cyrilzakka/clinical-trials huggingface dataset:
Eat Healthy for Families

This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.


Eligibility Criteria:
Inclusion Criteria:

* the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
* the child is 2-5 years-old with a BMI-for-age and sex \<95th percentile;
* the parent and child live together ≥50% of the time;
* the parent and child are able to read, speak and understand English;
* the family has transportation to the University of Delaware; and
* the family is committed to the 6-month program.

Exclusion Criteria:

* the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
* the child is taking weight loss medication or medication that impacts appetite; or
* the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.
In Vivo Corneal Confocal Microscopy for Non-invasive Assessment of Diabetic Peripheral Neuropathy

Clinical in vivo confocal microscopy (IVCM) is a relatively new technique of corneal evaluation that permits non-invasive imaging of corneal structures on the cellular level. Precise anatomic characterization of corneal structures, including corneal nerves, can be rapidly performed with high resolution.

Evaluation of the corneal nerve layer with IVCM provides a method of direct visualization of peripheral small fiber nerves and a quantifiable assessment of nerve abnormalities in a low risk, non-invasive manner. Therefore, our goal is to develop a non-invasive diagnostic protocol as a quantitative tool for the evaluation of DPN. The protocol and the tool we seek to develop could ultimately be used in large-scale clinical trials and in clinical practice to assess DPN severity and progression.

We hypothesize that in vivo confocal imaging of the corneal nerve layer is a clinically viable method to assess and quantify systemic peripheral nerve health. We emphasize that this imaging method can be used in both humans and animal models to provide quantifiable, longitudinal data on the same live individual to advance our understanding of the development and progression of DPN, and to evaluate treatment effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* diabetes

Exclusion Criteria:

* history of laser eye surgery, corneal disease, multiple sclerosis, Parkinson's disease, or any known systemic neuropathy.
Efficacy of Dentifrices Containing Arginine Versus Fluoride on Microbial Acid

This study will be conducted to evaluate the effect of arginine versus fluoride containing toothpaste on neutralization of microbial acid produced by Cariogenic bacteria in adult population using chair side assessment method.

.28 volunteer participants will be assigned in this study. Participants will be randomly divided into two groups(n=14) according to type of toothpaste D where groups D1 patient will use arginine containing toothpaste while groups D2 the patient will used the fluoride toothpaste with a number of 14 patients in each group. The pH will be evaluated according to time in relation to the brushing with toothpaste (T) where (T0) represent salivary pH before brushing with toothpaste , (T1) represent salivary pH 10 minutes after brushing with toothpaste at fixed time of the day.

Eligibility Criteria:
Inclusion Criteria:

* Participants should be over 18 years of age.
* Systematically healthy.
* Not taking any medication interfering with saliva secretion.
* Participants who signed informed consent.

Exclusion Criteria:

* Participants with a compromised medical history.
* Participants under systemic disease treatment, with antibiotic, steroid or any medication known to cause dry mouth.
* Severe or active periodontal disease.
* History of allergies or other adverse reactions to arginine, or oral care product or their ingredient.
Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of 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 ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any findings 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 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
Serratus Anterior Block for Video-assisted Thoracoscopic Surgery

Ultrasound-guided SAPB is a facial plane block which maintained analgesia with blockade of lateral branches of intercostal nerves at above or below serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by SAPB in VATS operations. The serratus plane block is used in our clinic for postoperative analgesia in VATS operations. The aim of this study was to evaluate the postoperative pain scores and use of analgesia in patients performed with the serratus plane block in VATS operations in a

1-year period.

Approval for the study was granted by the Clinical Research Ethics Committee and all procedures were carried out in accordance with the Helsinki Declaration. A retrospective examination was made of the anesthesia forms of patients underwent VATS May 2016 and June 2017. Due to incomplete data of 1 of these 35 patients, that case was excluded from the study. The patients were divided into two groups. 24 patients were performed SAPB and iv PCA (intravenous patient controlled analgesia) and 10 patient's pain management were provided with only PCA. No block was administered to 10 patients because of anticoagulant therapy and patient refused block application. The demographic data of the patients (age, gender, operation type, and duration) were obtained from the anesthesia forms. The postoperative pain scores of the patients, evaluated with a visual analog scale (VAS) at 1, 6, 12 and 24 hours postoperatively and the postoperative doses of analgesia used were taken from the block pain follow-up forms

Eligibility Criteria:
Inclusion Criteria:

VATS( Video-assisted thoracoscopy) operation

a.Serratus anterior plane block b.patient controlled analgesia

Exclusion Criteria:

missing data written consent
Safety and Efficacy Study of Autologous Bone Marrow Aspirate Concentrate for No-Option Critical Limb Ischemia

The aim of the presented clinical trial is to evaluate a hypothesis, that BMAC prepared from bone marrow aspirate and injected intramuscularly into ischemic areas of the lower extremity in patients with diabetes mellitus type II., intraarterially into the defect of the limb or with an intravenous application only, has a greater potential to improve the perfusion in the ischemic limbs than standard treatment of NO-CLI. Another aim of the study is to find out differences among three different therapeutic types of BMAC application, to define their effectiveness and safety and to compare the impact of different means of application to the speed of healing of the limb defects and the improvement of perfusion parameters.

