cyrilzakka/clinical-trials huggingface dataset:
Eight Units Extended Maxillary Fixed Retainer

Assessment of dental changes associated with an eight-unit extended maxillary fixed retainer in 3D. monitoring PDL response and evaluation of patient's satisfaction ,quality of life and speech with extended maxillary fixed retainer

single-arm prospective clinical trial will be conducted to assess of dental changes associated with an eight-unit extended maxillary fixed retainer in 3D. monitoring PDL response and evaluation of patient's satisfaction ,quality of life and speech with extended maxillary fixed retainer.

. Twenty-six patients who finished the active orthodontic treatment phase (14-28 years) will be recruited upon complying with the inclusion criteria. Eight-unit extended maxillary fixed retainer will be bonded to palatal surface of maxillary incisors, canines and first premolars, PDL assessment will be carried out and patient acceptance to the appliance through the valid questionnaire then the patients will be followed up for 6 months to document 3D post-treatment changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who finished the active orthodontic treatment and started the retention phase.
* Both genders.
* Extraction and non-extraction cases

Exclusion Criteria:

* Patients who had active transverse palatal expansion.
* Patients with active periodontal disease.
* Patients with systemic disease and bone diseases, or craniofacial syndromes, or the presence of cleft.
* Patients with abnormal surface or morphological tooth structure or restorations.
The Clinical Evaluation of the Dose of Erythropoietins Trial

Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option.

The purpose of this study is

1. the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
2. to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).

Phase III pragmatic, randomized-controlled trial comparing different doses of ESAs in patients with renal anaemia.

Study Sample:

Total of 900 participants from Italy

Background and Rationale:

Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies higher haemoglobin (Hb) levels (around 10-13 g/dL) are associated with improved survival and quality of life compared to lower Hb levels (around 9 g/dL). Randomized studies have found that higher Hb targets, achieved and maintained with ESA, cause an increased risk of death, mainly due to adverse cardiac-cerebrovascular outcomes. It is possible that such effect is mediated by ESA dose. This hypothesis has not been formally tested and is the aim of the Clinical Evaluation of the DOSe of Erythropoietins (CEDOSE) trial.

CEDOSE is the first independent multicentre trial exploring the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).

Hypothesis:

ESA resistance is associated with adverse vascular outcomes and poor quality of life in ESKD.

The CEDOSE trial will evaluate the biochemical markers to determine the efficacy of individual prediction of ESAs therapy; moreover it will evaluate the benefits and harms of two fixed ESA doses and explore the role of two treatment strategies, one based on a low and one based on a high ESA dose.

Interventions and Comparison:

Patients will be randomized 1:1 to 4000 IU/week iv. versus 18000 IU/week iv. of epoetin alfa, beta or any other epoetin in equivalent doses.

Eligibility Criteria:
Inclusion Criteria:

* Age \> = 18,
* End stage kidney disease and anemia
* Treatment with hemodialysis for renal replacement therapy
* no contraindications to erythropoietin stimulating agents (ESAs) or already treated with ESAs

Exclusion Criteria:

* Patients with Hb levels \> 10 g/dl without ESAs
Diagnosing Variable Primary Aldosteronism.

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

The main questions it aims to answer are:

* Can we diagnose more people if we used 24 hour urine measurements?
* In those with high amounts of aldosterone in their urine, is there a variable pattern to their aldosterone production?

Participants will have a 24 hour urine measurement. They will also have multiple blood tests throughout the day to study the variability in aldosterone secretion.

Eligibility Criteria:
Inclusion Criteria:

* People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity \<0.5 nmol/h/L or renin mass \<5 ng/L), plasma sodium \> 140mmol/L or plasma potassium \< 4mmol/L.
* Patients who have been diagnosed with PA and had previous aldosterone samples \<277 pmol/L, a level which would normally not qualify for confirmatory testing.
* Patients with aldosterone results done at different times that indicate variability in production.
* Willing to consent and participate in the study.

Exclusion Criteria:

* Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.
* People on end of life treatment.
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers

The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.

