cyrilzakka/clinical-trials huggingface dataset:
Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic Eczema

The aim of the study is an intra-individual comparison of skin conditions in addition to a patient based assessment of product appearance in the topical treatment of atopic eczema.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged 18 years or older;
* two comparable treatment areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of ≥ 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with

  1. erythema ≥ 2
  2. lichenification ≥ 1
  3. dryness ≥ 1
  4. itching ≥ 1
* Erlangen atopy score sum equal or higher than 10 points (3);
* the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
* female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices \[IUDs\], sexual abstinence or vasectomized partner;
* written informed consent obtained

Exclusion Criteria:

* acne, suntan, eczema, hyperpigmentation or tattoos in the test areas;
* dark-skinned persons whose skin color prevents ready assessment of skin reactions;
* evidence of drug or alcohol abuse;
* pregnancy or nursing;
* UV-therapy within 6 weeks before first treatment;
* symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
* participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study;
* known allergic reactions to components of the study preparations, hypersensitivity against cetostearyl alcohol;
* treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before study day 1and throughout the study period (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
* contraindications according to summary of product characteristics;
* in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
* patient is institutionalized because of legal or regulatory order
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis

The objective of this randomized controlled study was to demonstrate whether fetal hearing can be assessed in utero.

Unselected women at term of pregnancy (37-41 weeks of gestation) undergoing cardiotocography (CTG) according to routine clinical care and with a complete postnatal follow-up were consecutively recruited.

The two groups of women were selected in a random way, and it was an unblended randomization controlled trial (RCT), according to a list created by the website ww.randomization.com.

If the CTG was non-reactive for 10 minutes women who were eligible for the study were randomized into two groups.

An auditive stimulus was generated in group A. This stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.

The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes. Cardiac accelerations on the CTG and fetal movements perceived by the mother were recorded in the ten minutes after the stimulus was produced.

No stimulation was produced in group B, but the CTG was prosecuted until the clinical criteria were satisfied. The total length of the CTG was variable from a minimum of 20 minutes to a maximum of one hour.

All the clinical variables were recorded in the Case Report Form (CRF) in particular the lapse of time needed for the first fetal cardiac acceleration and for the first fetal movement to occur.

A complete postnatal follow-up was obtained through the examination of medical records and parental interview.

A power analysis was carried out using Power Analysis Sample Size (PASS) software (Kaysville,UT,USA) and was conducted before the enrollment started. It was estimated that, for a survival comparison test (Log Rank), given the sample allocation ratio=1:1, 100 cases per group would be needed to validate a hazard ratio between group A and group B of 1.5 with a power of 80% and a Type I error of 5%.

Eligibility Criteria:
Inclusion Criteria:

1. Understand the Italian language;
2. Informative consensus;
3. To be between 18 and 48 years old;
4. To be sure of their gestational age, included between 37 0/0 and 41 5/7 weeks;
5. Single fetus pregnancy in cephalic position;
6. CTG with normal frequency and variability, without cardiac acceleration for 10 minutes, and with no uterine contractions.

Excluding criteria:

1. BMI before pregnancy more than 30 kg/m2, and at the end of pregnancy more than 35 kg/m2;
2. Uterine fibromatosis;
3. Premature rupture of membranes or oligohydramnios;
4. Fetal pathology (malformation or genetic syndromes);
5. Infective illness contract in pregnancy (CMV, herpes virus, rubella, syphilis, toxoplasmosis);
6. Anomalous CTG, or with contractions
7. Gestational diabet with insulin therapy;

7) Cholestasis of pregnancy; 8) Use of corticosteroids within the last hours; 9) Use of prostaglandins for cervical ripening, within the last hours.
Effects of Exercise Training in Patients With Atrial Fibrillation and Sleep Apnea: A Pilot Study

Background: There are still many gaps in research concerning the effect of different physical training modalities on sleep deprivation in the population with different types of sleep apnea. Aims: The purpose of this study was to examine the effect of moderate-intensity interval training (MITT) on patients with different types of sleep apnea.