Secondary hypothesis assumes, that the intravenous application of BMAC in patients with T2DM older than 30 years of age, with a dose of insulin exceeding 0.7 U/kg/day or 50U/day will result in decreasing the insulin dose in the course of 6-month follow-up and in an improvement of the glycHBA1c levels, improvement of the liver and kidney function, decrease of the cholesterol levels and improvement of the immune response parameters, i.e. parameters of lymphocytar blastic transformation, more than in case of patients with intramuscular or intraarterial application of BMAC.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus
* diagnosis of critical limb ischemia
* non-healing defect on the study limb
* ABI value \< 50 mmHg or ABI\< 0.4
* TBI value \< 40 mmHg or TBI \< 0.4
* TcPO2 \< 20 mmHg in supine position
* no other suitable surgical or re-vascularization procedure
* age \> 18 years
* signed Informed Consent

Exclusion Criteria:

* non-signing of the Informed Consent
* anticipated life expectancy \< 6 months
* history of bone-marrow disease
* renal failure or dialysis dependency
* known malignant disease
* health risks excluding the possibility of general anaesthesia or sedation
* life-threatening ischaemic heart disease
* vast necrosis of the index limb
* active infectious disease, or ATB treatment
* treatment with immunosupressives
* pregnancy, breastfeeding
Evaluation of Staff COVID-19 Wellbeing Centres in a Healthcare Workplace: COVID-WELL Study

Evaluation of a workplace intervention to implement supported wellbeing centres in a healthcare workplace during and after the COVID-19 pandemic.

Mixed-Methods Evaluation study - including collection of service use monitoring data, online survey and qualitative interviews.

Project Aims:

1. To describe the cost, reach and usage of the Staff Wellbeing Centres
2. To gather insight into experiences of those who access the facility ('service users') as well as those of support workers ('wellbeing buddies').
3. To identify any facilitators, obstacles or barriers to accessing the facility.
4. To identify perceptions of facility users and non-users towards the value of the facilities during and after the coronavirus pandemic.
5. To establish recommendations for longer-term sustainability of the wellbeing centres.

Interviews will be conducted with up to 45 interview participants (10-15 Wellbeing Buddies, 25-30 Staff).

Online survey will be conducted - all Nottingham University Hospitals National Health Service (NHS) staff invited to take part (\>14,000).

The survey will include measures of mental wellbeing (Warwick-Edinburgh Wellbeing Scale, 14-item - license received), and single items measures of job stressfulness, job satisfaction, presenteeism, turnover intentions and work engagement.

Eligibility Criteria:
Inclusion Criteria:

* National Health Service staff which includes employees, volunteers or healthcare students, as well as bank staff (all have access to the Staff Wellbeing Centres).
* Ability to give informed consent. For survey element: Ability to access the internet (to complete the online survey) For interview element: Ability to attend an individual interview.

Exclusion Criteria:

• Inability to communicate in spoken English.
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.

All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. Oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. Patients were randomly divided into two groups randomly. IL-11 was used in experience group and control group, saline.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of nasopharyngeal carcinoma.
2. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
3. Age must beetween 18-75.
4. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
5. Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

1. chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
2. Treatment with palliative intent.;Previous malignancy.
3. Pregnancy or lactation.
4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
5. Diabetes, oral mucositis and senile dry stomatitis.
6. Any severe coexisting disease.
Adherence of Hispanic / Latina Breast Cancer - Patients to Adjuvant Aromatase Inhibitors

This is an observational trial designed to assess prospectively the adherence rate to AIs among women with invasive breast cancer (stages I-III) currently receiving AI adjuvant therapy after standard local and systemic therapy. We will study adherence by administrating the 8-item Morisky Medication Adherence Scale (MMAS - 8).

* Women with breast cancer seen at the Texas Tech Physicians Breast Care Center will be recruited during their routine follow-up visit with their medical oncologist.
* Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
* Patients must be on one of AI (steroidal or non-steroidal).
* Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
* Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish.

