cyrilzakka/clinical-trials huggingface dataset:
Sensor Measurement of Acupuncture Needle Manipulation

The purpose of this study is to develop and test a sensor system capable of measuring acupuncture needle manipulation and torque in a clinical setting.

Study hypothesis: Torque will be greater on the side of the back with musculoskeletal pain compared with the side without pain.

Acupuncture is an ancient Chinese practice that involves the use of specialized needles to stimulate parts of the body. The number of Americans who use acupuncture services continues to grow each year. Two elements required to deliver high-quality acupuncture treatment are identification of the appropriate acupuncture points and proper manipulation of the acupuncture needle. Despite a growing awareness of the importance of proper needle techniques, no tool capable of objectively measuring needle manipulation in a clinical setting has ever been developed. Such a tool would have applications in acupuncture research, teaching, and clinical practice.

This study will develop and test a simple hand-held sensor capable of making such objective needle torque measurements.

There are two parts to this study. In Part 1, researchers will develop the hand-held sensor (called the AcuSensor) that will be mounted to the handle of an acupuncture needle and will measure torque during manual needle manipulation.

In Part 2, the sensor will be tested for accuracy and reliability in three different groups. Group 1 will consist of patients with unilateral musculoskeletal back pain. Group 1 participants will undergo one session of acupuncture treatment while torque measurement and needle manipulation techniques are examined. In Group 2, practitioners and students at two leading acupuncture schools will use the AcuSensor during their teaching clinics. Teachers and students will complete a questionnaire to evaluate the sensor's usefulness. Experienced acupuncturists comprise Group 3; they will receive AcuSensor training and evaluate the performance of the AcuSensor in clinical practice. Information about the range and variability of torque measurements produced by different practitioners and techniques will be obtained from use of the sensor. Group 3 acupuncturists will also guess needle torque before and after training with the sensor turned off in order to determine the way AcuSensor training affects acupuncturists' sensory perception of needle grasp.

Eligibility Criteria:
Inclusion Criteria for Group 1 Participants:

* Asymmetric chronic musculoskeletal back pain
Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease

To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.

A total of 75 subjects will be recruited for the study based on the power of the study.

The selected subjects will be divided into 3 groups based on inclusion and exclusion criteria.

GROUP I:25Generalized chronic periodontitis subjects without coronary heart disease.

GROUP II: 25Generalized chronic periodontitis subjects diagnosed with coronary heart disease.

GROUP III: 25Periodontally healthy subjects diagnosed with coronary heart disease.

Demographic variables, periodontal parameters and biochemical parameters will be measured in all three groups

Eligibility Criteria:
Inclusion Criteria:

1. Patients willing to participate in the study.
2. Patients within the age group of 30-65 years.
3. Patients should have ≥ 20 remaining natural teeth.
4. For Group I

   • Systemically healthy, Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction.
5. For Group II

   • Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction along with coronary heart disease.
6. For Group III • Periodontally healthy subjects with Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sites, no periodontal treatment (Scaling and root planing or periodontal surgery) within the previous 6 months and without evident clinical signs of gingival inflammation along with the presence of coronary heart disease.

Exclusion Criteria:

1. Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
2. For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
3. Current smokers and individuals who quit smoking less than 6 months.
4. Patients who have undergone periodontal therapy within the previous 6 months.
5. Pregnant women (pregnancy may alter the oral flora)
Liraglutide as Add on Therapy on Metformin in Women With Polycystic Ovary Syndrome

The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease
* the use of medications known or suspected to affect reproductive or metabolic functions
* the use of statins, within 90 days prior to study entry
The Impact of Educational Materials on Family Behavior

The purpose of the research is to learn whether written materials or handouts that are given to parents are helpful in changing knowledge or behavior.

Few written resources for families have been tested in the primary care setting. Kid STRIDE (STRiving to Improve Diet \& Exercise) is an educational booklet designed for parents of overweight children. We hypothesize that this booklet will benefit a small percentage of the overweight and obese population of children as a first-tiered approach to treatment of overweight and obese children.

Eligibility Criteria:
Inclusion Criteria:

* Children with a BMI greater than or equal to 85% along with a parent.
* All subjects must speak English.

Exclusion Criteria:

* Genetic conditions associated with overweight.
* Endocrine conditions associated with overweight.
* Chronic steroid therapy.
* Current enrollment in a professional weight management program.
Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer

The aim of this study is to investigate the feasibility and efficacy of the v-NOTES approach for extremely obese patients with early-stage type 1 endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Extreme obese patients
* Early stage type-1 endometrial cancer proved by endometrial sampling

Exclusion Criteria:

* any contraindication for pneumoperitoneum
* any contraindication for the dorsal lithotomy position
* any contraindication for general anesthesia,
* any contraindication for v-NOTES
* suspicion of pelvic adhesions
* presence or suspicion of obliteration of the pouch of Douglas
An Innovative Model of Pediatric Acute Mental Health and Addictions Care

The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.