Methods: 15 Participants aged 45-65 years were randomized into two groups: obstructive sleep apnea group (OSA), and central sleep apnea group (CSA). The training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph together with the Pittsburg sleep quality index (PSQI) was used in sleep quality assessment. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one-minute intervals. The participants kept the device for a period of 96 hours, filled PSQI, and did 6MWT before the first and last training sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have AF confirmed by ECG
2. Their ages range from 45 and 65 years of age
3. Medically stable patients.
4. Current complaint of poor Sleep quality (SQ) (score \> 5 of the SQ scale)
5. Patients who have OSA or CSA confirmed by polysomnography

Exclusion Criteria:

* Any patient was known to have any unstable medical condition;or with any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise, was excluded from the study.
Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery

In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava respiratory variations in 540 medical and surgical ICU patients. But this indicator has not been investigated yet in cardiac surgery. The investigator aim to study respiratory variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.

In post-operative cardiac surgery patients with hemodynamic failure, the investigator will measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography). Then, the investigator will evaluate fluid responsiveness after a fluid challenge (Trendelenburg).

A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of this parameter.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamic instability with hypotension,
* Low cardiac output or norepinephrine requirements in the first 6 post-operative hours.

Exclusion Criteria:

* TEE (Trans oesophageal echocardiography) contra-indication
* Trendelenburg contra-indication
the Bispebjerg Study of Diurnal Variations

To evaluate the influence of time of day on the circulating concentrations of various biochemical markers in healthy men


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Normal sleep-wake pattern

Exclusion Criteria:

* acute or chronic medical diseases
* had worked nightshifts the last 14 days before the study
* transatlantic traveling the last 14 days before the study
* had been smoking the last 14 days before the study
* had an irregular sleep-wake pattern,
* didn't sleep 7-8 hours pr night
* were extreme morning- or evening types,
* had plasma hemoglobin \< 8.0 mmol/L
* ody mass index (BMI) \<18.5 kg/m2 or \>24.9 kg/m2.
Sit-to-stand in Spinal Cord Injury Patient

1. Were there differences in functional ability between ambulatory individuals with SCI who passed and failed the independent sit-to-stand (iSTS) task?
2. Did the ability of iSTS relate to ability of walking as determined using a type of AAD used?
3. What were factors associated with the ability of iSTS?

* To evaluate the proportion and compare functional abilities between subjects who passed and failed the independent sit-to-stand (iSTS) task.
* To assess the relationship between ability of iSTS and types of AAD used.
* To investigate factors associated with the ability of iSTS.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients with iSCI from both non-traumatic and traumatic causes
* Aged at least 18 years
* Who are able to walk independently with or without AADs at least 15 meters continuously \[FIM locomotor (FIM-L) scores = 5 to 7\]

Exclusion Criteria:

* Any patients with conditions that might affect ambulatory ability; such as brain function disorders, visual deficits, musculoskeletal pain (VAS \> 5), deformity of the musculoskeletal system, unable to follow a command of the tests, unstable medical conditions.
Pregnancies and Cystic Fibrosis

There have been substantial advances in care for individuals with CF, including improved nutrition and respiratory care. Women with CF are now likely to survive into adulthood with a median predicted survival of 49.7 years in 2012, which have resulted in increasingly normal lifestyles, including successful pregnancies in women with CF. The number of pregnancies in CF women has increased as reported by the 2013 Annual Data Report from the French CF Registry (6 pregnancies in 1992 to 53 in 2012). Pregnancy adds many physiological stresses to the body, particularly on pulmonary function (decrease in residual volume, expiratory reserve capacity) and nutritional status (increase in nutritional needs). In women with CF, these added stresses could theoretically affect survival, with difficulties to maintain adequate nutrition and an unpredictable effect on lung function. A number of studies published over the past 15 years have attempted to clarify the risk of pregnancy in women with CF to guide clinicians and women. Many authors compared the outcomes of pregnant CF women to non-pregnant CF women regardless of nutritional status, lung function, diabetes mellitus, bacteriological colonization. In literature, pregnancy was possible and well tolerated in CF women with mild disease if associated with more intensive monitoring and aggressive treatment during pregnancy, with particular emphasis on nutrition and weight gain. CF women have an increased likelihood of receiving treatment for diabetes both during and after pregnancy. Furthermore diabetes mellitus has been associated with more severe pulmonary disease, more frequent pulmonary exacerbations, poorer nutritional status and a reduced life expectancy. Pre-pregnancy diabetes mellitus is associated with a poorer prognosis for pregnancy in general population. Severe forms of CF, including pre-pregnancy diabetes mellitus might as well do badly with accelerated decline after pregnancy. To determine the effect of pre-pregnancy diabetes on maternal decline after pregnancy, we will compare FEV1 and BMI rates of decline, during a two-years follow-up period after pregnancies, reported in the French CF Registry, according to their diabetic status.


Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis women attending the CF French Registry between January 1, 2001 and December 31, 2010

Exclusion Criteria:

* Women who had received a pulmonary graft before pregnancy.
Selegiline Patch for Treatment of Nicotine Dependence

Relapse to smoking is a common problem affecting smokers who seek treatment. The purpose of this study is examine whether selegiline, given in the form of a skin patch, is effective in stopping smoking.

Most smokers relapse following smoking cessation treatment. More effective smoking cessation therapies are needed to prevent the high rates of relapse. Selegiline is a selective inhibitor of monoamine oxidase B (MAO B) and has been used clinically in combination with levodopa to treat Parkinson's disease. Selegiline permits the stabilization of dopamine (DA) levels in the brain by preventing the rapid degradation of DA by means of MAO B and is used as an adjunct to levodopa therapy causing a dose-sparing effect and enhancing dopaminergic transmission. Selegiline's effect on MAO B and the resulting effect on brain DA has interesting implications for the treatment of nicotine dependence because brain DA systems may play a key role in the mediation of reward learning behavior. Previous research suggests that the brains of living smokers show a 40% decrease in the level of MAO B relative to nonsmokers or former smokers. The purpose of this study is examine whether selegiline, administered in the form of a skin patch, is effective for smoking cessation.

Participants will be randomly assigned to one of two treatments: 1) transdermal selegiline patch (STS) or 2) placebo. Treatment with STS or placebo will be given for a period of 8 weeks. Participants will be stratified by gender to evaluate the role that gender plays in moderating smoking cessation treatment. Study visits will take place once each week for 30 to 45 minutes, and will include adverse events monitoring, biochemical verification of smoking status, and a physical exam. Follow-up visits will occur at Weeks 24 and 52 to determine response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Smokes greater than 20 cigarettes per day

Exclusion Criteria:

* History of Parkinson's disease, high blood pressure, or severe liver or kidney disease
* Current substance abuse
* Mental illness
* Skin conditions that could interfere with patch use
* Using antidepressant medications (e.g., levodopa/carbidopa, methyldopa, or any MAO inhibitor)
* Pregnant or breastfeeding
Effect of Ketamine on Analgesia Post-Cardiac Surgery

Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.

This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery

Exclusion Criteria:

* Minimally invasive cardiac surgery
* Preoperative opioid use
* Preoperative hepatic or renal dysfunction
Dextrose Gel Does Not Prevent Neonatal Hypoglycemia

This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.

OBJECTIVE: To test the hypothesis that prophylactic dextrose gel administered to newborns at risk for hypoglycemia will increase the initial blood glucose (BG) concentration after the first feeding and subsequently decrease NICU admissions for treatment of asymptomatic transient neonatal hypoglycemia (TNH) vs those given feedings alone.

STUDY DESIGN: This quasi-experimental pilot study allocated asymptomatic at-risk newborns (late preterm, birth weight \<2500 or \>4000 g, and infants of diabetic mothers) to receive prophylactic dextrose gel (Insta-Glucose®); other at-risk newborns served as controls. After the initial feeding, the prophylactic group received dextrose gel (0.5 ml/kg) rubbed into the buccal mucosa, and BG was checked 30 min later. Initial BG concentrations and rate of NICU admissions (for treatment of hypoglycemia) were compared between the prophylactic group and controls using the Wilcoxon rank-sum test and Fisher's exact test, where appropriate. A multivariable linear regression compared first BG between groups after adjusting for at-risk categories and age at first BG concentration.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age above 35 weeks
* Infants less than 1 hour of age
* Infants with informed parental consent
* Infants who are born at the Harris Health Ben Taub Hospital in Houston, TX

Exclusion Criteria:

* Infants with known metabolic, genetic, or congenital anomalies
* Infants not expected to survive the neonatal period
* Infants determined later to have a metabolic, genetic, or congenital anomaly that was not immediately obvious in the newborn period
* Hypoglycemic infants with symptoms
* Infants transferred to the Level 3 NICU for other reasons
Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital

Pulmonary hypertension (PH) is a complex condition that may be related to many clinical conditions. It is a serious disorder with a high morbidity and mortality rates. PH is classified into five groups according to clinical characteristics, pathological findings, hemodynamic characteristics and treatment response (Galie N, et al., 2016). These five groups include pulmonary arterial hypertension, PH due to left sided heart disease, PH due to lung disease and/or hypoxia, chronic thromboembolic pulmonary hypertension, or other pulmonary arterial obstruction and PH with unclear and/or multifactorial mechanisms (Simonneau G, et al., 2013).

