cyrilzakka/clinical-trials huggingface dataset:
CT-Based Changes in Bone and Marrow Among Patients on Oral Steroids

The goal of this study is to assess the feasibility of emerging CT-based tools to measure changes in central and peripheral bone density, micro-structure, and marrow adipose tissue (MAT) among patients treated with oral steroids.

This study aims to prove that emerging CT-based tools are suitable to measure changes in central and peripheral bone density, geometry, micro-structure, and marrow adipose tissue (MAT) among patients treated with oral steroids. To do this, investigators will recruit 10 non-smokers (defined as \< 10 pack-year smoking history) age 25-45 years with a diagnosis of severe, persistent asthma who either chronically use oral steroids or do not use any oral steroids. Participants will undergo dual-energy X-ray absorptiometry (DXA), dual-energy mid-tibia CT, high-resolution single-energy ankle CT, and low-radiation hip CT scans at baseline and 6-month follow-up visits. The images obtained will be used to analyze cross-sectional differences in central and peripheral bone density, geometry, micro-structure, and MAT between patients using oral steroids versus those who do not use any oral steroids. Differences in imaging at baseline and six-month follow visits will be used to analyze longitudinal bone changes among patients with oral steroid treatment.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion (all subjects):

  * Diagnosis of severe, persistent asthma (defined as using both a long-acting beta-agonist AND a high-dose inhaled steroid)
  * Age 25-45
* Inclusion (oral steroid group):

  * Chronic treatment with oral steroids for at least 45 days but less than 1 year

Exclusion Criteria:

* Exclusion (all subjects):

  * Pregnant or breastfeeding
  * History of any cancer, excluding non-melanoma skin cancer
  * Currently receiving dialysis
  * History of any lower extremity fracture
  * Hip or knee replacement
  * Non-ambulatory
  * Greater than 10 pack-year smoking history
  * BMI \> 50
  * Age \< 25 or \> 45
  * Current or past use of FDA-approved medication for osteoporosis:

Bisphosphonates (Alendronate/Fosamax, Ibandronate/Boniva, Risedronate/Actonel/Atelvia, Zoledronic Acid/Reclast) Calcitonin (Fortical, Miacalcin) Selective Estrogen Receptor Modulator (Raloxifene/Evista) Parathyroid Hormone Analogue (Teriparatide/Forteo) Monoclonal Antibody (Denosumab/Prolia)
The Effect Of Glycemic Control On Malondialdehyde, Glutathione Peroxidase, Glutathione And Paraoxonase

The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).

Reactive oxygen species (ROS) are products of normal cellular metabolism and play beneficial role in physiological functions. Overproduction of ROS and/or deficiency of enzymatic or non-enzymatic antioxidants, termed as oxidative stress, is involved in many pathological conditions such as Diabetes mellitus (DM) and chronic periodontitis (CP).

Several researches revealed that DM, with many determinants such as level of glycemic control, stands as a strong risk factor for periodontal diseases. On the other side, periodontal diseases induce an elevated chronic inflammatory state and exacerbated insulin resistance.

In the present study, the investigators examined the effect of glycemic control level on clinical periodontal status, levels of MDA, GSH-Px, GSH and PON activity in gingival crevicular fluid and blood samples of CP patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* to present T2DM diagnosis by an endocrinologist for at least the past 5 years
* diagnosis of CP was based on the clinical and radiographic criteria proposed by the 1999 World Workshop for Classification of Periodontal Diseases and Conditions

Exclusion Criteria:

* pregnancy
* lactation
* current smoking or smoking within the past 2 years, periodontal therapy in the previous 6 months
* antibiotic and/or antimicrobial therapies in the previous 3 months
* existence of serious diabetic complications or any pathology such as haemoglobinopathy which would affect haemoglobin profile
* diagnosis of another major medical pathology, middle or upper-level obesity according to WHO classification
* current anti-hyperlipidemic therapy
* non-T2DM patients with abnormal values of glucose and lipid metabolism parameters, major medical pathology and family history of DM
Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain

Background

The purpose of this study was to examine the heart rate variability (HRV) in the presence or the absence of pain in the lower back (L5), while receiving chiropractic care.

Methods

A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The investigators analyzed the five minute pre-treatment and post treatments intervals. The spectral analysis of the tachygram was performed with the Kubios Software (University of Kuopio, Finland).

Background The chiropractic profession has in the past utilized research results from other fields of and extrapolated them into their science and clinical interpretation 1-4. More recently, chiropractic researchers looked into autonomic nervous system (ANS) adaptations in an animal model following a mechanical stress to the spinal column 5, a noxious mechanical stimulation 6 or a spinal manipulation 7.

