cyrilzakka/clinical-trials huggingface dataset:
Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

This study will look at two FDA approved medications that improve how the pancreas works in patients with Type 2 Diabetes. In order to understand how these medications work in patients with diabetes we must first measure the normal response in healthy volunteers without diabetes. We will be looking at the body's normal physiological response to low blood sugar and whether this will be modified by these medicationsThe hypothesis would be that glimepiride induced insulin secretion will be inhibited by hypoglycemia.

In patients with type 2 diabetes, sulfonylurea drugs are a mainstay for effective glucose control. These agents produce their hypoglycemic effects via stimulation of endogenous insulin secretion. Oversecretion of insulin, per se, or a continued relative increase of the hormone even when plasma glucose is normal will result in hypoglycemia. This latter situation commonly occurs if a patient decides to omit, delay, or reduce the size of a meal. An important defense against hypoglycemia in the above situations is glucose dependent regulation of insulin secretion. In other words, a low ambient glucose concentration could regulate the magnitude of the amount of insulin released in response to a sulfonylurea. Thus during hypoglycemic conditions, the sulfonylurea would result in little or no insulin secretion, whereas its effects during hyperglycemia would be amplified. Glimepiride and glyburide are both second-generation sulfonlyurea drugs used commonly for treatment of type 2 diabetes. This study will compare the two and ask the following question:

Is Glimepiride insulin secretion dependent upon glucose concentration in-vivo?

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 30-60
* Body Mass Index 21-30 kg/m2
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities
* EKG treadmill stress test for volunteers over 40 years of age.
* Female volunteers of childbearing potential will undergo HCG pregnancy test.

Exclusion Criteria:

* Prior or current history of poor health
* Abnormal results following screening tests
* Pregnancy
* History of allergy to sulfonylurea or related drugs
Evaluation of Physical Capacities Within the Company and Effect of a Personalized Versus Traditional Training Program on the Quality of Life of Sedentary Employees

The practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. Several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. However, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. In this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

The originality of this project is to evaluate physical capacities directly within the company of the participants instead of hospital unit.

Physical activity (PA) is one of the major determinants of health. Indeed, the practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. The effects are beneficial regardless of age, gender and state of health. Moreover, in addition to the well-being of employees, several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. Today, the World Health Organization (WHO) prescribes 150 min of physical activity per week regardless of the person's profile (active employee, employee working in his office, construction worker, etc.).. In this project,the investigators therefore want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

Eligibility Criteria:
Inclusion Criteria

* Sedentary people
* Affiliate to health care organism
* Subject who gave their consent
* Employee of a company having accepted the terms of the study, as well as the agreement of the occupational physician

Exclusion Criteria:

* People with degenerative disease
* Cardiovascular trouble
* Subject who are not able to understand the proceeding of the study or to give their consent
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia

This study seeks to compare the use of ultrasound and electrophysiologic techniques to target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity. Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard ways of locating muscles during a treatment of BoNT injection.

This is a study to investigate the use of two targeting techniques for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity: Electrophysiologic guidance, using electrical stimulation, and ultrasound. Subjects will be selected from the clinical programs of both Icahn School of Medicine at Mount Sinai and the National Institutes of Health who are already receiving onabotulinum toxin A injections clinically. The study will consist of four visits. Visit one consists of screening subjects who will then be consented and randomized to one of the two treatment techniques for their ona-BoNT injection: 1) Electrophysiologic guidance using electrical stimulation or 2) ultrasound. Visit 2 will occur at week 4 where the subjects will return for a follow up visit to have blinded evaluator measurements of efficacy and strength and capture safety data. Visit 3 will be at week 12 when subjects will cross over and have the alternate treatment technique during their ona-BoNT injection. Visit 4 will occur at week 16 as the final assessment where subjects will have measurements of efficacy and strength and capture safety data by the blinded evaluator.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Confirmed diagnosis of focal upper extremity dystonia (FHD) or upper limb spasticity
* Stable onabotulinumtoxinA dose regimen with a stable response as judged by the physician and patient for at least 2 treatment sessions.

