cyrilzakka/clinical-trials huggingface dataset:
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study


Eligibility Criteria:
Inclusion Criteria:

* Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
* Current asthma therapy: The patient is currently being treated with 1 of the following:

  1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
* Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
* The patient is a pregnant or lactating female or plans to become pregnant.
* The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
* The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
* The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
* Other criteria apply, please contact the investigator for more information
Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose

This project aims to compare the acute metabolic effects of the three sweeteners sucrose, glucose, and fructose on GI hormones (GLP-1, PYY, CCK, and ghrelin).

Furthermore, glycemic control, erythritol and xylitol concentrations, blood coagulation function , blood lipids, uric acid, high-sensitive C-reactive protein (hsCRP), complete blood count, gastric emptying, appetite-related sensations, and GI symptoms will be investigated.

Sugar should not be defined by origin (added sugar, free sugar, simple sugar) but rather by chemical structure (sucrose, glucose, fructose, etc.). Although the disaccharide sucrose is hydrolysed by sucrase into its monosaccharides glucose and fructose, the administration of each of the three sweeteners alone results in different metabolic effects.

Although sucrose, glucose, and fructose are long known sweeteners in food and beverages and their metabolic effects have been extensively studied, there are still no comprehensive studies comparing the three sweeteners in a whole range of parameters. The main inconsistency in the literature is the study design which influences the outcomes. It is important to differentiate whether it is an acute or chronic study, whether the participants are adults or children, are healthy or have T2DM, have normal weight, overweight or obesity, whether the dosage is chosen to be isocaloric or isosweet, whether there is a control group or whether the sweeteners are administered orally or intragastrical.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-diabetic (glycated hemoglobin (HbA1c) \< 5.7%, fasting glucose \< 5.6 mmol/L), and normal weight participants with a body-mass index (BMI) of 19.0-24.9 kg/m2, parameters of complete blood count within normal range
* Age 18-55 years
* Stable body weight (± 5%) for at least three months
* Able to give informed consent as documented by signature

Exclusion Criteria:

* Fructose intolerance
* Any pre-existing diet (e.g., vegetarian diet, vegan diet, sugar free diet, paleo diet, Atkins diet, ketogenic diet) that deviates from normal eating habits
* Regular consumption (\>1/ week) of erythritol or xylitol
* Regular intake of medications, except contraceptives
* Pre-existing impairment of blood coagulation/thrombocyte function (e.g. hereditary, regular intake of anti-coagulant agents (e.g. NSAIDs, heparin, warfarin, etc.))Chronic or clinically relevant acute infections/diseases
* Substance abuse (more than 1 glass wine/beer per day; regular consumption of cannabis, consumption of cocaine, heroin, etc.), regular smoking
* Pregnancy: although no contraindication, pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants a urine pregnancy test is carried out upon screening.
* Shift worker
* Participation in another study with investigational drug within the 30 days preceding and during the present study
APT001 Plasma/NO Generator to Treat Diabetic Foot Ulcer in Adults

This is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the APT001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.

Approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. The nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. Subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. The wounds of both groups will be treated with sharp debridement as determined by the site Investigator. A collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy.

For an initial safety evaluation in patients with DFU, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. Following completion of the final assessment in these 10 patients, data will be submitted to FDA for review and approval before opening the enrolment for the remaining patients.

Eligibility Criteria:
Inclusion Criteria:

* 19 to 80 years of age
* Type 1 or 2 diabetes with hemoglobin A1c less than 12%
* ABI ≥ 0.7, palpable pulses and/or biphasic waveform study with Doppler
* Wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less)

Exclusion Criteria:

* Have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound
* Have a severe infection in the ulcer including the presence of an abscess, cellulitis extending \> 2 cm beyond the ulcer margin, or osteomyelitis
* Have involvement of deeper tissues including bone or tendon
* Be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound
* Have received topical or systemic antimicrobial therapy within 48 hours of screening
* Have a malignancy other than skin cancer currently being treated
* Have substance abuse issues within the 6 months prior to screening
* Is a woman who is pregnant or breast feeding
* Has been treated with another investigational product within 30 days of screening
* Has been treated with tissue engineered skin or a biological therapy within 30 days of screening
Evaluating System Accuracy and User Performance of Omnitest® Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus

