cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Physiotherapy Program Applied in the Neonatal Intensive Care Unit

The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding, and feeding performance in preterm infants.

Preterm babies have to stay in neonatal intensive care units (NICU) because they cannot complete intrauterine development and have difficulty maintaining their vital functions.

In very low birth weight babies, feeding may not be started at the desired time due to medical problems. Total parenteral nutrition should be started in order to prevent growth retardation in the baby who cannot receive adequate enteral nutrition in the first days. The infant who tolerates enteral feeding should also be transitioned to full enteral feeding as soon as possible. Early enteral nutrition and intensive early parenteral nutrition reduce growth retardation and improve the infant's mental developmental scores. The frequent occurrence of feeding intolerance in preterm infants with very low birth weight, especially extremely low birth weight, and the risk of NEC, which is a serious cause of mortality and morbidity in these infants, prevent reaching the desired nutritional goals. Therefore, the optimum initiation time and rate of increase of enteral feeding are still uncertain for these infants. The main purpose of preterm nutrition should be to minimize the problems that may occur in the short and long term. The aim of our study is to examine the effects of the physiotherapy program applied in the NICU on motor performance, behavior, transition time to full enteral feeding and feeding performance in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Born 30 weeks or younger of gestational age, Body weight below 1500 g, The baby's vital signs are stable.

Exclusion Criteria:

* Infants undergo surgery, Taking antibiotics or phototherapy, Having a genetic syndrome • Having other medical conditions that may affect physiotherapy practices, such as multiple congenital anomalies, tracheoesophageal fistula, diaphragmatic hernia, congenital heart malformation, and/or necrotizing enterocolitis, The baby is intubated.
Three-dimensional Upper Gastrointestinal Tract Model

This study aims to develop an upper body manikin with a high-fidelity upper gastrointestinal tract and apply into the nasogastric tube training program for nursing students.

Background：

Nursing trainees often fail to correctly prepare medical supplies and use stethoscopes for position assessment incorrectly when physicians perform nasogastric tube placement techniques. The traditional training model are expensive and difficult to access or maintain. It is easy to cause irreparable damage when repeated tearing and sticking of the elastic adhesive tape on the traditional model. Because of the high-priced the traditional model, it is impossible to use real milk, to simulate the nasogastric tube feeding. Inadequate clinical skills often raises patient safety concerns when assisting in changing nose pads and feeding. To enhance the nasogastric tube training for nursing students, the investigators used 3D-printed education model combined with clinical simulation-based training program.

Study Design：

This is a randomized controlled trial of medical education study.

Methods：

The investigators first designed our 3D upper body model using the 3D processing and analysis software. To create the basic outline of the 3D model, the investigators used a white-light handheld 3D scanner to scan a real human. To closely resemble the soft biological tissues of real human organs, an adequate material will be chosen in the study. The pre/post examination, student satisfaction, and direct observation of procedural skills will be used to evaluation the outcome of the study.

Effect：

The investigators expect the 3D-printed upper body manikin with a high-fidelity upper gastrointestinal tract model has potential in nasogastric tube training, particularly in helping trainees become familiar with the nasogastric tube care.

Keywords：

3D printing, upper body manikin, upper gastrointestinal tract, nasogastric tube care, simulation-based training

Eligibility Criteria:
Inclusion Criteria:

* Training at Fu Jen Catholic University Hospital.
* Signed the consent form.

Exclusion Criteria:

* Refused to participate in the study.
A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™

The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the relative bioavailability of DHA and PQ.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian or Asian healthy subjects, Male or female, aged between 18 and 50 years (inclusive)
* Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 36 kg.
* Agreed to use two approved methods of contraception
* Had given written informed consent to participate in this study in accordance with local regulations

Exclusion Criteria:

* Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing
* Pregnant or lactating (females only)
* Abnormal laboratory test results deemed clinically significant at screening
* Positive urine drug test or alcohol breath test
* Acute therapy for a serious infection within 30 days of study entry
* History of significant drug allergies or significant allergic reactions
* Had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug
* Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.

The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days;

For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:

* Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
* Children ≥ 6 months to \< 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).

The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.

