cyrilzakka/clinical-trials huggingface dataset:
Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory
* Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner
* Suffer from a life threatening disease or has a history of any clinically significant disease or disorder
* History of acute idiopathic or chronic pancreatitis
* Calcitonin value equal to or above 50 ng/L
* Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10\^9/L (normal range is 3.91 to 8.77x10\^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L)
* Any clinically significant abnormal ECG, as judged by the investigator
* Subjects who are smokers
Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers

The goal of this project is to use genomic profiling, candidate genes and proteins to develop guided surgical debridement to improve healing in chronic non-healing venous leg ulcers (VLUs) and to test the efficacy of this approach.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Conformation of venous disease by non-invasive venous studies with either Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie blanche, edema)
3. have a venous ulcer between the knee and ankle, at or above the malleolus
4. wound size would be greater than or equal to 5cm2 in area without exposed tendon, muscle or bone
5. wound duration of at least 6 months
6. VLU containing yellow/white slough with or without fibrous/scar tissue and/or non-viable tissue
7. ability of subject to tolerate limb compression bandage

Exclusion Criteria:

1. history of diabetes mellitus and a HbA1c \> 12% (obtained within past 6 months)
2. Ankle brachial index(ABI) less than 0.80
3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in remission for at least 5 years
4. suspicion of malignancy within VLU
5. life expectancy \<6 months
6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6 months)
7. history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin) \>2x upper limit of normal (obtained within past 6 months)
8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry
9. history of immunodeficiency
10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology
11. Untreated osteomyelitis
12. Hepatitis
13. acute deep venous thrombosis
14. allergy to lidocaine and/or epinephrine
15. Subject's inability to successfully tolerate compression therapy that is changed weekly
16. Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g. cell therapy or growth factors)
17. if currently incarcerated
18. known pregnancy
Trial to Evaluate the Immune Response to OPV When Administered Concomitantly With CAIV-T to Healthy Children.

Phase III trial to evaluate the immune response to oral poliovirus vaccine (OPV) when administered concomitantly with CAIV-T to healthy children.


Eligibility Criteria:
Inclusion Criteria:

* who are aged at least 6 months and less than 36 months of age at the time of first vaccination
* who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life
* who are in good health as determined by medical history, physical examination and clinical judgement
* whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
* who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (3 months)
* whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].

Exclusion Criteria:

* whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease
* with Down's syndrome or other known cytogenetic disorders
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (see Section 4.2.1)
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study
* have an immunosuppressed or an immunocompromised individual living in the same household
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)
* with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination or for which use is anticipated during the study
* with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results.

If any of these criteria are met following enrollment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
Home-based Cognitive Monitoring in MCI

This study is an observational study to confirm usefulness of a home-based cognitive monitoring in non-demented patients with high-risk of dementia

We prospectively enroll subjects who were diagnosed as mild cognitive impairment based on neuropsychological tests battery, brain MRI, and routine blood labs including thyroid function tests, vitamine B12 \& folate levels, and syphilis screening to rule out other secondary causes of dementia. We undergo peripheral blood-based amyloid beta levels and regular home-based cognitive monitoring (every 3 months) to investigate whether amyloid-positive MCIs progress rapidly using home-based cognitive monitoring during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* persistent cognitive complaints
* aged 50 years old or older
* below -1.0 standard deviation in any domain of detailed neuropsychological tests battery named SNSB (Seoul neuropsychological screening battery)
* no ADL (activities of daily living) limitation
* subjects who agreed to participate

Exclusion Criteria:

* dementia patients
* other structural brain disorders such as hydrocephalus, hemorrhage, or tumors
* other neurological disease such as Huntington's disease, Parkinson's disease, or epilepsy
Reduce Pediatric Sedation to Reduce Mechanical Ventilation Complication in ICU

Mechanical ventilation is a common procedure used in pediatric intensive care units (ICU). Its use requires almost always the establishment of a sedation. Sedation is a generic term for all procedures, pharmacological or not, ensuring physical and psychological comfort and the safety of patient admitted in intensive care units.

An inadequate sedation, insufficient or excessive, has common side effects, as increase of the duration of mechanical ventilation and of hospital-acquired infections (in particular, ventilator associated pneumonia), of hemodynamic disorders, of extubation failure or accidental extubation, of withdrawal syndrome, and of post-traumatic stress disorder (PTSD). All these complications increase mechanical ventilation time and ICU length of stay. Several studies in adult's population have shown that the implementation of a sedation algorithm allowed to decrease the incidence of these complications.

