cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment

This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and weight. As for all clinical trials, safety and tolerability of the drug will be evaluated as well to develop dosing recommendations for dosing of ZD4054 (Zibotentan) in subjects with varying stages of hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Hepatically impaired subjects - Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.
* Healthy volunteers - Clinical laboratory tests within the normal reference range or results with minor deviations which are not considered by the Investigator to be clinically significant

Exclusion Criteria:

* In the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, cardiac, or renal disease) or evidence of any other significant clinical disorder or laboratory finding
* Healthy volunteers - History or presence of hepatic disease known to interfere with absorption, distribution, metabolism or excretion of drug
* Hepatically impaired subjects - Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period
NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 yrs
* Hospitalization in intensive care unit
* Acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease
* Dyspnea majoration since at least 1 month
* Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload
* Hypoxemia requiring oxygen flows \> 6 L/min

Exclusion criteria:

* Contraindication to noninvasive ventilation or high-flow oxygen therapy
* Immediate indication to endotracheal intubation or hemodynamic assistance
* Body mass index \> 40
* Presence of a pacemaker or an implantable defibrillator
* Presence of cutaneous lesions where Pulmovista® belt should be placed
* Moribund patient
* Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
* Protected adult patient (tutorship or curatorship)
* Patient deprived of liberty by court or administrative decision
* No possibility to install nasogastric tube
* Endotracheal or tracheostomy tube requirement during the study
* Hemodynamic assistance requirement during the study
The Effect of Childhood Dyslipidemia on Endothelial and Renal Function

The aim of the study is to assess if abnormal lipid levels in childhood could cause early damage of the inner layer of the vessels, the endothelium. Dysfunction of the endothelium is the first event in the development of atherosclerosis, is present at all stages of atherosclerosis and is potentially reversible in childhood. It has been suggested that dyslipidemia, via its detrimental effects on endothelium, could impair renal function. This study will assess the dysfunction of the kidneys in children with dyslipidemia.

In children recruited in the study, family history of dyslipidemia or premature cardiovascular disease will be recorded. Furthermore, anthropometric and clinical characteristics will be noted and lipid measurements will be obtained at recruitment after a fasting period.

The investigators will test in children the flow-mediated dilation (FMD) which assesses the vasodilation due to the production of nitric oxide from the endothelium in response to occlusion-induced hyperaemia of the branchial artery and the carotid intima-media thickness (cIMT). These non-invasive ultrasound indices detect early vascular damage.

Renal function will be assessed in children with dyslipidemia by a new marker in serum, cystatin C, which is more accurate and reliable than creatinine. Also, creatinine serum levels and estimated glomerular filtration rate (eGFR) will be evaluated. Additionally, total protein, albumin, electrolyte and β2-microglobulin excretion in urine will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 7 to 17 years
* Dyslipidemia (serum levels of LDL-cholesterol ≥95th percentile or serum levels of triglycerides ≥95th percentile or serum levels of HDL-cholesterol ≤5th percentile for age and sex)

Exclusion Criteria:

* History of renal disease
* Dyslipidemia caused by nephrotic syndrome or chronic kidney disease
* Chronic use of medication
* Acute or chronic inflammatory process
Bioavailability of BIBR 953 ZW After Oral Administration of BIBR 1048 MS in Healthy Subjects

Study to assess the amount of BIBR 953 ZW in urine after administration of 50 mg BIBR 1048 bid over three days each administered as four experimental formulations relative to drinking solution with and without coadministration of 40 mg Pantoprazole


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 55 years
* Broca ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
The Effect of Pregnant Women's Maneuvers on Pregnancy Distress and Perception of Maternity Role"

The role of motherhood; Motherhood can be defined as a learning process that includes knowledge, skills, attitudes and behaviors of a woman who has been handed down from generation to generation. Mother-infant attachment; At the behavioral and emotional level, it is the mother's attachment to her baby, which becomes stronger as the pregnant woman's body changes, her uterus expands and the mother begins to feel fetal movements. The fact that women adopt the role of motherhood throughout pregnancy is very important for attachment behaviors and infant attachment patterns in the early and late postpartum period.

It is very important for midwives to implement and teach the interventions that will enable pregnant women to take an active role in this period, in terms of perception of the role of motherhood and pregnancy distress. . The literature provides a data source for leopard maneuvers. However, I and II. There is no study on the effect of Leopold maneuvers on pregnancy distress and the perception of maternal role. This study, which is planned to support and develop awareness in this area, is important in terms of literature.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous single pregnancy,
* 28th gestational week,
* Over the age of 18, under the age of 40,
* Not having communication difficulties and mental disabilities, Literate,
* Not having any chronic health problems (hypertension, heart disease,
* obesity etc.)
* Does not have a psychiatric disease and does not use psychiatric drugs, Exclusion Criteria
* Not open to communication and cooperation during the working period,
* Reluctant to participate in the research,
* Not completing the questionnaires,
* Pregnant women who gave birth prematurely were not included in the study.
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Besides the main objective, there are 4 other objectives as follows:

