cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 65mmHg or in salvage. Several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. We hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure.

This bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. Randomisation will be stratified between centers (two university affiliated intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. Patients with acute ischemic or septic heart failure are excluded of the study.

Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score difference between the groups at day 3. Secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and use of renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Dose of norepinephrine greater than 0.3 μg / kg / min
* Lactate greater than 2.0 mmol / l

Exclusion Criteria:

* A left heart failure objectified in ultrasound transthoracique by a fraction of left(awkward) ejection of the ventricle lower than 30 % either by thermodilution transpulmonaire with a cardiac index lower than 2,5 l / min / m2 after optimization of the volémie or a central venous saturation in oxygen ( SVcO2) lower than 60 % after optimization of the blood volume.
* Minors
* Pregnant
* Not having terlipressin allergy
* Not having excipient allergy
* A history known for recent acute coronary syndrome (\< 3mois)
* An acute coronary syndrome defined by an increase of the troponine and a rise of the segment ST in the electrocardiogram
Patient Communication Training Intervention

The purpose of this study is to test a class for Queens Cancer Center patients. We want to find out if patients think this program is helpful.

It is well accepted that effective physician-patient communication is associated with important outcomes. Communication training interventions for oncologists and other clinicians has been shown to be effective in changing behavior and improving outcomes. Less attention has been given to improving cancer patients' communication with their physicians. Most of the studies in this area have been focused on activating patients through training them to ask questions. Although question asking is a vitally important patient communication skill, other patient communication skills should also be encouraged for patients.

In the primary care setting, studies on patient communication training have focused on three additional communication skills to asking questions: presenting information, checking understanding, and expressing concerns. The goal of this study is to pilot test a patient communication workshop that builds on the work done in the primary care setting, offering an intervention that focuses on a broad range of skills. The proposal aims to improve communication skills in an underserved population, which may be a factor contributing to minority health disparities.

Eligibility Criteria:
Inclusion Criteria:

* Patients seeing a physician at Queens Cancer Center (not family members or partners)
* Able to provide informed consent.

Exclusion Criteria:

* Less than 18 years of age (as per self-report)
* Cognitive or physical impairment rendering patients incapable of providing informed consent to participate in the study.
* As the workshop will be given in English and the measures are all written in English, subjects who are not fluent in English will be excluded.
Miradry Treatment for Focal Axillary Hyperhidrosis

Primary hyperhidrosis is a pathological condition characterized by the idiopathic and excessive secretion of sweat beyond normal physiological demand and is localized at particular foci such as the face, axilla, palms of the hands, and soles of the feet. Patients seeking medical attention for hyperhidrosis often report disruptions to their professional and/or social lives due to sweating and subsequently experience many psychosocial difficulties, such as anxiety, social phobia, and depression. Therefore, a psychiatric explanation of causality is frequently offered for these patients during diagnosis. Excessive sweating is often mistakenly interpreted as a symptom of an anxiety disorder and can be cause for social embarrassment, exacerbating emotional stress and social avoidance. As currently constituted, the treatment of secondary psychosocial symptoms in primary hyperhidrosis is poorly understood and requires further investigation.

Primary Objective:

1. To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis.

   Secondary Objectives:
2. To characterize the outcomes of and clinical response to the MiraDry ® treatment system with respect to the aforementioned criteria.
3. To compare the results of non-invasive miraDry ® treatment system to the existing surgical correction with respect to the aforementioned criteria.

Eligibility Criteria:
Inclusion Criteria:

This study will recruit patients diagnosed with focal hyperhidrosis with a known diagnosis of primarily axillary localization.

We will only enroll patients available for both treatment visits. Availability for follow-up visit is optional.

Only patients between the ages of 18 and 29 years when the first HHIQ is administered will be eligible.

The upper age limit was so determined because patients over 29 years often present with psychopathology which is far more recalcitrant to correction of any kind regardless of effectiveness because of the duration of the condition.

The lower age limit was so determined because 18 years and up are the ages for which the miraDry ® procedure has been approved for use by the FDA.

All participants will be screened using the Hyperhidrosis Disease Severity Scale (HDSS).

Only patients reporting their condition as a 3 out of 4 or higher on the HDSS will be eligible for study because preliminary data suggests effective detection of psychological changes only at higher reported levels of sweating severity.

A patient's previous non-invasive treatment course, including but not limited to prescription of psychiatric medication and topical therapies, will not justify exclusion from this study.