Eligibility Criteria:
Inclusion Criteria:

* Post - menopausal women with histologically confirmed hormonal positive (ER and/or PR) invasive breast cancer stages I - III with no evidence of metastatic disease (M0).
* Patient must have completed local treatment (surgery /radiation) and recovered from all side effects of chemotherapy and surgery.
* Patient must be on one of AI (steroidal or non-steroidal).
* Patient must be able to complete a demographic and the MMAS - 8 questionnaires in English or Spanish

Exclusion Criteria:

* \< 18 years old
Group Hypnosis for Stress Reduction

This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy or health-stable participants between 18 and 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (VAS 0 - 100 mm)
* Ability to consent and sign declaration of informed consent

Exclusion Criteria:

* Current or planned participation in a stress management program within the next 17 weeks
* Current use of psychotherapeutic treatment
* presence of moderate or severe acute or chronic disease
* presence of an acute or chronic mental disorder
* Participation in a study within the last 2 months prior to enrollment
* Lack of understanding of the German language
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)

Too see percentage of subjects with HI titer \>= 1:40, 28 days after two doses in infants and children (6 months-8 years old) and one dose in children 9-11 years old for each strain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Parents have been informed properly regarding the study and signed the informed consent form
* Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

* Subjects concomitantly enrolled or scheduled to be enrolled in another trial
* Evolving mild, moderate, or severe illness, especially infectious diseases or fever (axillary temperature \>=37oC)
* Known history of allergy to egg and/or chicken protein or any other component of the vaccines
* Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
* Subject who has received a treatment likely to alter the immune response in the previous 4 weeks (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\>2 weeks)).
* Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives.
* Subjects has been immunized with influenza vaccine within 1 year
* Subjects receives any vaccination within 1 months before and after immunization of Flubio.
Furlow With Buccinator and Velopharyngeal Function

Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap


Eligibility Criteria:
Inclusion Criteria:

* - Age 3 to 7 years
* 1ry cleft repair by furrolow with buccal myomucosal flap
* Non syndromic previously treated children
* Cleft repaired by the same surgeon

Exclusion Criteria:

* - Syndromic patient
* Cleft palate repair by any technique except furlow with buccal myomucosal flap
Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease

The goal of this study is to study the incidence of post-operative Transient Neurologic Events (TNEs) within 30 days postoperatively, as assessed by clinical neurological scales, binned by week. Collect data on all interventions and assessments performed during the recovery post surgery up to 30 days, to understand what factors might cause Transient Neurologic Events (TNEs) and determine how these can be reduced in Moyamoya subjects post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Moyamoya Disease (MMD) patients undergoing direct extracranial-intracranial (ECIC) bypass. Patients above the age of 3 years old are eligible for the study

Exclusion Criteria:

* Renal dysfunction, electrolyte disturbances neuromuscular disorders including Myaesthenia Gravis, heart block
Assessment of Sleep Complaints in Brain Tumor Survivors

Survivors of pediatric brain tumors are noted to have increased rates of excessive daytime sleepiness. However, very little data are available regarding the specific sleep disturbances of pediatric brain tumor survivors. Children ages 8 to 18 years of age who are at least 5 years from diagnosis and at least 2 years post treatment or observation only for a brain tumor will be targeted to assess the prevalence of sleep complaints.

The study focuses on the following objectives:

* To estimate sleep disturbance in a cohort of pediatric brain tumor survivors.
* Estimate the rates of parent- and self-reported excessive daytime sleepiness in pediatric brain tumors
* Estimate the rates of parent-reported sleep-disordered breathing, including snoring and witnessed apneas, in pediatric brain tumor survivors
* Estimate the rates of parent- and self-reported behavioral sleep problems, including nocturnal enuresis, bedtime resistance, nighttime awakenings, nightmares, and fatigue in pediatric brain tumor survivors.

The Study focuses on the following secondary objectives:

* To describe bedtime patterns and sleep hygiene of pediatric brain tumor survivors.
* Estimate the typical parent- and self-reported weekday sleep duration of pediatric brain tumor survivors
* Estimate the typical parent- and self-reported weekend sleep duration of pediatric brain tumor survivors and if it differs from the weekday sleep duration
* Estimate the typical parent- and self-reported consistency of sleep hygiene in pediatric brain tumor survivors

This non-therapeutic single arm study will characterize the prevalence and types of sleep complaints of pediatric brain tumor survivors. Brain tumor survivors ages 8 to 18 years who are at least 5 years post diagnosis and 2 years post active therapy and their parents/guardians will be approached to participate during clinic visits. If the patient and guardian agree to participate, they will be administered three questionnaires in the clinic during the patient's visit. From the medical record, the following variables will be utilized to characterize the subjects and estimate which groups are at greatest risk of sleep disturbances:

* Specific brain tumor diagnosis
* Location of tumor (cerebral hemispheres, parasellar region, posterior fossa, or spine)
* Age at diagnosis
* Obesity status
* Treatment modality (surgery, radiation therapy, and/or chemotherapy vs. observation only)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥8 to ≤ 18 years of age
* Brain tumor survivor
* ≥5 years post diagnosis
* ≥2 years post active cancer-directed therapy or observation only
* Parents speak and read English fluently
* Potential participant reads English fluently
* Potential participant/guardian willing to sign consent

Exclusion Criteria:

* Survivor of any cancer other than a brain tumor.