cyrilzakka/clinical-trials huggingface dataset:
3D Tissue Engineered Bone Equivalent for Treatment of Traumatic Bone Defects

This study investigates safety and efficacy of traumatic bone defects treatment with use of 3D tissue engineered bone equivalent (3D-TEBE).

The aim of this study is to evaluate 3D-TEBE transplantation as a safe and efficient treatment for patients with traumatic long bone defects of critical size.

This new method of critical sized long bone defects treatment is under clinical development. Treatment of critical sized bone defects is an actual clinical challenge. The "gold standard" in this case is autologous bone grafting. The method disadvantage is associated with limited donor bone resources. Based on our preliminary clinical trial positive results on use of autologous cultured bone marrow-derived multipotent mesenchymal stromal cells (BM-MSCs) in traumatology, our aim was to develop 3D tissue-engineered bone equivalent transplantation technology for restoration of critical sized bone defects. The proposed 3D-TEBE transplantation for bone defects of critical size treatment expecting to restore the bone integrity, form new bone tissue in a site of bone defect, and reduce the rehabilitation period of a patient.

The data obtained from this study will have practical implications for the treatment of reparative osteogenesis alterations and will be based on the principles of evidence-based medicine

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* Patients with long bone defects of critical size of the traumatic genesis;
* Lack of consolidation of bone fragments for at least 9 months;
* At least two attempts to achieve bone consolidation using traditional methods of treatment;
* A negative pregnancy test at women of childbearing age;
* Confirmation of participation in the study by signing The Written Informed Consent, personally or through a responsible caretaker;

Exclusion Criteria:

* The infection in the area of bone defect;
* History of prior cancer;
* Diabetes;
* Severe chronic liver diseases or kidneys disease in history
* Pregnancy;
* The presence of vascular, endocrine and somatic pathology which has a direct impact on the osteoreparation;
* Any other physical diseases in decompensation or subcompensation, or those that are rated as severe or moderate;
* Therapeutic issues or psychiatric disorders of a patient which would make the subject unsuitable to participate in this study or to complete it;
* Participation in another clinical trial.
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous esophageal cancer
* The clinical stage T2-3N0M0 or T1-3N1-3M0
* Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
* ECOG PS of 0 to 1

Exclusion Criteria:

* clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
* previously received radiotherapy for esophageal cancer
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema

Intravitreal ranibizumab alone was Compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on CMT and BCVA at the end of the 6 months duration of the study. Any significant change in final IOP, compared to baseline, in either group is reported.

This prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and IOP in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema.

Study participants were randomized into 2 groups: the first group received 3 Intravitreal injections of ranibizumab alone 1 month apart. While the second group received 1 Intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 Intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up OCT shows less than 10% improvement from baseline). Treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema.

Final recorded central macular thickness in both groups compared to the baseline. By the end of the follow up period.

Final visual acuity was assessed in both groups compared to the baseline Change in final IOP, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group.

. The number of injections needed to achieve the same effect on CMT and BCVA.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography \[OCT\]).
* Best corrected visual acuity of 6/12 or less.

Exclusion Criteria:

* ● History of any treatment for DME (including grid or focal laser photocoagulation) within the last 6 months

  * History of panretinal photocoagulation within the last 6 months.
  * PDR as indicated with Fluorescein Angiography as it will require PRP which may affect DME.
  * Macular ischemia, as indicated with Fluorescein Angiography.
  * Cataract surgery within three months or cataract that requires surgical intervention during the follow-up period.
  * Pseudophakia with Irvine Gass syndrome, as indicated with Fluorescein Angiography.
  * Vitreomacular traction syndrome.
  * Other causes of macular edema (eg. CRVO, CNV, uveitis, etc).
  * Glaucoma, whether suspected or confirmed.
  * Significant media opacity.
  * Patients with ocular or periocular infections, or infection in the other eye
  * Signs of Active or resolved uveitis and intraocular inflammation.
  * Bad diabetic control as indicated by HbA1C \>8.
  * Renal impairment, hepatic impairment, or congestive heart failure.
  * History of cardiovascular insult or stroke.
The GErman Italian Spanish Takotsubo (GEIST) Registry

GEIST is a multicenter, international observational registry of patients with Takotsubo syndrome. Data regarding the clinical profile (demographic characteristics, clinical presentation, laboratory measures, electrocardiography /echocardiography / coronary angiography parameters, treatment and medication), in-hospital course and complications and short-/long-term outcome are collected prospectively and retrospectively to increase the understanding of the disease.