We hypothetized that the duration of mechanical ventilation would be reduced by a nurse-implemented sedative management protocol.

1. During the first period (15 months), no protocol is used. This period consists to assess current analgesia-sedation procedure used in the pediatric intensive care unit (PICU), associated with the collection of medical and socio-demographical data about mechanical ventilation duration, sedation complications, PTSD development. The severity of pathology can be evaluated using PIM2 and POPC scores. The sedation deepness will be determined using COMFORT-B scale. Eight weeks after hospitalization, families will be phoned to assess children memories, anxious troubles, and PTSD symptoms for the patients of more than 18 months old.
2. During the transition period (6 months), nurses and physicians develop the protocol and undergo training in its use.

During the third period, a nurse-implemented sedation is used. The collected data are the same that the collected data during the first period

Eligibility Criteria:
Inclusion Criteria:

* Children aged 28 days to 18 years
* Admitted in pediatric intensive care unit
* Necessity of mechanical ventilation \> 24 hours.

Exclusion Criteria:

* Sedation started in another intensive care unit \> 24 hours
GeRIatric Multidisciplinary Meeting

The primary objective of this study is to develop a typology of patients referred to the Geriatric Multidisciplinary Meeting (GMM) according to their demographic and clinical profile.

The secondary objectives are:

* To distinguish the different types of answers given by the GMM according to the demands and situations.
* To study the factors associated with the orientation proposed by the GMM
* To examine the adequacy between the orientation proposed by the GMM and the pathway actually taken
* To compare the diagnoses made during the following year with the data collected during the GMM

Increasing attention is paid to care pathways for elderly according to the principle of good care applied to the right patient at the right time and in the most appropriate care structure.

Since 2007, the geriatric mobile team (GMT) of the Angers University Hospital has formalized a geriatric multidisciplinary meeting (GMM) in connection with the geriatric network and branch of the geographical sector, in order to optimize the provision of care for elderly patients at the territorial level.

The weekly GMM brings together physicians from the geriatric department (GMT, acute care unit), memory center, long-term care and skilled nursing facilities, cognitive behavioral unit, psychiatry, retirement home, the local geriatric network of the city of Angers, the local information and coordination center, the home for autonomy and integration of Alzheimer patients (MAIA) and specialized Alzheimer (ESA) teams. Requests come either University Hospital services or from outside, via a standardized form. If necessary, additional data collection is carried out before the meeting by telephone with the patient, his family or the general practitioner. A letter explaining the decision of the GMM is sent to the applicant physician and to the general practitioner and recorded in the patient file.

Collegial guidance decisions within the health care system seem to follow implicit rules. Given the growing number of files presented, the investigators want to theorize the adopted mode of reflection.

Eligibility Criteria:
Inclusion Criteria:

* All the files discussed in GMM in the year 2015 following a request for geriatric care addressed to the Geriatrics department of the UH

Exclusion Criteria:

* No one
Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites

Kidney failure is a devastating illness requiring treatment with dialysis or transplantation to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis (PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube (catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients can have complications at this exit site. One possible complication is over-granulation. Over-granulation occurs as the wound attempts to heal and the skin around the exit site becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating exit site can lead to discomfort, pain, bleeding and harbour infection. More serious complications include dialysis failure, sepsis and death. There are several ways to treat over-granulation but there is limited research evidence to demonstrate which treatment is best. The study aims to compare current standard treatment which involves the application of silver nitrate by qualified nursing staff to chemically burn the tissue away, with an alternative treatment which involves the application of steroid impregnated tape to the area of over-granulating tissue by the patient themselves.

This study will be a United Kingdom wide multi-centre trial. A minimum of 40 patients in each arm will be recruited. Subjects will be identified using a standardised exit site assessment tool by PD nurses in participating units during the routine care of their PD population. Any subject with an over-granulating exit site deemed to meet the agreed standard for treatment will be invited to participate.