Exclusion Criteria:

Patients who are unable to provide informed consent, have known allergies to lidocaine, hibiclens with 4% chlorhexidine, and/or epinephrine, are pregnant (as determined by self-reporting), are unable to take oral antibiotics or antiseptic washes, have heart pacemakers or other electronic device implants, and who need supplemental oxygen are not eligible to participate in this study
Investigating Pathways Between Maternal Nutritional Status, Breastmilk Composition, and Infant Linear Growth in Rural Pakistan

Breastmilk is considered optimal for infant growth and development. However, evidence suggests that breastmilk composition can vary according to maternal nutritional status. Among women in Pakistan, there is a high burden of undernutrition and micronutrient deficiencies. As well, the prevalence of early stunting among Pakistani infants is high. Using a hypothesized pathway model, this study will assess pathways between maternal nutritional status, breastmilk composition, and infant linear growth. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the MaPPS Trial
* Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
* The infant must be term-born (\>37 weeks gestation)
* Infant must be 3 months ± 30 days old at the time of recruitment
* Mothers must be willing to provide a complete breastmilk expression from one breast
* Intervention arm only: mother reports compliance with study-administered MMN supplements at least 50% of the time (i.e., 4 out of 7 days per week)
* Able to provide informed consent

Exclusion Criteria:

* Mother reports mixed feeding in her infant with nutritive feeds (i.e., any provision of formula or animal milk)
* The infant was born preterm (earlier than 37 weeks gestation)
* Mother does not wish to provide a complete breast expression of one breast
* Intervention arm: mother reports compliance with MMN supplements \<50% of the time
Incidence and Impact of ICU-acquired Diaphragm Weakness

ICU survivors are at an increased risk of hospital and ICU readmission. Among the complications of ICU stay, diaphragmatic dysfunction is common, with a prevalence of 60 to 80%, and is associated with increased mortality and prolonged hospital stays. Furthermore, several studies have reported that the observation of impaired respiratory muscle function upon ICU discharge is associated with a poor long-term prognosis. However, the incidence and prognostic impact of persistent diaphragmatic dysfunction at ICU discharge have never been evaluated. The measurement of dyspnea, a composite evaluation of respiratory muscle function, has not been assessed for predicting prognosis upon ICU discharge.

The hypothesis of the project is that the presence of ICU-acquired diaphragmatic dysfunction at ICU discharge is associated with a poorer prognosis within 90 days.

Diaphragmatic function of patients will be assessed by ultrasound within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

ICU discharge will be defined a priori using a checklist. Diaphragmatic activity will be assessed by bedside diaphragmatic ultrasound. Patients will be positioned in a semi-sitting position (trunk inclination between 30 and 45°) to allow for better visualization of the right hemidiaphragm. The diaphragmatic assessment will include the measurement of inspiratory and expiratory thickness to calculate the diaphragmatic thickening fraction (intercostal approach) and the measurement of diaphragmatic excursion (subcostal approach) during the respiratory cycle. These measurements will be taken at rest. Diaphragmatic dysfunction will be defined by a thickening fraction strictly less than 20% and/or a diaphragmatic excursion strictly less than 1 cm at rest.

Dyspnea will be assessed using a visual analog scale (VAS) ranging from 0 (no dyspnea) to 10 (maximum dyspnea). It will be evaluated within 24 hours following the weaning from ventilatory support and on the day the patient is deemed eligible for ICU discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Invasive or non-invasive respiratory support (ventilation, high-flow oxygen therapy, whatever the reason) for at least 48 hours.
3. Weaning from respiratory support (invasive or not) within the last 24 hours.
4. Patient (or trusted person/relative) informed and not opposed to the study.

Exclusion Criteria:

1. Known pre-existing diaphragmatic dysfunction (phrenic lesion, neuromuscular disease, etc.)
2. Patients with tracheostomy
3. Non-communicating patients
4. Patients deprived of liberty by court or administrative order, or under legal protection (guardianship, curators).
A Study of the Effect of Short-term Structured Psychological Care in Patients

The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.


Eligibility Criteria:
Inclusion Criteria:

1. voluntary participation in the study and ability to cooperate with treatment and care;
2. patients who were to undergo enterostomy;
3. age ≥18 years;
4. consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
5. social impact scale (SIS) score ≥24.

Exclusion Criteria:

1. Critically ill and unable to cooperate with the study;
2. Impaired cognitive function that affects communication;
3. Patients with other organic diseases in combination.
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients

The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of African American origin.