The aim of this study is to determine the System Accuracy and User Performance evaluation of the mentioned BGM systems by gaining a sufficient amount of measured data from capillary blood.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with type 1 or type 2 diabetes, for the evaluation of System Accuracy also healthy subjects
* Age ≥ 18
* Signed and dated informed consent form
* For small modifications of the insulin doses to achieve certain blood glucose values (System Accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy - I.C.T.) or insulin pump therapy (continuous subcutaneous insulin infusion - C.S.I.I.)

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute illness that, in the opinion of the investigating physician, might confound the results of the test or which could result in a risk to the subject caused by the test.
* Severe chronic illness besides Diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the subject caused by the test.
* Mental incapacity or language barriers precluding adequate compliance with the test procedures
* Legal incompetence or limited legal competence
* Dependency from the Sponsor or the clinical Investigator (e.g. co-workers of the Sponsor or the clinical research centre)
* For User Performance evaluation: Subjects having participated in a study with Omnitest® 5 before.
* For System Accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease or impaired hypoglycaemia awareness
* Anamnestically relevant amounts of interfering substances in the blood, following labelling in the instructions for use as reviewed and evaluated by a physician during screening.
Intermittent Pneumatic Compression to Improve Revascularization Outcome

The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.

Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Scheduled for endovascular revascularization of one or both lower extremities.

Exclusion Criteria:

* Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
* Open and/or non-healing wounds in the areas covered by IPC cuff
* Walking limited by a symptom other than PAD
* Presence of any clinical condition that makes the patient unsuitable to participate in the trial
* Concern for inability of the patient to comply with study procedures and/or follow-up
Midodrine for the Treatment of Refractory Hypotension

We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of stay without increasing MGH length of stay or putting the patient at risk of being readmitted to an ICU.

Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the intensive care unit (ICU). In our hospital, in patients with adequate tissue perfusion, midodrine has been observed to treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge. There are several possible etiologies of hypotension in the ICU. The most frequently seen causes include septic shock, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, midodrine may prove to be a useful adjunctive medication to successfully increase blood pressure. No previous studies have examined the use of midodrine for the treatment of hypotension in an ICU setting. Therefore, we are investigating a new indication for midodrine as the treatment of hypotension in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Admitted to the SICU
* Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8 mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more than 24 hours while still maintaining desired blood pressure goal

Exclusion Criteria:

* Inadequate tissue oxygenation
* Liver failure
* Renal failure
* Hypovolemic shock or hypotension due to adrenal insufficiency
* Pregnancy
* Severe organic heart disease
* Urinary retention
* Pheochromocytoma
* Thyrotoxicosis
* Midodrine as pre-admission medication
* Any known allergies to midodrine
* Enrollment in another clinical trial
Effects of Rosiglitazone on the Metabolic Phenotype of Impaired Glucose Tolerance in Youth

The purpose of the study is to determine whether treatment of children and adolescents with Impaired Glucose Tolerance (IGT) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.

Impaired Glucose Tolerance (IGT) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. This condition tends to progress to Type 2 Diabetes Mellitus (T2DM) at an alarmingly rapid tempo. The increased prevalence of childhood and adolescent obesity and greater risk of IGT, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. The investigators found that obese children and adolescents with IGT are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. Furthermore, the investigators found an impairment of the acute insulin response in these youngsters. Follow-up revealed a rapid deterioration from IGT to frank diabetes. Based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity.

The primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with IGT, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. Secondary objectives are to determine whether rosiglitazone is safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Aged 10 to 18 yrs (females: Tanner stage II-V;and males:testes size\>6ml)
* IGT based on 2-hr plasma glucose\>140mg/dl and \<200mg/dl during an OGTT.

