cyrilzakka/clinical-trials huggingface dataset:
Maxillary Segmental Distalization Using Digitally Printed Appliances

Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.

Ethical approval All selected patients will be informed about the aims and characteristics of the study, the potential risks and benefits and the option of withdrawing from it whenever they desire. Then all patients will sign the informed consent document. All patients will be informed about the results after finishing. All selected patients' personal data and details will be held and handled confidentially and privately in the orthodontic department, faculty of dentistry, Mansoura university.

Trial design

Patients will be randomly allocated into two groups as follow:

1. First group: Buccal segmental digitally printed maxillary distalizer (infrazygomatic mini-implant IZC).
2. Second group: palatal segmental digitally printed maxillary distalizer.

The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews.

The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment.

Transpalatal arm will connect the two sides to avoid buccal tipping during distalization.

The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance.

The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate.

The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks.

The distalization will be performed by using chain elastics between the anterior and posterior hooks.

Force: 300-350 gram per side which will be measured using force gauge.

A follow-up session will be scheduled every 3weeks, and the appliance will be removed in both groups after the patient reach a Class I relationship. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients age (13- 18) years.
* Full permanent dentition except third molar.
* Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
* normal or short lower facial height.

Exclusion Criteria:

* Systemic conditions that may interfere with the treatment.
* Bad habits that might jeopardize the appliance.
* Transverse discrepancy.
* Previous orthodontic treatment.
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin

Primary Objective:

To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300.

Secondary Objectives:

To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes.

To evaluate the safety of Gla-300.

Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.

Eligibility Criteria:
Inclusion criteria :

* Participants with type 2 diabetes mellitus.
* Participants on "standard of care" basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin.
* Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
* Fasting plasma glucose values above 130 mg/dL.

Exclusion criteria:

* Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses \[variation more than ±20%\]).
* Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effect of Dynamic Light Application on Performance of ICU Nurses

In two sessions of four days nurses will be exposed to dynamic lighting and normal (reference) lighting. Through the psychological tests T.O.D.A. (Test or divided attention) and T.O.S.S.A. (Test of sustained selective attention), then the focus tested. These two tests run both 5 times. The investigators also ask to fill out: 3 questionnaires, fatigue and mood, sleep and Questions of Life.


Eligibility Criteria:
ICU nurses working 32 hours/week or more
Barriers and Facilitators to Vegetable Intake

The purpose of this study is to find out why people do or do not eat vegetables.

The Dietary Guidelines for Americans (DGA) stress the importance of a diet high in fruits and vegetables (FV) to achieve health benefits. Despite the recommendations, adherence is low; only 12% of the population meets the recommendation for fruits and even less of the population (9%) meets the recommendation for vegetables. Recently, it was found that vegetable consumption increased when individuals were provided the recommended daily amounts while participating in a clinical study, but returned to pre-study low levels when vegetables were no longer supplied. This result suggests that habitual consumption of FV is strongly regulated by behaviors influenced by social, environmental, and/or individual factors. Therefore, identifying regulatory factors of vegetable consumption will greatly assist in developing successful strategies to increase vegetable intake to achieve health benefits. The overall objective of this study is to examine both barriers and facilitators to adherence to consuming DGA-recommended amounts of vegetables in participants who completed a randomized controlled trial with provided vegetables or who were in a control group, using the Nominal Group Technique (NGT).

Eligibility Criteria:
Inclusion Criteria:

* Participant in NCT02585102 who gave permission to be contacted for a follow-up study.

Exclusion Criteria:

* Did not participate in NCT02585102.
* Participant in NCT02585102 who did not give permission to be contacted for a follow-up study.
Study Evaluating Rapamune® Maintenance Regimen

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 13 years of age.
2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion Criteria:

1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
* Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
* Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
* Age \> 18 years.
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:

Absolute Neutrophil Count (ANC) \> 1,500/µL Platelets \> 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)\<2.5X institutional upper limit of normal Creatinine clearance \> 60mL/min for patients with creatinine levels above institutional normal.

* Patients must be \> 4 weeks and \< 12 weeks post-surgery at time of study registration.
* Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
* Women must not be pregnant or breast-feeding.

Exclusion Criteria:

* Patients receiving any other investigational agents.
* Patients with known metastases.
* Patients with wounds that have not fully healed.
Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction

The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.

The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest 2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients: 2 years since ACL reconstruction with autologous hamstring tendon
* Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee

Exclusion Criteria:

* BMI \> 35 kg / m2
* neuromuscular diseases that affect lower limb movement
* Inability to give informed consent
* Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

The objective of this proposal is to test the feasibility of red blood cell (RBC) rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of RBC rejuvenation in this population to determine if a larger clinical trial powered to definitively characterize the benefits of rejuvenation is warranted.

This is a small pilot study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6 transfusions (over approximately a 6-month period) in a pre-defined order to maximize detection of any signal.

Blood transfusion is part of the standard care for individuals that have sickle cell disease. Often these transfusions become needed quite frequently. The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. People with sickle cell disease have abnormal red blood cells. Stored blood undergoes some changes that may make it less effective in achieving this goal.

The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to individuals who need frequent transfusions. Potential advantages include better delivery of oxygen by the transfused red blood cells and easier release of oxygen to the tissues. In addition the study will assess how using the rejuvenated blood affects the interval between transfusions. This means possibly that transfusions may not be needed as often.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to individuals who have sickle cell disease. Use of Rejuvesol in this study is considered investigational.