This is an open label study to investigative the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers \< 2 years of age with suspected sepsis. There will be two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose 25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts within each group: pre-term \< 30 week EGA infants \> 48 hours and \< 31 days; \> 30 weeks EGA infants \> 48 hours and \< 31 days; infants ≥ 31 days and \< 2 years of age. The study requires administration of fluconazole over 1-5 days depending on treatment group followed by 1 week of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antifungal therapy), and information from the study may benefit a large number of other infants and toddlers with suspected or proven fungal sepsis. There is a data analysis plan.

Eligibility Criteria:
Inclusion Criteria:

* suspected sepsis with blood culture within 48 hours
* age ≥ 48 hours and \< 2 years of age
* sufficient venous access to permit study drug administration

Exclusion Criteria:

* allergic reaction to azole
* history of fluconazole administration in prior 5 days
* liver dysfunction
* renal failure
* concomitant use of cyclosporine, tacrolimus, or azithromycin
Accuracy and Safety of Real Time Continuous Glucose Monitoring Before, During and After Surgery

The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous Glucose monitoring System (RT-CGMS)in measuring glucose in patients scheduled for surgery; before, during and after surgery.

Rationale:Strict glycaemic control improves outcome of critically ill patients. Real Time Continuous Glucose monitoring System (RT-CGMS) is a novel system which can provide health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. Furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. Its accuracy and safety have never been tested in a population of patients admitted to an intensive care unit.

Objective:To investigate the accuracy and safety of the RT-CGMS in patients scheduled for elective cardiac surgery. Our secondary objective is to define the possible factors interfering with reliable and adequate glucose measurements and to investigate the effect of RT-CGMS on glucose control.

Study design: Open label, randomised controlled trial. Study population:Patients scheduled for elective cardiac surgery. Intervention:After informed consent and randomisation, all patients will have the RT-CGMS inserted pre-operatively. In one group (Control group; 15 subjects), the RT-CGMS will be blinded, so that no information on blood glucose values measured and stored by the RT-CGMS will be available to care-givers, investigators or patients during the study period. In the other group (Active group, 15 subjects), the RT-CGMS will not be blinded. The system will alert whenever a glucose level falls below or rises above preset values. Sensor values are not intended to be used directly for making therapy adjustments. Whenever a value is below or above the preset value, the blood glucose level will be measured using separate blood analysis and therapy adjustments based on this value will be done according to the (ICU) protocol.

Study endpoints: Correlation between data obtained with the RT-CGMS and the conventional method. Degree of glucose control defined as the time spent in normoglycaemia, hypoglycaemia and hyperglycaemia, as recorded both with sensor measurements and ward measurements. Occurrence of significant clinical events and its effect on RT-CGMS.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cardiac surgery
* Age \>18 years
* Both patients with diabetes mellitus as non-diabetic patients are eligible

Exclusion Criteria:

* Failure to obtain informed consent
* pre-admission insulin treatment for diabetes mellitus
Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee

Safety \& Efficacy of FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to Osteoarthritis of the Knee.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent to participate in the study.
* Willing and able to participate in all procedures and follow-up evaluations necessary to complete the study.
* Subject is 30 years or older.
* Moderate OA pain (rating of at least 20mm on the VAS) assessed at Baseline.
* Moderate to moderately-severe OA pain in the index knee (rating of at least 1.5 on the WOMAC Index 3.1 5-point Likert Pain Subscale) assessed at Baseline.
* Must be ambulatory.
* No analgesia (including acetaminophen \[paracetamol\]) taken 12 hours prior to an efficacy measure.