* To assess the safety of Oratecan in combination with capecitabine
* To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies
* To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumor
* Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
* Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
* Aged ≥19
* Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
* A life expectancy greater than 12 weeks
* Adequate bone marrow, renal and liver function.
* Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

* Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
* Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
* Patients who have GI malabsorption or difficulty taking oral medication
* Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
* Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
Effıcıency Of Hybrıd Based Sımulatıon Method In Breastfeedıng Educatıon

It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences

This study was planned to determine the effect of hybrid simulation-based breastfeeding education on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences. The research, planned in a randomized controlled experimental design, will be conducted with Istanbul Health Sciences University Hamidiye Health Sciences Faculty midwifery 2nd year students (N: 84). Students participating in the study will be divided into intervention (n: 42) and control (n: 42) groups according to the computer-assisted simple random sampling technique. Both groups will be given 4 hours of theoretical information about breast milk and breastfeeding education before the application. 42 students assigned to the intervention group will receive training with a high-reality simulator fitted to a standard patient, accompanied by a scenario, and 42 students assigned to the control group will receive practice training with an adult standard patient care model. Introductory Information Form, Simulation-Based Learning Evaluation Scale, Student Satisfaction and Self-Confidence in Learning Scale, Self-Efficacy-Sufficiency Scale, Breastfeeding Management Skill Evaluation Form will be applied to the students participating in the research.

As a result of the findings, discussion and conclusions of the study will be written.

It is important to increase the competency level of midwifery students in breastfeeding management in a simulation environment that creates virtual reality, before the care applied on real patients in a clinical environment. It is recommended to integrate high-reality simulators and standard patient methods into the curriculum in the education of midwifery students . This study aims to increase the application skills, satisfaction, self-confidence and self-efficacy levels of midwifery department students with hybrid simulation-based Breastfeeding education, in which two or more simulation types (standard patient and Lactation Simulator) are combined to produce a more realistic simulation experience.

Eligibility Criteria:
Inclusion Criteria:

Having a statement of consent Being a second year midwifery student

Exclusion Criteria:

Wishing to withdraw from the research at any time. Not participating in all simulation applications Incompletely filling out data collection forms
The Lunch Study: the Combined Effects of Food Texture and Portion Size on Intake

Meal size is strongly influenced by a number of external features of the food environment which can promote over-consumption, such as the availability of palatable energy dense foods and large portion sizes. The current research aimed to investigate whether natural food-based differences in texture could be used to slow down eating rate and reduce intake from large portions.

A four-session randomised crossover study assessed the effect of faster vs. slower eating rate, achieved through manipulating food texture, on ad-libitum consumption (weight and calories) of a meal, alone and in combination with variations in meal portion size (regular vs. large)

The current obesogenic environment is characterized by the abundance of palatable and high energy dense foods. Eating from large portions can promote sustained overcompensation at meal times. On the other hand, eating at a slower rate has been shown to reduce meal size, and food-based texture differences can slow eating rate. It is possible that texture-based differences in eating rate could be used to reduce energy intake in of foods that are served in large portions.

This study was conducted to quantify the effect of eating rate (fast vs. slow) on ad-libitum consumption of a meal, alone and in combination with variations in portion size (100 % 700 g vs 150 % 1050 g). The meal combinations were as follows:

Meal 1: thin/100% portion; Meal 2: thin/150% portion; Meal 3: thick/100% portion; Meal 4: thick /150% portion

Participants consumed the four test meals over four non-consecutive test sessions at the Clinical Nutrition Research Centre, with at least three days washout between each session. Each part followed a completely randomised full crossover design.

The primary objective was to assess ad libitum intake (both kcal and g) of the test meals, depending on the combination of food texture and energy density.

The secondary objectives were to assess the eating rate, oral processing characteristics, changes in rated appetite up to 90 minutes post-consumption and energy intake (kcal) for the rest of the test day (food diary), as a function of the test meal texture and energy density

Eligibility Criteria:
Inclusion criteria:

* Aged between 21 and 50 years
* BMI \< 30 kg/m2

Exclusion criteria:

* Individuals whose body weight has changed more than 5 kilograms in the last 12 months
* People who are taking insulin or medications known to affect glucose metabolism, appetite or energy metabolism
* Individuals who are currently dieting
* People with intolerances or allergies to study foods or test products, e.g. soya, wheat, gluten, cereal, fruits, biscuits, dairy products, rice, vegetable, meat, seafood, sugar and sweetener, gelatin, natural food colourings or flavourings, etc
* Pregnant women
Graphene Oxide in the Surgical Management of Intrabony Periodontal Defects

Using Graphene oxide in the surgical management of periodontal intrabony defects.

Evaluation of the effect of Graphene oxide in the surgical management of periodontal intrabony defects in animals in periodontal clinical parameters with histomorphometric evaluation .