Eligibility Criteria:
Inclusion criteria:

1. Glycosylated haemoglobin \>=7 and \<= 10%
2. Age \>=21 and \<= 65
3. Body Mass Index \>=18.5 and \<=38 kg/m2
4. African American origin
5. Signed and dated informed consent prior to admission to the study

Exclusion criteria:

1. Any finding of the medical examination considered clinically relevant by the Investigator
2. Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease including hypertension \>160-100 mmHg (under current treatment), stroke and transient ischemic attack (TIA).
3. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes
4. Clinically relevant diseases of central nervous system or psychiatric disorders or relevant neurological disorders besides polyneuropathy
5. Diagnosis of sickle cell anemia or known chronic anemia
6. History of chronic or relevant infections (for example human immunodeficieny virus (HIV), Hepatitis B)
7. History of relevant allergy/hypersensitivity
8. Intake of drugs with a long half life (\>24hours) within at least one month or less than 10 half lives of the respective drug prior to administration except allowed co medication
9. Alcohol abuse, drug abuse
10. Any laboratory value of clinical relevance that is outside an acceptable range
11. Change of drug dosing of allowed co medication
12. Any (electrocardiogram) ECG value outside the reference range and of clinical relevance.
13. Fasted glucose \>270 mg/dl or randomly determined blood glucose \>400 mg/dl on two consecutive days during screening or wash out
14. Serum creatinine above upper limit normal at screening
Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability

To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation


Eligibility Criteria:
Inclusion Criteria:

(1) Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated

Exclusion Criteria:

(1) Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome
Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

The purpose of this study is to see if the combination of entinostat and pembrolizumab can be an effective treatment for patients with melanoma of the eye (uveal melanoma) that has spread to other sites of the body (metastatic disease). Pembrolizumab is an antibody that helps the immune system to attack cancer cells. Although pembrolizumab has proven clinical efficacy in treating patients with metastatic cutaneous melanoma, an effect on metastatic uveal melanoma has not been established. Entinostat is a histone deacetylase (HDAC) inhibitor that has effects on both cancer cells and immune regulatory cells, thus potentially enhancing the effects of immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years.
* Signed and dated written informed consent before the start of specific protocol procedures.
* ECOG PS 0-1
* Histologically/cytologically confirmed stage IV uveal melanoma
* Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
* Any number of prior therapies (including none), with the exception of anticancer immunotherapy

Exclusion Criteria:

* Active brain metastases (symptomatic and/or requiring corticosteroids) or leptomeningeal metastases
* Previous treatment with anticancer immunotherapy
* Pregnant or nursing (lactating) women
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
* Active autoimmune disease
* Immune deficiency or treatment with systemic corticosteroids
* Use of other investigational drugs (drugs not marketed for any indication) within 28 days before study drug administration
* Life expectancy of less than 3 months
GLP-1 Infusion and Long-Time Fasting

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia has been shown to be preserved during GLP-1 infusion. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men.

Also the effect on 24 hour blood pressure will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure \< 140/90 mmHg, caucasian.

Exclusion Criteria:

* Diabetes in relatives, anaemia, any significant disease, smoking.
Inappropriate Medications Associated With Anticholinesterase and/or Memantine Treatment in the Elderly

In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and over identified as having Alzheimer disease and who have been treated for more than 3 months with anticholinesterase and/or memantine

Exclusion Criteria:

* Patients with decompensated chronic condition or acute phase disease
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion

This study proposed to construct an ultrasound-based diagnostic model for Differentiating Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and prospective part, which are designed for model construction and independent validation, respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the efficacy of the model for identifying malignant breast lesion from benign lesion, and finally promote the application of this diagnostic model in more clinics.


Eligibility Criteria:
Inclusion Criteria:

* female
* with single breast lesion(maximum diameter\>0.8 cm)
* agree to receive follow-up in six months and take the second breast ultrasound six month after the first breast ultrasound, if a benign diagnosis is achieved at the first ultrasound
* sign the informed consent

Exclusion Criteria:

* lost to follow-up
* failed to take the second breast ultrasound six month after the first breast ultrasound
Mannheim Register of Sepsis and Septic Shock

The study aims to investigate clinically and prognostically relevant parameters in patients with sepsis and septic shock within a monocentric observational clinical register.

All consecutive septic patients at the internists intensive care Unit (ICU) at the University of Mannheim are included in the register and follow up during ICU stay and after that. Data of patients' admission status, septic focus, baseline parameters, and comorbidities are collected. Extensive information about echocardiography, electrocardiography, and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2,3, 5,7, and 10). Standard scores for critically ill patients were calculated for the day before admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality, and septic patients' 1-year mortality.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis and septic shock according to current guidelines

Exclusion Criteria:

* other forms of shock not associated with an infection
a Flexible Wound Dressing for the Management of Genital Skin Conditions

The objective of the study is to determine the efficacy of 7-0940 in the management of genital skin conditions in female patients


Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Diagnosed genital skin condition

Exclusion Criteria:

* Unable to give informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products