The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, emergency mental health and addictions care. This care bundle will provide high value to families, matching resources and services to need while eliminating healthcare inefficiencies and closing care gaps. The bundle will introduce two well-established tools for healthcare providers to use in EDs, walk-in clinics, and urgent mental health care appointments. These tools are the Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education \& Employment; Activities \& Peers; Drugs \& Alcohol; Suicidality; Emotions \& Behaviours; Discharge or Current Resources).

The bundle will also introduce new processes to improve healthcare system efficiencies, navigation and transitions between healthcare sectors. For families who receive care in the ED, the investigators will remove the physician gatekeeper role so that children/youth who are screened as low-risk will be offered a follow-up appointment in an urgent mental health care clinic within 24-48 hours. Those who screen as high-risk will see a mental health specialist and undergo a HEADS-ED assessment. Families who follow up in the clinic will receive care that applies a Choice And Partnership Approach (CAPA). CAPA is a collaborative approach to healthcare, where healthcare providers work in partnership with children/youth and their parents to identify choices for care that best match individual needs and preferences.

Study Goal: The investigators' goal is the right care, with the right people, at the right place and time.

Study Design: To measure the bundle's impact, the investigators will use an interrupted time series (ITS) design.

Eligibility Criteria:
Inclusion Criteria:

* Patient is under 18 years of age
* Patient came to the emergency department with a mental health and/or addiction concern
* Patient presented with one of the following CEDIS complaints:

Anxiety, bizarre behaviour, concern for patient's welfare, deliberate self-harm, depression/suicidal, homicidal behaviour, insomnia, pediatric disruptive behaviour, situational crisis, violent behaviour

Exclusion Criteria:

* Brought to the ED by police, peace officer or EMS?
* Held under Form 10
* Features of schizophrenia, schizotypal and delusional disorders (e.g., hallucinations, delusions, active psychosis)
* Behavioural syndromes or other medical concerns requiring medical clearance (e.g., eating disorders)
* Significant self-harm requiring medical clearance (e.g., deep laceration, ingestion, hanging)
* Barriers to communication at triage (e.g., language)
* Previous participation in the study
Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy

Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the pharmacokinetic (PK) parameters of an ENG-releasing implant in women with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* women 18- 45 years old;
* with regular menstrual cycles;
* with BMI between 18 and 29.9 (kg/m2);
* who has selected the ENG implant as a contraceptive method;
* Using a stable antiepileptic drug regimen including carbamazepine or topiramate for ate least 3 months (only for women with epilepsy).

Exclusion Criteria:

* use of short-acting hormonal contraceptives in the month prior to enrollment;
* use of depomedroxyprogesterone acetate in the 6 months prior to enrollment;
* women with conditions classified as category 3 and/or 4 for etonogestrel implant use according to the World Health Organization Medical Eligibility Criteria for contraceptive use;
* drug or alcohol addiction;
* use of other drugs metabolized by CYP3A4 30 days prior to enrollment;
* non adherence to antiepileptic drug regimen (only for women with epilepsy);
* illiteracy
Accelerated Versus Standard CXL in the Treatment of Ectasia Post Refractive Surgery and Penetrating Keratoplasty.

WHAT WAS KNOWN

\*Standard CXL is the common procedure for treating progressive corneal ectasia. Modifications of the standard protocol were introduces to reduce its complications especially long exposure to ultraviolet rays. The Accelerated protocol, while believed to overcome this issue with comparable outcomes, has not been studied fully in patients with ectasia following corneal refractive surgery and penetrating keratoplasty.

WHAT THIS PAPER ADDS Accelerated CXL is as safe and effective as the Standard CXL in halting the progression of ectasia post refractive surgery and penetrating keratoplasty with the benefit of: reduced ultraviolet exposure, reduced operation time, and reduced patient discomfort.

Purpose:

The aim of this study is to compare the clinical outcomes of the Standard CXL and the AC CXL in patients with progressive corneal ectasia post refractive surgery and penetrating keratoplasty.

Setting:

Menoufia University Hospital, Egypt

Design:

Prospective, randomised comparison.

Methods:

Patients scheduled to receive either Standard CXL (3mW/cm2 for a period of 30 min) or Accelerated CXL (18mW/cm2 for a period of 5 min).The main outcomes for comparison were the change in; Maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central corneal thickness (CCT), and the best corrected distance visual acuity (CDVA).

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were:
* adults aged above 18 years.
* They have been diagnosed clinically with progressive corneal ectasia following refractive surgery procedure (LASIK, PRK, ReLex smile), or penetrating keratoplasty
* CCT above 400µ.