Eligibility Criteria:
Inclusion Criteria:

* male dogs
* 12-24 months old with approximate weight of 20-30 kg and general good health will be used

Exclusion Criteria:

-
Is Less More? Dosing and Sequencing Effect

The investigators want to evaluate core components from cognitive behavioral psychotherapies (CBTs) with the aim of investigating dosing and combinatory effects on conditions of anxiety and depression.

In the present study, participants will be randomly assigned to one of four groups, receiving one or both treatment components under investigation, all over the course of six sessions of treatment.

1. It is hypothesized that both component A (Cognitive Restructuring) and component B (External Attention Allocation) will be efficient in reducing symptoms of depression and anxiety when delivered separately, both when delivered over 3 and 6 sessions. The difference between components as well as between the number of sessions on primary and secondary outcomes will be explored.
2. The combinatory effects, comparing the effect of receiving Component A subsequent to Component B and vice versa will be explored.
3. The process of change in both components will be explored.
4. Group differences in participants' experience of being the recipient of the components (either individually or combination) both qualitatively (free descriptions of their experience with using them) and quantitatively (questionnaires concerning the understanding and employment) will be explored.
5. The moderating effect of baseline characteristics including baseline symptomatology, diagnoses, personality functioning, and working alliance will be explored.
6. Potential harmful effects will be explored in each group.

Eligibility Criteria:
Inclusion Criteria:

(i) age ≥ 18 years, (ii) Clinically relevant symptoms of an anxiety disorder (with the exception of specific phobia) and/or depressive disorder according to GAD-7≥10, SIAS ≥37, PHQ-9 ≥10, or PDSS ≥9, (iii) Danish language proficiency, (iv) ability and willingness to give informed consent, (v) no or stable antidepressant/antianxiety medication (i.e., same dosage for ≥ 6 weeks), (vi) access to either a smartphone, tablet, or computer with video camera.

Exclusion Criteria:

(i) severe depression deemed to require more intense psychotherapy or medication (PHQ-9-score of 20 or more combined with a clinical evaluation), (ii) currently receiving other psychotherapy or counseling, (iii) a history of bipolar disorder, (iv) current or past psychotic episode, (v) substance abuse or dependence judged to require treatment, (vi) suicide risk requiring immediate hospitalization.
Effect of Ginseng on Glycemic Control

Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive hypoglycemic effects, including improvements in glycated blood proteins\[HbA1c\], fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance \[HOMA-IR\]).

Ginseng has demonstrated to have significant hypoglycemic effect. Its major pharmacological component is considered to be ginsenosides. Several trials have been undertaken in diabetes some of which have demonstrated advantages in glycemic control in both diabetic as well as non diabetic individuals although clinical consistency of results is lacking.The lack of high quality data in this area to support diabetes recommendations represents an urgent call for stronger evidence. A systematic review and meta-analysis of controlled trials remains the "Gold Standard" of evidence for recommendations and clinical guidelines development. Therefore, investigators will conduct a systematic review and meta-analyses of controlled trials to assess the effect of ginseng on glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Dietary trials in humans
* Randomized treatment allocation
* 1 month
* Suitable control
* Viable endpoint data

Exclusion Criteria:

* Non-human studies
* Non-randomized treatment allocation
* \<1 month
* Lack of a suitable control
* No viable endpoint data
Famotidine and Antacids for Treatment of Dyspepsia

The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.

This study will be conducted in the Emergency Department at Stony Brook University Hospital. Investigators intend to enroll approximately 80 patients who present to the emergency department with dyspepsia symptoms. The patients will be randomized to one of two groups: one group will receive 20 mg of intravenous famotidine and the other will receive 30 ml of oral Maalox/ Mylanta. The verbal numeric pain score (VNP) will be used to measure pain at 0 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes after administration of the study drug. Pain severity assessments will be performed by an investigator blinded to study treatment. Data will also be collected regarding demographic, clinical information, patient satisfaction and the need for rescue medications in each of the two study groups at the end of the 60-minute study period. At the end of the study period, the patients may be treated with additional analgesia at the discretion of their ED provider.

Eligibility Criteria:
Inclusion Criteria:

1. Subject Age ≥ 18 years of age
2. Patient diagnosed with dyspepsia
3. Present at the ED with upper abdominal pain score of at least 3

Exclusion Criteria:

1. Hypersensitivity to an ingredient in Maalox/ Mylanta or Famotidine
2. Moderate to Severe Renal Insufficiency (precaution)
3. Kidney Failure
4. Pregnant or Nursing
5. Verbal pain score less than 3
6. Inability to tolerate oral medications
7. Bowel Obstruction
8. Proton pump inhibitor within 2 hours of study treatment
Antro-pyloro-duodenal Motility in Idiopathic Gastroparesis

Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

The aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic gastroparesis or healthy volunteers
* Idiopathic gastroparesis must have delayed gastric emptying shown using C13 breath test

Exclusion Criteria:

* Diabetic or post-surgical gastroparesis
* Treatment modifying GI motility (prokinetics, opioids...)
* Parkinson or neurologic disease
* Evoluting inflammatory process or neoplasia
* Treatment modifying coagulation
* Patients not affiliated to the French healthcare insurance