cyrilzakka/clinical-trials huggingface dataset:
Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body

Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. Inflammation is a driving force in both of these diseases, creating a potential bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. In this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. A definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.

Dental probes will be used to probe depth of gum recession in subjects with and without a history of cardiac events. Venous blood samples will also be collected from all subjects for measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will then be done, in attempt to identify a difference in gum recession depth and/or serum inflammatory markers among those with and without prior cardiac events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with known CAD with previous MI, OR
2. Patients without known CAD
3. Ages 18-89 years
4. Patients who have dental implants with a recorded patient history of how the teeth were lost
5. Patients with at least one tooth in each of the four quadrants of the mouth
6. Able to obtain all necessary pocket measurements and blood samples needed for the study

Exclusion Criteria:

1. Patients with a known history of rheumatoid arthritis
2. Patients with a known history of lupus
3. Patients currently under the care of a rheumatologist
4. Patients who have had a MI in the two weeks prior to entering the study
5. Patients with a previous history of coronary artery bypass graft
6. Current smokers and tobacco users
7. Patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10. Patients who have undergone chemotherapy in the past five years
8. Patients who currently use steroids or immunosuppressive agents
Efficacy of Electro-acupuncture for Abdominal Obesity: Study for a Randomized Controlled Trial

Electro-acupuncture provides stimulation to acupoints, and has been widely used to treat abdominal obesity in China despite of lack of high-level evidence for treatment efficacy. The study will investigate whether the electroacupuncture can alleviate clinical symptoms and the mechanism of action in patients with abdominal obesity.

The study will be a randomized controlled trial from May 2021 to December 2022, including 68 participants with abdominal obesity. The participants will be randomly divided into 2 groups in a 1:1 allocation ratio.The intervention group will receive electroacupuncture; the control group will receive sham acupuncture. Each treatment will last 12 weeks, including 8 weeks of intervention period and 24 weeks of follow-up. The primary outcome is the waist circumference (WC), the secondary outcomes include weight, body mass index (BMI), hipline, waist-hip-ratio (WHR), Insulin resistance index (IRI), blood fat, metabolomics will be used analysis the mechanism. The adverse events will be recorded during the intervention and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patients recruited for this study should meet the following inclusion criteria:

  1.Satisfying the criteria for the diagnosis of abdominal obesity; 2.18 years old≤age≤55 years old; 3.Being able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

* Patients with any of the following criteria will be excluded from the study:

  1. Presence of endocrine disorders such as: polycystic ovary syndrome; Cushing's syndrome; uncorrected thyroid disease.
  2. Presence of diabetes mellitus, or hypertension, or abnormal liver and kidney functions, or mental diseases.
  3. Pregnant or lactating state, women who plan to become pregnant within 12 weeks.
  4. History of bulimia, anorexia, or any other eating disorders.
  5. Use of medications in the past 3 months, such as diet drugs, corticosteroids, antidepressants, which may affect weight or appetite.
  6. History of surgical weight loss, postoperative adhesions.
  7. History of participating in a clinical study of weight loss or any other therapies to lose weight in the past 3 months.
  8. Unable to cooperate with the research caused by other diseases or reasons.
  9. Received acupuncture within 6 months before enrollment
A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment

This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult subjects with moderate renal impairment and in healthy adult subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 85 years (inclusive) of age, with body weight 50 kg or more.
* Subjects with renal impairment (RI) must have stable chronic moderate RI (estimated glomerular filtration rate \[eGFR\] ≥ 30 and \< 60 mL/min/1.73 m2)
* Healthy subjects must have normal renal function (eGFR ≥ 90 mL/min/1.73 m2)

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study, including: history of cancer, low platelet count, bleeding disorder or coagulopathy, significantly altered electrocardiogram waveform, unstable glycemia control in subjects with diabetes, acute renal failure, recent donation or loss of blood
* Evidence or history of alcohol or substance abuse
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers

We hypothesize the herbal preparation will enhance the preschoolers' immune response and when taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections and gastroenteritis in the active versus the control group.

This combination of herbs has been studied only once before in preschoolers. In a study of 430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004, a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory infections by 55% (308 to 138). We are repeating this study to see if our results confirm or contradict those of the previous study.