Exclusion Criteria:

* The exclusion criteria involved:
* history of herpetic ocular diseases (including herpes simplex virus and varicella zoster virus) in the study eye
* active or recurrent ocular disease in either eye (e.g., uveitis, chronic moderate to severe blepharitis or severe dry eye) or sight-threatening diseases (e.g., previous retinal or optic nerve diseases) that would interfere with the interpretation of the study data.
A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis

Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the blood, and reduce inflammation. By applying a statistical technique for combining the findings from a systematic literature review (meta analysis), researchers want to learn more about the relationship of the risk to develop a separation in the roof of the mouth (cleft palate) in newborns and contact with glucocorticoids during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Population: Pregnant women
* Intervention: Any glucocorticoid or corticosteroid or steroids use irrespective of mode of administration
* Comparator: Any/none
* Outcomes: Incidence/ risk of cleft lip/palate in infants
* Study Design:

  * Meta-analysis and systematic literature reviews
  * Observational studies (such as cohort study, case-control study, registries data)
  * Clinical trials - Phase IIb, III, and IV
  * Conference abstracts/posters
* Time period: No time period restriction
* Geography: No geography restriction

Exclusion Criteria:

* Population: Nonpregnant women
* Intervention: Drugs other than glucocorticoid or corticosteroid or steroid
* Outcomes: Incidence/ risk of cleft lip/palate in infants
* Study Design:

  * Animal Study
  * In vitro studies
  * Editorial, letters, comment
  * Clinical trials - Phase I or preclinical
  * Case reports, case series
  * Reviews
* Studies focusing on:

  * Diagnosis and surgical procedure for cleft repair
  * Impact of Increased internal corticosteroids due to stress
  * The relationship between genetic mutations and cleft patients
  * Adverse events for other drugs
  * Safety profiles of glucocorticoid or corticosteroid
Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
* Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
* Baseline VAS pain rating ≥60 mm in the primary area of pain

Exclusion Criteria:

* No further exclusion criteria
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent,
* 30 to 85 years old,
* Plan to undergo PCI and LDL-C \>= 100 mg/dL

Exclusion Criteria:

* Familial hypercholesterolemia
* Being treated with Zetia (Ezetimibe)
* Being treated with Fibrates
* Renal insufficiency (serum creatinine \>= 2.0 mg/dl)
* Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase \>= 3-folds of standard value in each institute)
* Undergoing hemodialysis or peritoneal dialysis
* Allergic to Lipitor and/or Zetia
* Severe underlying disease
* Lack of decision-making capacity
* Recognized as inadequate by attending doctor
Harmonic FOCUS Versus Conventional Technique in Total Thyroidectomy for Benign Thyroid Disease

New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

Thyroidectomy is one of the most frequently performed operations in endocrine surgery. Results are generally excellent, and morbidity and mortality are usually negligible. The operation requires proper identification of important structures such as the recurrent laryngeal nerve (RLN) and the parathyroid glands. Meticulous dissection and exhaustive hemostasis are important to ensure a dry field and to avoid inadvertent damage to the adjacent structures. The two most common techniques for hemostasis are suture ligatures and electrocoagulation. The use of electrocoagulation (EC) to control bleeding has the potential risk of injuring the surrounding structures from lateral dispersion of heat. New haemostatic techniques have been developed with the advent of laparoscopic surgery. Among other things, ultrasound instruments have been used for the dissection, division and coagulation of vessels and other tissue. Previous studies in Thyroidectomy observed a clinically and economically significant reduction in operating time with no increase in the complication rate when the Harmonic device has been used. The aim of the present clinical trial is to evaluate potential advantages of a new Harmonic device (FOCUS), developed especially for Thyroid procedures, in the use of HS in thyroidectomies when compared with EC in terms of operative time, number of ligatures, QoL, blood loss, pain intensity at the surgical site, amount of drainage, and complications, including the incidence of RLN palsy and hypoparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Elected to undergo total thyroidectomy.
* Able to comprehend and sign the applicable study informed consent form.
* Able to return for all study mandated visits (visit 1 and 2)
* Be greater than or equal to 18 years of age.

Exclusion Criteria:

* Previous neck operation
* History of neck irritation
* Need for central or lateral compartment lymphadenectomy
* Patients under permanent pain killer medication
* Patients under anticoagulation medication
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

The objective of this study was to evaluate the AqueSys XEN Implant \[XEN® Gel Stent (XEN45 Implant)\] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma
* Participants are taking at least one and no more than four topical IOP-lowering medications.

Exclusion Criteria:

* Angle Closure Glaucoma
* Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
* Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

This pilot study aims to i) represents the feasibility of the study design and ii) to point out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the sympathetic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* age 20 - 30 years
* healthy persons

Exclusion Criteria:

* current pain
* blood pressure medications
* osteoporosis
* cardiac or neurological symptoms
* pregnancy
* thromobosis