Eligibility Criteria:
Inclusion Criteria:

* Stable, compliant, chronically transfused sickle cell disease (SCD) patients
* Currently maintained crisis-free with repeated RBC therapy for at least 3 consecutive sessions
* ≥18 years old
* Have Hb SS disease
* Have the capacity to give informed consent

Exclusion Criteria:

* Baseline need for washed RBCs
* Pre-treatment SaO2 \< 92%.
A Clinical Study Aiming to Validate the Equipment: VoluSense Pediatrics (VSP)

This is a cross-sectional observational study, aiming to validate the accuracy of tidal breathing measurements in infants made by VoluSense Pediatrics, a lung function method based on electromagnetic inductance plethysmography, compared to an ultrasonic flowmeter. VoluSense Pediatrics consists of a flexible vest placed around the torso of the baby, and changes in tidal volume and flow is measured. The study will enable a better understanding of the usefulness of this equipment. The equipment is made by VoluSense Norway AS, and is owned by Haukeland University Hospital.

All infants will be assessed at the pediatric department at Haukeland University Hospital, and all data obtained by the same two investigators (Bentsen and Olsen). The infants will be dressed in the appropriate-sized vest selected according to the length from the armpit to the hip of the child. Care will be taken to ensure that the vest fits snugly around the torso and that the width of the copper wire zig-zag coveres the entire thorax and abdomen including the pubic region. The vest will be applied directly to the skin; neither body nor diaper will be worn underneath. The infants will then be fed before they will be placed supine in a cot and encouraged to sleep. No sedation will be used. Once the infant has fallen asleep, data will be collected with VSP for 2-3 minutes before the Exhalyzer D® neonatal facemask connected in series with the ultrasonic flow sensor will be placed gently, but firmly over the infant's mouth and nose, ensuring a good seal. Once the facemask is in place, a marker will be inserted in the VSP recording. The Exhalyzer D® measurement will be started about thirty seconds after the facemask has been put on, to allow adaptation to the facemask. Simultaneous recording using both devices will then be done for about 1 minute before the mask will be removed. New markers will be inserted in the VSP recording as the Exhalyzer D® measurement is started and stopped facilitating analysis of the same breathing cycles.

Data will be analysed and graphs will be created with SPSS version 22 (IBM SPSS Statistics, New York, US) and MedCalc version 13.1 (MedCalc Software, Mariakerke, Belgium). Bland-Altman plots will be used to visualize agreement between the two measurement techniques. For each pair of measurements, the pairwise mean of the breathing parameters will be plotted on the x-axis, and the pairwise difference expressed as a percentage of their mean value on the y-axis. The mean difference and the 95% limits of agreement and their confidence intervals will be represented by horizontal lines in the graphs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term born or preterm born babies ≥ 2000 grams.

Exclusion Criteria:

* Being in an unstable clinical condition.
* Weight \< 2000 grams.
Maekmoondong-tang on Post-operative Cough in Patients With Lung Cancer

The aim of the present study is to evaluate the efficacy and safety of Maekmoondong-tang on post-operative cough in patients with lung cancer. A randomized, double-blind, placebo-controlled trial will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years old.
* Patients undergone segmentectomy or lobectomy for lung cancer within 1 month
* Patients who do not or poorly respond to one week administration of common antitussive agents.
* Eastern Cooperative Oncology Group(ECOG) 0 to 2
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patients undergoing adjuvant chemotherapy.
* Patients who have been diagnosed with acute respiratory disease within 1 month.
* Patients who have been diagnosed with bronchial asthma or bronchiectasis within 1 year
* Patients taking Angiotensin Converting Enzyme Inhibitor
* Patients with pseudoaldosteronism.
* Participants who have known prior hypersensitivity to any investigational product component
* Patient with acute or chronic infections requiring treatment (active HAV, HBV, HCV, HIV, TB)
* Pregnant or lactating females
* Women of childbearing potential
* Patient who do not agrees to use effective means of contraception and not to donate sperm during the trial and up to 1 month after final administration
* Patient who participated other clinical trials of medicine or medical devices within 1 month
* Individuals who are judged inappropriate for the study by investigator
Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans

Eligibility Criteria:
Inclusion Criteria:

* healthy male
* ≥18 to ≤45 years old
* Body mass index (BMI) between 18-30 kg/m² inclusive
* Written informed consent to participate.

Main Exclusion Criteria:

* Any clinically relevant acute or chronic diseases
* Any history of drug or alcohol abuse
* Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.
Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection.

Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti-vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases.

Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss from endophthalmitis is high. The objective is to examine the change in antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD.

Yin, V. T., Weisbrod, D. J., Eng, K. T., Schwartz, C., Kohly, R., Mandelcorn, E., Lam, W., Daneman, N., Simor, A., \& Kertes, P. J. (2013). Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA ophthalmology, 131(4), 456-461.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
* 65 years or older
* able to provide informed consent.

Exclusion Criteria:

* diagnosed with an active ocular, periocular or systemic infection
* previously received treatment with an intravitreal injection
* previously treated with antibiotics in the past three months
* unable to attend the scheduled follow-up appointments or to complete treatment for any reason