit elevated plasma glucagon levels in the fasting state, and glucagon concentrations fail to decrease appropriately and may even increase in response to ingestion of glucose and show exaggerated increases after a mixed meal. With the current project the investigators wish to elucidate how this paradoxical glucagon response observed in patients with type 2 diabetes affects the GIGD, the incretin effect and postprandial glucose excursions.

Ten patients with type 2 diabetes and 10 healthy matched control subjects will be enrolled in this randomised, placebo-controlled, double-blinded study. The aim is to examine the effect of a glucagon receptor antagonist (GRA) on gastrointestinal-mediated glucose disposal (GIGD), incretin effect and postprandial glucose excursions in patients with type 2 diabetes and healthy controls. Participants will attend two oral glucose tolerance tests (OGTT), two isoglycaemic iv glucose infusion (IIGI) and two standardised liquid meals.


Eligibility Criteria:
Inclusion Criteria:

Patients with type 2 diabetes

* Caucasians above 35 years of age with diet or metformin treated type 2 diabetes for at least 3 month (diagnosed according to the criteria of the World Health Organization (WHO)
* Normal haemoglobin
* Informed consent

Healthy subjects

* Normal fasting plasma glucose (FPG) \<6.1 mmol/l and HbA1c \<42 mmol/mol (6.0%)
* Normal haemoglobin
* Age above 35 years
* Informed consent

Exclusion Criteria:

Patients with type 2 diabetes

* Inflammatory bowel disease
* Intestinal resections
* Nephropathy (serum creatinine above normal range and/or albuminuria)
* Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2×normal values)
* Treatment with medicine that cannot be paused for 12 hours
* Pregnancy and/or breastfeeding
* Family history of pancreatic islet tumours
* Age above 80 years

Healthy subjects

* Diabetes or prediabetes with reduced glucose tolerance: FPG \>6.0 mmol/l and/or HbA1c \>42 mmol/mol
* First degree relatives with type 2 diabetes
* Inflammatory bowel disease
* Intestinal resections
* Treatment with medicine that cannot be paused for 12 hours
* Pregnancy and/or breastfeeding
* Age above 80 years
Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy

The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Planning medical abortion
* Planning LNG-IUD (Mirena) contraception

Exclusion Criteria:

* Pathological pregnancies or abnormality of the uterus or cervix
* Acute endometritis
Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients

This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in cough variant asthma in patient aged 5-year old or younger in outpatient department


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Patient who has been prescribed Pulmicort® Respules® according to physician's judgement, irrespective of the inclusion in the study.
* The usage of Pulmicort® Respules® follows local authorised package insert.

Exclusion Criteria:

* Allergy to any ingredient of Pulmicort® Respules®
* With history of Leukotriene Modifier (LM) usage prior to 2 weeks of recruitment or following plan.
* Have used systemic/inhaled steroid prior to 2 weeks of recruitment
The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -

To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population. The investigators aim is to assess the use of optimal screening methods to assess HAND. For this the investigators will be comparing the performance of a group of persons who are HIV positive and a group of persons who are HIV negative to test their memory and concentration abilities over-time.


Eligibility Criteria:
HIV positive Inclusion Criteria:

* Documented HIV infection
* Able to participate in study procedures

HIV positive Exclusion Criteria:

* Inability to comprehend or read English (as established by the English proficiency questionnaire)
* Drug or alcohol intoxicated (as determined by the investigator)
* Lack of information in medical records to determine the HAND predictive algorithm (current CD4 count, past CNS HIV-related disease, and duration of HIV therapy)
* Life expectancy \<6 months
* Inability to attend the clinic for required study follow up visits

HIV-negative Inclusion Criteria:

* Negative HIV-1 test within 12 months of study entry

HIV-negative Exclusion Criteria:

* Life time traumatic brain injury leading to loss of consciousness of at least 30 minutes.
* Inability to comprehend or read English (as established by the English proficiency questionnaire).
* Inability to attend the clinic for required study follow up visits.
* History of chronic neurological illness.
* Unstable psychiatric conditions such as bipolar disorder or depression.
* Individuals with psychiatric disorder on the psychotic axis.
* Active or past (within the last 6 months) severe alcohol or substance abuse sufficient, in the investigator's judgement, to prevent completion of tests or Inability to attend for the planned required study follow up visits.
Reading and Stuttering

Dyslexia is a common neurodevelopmental condition, which manifests itself in the form of reading difficulties and occurs in 7-10% of the population (Peterson \& Pennington, 2012).

