cyrilzakka/clinical-trials huggingface dataset:
En Masse Distaliaztion Via Skeletal Anchorage

Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.


Eligibility Criteria:
Inclusion Criteria:

* Full set of permanent teeth present, except for third molar
* Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
* No systemic conditions interfering with treatment, as reported by patient
* No previous Orthodontic treatment
* Good Oral Hygiene
* No use of any for of anti-inflammatory drugs

Exclusion Criteria:

* Patient who required surgery to correct skeletal discrepancies
* Patient with congenital dentoskeletal disorders
* Missed or Mutilated teeth in Maxillary arch
* Patients with poor oral hygiene
Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* systolic blood pressure \>=160mmHg (\>=150 mmHg for type 2 diabetics);
* on 3 or more antihypertensive medications
* \>= 18 and =\< 85 years of age.

Exclusion Criteria:

* renal artery abnormalities
* eGFR \< 45mL/min
* MI, angina, CVA within 6 months
* Type 1 diabetes
* ICD or pacemaker, or any other metallic implant not compatible with MRI
* others
Evaluating the Effect of the Use of Virtual Reality Headset in School Vaccinations

This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations.

Research Hypotheses:

Hypothesis 0a (H0a): There is no difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 1a (H1a): There is a difference in fear scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 0b (H0b): There is no difference in anxiety scores between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Hypothesis 1b (H1b): There is a difference in anxiety scores experienced between the experimental group in which virtual reality glasses were used during vaccination administration and the control group.

Interventions made for protecting health or curing diseases, significantly affect children's psychological state and social adaptation. Being one of these interventions, vaccination may cause fear and anxiety in children. This fear and anxiety may affect children's future treatment and care experiences and result in fright and avoidance in them. Thus, it is important to try and reduce biological stress and to cope with psychosocial stress. One of the methods which can be used for this purpose is virtual reality headset used as a distraction method. This study was conducted with a randomized controlled experimental design to determine the effect of virtual reality headset on children's fear and anxiety during vaccinations. The population of the study consisted of first grade students attending primary schools in the city center of Ordu. The study was completed with 84 students in the experimental group and 85 students in the control group. With the sample number obtained as a result of the study, the test power was found to be 89.8% when the alpha error was 0.05 and the effect size was kept at 0.5. The data were collected using the Child and Parent Introductory Information Form, Children's Fear Scale, and Children's Anxiety Scale-State Scale.

Eligibility Criteria:
Inclusion Criteria:

* Parental consent
* Student's willingness to participate in the research
* The student does not have a mental or neurological disability
* Not being able to communicate
* The student does not have a chronic illness
* The student does not have an illness that causes acute or chronic pain
* The student has not used any analgesic medication in the last 24 hours.

Exclusion Criteria:

* Lack of parental consent
* Student's unwillingness to participate in the research
* The student has a mental or neurological disability
* The student has a communication disability
* The student has a chronic illness
* The student has an illness that causes acute or chronic pain
* The student's use of medication that will have an analgesic effect in the last 24 hours.
Bariatric and Obstructive Lung Disease Study II

The prevalence of obesity and asthma has significantly increased over the past two decades. The purpose of this study is to try and understand the mechanism by which obesity leads to airway hyperresponsiveness (AHR), one of the defining features of asthma. This research is being done to determine how weight or body size affects airway size and airway smooth muscle (ASM) tone and function. The goal of the study will be to look at if and how, weight might affect lung functioning.

The investigators hypothesize that low lung volumes in obesity lead to AHR by reducing airway caliber causing increased ASM tone with impairment in deep inspiration (DI) response similar to what is seen in asthma.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* BMI over 35 kg/m2 (Bariatric) or BMI between 25 and 28 kg/m2 (Control)
* Physician diagnosis of asthma and on active asthma medication (if asthmatic)

Exclusion Criteria:

* Weight greater than 450 lbs
* Unstable cardiovascular disease
* Uncontrolled hypertension
* Renal failure on dialysis
* Cirrhosis
* Pregnant or lactating
* Bleeding disorders or Coumadin use
* Recent hospitalization for asthma in the past 3 months
* Active smoking or more than 10 pack year smoking history
Glycated Albumin in Pregnancy

This is an observational study at the Obstetrical outpatient clinic at Stavanger University Hospital, Norway. The purpose of the study is to compare glycated albumin and glycated hemoglobin (HbA1c), both markers of "long-term blood sugar" with oral glucose tolerance test (OGTT). The OGTT is a screening test for gestational diabetes, a condition that increases risk of adverse pregnancy outcome for mother and child. The risks are reduced with good glycaemic control throughout pregnancy, therefore, it is important to screen for gestational diabetes.

According to the new guideline by the Norwegian Directorate of Health published april 2017, screening for gestational diabetes is increased. All pregnant women with a slight risk, approximately 70 % of pregnant women i Norway, should have an OGTT performed in gestational week 24-28. Among those women, all primiparas above the age of 25 years old.

The investigators will include 150 primiparas above the age of 25 years old in the study. The women will be asked to participate in the study when they attend an ultrasound examination at the Obstetric outpatient clinic in gestational week 18-20. Prior to inclusion, participants need to sign written informed consent.