Exclusion Criteria:

* Contraindications to botulinum toxin
* Pregnancy or nursing
* Cognitive impairment that prevents reliable outcome measures of self-report
Use of Chamomilla Recutita in Mucositis

To determine the Chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to HSCT.

Population: adult subjects, submitted to hematopoietic stem cell transplantation (HSCT) at a cancer hospital in the interior of São Paulo State. The following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic HSCT and with intact oral cavity on the first day of conditioning. Subjects will be excluded if they present any adverse reaction to the active principles of Chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.

Eligibility Criteria:
Inclusion Criteria:

* subjects over 18 years of age;
* candidates for allogeneic HSCT;
* with intact oral cavity on the first day of conditioning.

Exclusion Criteria:

* present any adverse reaction to the active principles of Chamomilla recutita;
* receive oral or intravenous anticoagulation therapy;
* use oral or systemic topical anti-inflammatory medication;
* receive any other type of intervention for mucositis not included in the standard oral care protocol.
Bendamustine in Patients With Refractory or Relapsed T-cell Lymphoma

A Phase II clinical study to determine the efficacy of single agent Bendamustine for T cell lymphoma "BENTLY".

The primary objective of this study is to define the activity of Bendamustine for the treatment of T cells lymphomas. The activity of Bendamustine is determined by the response rate (RR) to the treatment within 22 days after intravenous infusion which enables to get a confidence interval of 95 % for the probability of an overall response rate (ORR).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years.
* Refractory or relapsed peripheral T-cell NHL (PTCL)
* Cutaneous T cell lymphoma (CTCL) in relapse or refractory to topical therapy
* ECOG score less than 2
* No major organ dysfunction unrelated to lymphoma.

Exclusion Criteria:

* Pregnant or breast feeding women
* ECOG score \> 2
* Estimate survival time \< 3 months
* Active infection or severe organ dysfunction or psychiatric condition that unable patients to receive chemotherapy
* Creatinine clearance \< 10 ml/min or severe hepatic dysfunction not related to lymphoma.
* Previous chemotherapy/immunotherapy within 3 weeks before study entry
* Known seropositive for or active viral infection HIV, EBV, HCV
* CNS lymphoma
* T-cell Leukemia lymphoma associated with HTLV1
* Sezary syndrome
Treatment De-Intensification and Residual HIV-1 in Youth

This laboratory-based sub-study of ATN 061 and ATN 071 will examine the effect of early treatment followed by treatment de-intensification to atazanavir/ritonavir (ATV/r) monotherapy on steady-state frequencies of replication-competent CD4+ T cell Human Immunodeficiency Virus (HIV)-1 reservoirs or cell-associated infectivity (CAI) and persistent low-level viremia (LLV), and their contribution to successful long-term control of HIV-1 replication among HIV-1 infected adolescents and young adults.


Eligibility Criteria:
081 participants must first be enrolled in either ATN 061 or ATN 071 and meet the eligibility criteria of those protocols in addition to those below.

Inclusion Criteria:

061 Participants

* Currently on treatment with an ATV/r-based HAART regimen (ATV/r, FTC, TDF is the preferred regimen);
* HIV-1 viral load \< 100 copies at week 24;
* CD4+ T cell count \> 350 cells/mm3 at week 24; and
* Able to provide informed consent for the sub-study and adhere to the protocol.

  071 Participants
* Initiated HAART according to current DHHS guidelines (CD4+ T cells \< 350 cells/ mm3);
* Currently on treatment with a PI-containing HAART regimen; subjects taking a protease inhibitor OTHER than ATV/r must receive approval by the team via the ATN QNS;
* Plasma HIV-1 viral load \< 100 copies at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy;
* CD4+ T cell count \> 350 cells/mm3 at week 24 on HAART; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy; and
* Able to provide informed consent for the sub-study and adhere to the protocol.