As for dyslexia, it is one of the most common learning disorders and the most common cause of difficulties with reading, writing, and spelling. The global prevalence of dyslexia is estimated to be between 5% and 10% of the population, but it may be as high as 17% (Sprenger-Charolles et al., 2011). Stuttering is a speech disorder characterized by involuntary, audible, or silent repetitions or prolongations of sounds or syllables, along with disturbances in the fluency of verbal phrases.Stuttering and dyslexia are two processing deficits that have an impact on a person's social and academic lives, especially as they usually affect the pediatric population more than adults. Even though they affect different domains, they have similar characteristics in their pathogenesis, epidemiology, and impact on life (Algaidy et al., 2023). The aim of the study will be to identify the prevelance of dyslexia in developmental stuttering.


Eligibility Criteria:
Inclusion Criteria:

* children with stuttering

Exclusion Criteria:

* children with delayed language development
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer Post Neoadjuvant Chemotherapy

The primary goals of this trial will be to determine the safety and immune activity of HER-2 pulsed DC1 vaccine in patients with high risk HER-2pos breast cancer with residual disease post neoadjuvant therapy. Investigators will also explore the possibility of determining whether circulating tumor cells can be used as surrogate to assess response to vaccination.

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. There is a need to determine whether this ICAIT DC1 can activate CD4 and CD8 T cells prior to or in combination with chemotherapy with or without added trastuzumab.

This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 18 years.
* HER-2 expressing stage I - III breast cancer with residual disease in the breast or axillary nodes post-neoadjuvant chemotherapy.
* Women of childbearing age with a negative pregnancy serum test documented prior to enrollment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
* Women of childbearing potential must agree to use a medically acceptable form of birth control during their participation in the study.
* Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.

Exclusion Criteria:

* Pregnant or lactating.
* Positive for HIV or hepatitis C at baseline by self report.
* Potential participants with coagulopathies, including thrombocytopenia with platelet count \<75,000, INR \> 1.5 and partial thromboplastin time \> 50 sec.
* Potential participants with MUGA \< 50% EF.
* Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions

The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types III to IV.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections
4. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
5. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
6. The subject has used Accutane within 6 months prior to enrollment.
7. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
8. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
9. The subjects had prior treatment with laser or other devices in the treatment area within 3 months.
10. The subject has a history of keloids or hypertrophic scarring.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. Is allergic to topical lidocaine or topical steroids.
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception

Exclusion Criteria:

* Any condition, including genital conditions, sexually transmitted infection, menopause, and/or allergies that would make the study participant unsuitable for the study.
* Pregnancy or breast-feeding
Children's Attention Deficit Disorder With Hyperactivity (ADHD) Telemental Health Treatment Study

While telemental health (TMH) programs are increasing nationally to address the inequity of access to psychiatric services, there are few reports of their efficacy, particularly with children. The current proposal will complete the second stage of our program development. In the first stage, we established the feasibility of a TMH service and its acceptability to families and PCPs. In the second stage of program development we will conduct a randomized clinical trial (RCT) that will determine whether it is possible to use technological advances to: 1) improve clinical outcomes for children with ADHD over outcomes achieved in usual PC; and 2) adhere to an EBT protocol implemented through TMH. Future studies will examine whether other types of complicated psychiatric disorders and EBTs are amenable to delivery via TMH.

The overall goal of this study is to determine whether an evidence-based model of care can be faithfully implemented when delivered using TMH to children with ADHD living in rural areas and can improve outcomes over treatment as usual (TAU) in PC. ADHD is an excellent focus for assessment of TMH, as PCPs encounter this disorder frequently, EBT guidelines are available, pharmacotherapy is the core treatment and is easily delivered in PC through videoconferencing, and stabilization may be readily achieved for most youth.


Eligibility Criteria:
Inclusion Criteria:

* is 5.5 - 12 years of age
* resides at home with parents/relatives
* has a dx of ADHD (CBCL DSM-oriented elevation or previous diagnosis of ADHD; C-DISC diagnosis)
* attends school 80% of time or more (including home-schooled children)
* speaks English or Spanish and parent speaks English or Spanish

Exclusion Criteria:

* child has a diagnosis of: CD, OCD, psychosis, BPD, Autism, mental retardation, major medical illness
* resident parent has a drug use problem
Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)

Non-small cell lung cancer (NSCLC) is one of the leading causes of death in Western countries. Today, a new frontier in the fight against cancer is immunotherapy, a treatment that aims to "awaken" the patient's immune system to help it recognize and attack cancer cells.

Among the various approaches, there is significant focus on therapies that activate T lymphocytes, a type of immune cell, encouraging them to react against the tumor. These treatments have led to important progress and represent a hope for the future.

Prospective study aimed at evaluating the development of anti-drug antibodies in patients with NSCLC treated with immune checkpoint inhibitors, either as monotherapy or in combination, and the correlation between the presence of anti-drug antibodies, treatment efficacy, and the occurrence of adverse drug reactions.