For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows:

* Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).
* Children ≥ 6 months to \< 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily).

However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.

Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV) treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 1 month and 4 years of age, inclusive
* The subject suffers from epilepsy (except status epilepticus)
* The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

* The subject has difficult venous accessibility
* History of status epilepticus during the 3 months prior to Screening
* The subject is on felbamate with less than 18 months continuous exposure before Screening.
* The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.
Community Based Obesity Prevention Among Blacks

The purpose of this study is to examine whether pedometer step count recommendations (10,000 steps/day versus an adaptive recommendation) are differentially associated with the primary outcome of adherence to the pedometer-based physical activity regimen and the secondary outcomes of change in physical activity and body mass index (BMI).

Long-term promotion of physical activity is necessary to achieve obesity prevention. This represents a particular challenge for our intervention design, as few studies have demonstrated positive long-term physical activity promotion outcomes among Black women. We have demonstrated the utility of pedometers among low income, ethnically diverse populations. The efficacy of pedometer utilization for the prevention of weight gain, however, hinges on long-term utilization of the devices. We hypothesize that recommendation for the step count attainment may affect individual's long-term utilization of pedometers, as well as physical activity levels and BMI.

This study is a 24-week experimental trial to examine whether intervention recommendations promote long-term adherence to a pedometer-based physical activity regimen. A two-group, block design will be used in the proposed study. Eligible women will be randomly assigned to one of two experimental conditions (n=75 per condition): 1) receiving a 10,000 steps/day recommendation and 3 health education sessions or 2) receiving an adaptive recommendation and an obesity prevention intervention. The adaptive step recommendation will update participants' recommended step counts, starting at 7,000 steps/day, then 8,000 steps/day, then finally 10,000 steps/day. Participants in the adaptive recommendation group will be provided with 3 educational sessions and will be asked to report their daily progress on weight maintenance goals via text message.

Participants will be provided pedometers and will be asked to wear them every day of the 24-week trial period.

Assessments (including self-report survey and anthropometric measurements) will be conducted at baseline, 12 weeks and 24 weeks post-baseline.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Ages 25 and over
* BMI 25 and over
* English fluency
* Not currently pregnant
* No restrictions to ambulatory activity

Exclusion Criteria:

* Current pregnancy
* Childbearing in the past 12 months
* History of myocardial infarction or stroke in last 2 years
Safety and Pharmacokinetics of GH002 in Healthy Volunteers

The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at Screening.
* Is deemed in good physical health by the investigator.
* Is in good mental health in the opinion of the investigator and clinical psychologist

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contra-indication to 5-MeO-DMT.
* Has received any investigational medication, including investigational vaccines, within the 6 weeks prior to baseline
* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the Investigator's judgement.
Perception and Prevalence of Fungal Infections in Berlin - Brandenburg

This is a structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field of invasive mycoses.

Intensive care patients with invasive mycosis require a special clinical expertise especially in light of a high lethality. Early identification of patients at risk to develop a fungal infection is of utmost importance to start effective antifungal therapy. The implementation of current knowledge into clinical practice to fight fungal infection is not clear.

Eligibility Criteria:
Inclusion Criteria:

* Intensive care units of hospitals in the INABBRA alliance.
* Patients with invasive mycosis.

Exclusion Criteria:

* Hospitals without intensive care unit.
Oxytocin Effects on Self Versus Other Touch

The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.

In a double-blind placebo-controlled within-subject experimental design, 40 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU, medicated lollipop) or placebo (lollipop without oxytocin). Starting 45 minutes after treatment a resting state functional magnetic resonance imaging (fMRI) will be recorded (8min) and next subjects will be applied two different types of stroking touch (self- vs. other-produced touch) to their left arm repeated in 16 blocks. After each block of applied touch stimulation, subjects will be required to rate their perceived pleasantness of touch from -4 (extremely unpleasant) to 4 (extremely pleasant). The neural basis of touch processing will be measured via simultaneously acquired fMRI.

To control potential confounding effects among subjects, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and interoceptive ability: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ),Sensory Over-Responsivity (SensOR) Scales, Interpersonal Reactivity Index (C-IRI), Self-Concept Clarity Scale (SCCS), Interoceptive Confusion Questionnaire(ICQ) and Multidimensional Assessment of Interoceptive Awareness(MAIA) scale. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after the touch stimulations to further measure the modulatory effects of touch on mood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.