General Exclusion Criteria:

* Currently enrolled in the Standard Care Arm of ATN 061;
* Pregnancy or breast feeding;
* Severe (Grade ≥ 3) anemia or other conditions that would not allow adequate blood volume to be drawn;
* Active treatment for systemic infections;
* Treatment with immune modulators, including immunosuppressive or immune modulating therapy (IL-2, intravenous gammaglobulin, and therapeutic or other experimental vaccines including HIV-1 vaccine given for primary prevention at any time (short courses (\<14 days) of prednisone for reactive airway disease (RAD) are permitted);
* Active hepatitis B infection as defined by Hepatitis B antigen (Ag) positive;
* Disallowed Medications (see Section 5.3.2);
* Active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study; or
* History of chronic renal insufficiency or Grade 3 or greater serum creatinine.

  061-Specific Exclusion Criteria
* History of an Acquired Immunodeficiency Syndrome (AIDS)-defining illness;
* Meets any ATN 061 exclusion criteria for de-intensification; or
* Meets any ATN 061 premature study discontinuation criteria.

  071-Specific Exclusion Criteria: None
Use of EtCO2 as a PaCO2 Predictor Under Non Invasive Ventilation (NIV) in Cases of Acute Hypercapnic Respiratory Failure

In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.


Eligibility Criteria:
Inclusion Criteria:

* ICU patient equipped with arterial line
* NIV requirement
* Hypercapnia: PaCO2 \> 45mmhg

Exclusion Criteria:

* Severe hemodynamic instability
* Severe psychiatric disorders
* nasal lesions
* denied consent
Leave or Laparoscopic Appendectomy With Normal Findings - a Regional Cohort Study

Based on a regional cohort, this study we will try to demonstrate the superiority of routine laparoscopic appendectomy vs. leaving an intraoperative assessed normal appendix in situ in cases of normal findings at diagnostic laparoscopy. If routine laparoscopic appendectomy is not superior, we will recommend leaving the "normal" appendix in situ.

The study is a retrospective cohort study with a superiority design. It will be carried out at the surgical departments of the four public university hospitals providing emergency surgical service to the entire population of 1,8 million in the Capital Region of Denmark.

On March 17, 2017, a new electronic health record (EHR) had been implemented at three of the hospital, while it was implemented at Copenhagen University Hospital - Bispebjerg on May 20, 2017. These dates mark the start of the inclusion period for each hospital, while the inclusion period ended April 1, 2021 for all four hospitals.

The "snap boards" covering the relevant operation rooms at the four hospitals will be systematically review. For all cases, where diagnostic laparoscopy was performed on suspicion of acute appendicitis, the EHR will be reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic laparoscopy with normal intraoperative findings (including mesenteric adenitis
* Laparoscopic appendectomy and a histopathological normal appendix and otherwise normal intraoperative findings (including mesenteric adenitis)

Exclusion Criteria:

* Diagnostic laparoscopy with abnormal intraoperative findings.
* Laparoscopic appendectomy and a histopathological non-normal appendix.
* Laparoscopic appendectomy and a histopathological normal appendix and abnormal intraoperative findings.
Inhaled Corticosteroids in U-5 Children With Acute Respiratory Infection in Uganda: A Randomised Trial

The purpose of this study is to find out whether adjunct treatment with inhaled corticosteroids lead to faster improvement and reduce mortality of children under 5 years of age admitted to hospital with ALRI.

Pneumonia is one of the common causes of serious illness in children under 5 years of age. It is one of the common causes of admission to hospital and the commonest cause of death in Ugandan children under 5 years of age. The signs of pneumonia also occur in children with asthma making it difficult to differentiate the two. Other researchers have found that one of two children under five years of age with pneumonia have asthma. Wheeze which is regarded as a sign of asthma is heard in only one of three children with asthma, implying that many children with asthma especially in the first few years of life are less likely to be diagnosed. They are also less likely to receive inhaled steroids, the recommended treatment for asthma. Failure to administer asthma medicines may contribute to delayed improvement and increase the risk of death. The study hypothesizes that use of inhaled corticosteroids in addition to standard treatment in children hospitalized with ALRI will be associated with reduced morbidity and mortality and that the improvement will be more marked in children diagnosed with asthma posthoc. Outcomes: Reduction in case fatality, Time to normalization of respiratory rate, Time to normalization of oxygen saturation, Duration of hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* children aged 2 to 59 months with cough and or difficult breathing

Exclusion Criteria:

* Presence of a serious concurrent illness such as meningitis, Children with congenital or acquired heart disease Severe anaemia Measles pneumonia Foreign body inhalation A confirmed diagnosis of pulmonary tuberculosis
Deep Learning Algorithms for Prediction of Lymph Node Metastasis and Prognosis in Breast Cancer MRI Radiomics (RBC-01)

This bi-directional, multicentre study aims to assess multiparametric MRI Radiomics-based prediction model for identifying metastasis lymph nodes and prognostic prediction in breast cancer.