Exclusion Criteria:

* Subject has active infection at the injection site.
* Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
* BMI greater than 40 kg/m2.
* Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
* Subject has received an intra-articular amniotic fluid, amniotic membrane or amniotic fluid/membrane combination injection for the treatment of OA of the target knee within 3 months prior to screening.
* Subject has received a steroid, bone marrow aspirate concentrate (BMAC) or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
* Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
* Subject is pregnant or plans to become pregnant within 180 days of treatment.
* Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
* Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
* Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin).
* Diagnosis of gout in the past 6 month.
* Major injury to the target knee within the 12 months prior to the screening.
* Severe hip osteoarthritis ipsilateral to the target knee.
* Any pain that could interfere with the assessment of the target knee pain (e.g. pain in any other part of the lower extremities, pain radiating to the knee).
TechSAge Tele Tai Chi for People Aging With Mobility Disabilities

This study uses videoconferencing to deliver an evidence-based exercise program, Seated Tai Chi for Arthritis, to adults aging with long-term mobility disabilities. In the 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class. The study will examine the effects of the Tele Tai Chi program on physical activity and social connectedness for adults aging with long-term mobility disabilities, a population likely to experience barriers to exercise participation.

This study is part of the Rehabilitation Engineering Research Center on Technologies to Support Aging-in-Place for People with Long-Term Disabilities (RERC TechSAge). This study uses videoconferencing to translate an evidence-based exercise program for older adults, Seated Tai Chi for Arthritis, from an in-person setting to a remote class and to a different population, adults aging with mobility disabilities. In the 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class. The study will examine the effects of the Tele Tai Chi program on physical activity and social connectedness (primary outcomes), as well as exercise self-efficacy, falls efficacy, depression, quality of life, and pain (secondary outcomes) for adults aging with long-term mobility disabilities, a population likely to experience barriers to in-person exercise participation.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 60-80
* Self-identify as having a mobility disability, use a mobility aid (i.e., cane, crutches, wheelchair, walker, or scooter) or have serious difficulty walking or climbing stairs
* Mobility disability for at least 10 years
* Passing score on Physical Activity Readiness Questionnaire (PAR-Q) or letter from physician stating approved to participate in the intervention
* Passing score on Telephone Interview for Cognitive Status (TICS)-score 26 and above included
* Passing score of brief Technology Proficiency Screen (e.g., be able to do send and receive email)
* Have access to a webcam on computer or tablet
* Plan to have internet access for six months from screening
* Live in the US
* Be conversational in English
* Available to attend 1 hr online class 2x a week for 8 weeks

Exclusion Criteria:

* Blind or deaf
* Significant Tai Chi practice during the past 6 months
Feasibility of a Combination of Graded Pain Exposure and Graded Motor Imagery in People With Complex Regional Pain Syndrome Type 1

Background:

There is low quality evidence supporting the use of rehabilitation in Complex Regional Pain Syndrome (CRPS), despite it is the first line approach in the Guidelines . Graded Motor Imagery (GMI) may be useful to improve pain and function at mid term (6 months). Graded Pain Exposure Approaches (GPE) seem to improve pain but not function at mid term. In other type of chronic pain conditions GPE offers better outcomes than "pain contingent" (exercises avoiding pain) approaches at short term (3 months) and similar at mid term. Following the recommendations of Authors, we will evaluate the efficacy and safety of a combined therapy of GMI and GPE in people with CRPS type 1.

Objective:

To evaluate the feasibility of a combined therapy of GPE and GMI in front of only GMI in people with CRPS-1 and the clinical impact on the primary outcome (Severity of the disease) of the intervention.

Design:

Feasibility Randomized controlled Trial, single blind of evaluator, 2 parallel arms. Measurement pre-intervention, post-intervention , 1 and 3 months follow-up.

Population:

People 18 years old or above with CRPS type 1 diagnosed by Budapest criteria and (1) without any psychological or psychiatric disease, (2) nor any neurosensorial issue that could compromise the realization of the therapy proposed (3) neither any major surgery intervention related to CRPS (e.g neurostimulation or sympathectomy) (4) nor minor intervention on the last 3 months (e.g. nerve blocks).

Outcomes:

Primary outcomes: Complex Regional Pain Syndrome Severity Scale (severity of the disease) and Safety Outcomes ( oedema, pain, temperature, Range of Motion). Secondary outcomes: 5Q-5D-5L (quality of life), SF-MPQ (Quality, Intensity and location of pain), PPT (pain pressure threshold), CPM ( pain inhibition pathways), FAAM or Quick Dash (function), PCS (catastrophism), Self efficacy in chronic pain questionnaire (self-efficacy), Dynamometry (Hand Grip strength),


Eligibility Criteria:
Inclusion Criteria:

* No difficulties understanding Spanish or Catalan.
* Diagnosed according to Budapest criteria.