Exclusion Criteria:

* Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.
Effects of Adjustable School Furniture

The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Firstly, we will obtain the anthropometric measures of all students participating in the study. Secondly, we will calculate the mismatch between the student's anthropometric measures and current school furniture. In the next step, the participants will be separated in two groups, the experimental and the control group. The participants in the experimental group will use adjustable school furniture for one week, whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.

Sedentary behavior is a risk factor affecting not only working population but also adolescents. Students spend long period of time seated, which is being associated with reports of musculoskeletal discomfort and pain. The high level of mismatch between students and school furniture is being associated with adolescent lower back pain. The aim of this study is to evaluate the level of mismatch between students and school furniture and to assess the effects of adjustable furniture on sedentary behavior, physical activity levels, and sitting posture in students. Before the experimental part of the study, we will obtain the anthropometric measures of all students participating in the study to calculate the mismatch between the students and the school furniture. In the next step, the participants will be separated to the experimental or the control group. The experimental group will use adjustable school furniture for one week whereas the control group will use the conventional school furniture. All the participants will wear an accelerometer for five consecutive days. The participants will also complete questionnaires about the sedentary behavior and physical activity levels. The sitting posture will be evaluated with Rapid Upper Limb Assessment tool (RULA). Moreover, at the baseline and on the last day of measurements we will measure the classroom environment factors (light, noise, air flow, temperature). The results obtained will indicate the furniture mismatch prevalence and demonstrate the effects of adjustable furniture on health-related parameters in students.

Eligibility Criteria:
Inclusion Criteria:

* aged between 16 and 24 years
* student

Exclusion Criteria:

* body mass index \> 30kg/m2
* pain presence in any musculoskeletal part \> 3 on 10-level scale
* presence of any non-communicable chronical diseases
* pregnancy
Study to Evaluate the Effects of Psyllium on Blood Glucose

This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.


Eligibility Criteria:
Inclusion Criteria:

* male
* 18 to 50 years of age
* general good health
* Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
* fasting plasma blood glucose \<126mg/dL
* not actively treated for high blood glucose
* willing and able to have blood drawn at multiple times during each 4 visits

Exclusion Criteria:

* history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
* Phenylketonuria (PKU)
* an eating disorder
* following special medical or weight-loss dietary restrictions
* taking dietary supplements or prescription medication for the purpose of weight loss/management
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and willing to sign the ICF and able to comply with the study restrictions
* Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent
* Female subjects must be non-childbearing potential

Additional criteria for hepatically impaired subjects

* Confirmed diagnosis of cirrhosis due to parenchymal liver disease
* Stable hepatic impairment, defined as no clinically significant change in disease status, as judged by the Investigator

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with compromised hepatic function
* Clinically significant renal disease

Additional criteria for hepatically impaired Subjects

* History of esophageal bleeding within the last 3 months prior to study drug administration
* Severe hepatic encephalopathy (Grade \>2) or degree of central nervous system (CNS) impairment
* History of liver transplantation
* Presence of Hepatocellular Carcinoma, or suspicion of Hepatocellular Carcinoma based on Investigator's judgment
* Hepato-renal or hepato-pulmonary syndrome
* Prior placement of a portosystemic shunt
* Spontaneous bacterial peritonitis currently or within the last 6 months
* Hospitalization within the last 2 months related to cirrhosis
* Advanced ascites and ascites which require emptying and albumin supplementation, as judged by the Investigator
* Hemoglobin concentration \< 10.0 g/dL
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:

• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels

Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.

Participants will:

* Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose
* All participants receives standard of care
* Visit site 4-5 times and have 7 video/phone-calls


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Both women and men can join
* Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
* Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
* Have low iron levels in the blood
* New York Heart Association (NYHA) Heart Failure Classification II, III or IV

Exclusion Criteria:

* Planned cardiac surgery or revascularization or cardiac device implantation
* Pregnant or nursing women
* Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
* Treatment with radiotherapy or chemotherapy