Therapy will be administered for two weeks followed by an additional two weeks if clinically indicated. Treatment must be according to randomisation for the first 28 days. If after 14 days the over-granulation is worse than at day 0, then a medical decision to continue treatment may be taken. A further two weeks of the designated treatment may then be administered although this can be discontinued at any point if a satisfactory clinical response is observed.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been established on PD for \> 3 months
* Subject has an over-granulating exit site judged to require treatment according to standard (appendix 1)
* If patient has exit site infection, they must currently be treated with antibiotics and the site must be clinically improving.
* Subject is \> 18 years of age
* Subject is able to give informed consent

Exclusion Criteria:

* Subject has had peritonitis treated in the previous month
* Subject has been treated with silver nitrate or topical steroids in the previous 2 weeks
* Subject is receiving oral steroids
* Patient is unable to give informed consent
* Patient is participating in a clinical trial of an intervention relating to PD catheters.
* Subject is pregnant or unwilling to use an effective method of contraception during the course of the study
A Trial Of Azithromycin SR For The Treatment Of Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

To evaluate the clinical efficacy and safety in patients with Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis receiving a dose of 2 g of azithromycin in the SR formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed Laryngopharyngitis or Tonsillitis or Acute Bacterial Rhinosinusitis

Exclusion Criteria:

* Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
CMR for Prognosis Assessment in NSTEMI

The prognostic significance of cardiac magnetic resonance (CMR) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-ST-Elevation myocardial infarction (NSTEMI) patients. In the present study the investigators aim to comprehensively investigate the prognostic significance of CMR in a prospective, multicentre registry cohort of NSTEMI patients undergoing early percutaneous coronary intervention (PCI). CMR will be performed within the first week following the index event. The primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.


Eligibility Criteria:
Inclusion Criteria: Patients are eligible for the study if they have: 1) ischemic symptoms in accordance with a possible NSTEMI diagnosis; 2) elevated cardiac troponin levels above the 99th percentile; and 3) identifiable culprit lesion during early invasive coronary angiography with performed PCI.

Exclusion Criteria: 1) STEMI; 2) presence of cardiogenic shock; 3) no identifiable culprit lesion or culprit lesion ineligible for PCI; 4) indication for acute bypass surgery; 5) age less than 18 years or more than 90 years; 6) pregnancy; and 7) typical contraindications to CMR (e.g. severe claustrophobia, implanted pacemakers and internal cardioverter defibrillators, cerebral or intracranial metallic implants, known allergy to gadolinium and creatinine clearance \<30 mL/min).
Global Utilization And Registry Database for Improved heArt preservatioN

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study.

Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution.

This study will be conducted at an estimated 25 institutions globally and will have about up to 3000 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, 1-year, 2-years, 3-years, 4-years, 5-years).

GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning, Inotrope use, CAV diagnosis, rejection, and survival.

Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.

Eligibility Criteria:
Inclusion Criteria:

* Donor and donor hearts matched to the prospective recipient based upon institutional medical practice
* Registered male or female primary heart transplant candidates including pediatric candidates

Exclusion Criteria:

* Donor and donor hearts that do not meet institutional clinical requirements for transplantation
* When safe connection with the aorta cannot be made, e.g., due to lack of enough length of the aortic root
* Patients who are incarcerated persons (prisoners)
* Patients who have had a previous organ transplant
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

OBJECTIVES:

* Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
* Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
* Determine the tolerance of these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after 3 courses, and at treatment completion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic adenocarcinoma of the breast
* Bidimensionally measurable or evaluable disease

  * At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
  * Serous drainage, cutaneous metastasis, osseous metastasis, etc.
* No symptomatic cerebral metastasis
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 75 to 90

Sex:

* Female

Menopausal status:

* Postmenopausal

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3

Hepatic:

* Alkaline phosphatase less than 3 times normal
* Bilirubin less than 1.5 times normal
* Transaminases less than 3 times normal
* Total protein greater than 60%
* Albumin greater than 30 g/L

Renal:

* Creatinine clearance greater than 60 mL/min

Cardiovascular:

* LVEF greater than 50% by echocardiogram or scintigraph
* ECG normal
* No uncontrolled angina
* No myocardial infarction within past 6 months

Other:

* No other medical illness or condition that would preclude study
* No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
* No psychological, social, familial, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior adjuvant chemotherapy allowed
* No prior adjuvant anthracyclines
* No prior chemotherapy for metastatic disease

Endocrine therapy:

* One or two prior regimens of hormonal therapy allowed for metastatic disease

Radiotherapy:

* No prior radiotherapy for metastatic disease

Surgery:

* Not specified

Other:

* No concurrent participation in another study