Included women will get an appointment for OGTT in gestational week 24-28 at the Clinical trial unit, Stavanger University hospital. The OGTT will be performed according to national guidelines. The participants will fill in a single questionaire with information on age, height, ethnicity, whether there is diabetes in close family, any other illnesses, smoking habits and other medications/supplements.

In addition, to blood sugar levels, markers of importance for glycaemic control, iron status and vitamin-D status will be analyzed.

Women diagnosed with gestational diabetes or overt diabetes mellitus, will be followed up according to national guidelines.

Eligibility Criteria:
Inclusion Criteria:

* primiparas \>25 years old
* singleton pregnancy

Exclusion criteria:

- prior diagnosed with diabetes
The Effect of Intra-pulpal Anesthesia With Cryotherapy on Intra-operative Pain

The goal of this clinical trial is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. The main question it aims to answer is: Is there a difference in intra-operative pain levels using intra-pulpal anesthesia with and without cryotherapy during root canal treatment? Participants will undergo root canal treatment using intrapulpal anesthesia with and without cooling. Researchers will compare cold and room temperature intrapulpal anesthesia to see the intensity of intraoperative pain.

The study will be conducted on 40 mandibular molars in each group n = 20. The patient will be asked to pick an opaque sealed envelope that will contain a number 1 or 2. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group.

Group 1: Will receive intrapulpal local anesthesia at 4-5 C after pulp exposure.

Group 2: Will receive intrapulpal local anesthesia at room temperature after pulp exposure.

Procedural steps:

1. A history of present illness will be recorded from the patient and the suspected tooth will be tested for vitality using a cold test and an electric pulp tester, to ensure the correct diagnosis is reached.
2. Once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000).
3. A rubber dam will be used to achieve isolation, and an access cavity will be prepared using a high-speed handpiece, a round bur (no.4), and an Endo-Z bur.
4. If the patient reports feeling any pain, the procedure will stop, and the patient will be presented with a Visual Analogue Scale and asked to rate the pain on a scale of 1-10. Pain levels of more than 5 will be included in the study.
5. Intra-pulpal anesthesia (2% lidocaine 1:100,000) will be administered, and the needle will be surrounded by a piece of sterile gauze to ensure it is under back pressure.
6. After administering the intra-pulpal injection, the patient will again be presented with the same VAS and asked to rate their current pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
* Mandibular molars with closed apices.
* Patients who are experiencing pain during access cavity drilling above 5 visual analog scale.

Exclusion Criteria:

* • Patients with a known allergy to lidocaine.

  * Root canal-treated mandibular molars.
  * Patients with systemic diseases.
  * Mandibular molars with open apices.
  * Mandibular molars with external/internal resorption.
  * Non-restorable mandibular molars.
Effectiveness of Electrical Stimulation or Kinesio Taping on Recovery Disability in Low Back Pain

The purpose of this study is to analyze the effectiveness of electrical stimulation and kinesio taping in combination with exercise in People with Chronic Low Back Pain


Eligibility Criteria:
Inclusion Criteria:

1. LBP for three months or more;
2. age between 25 and 65 years;
3. a score of four points or more on the Roland Morris Disability Questionnaire;
4. not currently receiving physical therapy.

Exclusion Criteria:

1. the presence of lumbar stenosis;
2. any clinical signs of radiculopathy;
3. a diagnosis of spondylolisthesis;
4. a diagnosis of fibromyalgia;
5. treatment with corticosteroid or oral medication within the past two weeks;
6. a history of spinal surgery;
7. disease of the central or peripheral nervous system.
The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia

Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.

Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

1- Patients in good general health. 2. Baseline MDAS \<13. 3. No seizure disorder.

Exclusion Criteria:

1. Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
2. Patients with a history of acute or chronic confusion.
3. Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
4. Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).
FLI Normative Study

Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.

The primary objective is the assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). The FLI-P has been developed to address a substantial gap in the current tools available to measure the development of auditory skills in children. The FLI-P provides a measure of listening skills acquisition in children from birth to six years of age (0 - 72 months). The FLI-P will be administered by an investigator who has received appropriate training in its use or completed by parents/caregivers themselves. The FLI-P assessment will be conducted using an application running on a Personal Computer, tablet or online device. There are no specific medical or surgical procedures involved in this clinical investigation and the FLI-P is a non-interventional application.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 0 and 6 years of age.
* Pass on the Newborn Hearing Screen Status conducted during the New South Wales Statewide Infant Screening - Hearing (SWISH) Program.
* No current parental or professional concern regarding hearing status.

Exclusion Criteria:

* Pre-existing diagnosis of additional needs.
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of the study.
* Unwillingness or inability of the subject to comply with all investigational requirements.
Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker

Voice Assist Arrhythmia Monitoring (VAAM) is an application running on smartphones and/or landline phones that performs vocal tests for the monitoring of abnormalities in the heart rhythm.

Following ICF signature and process and eligibility confirmation, subject will have a training session to assure correct application use. The subjects will be asked to pronounce few vowels 3 times a day to be evaluated by the application analysis algorithm at the patient natural environment.