Sensitivity for prediction of lymph node metastasis and survival of currently available prognostic scores in limited. This study proposes to establish a deep learning algorithms of multiparametric MRI radiomics and nomogram for identifying lymph node metastasis and prognostic prediction of breast cancer. The study will investigate the relationship between the radiomics and the tumor microenvironment. The study includes the construction of multiparametric MRI radiomics-based prediction model and the validation of the prediction model.

Eligibility Criteria:
Inclusion Criteria:

* The primary lesion was diagnosed as invasive breast cancer
* Patients can have regional lymph node metastasis,but no distant organ metastasis
* Complete the breast MRI examination before treatment
* Accept breast cancer surgery or lymph node biopsy
* Eastern Cooperative Oncology Group performance status 0-2

Exclusion Criteria:

* Inflammatory breast cancer
* Accompanied with other primary malignant tumors
* Perform surgery,radiotherapy and lymph node biopsy before breast MRI examination
* Patients who have neoadjuvant chemotherapy
* Patients had distant and contralateral axillary lymph node metastasis
* The pathologic diagnosis was extensive ductal carcinoma in situ
Outpatient Follow-up on Demand in Rheumatoid Arthritis

A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. Patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity and reporting of outcomes measures on a touch screen at the clinic.

A two-year randomized controlled trial with rheumatoid arthritis (RA) patients. At baseline, patients were randomized electronically with stratification according to biologic and non-biologic treatment to the open outpatient clinic programme, or usual care. Patients were evaluated at baseline, year 1 and 2, including assessment of disease activity (DAS-28), blood tests, bone erosions on plain radiographs of hands and feet, and patient reported outcome measures.

The objective of the study was to compare an outpatient system for Danish RA patients based on patient self-controlled outpatient follow up on demand, Open Outpatient Clinic Programme with traditional scheduled routine follow-up regarding patient satisfaction and effect on traditional disease markers.

The Danish National Patient Registry (DANBIO) was used to identify eligible patients with RA. At pre-planned routine visits with the rheumatologist, identified patients were screened according to inclusion and exclusion criteria.

The intervention group had no scheduled appointments at the outpatient clinic, but they could book acute appointments with their contact rheumatologist within 5 days or less whenever they deemed it necessary. They also had access to nurse-led consultations without pre-booked appointments and to a nurse-led telephone helpline

Eligibility Criteria:
Inclusion Criteria:

RA. Disease duration of at least 1 year.

Exclusion Criteria:

Patients treated with monthly intravenous biological medicine
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction

The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 18 years of age;
* Minimum 6 months of erectile dysfunction;
* In a monogamous, heterosexual relationship for at least 3 months;
* Agree to make at least 4 attempts at intercourse per month;
* Provide written informed consent;
* Agree not to use any other ED treatments for erectile dysfunction;
* Willing and able to comply with all study requirements.

Exclusion Criteria:

* Allergy or hypersensitivity to PDE5 inhibitors;
* History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;
* Concomitant use of one or more of the following medications:

  * Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
  * Dose of an alpha blocker that has not been stable for at least 14 days;
  * Any nitrate;
* ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
* Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
* Unstable angina, angina with sexual intercourse, or congestive heart failure \> NYHA Class II;
* Poorly controlled type 1 or type 2 diabetes;
* Evidence of prostate cancer or previous radical prostatectomy;
* Untreated hypogonadism or total testosterone levels outside normal reference range;
* Abnormal laboratory value(s) judged to be clinically significant by the investigator;
* Positive urine drug screen;
* History of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma;
* Previous participation in any other study with avanafil;
* Use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study;
* Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.