Exclusion Criteria:

* Diagnosis of psychological or psychiatric illness
* Having received any major invasive treatment (e.g: Spinal cord Implants or sympathectomy of the affected extremity).
* Having received any minor invasive treatment (e.g: Nerves block) in the last three months.
* Having any neurosensorial difficulty that could compromise the execution of the therapy proposed.
Polyphenols in Sorghum and Iron Absorption

Iron deficiency and iron deficiency anemia are two major public health problems in developing countries. In these countries, the use of monotonous plant-based diets, low in animal source food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor iron status or aggravate poor iron status caused by infections. In many West African countries sorghum is a major source of energy, protein, vitamins and minerals especially for the most poverty-stricken people. Some sorghum varieties are known to contain high levels of polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a huge group of plant metabolites with varying chemical structures. Depending on their structure, the level of complex formation with iron in the intestine and thus the negative effect on iron absorption is different.

Micronutrient deficiency can be combated by fortification of plant-based staples. Fortification is a promising food-based approach which can be applied when other strategies fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods with iron, a wide variety of different iron compounds have been used. The iron compound sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in presence of polyphenol is available.

The aims of the study are to investigate the effect of different sorghum polyphenol concentrations on human iron absorption and to investigate if the negative impact of the polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32 apparently healthy young women which will consume sorghum porridges with different polyphenol levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA. Furthermore test meals with added vitamin C or added laccase will be compared to a control meal. Iron absorption will be determined by stable isotope technique.


Eligibility Criteria:
Inclusion Criteria:

* Females of reproductive age, 18-40 years
* Maximum body weight 65 kg
* Normal body mass index (18.5-25 kg/m2)
* No intake of mineral/vitamin supplements 2 weeks before and during the study
* No metabolic or gastrointestinal disorders

Exclusion Criteria:

* Pregnancy or lactation
* Regular intake of medication (except oral contraceptives)
* Blood donation or significant blood loss (accident, surgery) over the past 4 months
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* Former participation in a study involving administration of iron stable isotopes
* Subject who cannot be expected to comply with study protocol
* Eating disorders or food allergy
* High C-reactive protein levels (\>5 mg/L)
Music and Child Health and Development

The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old children from low-income families. The main questions it aims to answer are:

1. Does participation in a music enrichment program improve the quality of parent-child interactions?
2. Does participation in a music enrichment program reduce motivation for food
3. Does participation in a music enrichment program improve the quality of the language environment?

Participants will:

1. Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.
2. At the beginning, after the first 8 weeks and after the second 8 weeks, a researcher will come to the participants house and parent-child pairs will:

   1. be video recorded during 10 minutes of playtime and meal time.
   2. fill out questionnaires
   3. wear a small wearable language recorder for 16 hours
3. At the beginning, after the first 8 weeks and after the second 8 weeks, the parent and child will come to the baby lab and will:

   1. Play a computer game to test motivation for food
   2. have height and weight measurements collected

Researchers will compare the music and play groups to see if there is a difference in the quality of parent child interaction, food motivation or language environment.


Eligibility Criteria:
Inclusion Criteria:

* Family income meets criteria for the National Women, Infant, and Children (WIC) program
* Family is able and willing to commit to a 6-month program

Exclusion Criteria:

* Mother \<18 years old at the time of delivery
* During pregnancy:
* Mother smoked \>10 cigarettes/day
* Mother used \>1 marijuana joint/day
* Mother used any other illicit drugs
* Mother drank \> 3 standard drinks on a single occasion or \>1 standard drink on a daily basis
* Preterm birth \<37 weeks gestation
* Child with significant health issues, and/or genetic conditions (e.g., cerebral palsy, down's syndrome)
* Mother with major health concerns during pregnancy (e.g., gestational diabetes, pre-eclampsia, etc)
* Parent/child who do not speak English