PH is a major complication of several hematologic disorders including myeloproliferative neoplasms (MPNs). MPNs are a group of diseases characterized by uncontrolled proliferation of at least one myeloid series due to an abnormal hematopoietic cell clone. There are different types of MPNs including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) \& chronic myeloid leukemia ( CML). Myeloproliferative neoplasms (MPNs) are included in group 5 PH (Arber DA, et al., 2016).

This study will analyze the clinical and laboratory data of MPNs patients and correlate them with development of PH in these patients aiming to identify parameters that can predict PH in MPNs patients and thus, identifying MPNs patients at highest risk for PH who require close monitoring \& screening for PH hoping that early detection and management of PH in MPNs patients can improve morbidity, prognosis and survival in those patients


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Patients diagnosed with polycythemia vera, essential thrombocythemia, primary myelofibrosis and chronic myeloid leukemia according to the 2016 WHO classification and attended the outpatient Hematology Clinic at Sohag University Hospital.

Exclusion Criteria:

* Patients less than 18 years old.
* Patients with pre-existing pulmonary hypertension from any other cause.
* Patients with left sided heart disease e.g. left sided heart failure, left sided valvular diseases, cardiomyopathies, left ventricular systolic or diastolic dysfunction.
* Patients with chronic lung disease e.g. COPD \& interstitial lung disease.
* Patients with chronic kidney disease.
* Patients with connective tissue diseases.
* Patients with congenital heart diseases.
The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients

The aim of this study is to explore and identify the effects of acetylcysteine, a common mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative stress in hemodialysis patients.

Oxidative stress in patients with renal failure is higher than in healthy controls. Once undergoing hemodialysis (HD) therapy, patients with end-stage renal disease even have more oxidative stress. Reactive oxygen species (ROS) denature the vital molecules, such as lipids, proteins, and nucleic acids.

Increased ROS produce oxidized low-density lipoproteins (ox-LDL), which, in turn, induce atherosclerosis and subsequent cardiovascular disease. Cardiovascular disease is the leading cause of death of HD patients. On the other hand, ROS damage RBC membrane and cause hemolysis. Hemolysis exaggerates uremic anemia and results in resistance to erythropoietin (EPO) therapy.

Acetylcysteine, a common mucolytic, is an antioxidant as well. In vivo experiments, acetylcysteine has been demonstrated to inhibit the production of ox-LDL by ROS. Acetylcysteine has also been shown as an effective drug for prevention of contrast media-induced nephropathy in high-risk patients.

Thus we hypothesize HD patients taking acetylcysteine may have less ox-LDL produced by ROS and, consequently, lower risk of cardiovascular disease. Moreover, having less damage to RBC membrane by ROS, HD patients taking acetylcysteine may have milder anemia and better responsiveness to erythropoietin therapy. Therefore, we plan to conduct a prospective trial, in which acetylcysteine is administrated to the enrolled HD patients for three months. The primary goals of the study are to realize the changes of 1) plasma ox-LDL levels, 2) the anemia status, 3) the responsiveness to EPO therapy, and 4) severity of atherosclerosis. The secondary goals are to identify the changes of oxidative stress and pro-inflammatory status in the patients.

Eligibility Criteria:
Inclusion Criteria:

* On HD thrice a week at our HD unit for more than three months
* Informed consent
* The dose of EPO and iron supplement is stationary in the previous one month
* No taking acetylcysteine in previous one month
* No using vitamin E-bonded dialysis membrane

Exclusion Criteria:

* Severe liver disease (AST or ALT \>40 IU/L), proven malignancy, and severe cardiovascular disease (proved by cardiac catheter or echography examination)
* Active infection or hospitalization in previous one month
* Clinically significant bleeding episode in previous one month
* Taking vitamin C, vitamin E or other known antioxidants.