Eligibility Criteria:
Inclusion Criteria:

* Age 3-6

Exclusion Criteria:

* Cystic fibrosis
* Immunodeficiency
* Bronchopulmonary dysplasia
* Anatomic abnormalities of respiratory tract
* Intestinal malabsorption
* Allergy to sunflower seeds
Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine

To evaluate the effect of erenumab compared to placebo on disability in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Migraine prevention continues to be an area of large, unmet medical need, with existing therapies often having modest efficacy and poor tolerability. Calcitonin gene-related peptide (CGRP) has an important role in the pathophysiology of migraine. Erenumab-aooe is a fully human monoclonal antibody that targets the CGRP receptor, and interrupts its downstream effects. Erenumab has been approved for the preventive treatment of migraine in adults. The present study is a Phase IV trial that will assess the effect of erenumab on disability and work productivity in employed subjects with episodic migraine (EM) who have previously failed 1 or more migraine preventive treatments.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age upon entry into screening.
* Documented history of migraine with or without aura according to the IHS ICHD-III for greater than or equal to 12 months
* Has EM defined as history of greater than or equal to 4 and less than 15 migraine days and less than 15 headache days per month on average during the 3 months prior to initial screening
* Employed greater than or equal to 20 hours/week upon entry into initial screening, stable for at least 3 months in the same job and has not specified willful termination of employment throughout the duration of the study. Employment is defined by work outside the home, self-employed, or works from home
* Has greater than or equal to 4 hours of lost productive time due to headache/migraine and/or related symptoms in the past month prior to initial screening as determined by subject
* Has total disability score of greater than 10 as assessed by MIDAS (3-month recall) at initial screening
* History of treatment failure with at least 1 preventive treatment category for migraine

Exclusion Criteria:

* Older than 50 years of age at migraine onset
* History of cluster headache, hemiplegic migraine, or other trigeminal autonomic cephalalgia.
* Taken an opioid and/or opioid-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
* Taken a butalbital and/or butalbital-containing analgesic greater than or equal to 4 days during the 1 month prior to screening for any indication
* Change in the regimen of current migraine preventive treatment or a concomitant medication that may have migraine prevention effects during baseline
* Taken an opioid and/or opioid-containing analgesic ≥ 4 days during baseline for any indication.
* Taken a butalbital and/or butalbital-containing analgesic ≥ 4 days during baseline for any indication.
* Previously treated with any agent (monoclonal antibody or small molecule) targeting the CGRP pathway (ligand or receptor) in preventive settings

Other inclusion and exclusion criteria may apply.
Yoga and Aerobic Exercise in Epilepsy

In recent years, there is growing interest in illustrating the health benefits of exercise among epilepsy. Although exercise is recommended for patients with epilepsy, there is uncertainty concerning the effects of yoga and aerobic exercise on multiple health outcomes in epilepsy. The aim of this trial is to examine the effects of yoga and aerobic exercise training on physical activity, health-related physical fitness, mental, emotional, and psychological health status, seizure frequency and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy diagnosed by a neurologist using the International League Against Epilepsy (ILAE) criteria,
* Having access to the internet at least three per week.

Exclusion Criteria:

* Any history of neurological disorders other than epilepsy,
* Significant physical and cognitive impairments,
* Musculoskeletal comorbid conditions,
* Contraindications for an exercise intervention including diagnosed cardiovascular, pulmonary, or endocrine diseases,
* Pregnancy,
* Mental deficiency or low education level to understand the questionnaires,
* Currently participating in an exercise program,
* Volunteers who miss 3 consecutive intervention sessions, and do not participate in 10% of sessions.
Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children

Skin injury due to the use of medical adhesives is a common but under recognized complication in children. To prevent central venous catheter-related complications, care interventions should be planned in such a way that they do not lead to medical adhesive-related skin injury. Systematic administration of preventive care interventions is needed to reduce skin injuries associated with medical adhesive used for central venous catheter fixation. The SECURE Care Bundle has been developed by researchers based on the latest evidence to prevent medical adhesive-related skin injuries associated with central venous catheter fixation in children.

The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, correctly applying and removing medical adhesives and registering medical adhesive related skin injury.

The goal of this randomized controlled trial study is to evaluate about SECURE care bundle in preventing medical adhesive-related skin injury due to central venous catheter fixation in children.

The main questions it aims to answer are

1. Is the SECURE Care Bundle effective in reducing the incidence of medical adhesive-related skin injuries due to central venous catheter fixation?
2. Does the SECURE Care Bundle have an effect on the first central venous catheter dressing change time?

Data will collect after the parents of the children who meet the case selection criteria will inform about the research, their oral and written consents will be obtained through the "Informed Consent Form".

Researchers will compare the SECURE Care Bundle group to the standard care group to see medical adhesive-related skin injury due to central venous catheter fixation.


Eligibility Criteria:
Inclusion Criteria:

* The child is being treated with a central venous catheter (CVC) in the intensive care unit
* 28 days to 5 years old
* Patients with a Braden Q score of intermediate risk and above will be included in the study.

Exclusion Criteria:

* Children without CVC,
* Children with previous skin and tissue damage in the area where CVC will be opened,
* Children with allergies to the products used
* Patients who are already receiving treatment with CVC at the beginning of the study periods will not be included in the study.
Erector Spinae Plane Block in Cardiac Surgery

ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* emergency
* patient refusal
* infection at or near catheter insertion
DMEK Versus DSAEK Study

The purpose of this study is to determine whether corneal transplantation by Descemet Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.