Primary objective:

To assess whether patients treated with checkpoint inhibitors as single agent or in combination with other checkpoint inhibitors or chemotherapy develop anti-drug antibodies during the course of treatment Secondary objective: To assess whether development of anti-drug antibodies is associated with response, duration of response, PFS, OS, toxicity For each eligible patient, a blood sample (6 ml) will be collected before the start of therapy and before each treatment cycle until disease progression or the completion of the planned cycles. The tests and procedures the patient will undergo are all considered routine and part of standard medical care, so they do not entail any additional risks associated with participation in this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC
* Possibility to obtain blood samples
* Patient candidate, in any therapy line, for a therapy with any checkpoint inhibitor including single agent pembrolizumab, single agent atezolizumab, single agent nivolumab, single agent durvalumab or combination of nivolumab and ipilimumab
* Performance status 0-2 (ECOG)
* Patient compliance to trial procedures
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* No possibility to obtain blood samples
* Previous therapy with any checkpoint inhibitor
* Patient candidate for a therapy with a checkpoint inhibitor in combination with chemotherapy or any other non-checkpoint inhibitors
* Pregnancy or lactating
Community and Familial Impacts of the Opioid Crisis

This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. Mental health status related to the death or support of a loved one will be assessed through a survey and through the use of several modules of the CAT-MH (computerized adaptive testing-mental health suite) questionnaire.

This study aims to establish the level of needs in the community among those who have lost loved ones to opioid overdose and/or currently support those in opioid addiction recovery. This study aims to analyze the needs of those who have lost a loved one to opioid-related death and/or those currently supporting a loved one in treatment for Opioid Use Disorder. The study will evaluate the mental health status for each study participant through a primary survey as well as current participant mental health status through the use of several modules of the CAT-MH adaptive testing questionnaire. CAT-MH will be used to rapidly measure severity levels of depression, anxiety, and substance use risk after participants complete the primary survey. The primary survey assesses the immediate impact of overdose death by a loved one and recognition of the onset of opioid addiction in the years after the event on family and community members. The primary survey will compare the impact of loss and/or recovery support on mental health and substance use at specified time points before and after the loss and/or an individual finding out about a loved one's opioid addiction. The primary survey will also evaluate attitudes in this population about mindfulness and self-compassion skills training, openness to technology and various treatment options, current and past levels of depression, anxiety and grief, as well as thematic areas of need specific to those who have lost a loved one to opioid overdose and/or currently support a loved one in opioid addiction recovery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18+, inclusive, who are competent, wish to participate and willing to provide informed consent
* Willing and able to participate in completing the surveys using the internet on via smartphone as requested
* Identify in one of the 3 groups: (a) Adults who have lost a direct relative or friend to opioid overdose or opioid-related death prior to taking the survey; (2) Adults who are currently supporting a loved one with active opioid addiction; (3) Adults who have lost a direct relative or friend to opioid overdose or opioid related death at least six months prior to survey participation and also currently support a loved one in active addiction recovery.

Exclusion Criteria:

* Inability to complete the survey
* Inability to speak, read, and understand English
Progestin Treatment for Endometrial Stromal Cells in Adenomyosis

Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the beneficial effect of progestin was limited. It might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis.

Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It may be a compensatory effect in which the NK cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies that the formation of adenomyosis might be due to "abnormal" endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. This finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women.

In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment.

Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).

After becoming pre-confluent (covering 80% of the culture well), ESC was cultured for 8 days solely or with the addition of medroxyprogesterone (MPA) or danazol.

ELISA was done to measure IL-6, IL-8, and TNF-alpha concentrations of the culture media.

Real-time quantitative RT-PCR was done to measure IL-6, IL-8, and TNF-alpha RNA levels in ESC.

Eligibility Criteria:
Inclusion Criteria:

* women with adenomyosis
* at early- to mid-secretory phases

Exclusion Criteria:

* postmenopausal
* malignancy
Effect of an Unsupervised Multi-domain Intervention on Injury Risk Reduction in Athletics (I-ReductAI).

In athletics, injuries can affect athletes' participation in athletics, their performance and career, but also their health in physical, psychological and social aspects, in the short, medium and long term.

This justifies the development and implementation of injury risk reduction strategies. These should be developed according to a holistic approach that considers the complex aetiology of injuries in sport. Although many different injury risk reduction strategies have been studied in sport, in general, each has been evaluated in isolation, including for example education, neuromuscular exercises, psychological techniques or individual injury risk assessment. The investigators therefore hypothesized that their combination could improve the overall effectiveness of an intervention aimed at reducing the risk of injuries in athletics.

Eligibility Criteria:
Inclusion Criteria:

* be licensed at the French Athletics Federation (FFA) for competition (sprints, hurdles, jumps, throws, combined events, and endurance disciplines), without any counter-indications for competitive athletics activity attested by the license at the FFA;
* have daily access to a digital device (smartphone, computer, tablet) with a network connection (public or private).

Exclusion Criteria:

* Any athlete deprived of liberty or subject to legal protection (guardianship, under curatorship, legal protection).