The open-ended, multicenter, international GEIST registry collects data from patients with Takotsubo syndrome during the index hospitalization and follow-up. Furthermore, long-term outcome data are acquired with structured telephone interviews, in case patients do not undergo regular outpatient visits in the participating study centers. The GEIST registry retrospectively includes data, which have already been collected, and prospectively continues to enroll patients with newly diagnosed Takotsubo syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Takotsubo syndrome

Exclusion Criteria:

* Non
Role of the Oral Microbiome in Blood Pressure Regulation in Pregnancy

High blood pressure in pregnancy is associated with poor outcomes for both mum and baby, increasing the risk of pregnancy complications including pre-eclampsia, fetal growth restriction and preterm birth. The development of new blood pressure lowering interventions suitable for use in pregnancy is a key research priority.

Inorganic nitrate is a compound found in certain types of food, particularly green leafy vegetables and beetroot. Nitrate provides an important source of nitric oxide (NO), a molecule involved in keeping blood vessels healthy and regulating blood pressure. Supplementation with nitrate in the diet, using interventions such as beetroot juice, has been shown to reduce blood pressure and improve blood vessel function.

In order for dietary nitrate to have these beneficial effects, it needs to be converted in the body to nitrite, via bacteria that live in the mouth (oral bacteria). Differences in oral bacteria, and how they metabolise nitrate, are thought to influence blood pressure regulation and potentially response to dietary nitrate supplementation.

This study aims to understand (1) whether pregnant women with high blood pressure have a different composition of oral bacteria compared to healthy pregnant women and women who are not pregnant, and (2) how differences in oral bacteria affect blood pressure responses to a dose of dietary nitrate (in the form of beetroot juice).


Eligibility Criteria:
Inclusion Criteria:

* Normotensive or hypertensive women (hypertension as systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg OR on anti-hypertensive medication)
* For pregnant women, between 20-28 weeks gestation

Exclusion Criteria:

* Multi-fetal pregnancy (for pregnant women)
* Age under 16, or over 45 years of age
* Lacking ability to consent
* Pre-existing diabetes (Type 1/Type 2)
* Previous history of pre-term FGR (delivery before 32 weeks with FGR)
* Current tobacco smoker
* Body Mass Index greater than or equal to 40 or less than or equal to 18
* Use of any of the following drugs in the last 6 months: systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral)
* Large doses of commercial probiotics (greater than or equal to 108 cfu or organisms per day) including tablets, capsules, lozenges, chewing gum or powders (ordinary dietary components such as yoghurts do not apply)
* Evidence of oral disease, assessed on screening proforma (current conditions of: oral candidiasis (thrush); Dental caries (tooth decay); Halitosis; Oral ulcerations/mouth ulcers; Wisdom tooth pain; Chronic dry mouth)
* Allergy to beetroot juice or lemon juice (both contained within the juice shot)
Auricular Neurostimulation for Cyclic Vomiting Syndrome

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting syndrome.

Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder. Majority of children and adults with CVS have concurrent severe abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.

The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.

Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle. They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle. Subjects in a separate sub-study receive 6 weeks of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored before and after therapy for the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Meeting Rome IV Pediatric or Adult criteria for Cyclic Vomiting Syndrome (CVS)
* Concurrent abdominal pain with CVS cycle
* English-speaking
* Lack of other explanation for symptoms
* Either predictable, 'calendar-timed' episodes or prodromal symptoms for 12-24 hours that are predictive of episodes onset

Exclusion Criteria:

* Medically complex and/or suffering from medical condition that may explain symptoms
* Taking a medication that may explain symptoms
* Significant developmental delays
* Patients treated with a new drug affecting the central nervous system within one week of enrollment
* Infection or severe dermatological condition of ear
* Stable vital signs
* No currently implanted electrical device
* For adults (and adolescents as applicable): pregnancy, severe cardiopulmonary disease, concurrent chronic marijuana use (\>2 times/month over past 6 months prior to enrollment)
Comparison of Effectiveness of Two Different Electrotherapy Agents on Central Sensitization

The aim of this study is to compare the efficacy of transcutaneous electrical nerve stimulation (TENS), interferential currents (IFCs) and sham devices in improving central sensitization (CS) findings, including pressure pain thresholds, pain catastrophizing, depression, and kinesiophobia in patients with knee osteoarthritis (OA).

Knee OA, which is the most frequently encountered type of OA is a leading cause of disability and chronic pain. CS is as important as nociceptive component in the pathogenesis of OA-related pain. Therefore, the necessary interventions for CS should be also considered when deciding the treatment protocol.TENS and IFC have been safely and commonly employed in the conservative treatment of knee OA. However, there are limited and inconsistent data concerning the impact of these modalities on CS component of pain.Therefore, the aim of this study is to investigate whether these agents are effective on CS and they are superior to each other.

Eligibility Criteria:
Inclusion Criteria:

40 to 75 years of age, Having bilateral knee OA radiologically with a Kellgren-Lawrence grade of 2 or 3.

Reporting knee pain of more than 3 on the visual analog scale (VAS) over the last 6 months Being unfamiliar with TENS and IFC use

-

Exclusion Criteria:

1. Having the history of any contraindication for electrotherapy (pacemakers, epilepsy, dermatological conditions, abnormal sensation in the knees, pregnancy),
2. Having a knee surgery or intra-articular corticosteroid or hyaluronic acid injection within 6 months.
3. Taking any drugs acting on the nervous system such as anticonvulsants, antidepressants, myorelaxants, or opioid drugs in the study period.
4. Having fibromyalgia, inflammatory rheumatologic, severe psychological disorders -
Pediatric Preventative Health Screenings - Obesity and Family-Centered Outcomes

In 2012, an Expert Panel of the National Heart Lung and Blood Institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. Following publication of this report there was a call for caution and for increased patient (parent, child) input on implementing these guidelines. There are limited current studies evaluating patient-centered outcomes (PCO) in the well-child setting, however, given the childhood obesity epidemic, there is a clear need for such an evaluation. The city of Detroit, MI ranks first among 22 cities with data for the prevalence of overweight and obese youth (39.7%), making Henry Ford Health System, which is located in Detroit, MI, an ideal setting to study childhood obesity related research questions.

Within this patient population, our specific aims therefore are to (1) examine current trends in screening and management of obesity and obesity-related conditions in a real-world urban practice setting; (2) examine the family (patient and parent/guardian) and clinician preferences for the identification and management of obesity and obesity-related conditions; and (3) design and conduct a Phase II pragmatic cluster randomized trial (PCRT) of an educational intervention in providers for guiding screening for obesity and obesity-related conditions during the well-child visit that incorporates and leverages PCO. Staff dedicated solely to this project will partner with the Henry Ford Health System's proposed Patient-Centered Outcomes Research Center's Cores staff members to design, execute and disseminate study results in order to affect clinical care. By seeking to understand the current screening patterns in pediatrics and by creating an education intervention for providers aimed at taking a patient/family centered approach to these preventative health screenings, we may increase PCOs which in turn may have meaningful implications for future adult health.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 2 and 18
* Henry Ford Health System Patient
* Well-child visit with participating provider
* Fluent in English

Exclusion Criteria:

* Unable to provide consent
A Randomized Clinical Trial Comparing Executive Function and Language Skills Training on School Readiness in Preschool Children