FECD is a progressive, multifactorial and irreversible disease characterized by accelerated loss of corneal endothelial cells in the innermost layer of the cornea that leads to vision impairment and potential blindness if left untreated. FECD is responsible for more than 50% of the 1.300 annual corneal transplantations in the Netherlands.

Corneal transplantation improves vision and quality of life in patients with corneal disease. Currently, the standard of care for patients with Fuchs Endothelial Corneal Dystrophy (FECD) is Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), in which only the posterior layers of the cornea are transplanted. However, visual recovery following DSAEK is suboptimal. Descemet Membrane Endothelial Keratoplasty (DMEK), the latest technique in corneal transplantation involves transplantation of only a monolayer of corneal endothelium and Descemet's membrane providing the thinnest endothelial graft possible. DMEK has been suggested to result in faster and better visual recovery compared to DSAEK. While the economic burden, both medical and social, from this disease has not been assessed to date, costs associated with corneal transplantation reach $ 110 million dollars yearly for the 47.000 transplantations in the USA.

The objective of this project is to assess the effects and costs of DMEK vs. DSAEK in order to determine whether the new technique is effective and cost-effective over the standard technique.

The primary outcome measure is best-corrected visual acuity. Secondary outcome measures are contrast acuity, astigmatism, quality of vision, endothelial cell loss, incidence of graft rejection, primary graft failure, cornea donor loss due to preparation, and generic and vision-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy

Exclusion Criteria:

* Ocular comorbidities other than cataract
* Previous corneal transplantation
* Human leukocyte antigen (HLA) matched keratoplasty
* Inability to complete follow-up
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.

To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male or female volunteers 16-40 years of age;
* Body mass index 18.0 to 30.0 kg/m\^2 inclusive;
* Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
* Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;

Exclusion Criteria:

* History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
PEAK Study (Physical Exercise and Activity in Kids)

The objectives of this study are to study the effect of formal exercise training on motor function and overall physical fitness in children with arthritis. A 12-week comprehensive exercise program will be used. Formal exercise training will be compared to Qi gong.

Childhood arthritis is a common and often debilitating disease. Children with arthritis are less active than their peers, and consequently they often have poor physical fitness. This study follows up our pilot study, in which we showed that exercise training can be safely carried out in children who have arthritis.

We plan to randomly assign 80 children with arthritis to one of two groups. The experimental group undergoes a vigorous exercise training program consisting of twelve weekly supervised sessions as well as twice weekly at home sessions using an exercise video. The control group also has twelve supervised sessions and two home sessions. However, their exercises are non-strenuous, based on Qi gong. All children have comprehensive fitness testing before and after the training at the exercise lab at the Hospital for Sick Children.

If we show that fitness exercise leads to improved motor function and improved ability to carry out activities of daily living, then we will change the way in which we provide therapy for childhood arthritis. We hope that this study will lead to an improved quality of life for children with arthritis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8 - 16 years.
2. Diagnosis of Juvenile Idiopathic Arthritis - based on the revised Durban criteria.
3. Polyarticular or pauciarticular course.
4. Stable Disease - on a stable dose of NSAID, and if applicable methotrexate or other second line agents - in the preceding month, and judged by the attending rheumatologist to be clinically stable and unlikely to need a change in medication over the course of the trial.
5. Medications. There are no restrictions on medication use for this study; however, every effort is made to keep medication dosage stable over the course of study.

Exclusion Criteria:

1. Co-morbidity with cardiac, pulmonary or metabolic disease.
2. Moderate or severe hip pain while walking (as judged by the patient and scored on a 4 point scale) or active systemic symptoms (fever, rash).
3. Children who engage in more than 3 hours of structured extracurricular physical activity weekly may not show additional gains from fitness training and, therefore, are not studied. Children are not otherwise excluded from the study if currently attending a physiotherapy pool program with emphasis on joint range of motion and stretching.
4. Children who are unable to cooperate with testing procedures.
Treatment of Chronic Cluster Headache with TENS and ONS

The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH).

Study outline

Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days.

Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four.

Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven.

Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS.

Clinical follow-up visit by the end of month ten.

During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above
2. Signed informed written consent
3. Diagnosed with chronic CH according to the ICHD-3 criteria
4. 15 or more CH attacks per month
5. Stable use of preventive headache medication one month prior to enrollment

Exclusion Criteria:

1. Other ongoing neuromodulation therapy
2. Current alcohol and/or drug abuse
3. Severe psychiatric disorder
4. Other chronic primary or chronic secondary headache disorder (e.g. chronic migraine)
5. Major posterior neck surgery in C2-C3 level and above
6. Pregnancy
7. Treatment with oral steroids or GON injection within one month of study participation