Exclusion Criteria:

* Baseline creatinine\>1.0mg
* AST and ALT\>2.5 ULN
* Anemia (Hct\<30)
* Pregnancy (females must have a negative urine pregnancy test during the study)
* Cardiac or pulmonary or other significant chronic illness
* Plans to increase the frequency or intensity of a regular exercise program
* Psychiatric disorder or substance abuse of anorexic agents.
Matrilysin Expression in Different Stages of Colorectal Tumors

Matrix metalloproteinases (MMPs) have been shown to be involved in cancer biology. Significant expression of MMP-7 (matrilysin) in colorectal cancer is mainly associated with metastatic disease even though it is expressed in most tumor states. Our purpose is to analyse MMP-7 in bowel and lymph nodes of different tumor stages and to evaluate its expression as a potential biomarker of cancer disease in patients surgically treated for benign and malignant colorectal tumors. Tumoral tissue, lymph nodes and serum samples from recruited Patients plus serum samples from healthy volunteers are analysed for matrilysin expression by histology, immunohistochemistry, ELISA and Western blotting.

If Matrilysin increases with increasing dysplasia and cancer disease stage in tumor tissue as well as in the regional lymph nodes it might be used as a complement in investigating suspected locally advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* benign colonic neoplasm not suitable for endoscopic treatment,
* malignant colonic neoplasm with indication to primary surgical treatment

Exclusion Criteria:

* neo-adjuvant radiotherapy,
* chemo-radiotherapy,
* language problems and withdrawal of consent
Elevate to Alleviate Evidence Based Study

Venous return in the circulatory system of lower limbs results from the interaction of several mechanisms, and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position especially with leg elevation. In fact, patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.

The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.

The venous system makes the blood return to the heart with low-pressure and slow-velocity flow, within the venous system. Venous return results from the interaction of diverse mechanisms, such a central pump (respiratory cycle and the heart), a pressure gradient, a peripheral venous muscular pump, and the veins valvular system. Therefore, the venous volume in the lower limb is the result of the interaction between these mechanisms and reflects the balance between blood inflow and outflow. Blood outflow improves during sleeping because of the lying position and, in this position, even more with leg elevation. In fact, it is known patients with chronic venous disease (CVD) improve leg symptoms in lying position and with leg elevation.

The aim of this study is to evaluate the level of comfort of hospital inpatients, without CVD, if they lie with a moderate leg elevation during hospital stay.

Unselected patients with a hospital stay of at least seven days will be recruited and random assigned to two groups of patients: Group A, that will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees). Group B, that will lie in their hospital bed without leg elevation.

All patients will undergo echo duplex scanning of vascular system of lower limbs to exclude any vascular disease.

For every patient complete demographic and comorbidity data will be collected. Every single the day, the following parameters will be retrieved for each patient: ankle and calf diameters, heart rate, blood pressure, breath frequency, body temperature, leg heaviness (rating scale 1-10), perceived leg comfort (rating scale 1-10), hours of night sleep (number).

Eligibility Criteria:
Inclusion Criteria:

* Every hospital inpatient with at least 7 hospital stay.

Exclusion Criteria:

* Patients with vascular or osteoarticular leg problems that affect or prevent leg elevation during rest.
Hemoglobin Concentration in Patients With an Acute Respiratory Distress Syndrome

Retrospective analysis of hemoglobin concentrations and red cell transfusion thresholds in patients with an Acute Respiratory Distress Syndrome (ARDS) admitted to an ARDS-center of a German university hospital.

Transfusion of packed red blood cells is a common procedure in critically ill patients. In recent years it has been shown that for many patient populations a restrictive transfusion strategy is not inferior compared to a liberal transfusion strategy with regard to overall outcome.

So far it is unclear whether patients with an ARDS should receive blood transfusions according to a restrictive or liberal transfusion strategy. Besides pulmonary gar exchange and cardiac output, the hemoglobin concentration is an important determinant for oxygen delivery.

The aim of this retrospective observational study is to analyze if low levels of hemoglobin/a restrictive transfusion strategy and are associated with a different mortality compared to higher levels of hemoglobin/a liberal transfusion strategy in patients with an ARDS.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with ARDS
* Admission to the Charité ARDS center

Exclusion Criteria:

* All patients \<18 years at the time of admission
* All patients with ARDS not admitted to the Charité ARDS center