At the same time, a single lead ECG system will be recorded synchronously ECG for reference with the use of dedicated recording device

Eligibility Criteria:
Inclusion Criteria:

1. Female and male at age of ≥18 years and above.
2. All AF types Or Medical history of Cryptogenic stroke.
3. Ability and willingness to sign an informed consent form

Exclusion Criteria:

1. Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps.
2. Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC.
3. Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm.
4. Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant)
5. Tremor or Parkinson's disease
6. Current hoarseness
7. Barriers for communication and lack of capability to execute the handlings required for this study.
8. Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.
The Predictive Value of Lubricin in Patients With Infective Endocarditis

The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients

Infective endocarditis is a challenging disease with a wide range of clinical presentations, making it difficult to diagnose. Diagnosis primarily relies on clinical suspicion based on symptoms. Blood cultures or other microbial tests confirming the presence of infection and echocardiography are supportive diagnostic tools. Another marker that may become valuable in the near future for diagnosing infective endocarditis is Lubricin. Lubricin, a glycoprotein expressed by the PRG4 gene, has been found to have significantly elevated levels in the plasma of animals with damaged or infected heart valves compared to healthy animals. Furthermore, plasma lubricin levels can potentially serve as a biomarker in situations like endocardial injury and infection. Lubricin and Procalcitonin will be studied from the blood samples routinely collected. During this academic study, procalcitonin and lubricin values will be measured by investigators. Thus, the sensitivity and specificity of the Lubricin parameter in patients with infective endocarditis will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be between 18 and 65 years old
* Patients diagnosed with infective endocarditis according to the Duke criteria

Exclusion Criteria:

- The patient being pregnant
Periodontitis and Cardiovascular Events or "PAVE"

The purpose of this study is to determine if treating periodontal infections (gum problems) will lead to fewer heart problems in patients at high risk for cardiovascular disease.

There is growing evidence of a strong association between infection and atherosclerosis as well as a specific link between periodontal infection (gum problems) and heart disease. Previous studies have established possible effective treatments of periodontal disease. These treatments may lead to fewer heart events in persons at high risk for cardiovascular disease. In contrast to previous heart disease studies, the primary treatment in this project is directed toward infectious agents at periodontal sites. This project is a pilot randomized clinical trial to test the feasibility of selecting and refining a periodontal infection treatment and examining the effect of that treatment on future heart events. It is a multi-center planning and pilot study involving five investigational centers at the University at Buffalo (lead and overall coordinating center), University of North Carolina, Boston University, Kaiser Permanente/Oregon Health Science University, University of Maryland, and a data coordinating center at the University of North Carolina. Central microbiology and cytokine laboratories and a biologic specimen bank are also included. A team of cardiologists, periodontists, epidemiologists, infectious disease specialists, biostatisticians, research nurses in periodontics and cardiology, and data managers has been assembled to accomplish the research with a careful, cost-effective approach. The ultimate goal is to develop a definitive randomized clinical trial that will include about 4,000 participants from approximately 15 centers across the United States

Eligibility Criteria:
Eligibility:

* Aged 75 years or less AND 50% or more blockage of at least one artery in the heart,
* Heart problems in the last 3 years (including previous heart attack),
* Previous heart bypass surgery, or previous heart angioplasty with or without a stent, AND at least 6 natural teeth present in the mouth AND evidence of mild to severe gum problems.

Exclusion:

Any of the following:

* A major illness requiring hospitalization,
* Renal dialysis,
* Serum creatinine \> 3 mg/dl,
* Organ transplant recipient requiring immunosuppression medication,
* Surgery needed in the next 3 years,
* Chemotherapy in the past 3 years,
* Head and/or neck radiation at any time in the past,
* Liver dysfunction,
* Class IV congestive heart failure,
* Drug or alcohol abuse,
* Pacemaker or AICD/defibrillator.
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. pathological confirmed adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 12 cm
4. without distance metastases
5. age 18-70 years old, female and male
6. KPS \>=70
7. UGT1A1\*28 6/6 or 6/7
8. the MSI status is MSI-H or d-MMR
9. without previous anti-cancer therapy or immunotherapy
10. with good compliance
11. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
6. DPD deficiency
7. UGT1A1\*28 7/7
8. the MSI status is MSS or p-MMR
9. allergic to any component of the therapy
Thromboelastography and Pancreas-kidney Transplantation

Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.

Objectives:

* The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)
* The secondary objectives are:

  1. To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
  2. To study correlation values between thrombolelastogram and standard coagulation parameters

Population study:

* Evaluated group: 40 pancreas-kidney recipients
* Control group: 80 kidney recipients
* Recruitment periods: 24 months
* Patient Monitoring: 48 hours
* Total duration of the study: 36 months.
* Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)


Eligibility Criteria:
Inclusion Criteria:

* Men, women \> 18 years old
* Kidney or pancreas-kidney recipients
* Not opposed to research
* With no legal protection
* Affiliated to social security system

Exclusion Criteria:

-Enrollment in an other research protocol, incompatible with the trial according to the investigator