Background: environmental influences in the first years of life have a great impact on adulthood. Adequate environmental stimulation in the first years of life positively influence cognitive, emotional and neurological development. Studies show that high quality education for 3 to 6 years old children are cost-effective for diverse outcomes, such as socioemotional and cognitive development, as well as school performance. However, it is not clear why specific types of interventions are most effective on school readiness, an important precursor of literacy status and later life outcomes. Objectives: adapt to the Brazilian context two well-known intervention programs: (1) executive functions training developed by Diamond, and (2) oral language skills based on the Nuffield Programme developed by Snowling and colleagues. Methods: a randomized controlled trial involving 720 children (4 to 5 years old) allocated to three groups: (1) adapted school curriculum focusing on executive functions training, (2) adapted school curriculum focusing on oral language skills training, and (3) regular school curriculum.


Eligibility Criteria:
Inclusion Criteria:

* Schools interested in the intervention program
* Preschool children (4 to 6 years old)

Exclusion Criteria:

* Presence of any sensory impairment
* Intellectual disability
Application of Physical Activity Counseling Program

Abstract Implementation of Physical Activity Counseling Program in Healthy Adult Individuals It was planned to investigate the effects of physical activity counseling on physical fitness level, physical activity level, depression level, sleep quality, quality of life and the change in the number of daily steps. 48 healthy adults aged 18-65 years will be included in the study. Participants will be randomized to the experimental group receiving videoconferencing counseling for eight weeks and the control group receiving single-session informational counseling. Participants will be evaluated with online questionnaires and physical fitness tests during the video conference before the study begins, at the end of the first month and at the end of the second month. Online surveys to be applied; PACE Score, Physical Activity Readiness Questionnaire (PAR-Q), Short Form International Physical Activity Questionnaire (IPAQ-SF), Pittsburgh Sleep Quality Index (PUKI), Beck Depression Inventory (BDI), World Health Organization Quality of Life Scale-Short Form ( WHOQOL-BREF) and physical fitness tests; Plank Test, Curl Up Test, Modified Push Up Test and Squat Test. Demographic information of the participants such as age, weight, height will be recorded. In addition, all participants will record their step counts with the pedometer application they download to their phones one week before the study starts and for one week after the study ends.


Eligibility Criteria:
Inclusion Criteria:

* Not having a co-morbid disease that would prevent physical activity
* Having internet access and equipment to make video calls
* Working remotely

Exclusion Criteria:

* Having a diagnosis of any neurodegenerative or chronic disease
* Having significant cardiovascular, neuromuscular or endocrine disorders that limit regular physical activity
* Recent myocardial infarction or other acute cardiac event, unstable angina, uncontrolled cardiac arrhythmias
* In the past 2 months having had Covid 19
Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children

The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.

Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.

Eligibility Criteria:
Inclusion Criteria:

* school children aged 6-8 years with written informed consent from parents/caregivers

Exclusion Criteria:

* hemoglobin concentrations \< 80g/L
* chronic disease
* congenital abnormalities
* mental or severe physical handicap
* severe malnutrition
* obesity
* receiving deworming within the previous 6 mo
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development

Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.

2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to record the signal continuously: During an EP session (different types) a bedside recorder, and a holter monitor is used during holter recordings. Ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ECG morphology due to activity, position changes, circadian cycles etc. The data is saved and used in the development of the ISSD.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for ICD implantation
* Candidate for EP study
* Candidate for 24 hour holter monitor recording

Exclusion Criteria:

* age\<18
School Readiness in Children with Type 1 Diabetes

It is known that motor and sensory functions are affected in children with type 1 diabetes (T1DM).This may cause children to have restrictions in their daily lives and decrease their participation in activities.Motor and sensory factors and participation are important factors affecting children's school readiness.This study was planned to investigate the effects of motor performance, sensory processing, quality of life and participation on school readiness in preschool children with T1DM.


Eligibility Criteria:
Inclusion Criteria:

Having been diagnosed with Type 1 DM in the last 6 months (for type 1 diabetes group) Being 60-78 months old

Exclusion Criteria:

* - Having any neurodevelopmental disorder in addition to diabetes (EX: cerebral palsy, down syndrome, muscular dystrophies..)
* Starting 1st grade