In the human model, several investigations have been done to measure modifications of the heart rate variability (HRV) following cervical 8 and thoracic manipulations 9 or in a multisite clinical study 10 where details of the manipulation site were not provided. The site of interest for the chiropractic intervention was defined at the level of the lumbar spine, left and right L-5. This site was selected because most studies 8-10 measuring HRV have used the cervical or thoracic component of the spine. The effect of the lumbar parasympathetic nervous system has not been evaluated. In these studies 8-10, changes were observed in various HRV variables, while in two of those studies 8, 9, where sham groups were included, the sham conditions did not demonstrate any changes in the reported HRV parameters. There are strong indications that HRV is a good marker of ANS activity 19-24. Thus, in the three above mentioned studies, it appears that chiropractic interventions have an effect on the ANS.

At present, however, no studies to evaluate whether a lumbar spinal manipulation would produce a change in the HRV have been reported. Thus, the present study seeks to measure the effect of a lumbar adjustment, with a manually assisted mechanical force, producing a chiropractic adjustment, in participants without lumbar pain and a traditional adjustment in participants with lumbar pain on HRV. The hypothesis being that a lumbar intervention would have an acute effect on the ANS as demonstrated by the modulation of HRV variables.

Eligibility Criteria:
Inclusion Criteria:

* Acute low back pain (pain group)
* Maintenance care for the pain free group and the control group

Exclusion Criteria:

* For the control group (pain)
* For the non pain group pain
Kinetics of Plasma Fibrinogen in Cardiac Surgery

The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.


Eligibility Criteria:
Inclusion Criteria:

* Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
* Signed written informed consent

Exclusion Criteria:

* Participation in another study
* Language barrier to understand study purposes (e.g. french as a native language)
* Preoperative low level of plasma fibrinogen (\< 1.75 g/l)
* Preoperative anemia (Hb \< 10g/dl)
* Emergency treatment
* Intake of anticoagulants other than aspirin within 14 days preceding surgery.
* Known coagulation disorder.
* Jehovah's witnesses
REseArCH INteGration in Women, Infants, and Children

WIC is a governmental program that provides healthy foods, nutrition education and referrals to other health and social services. With the goal of applying for a future grant to expand the dissemination of SmartLoss® within the WIC program, feedback from WIC staff and WIC clients must be solicited to better understand the burden and barriers of integrating these kinds of programs and with WIC participants.

Participants will complete a 15 minute online survey. WIC Staff will be eligible to complete the WIC staff survey and WIC clients will be eligible to complete the WIC client survey. This is a qualitative research study designed to identify the receptiveness of implementing a weight management program in the WIC program and the barriers to weight management intervention as described by WIC staff and WIC clients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are at least 18 years old
* Have been employed or volunteered at a WIC Clinic or DHH in Louisiana for at least 6 months in the past 2 years OR received WIC services during pregnancy or postpartum or have had a child who received WIC services in the past 2 years

Exclusion Criteria:

* Less than 18 years old
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau

The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)

This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Any patient undergoing annual imaging screening is eligible, but the investigators will target inclusion of at least 10 subjects who have at least 1 kidney lesion. Therefore, up to 5 subjects may have no current kidney lesions. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.

Following completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the present study, patients must meet the following criteria:

1. Able to provide written informed consent
2. Willing to comply with protocol requirements
3. At least 16 years of age
4. Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC

Exclusion Criteria:

1. Critically ill or medically unstable or in an intensive care setting and whose critical course during the observation period would be unpredictable
2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)
3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \>90mmHg), or adult respiratory distress syndrome
4. Active cardiac disease including any of the following:

   A. Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) B.Unstable angina. C.Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation).

   D.Myocardial infarction within 14 days prior to the date of proposed microbubble administration.
5. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

   * Mental illness
   * Drug abuse
6. Female patient who is pregnant or lactating
7. Obesity that limits obtainment of acceptable images
Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability

Microinstability of the hip joint is an important cause of hip pain and reduced hip function in young and active individuals. Hip microinstability is due to extraphysiologic hip motion and could be secondary to acetabular dysplasia, connective tissue disorder, macrotrauma, microtrauma, iatrogenic- and idiopathic causes. Treatment for hip microinstability is initiated with non-surgical treatment consisting of physiotherapy aimed mainly at stability. If non-surgical treatment fails, surgery with arthroscopic plication of the hip joint capsule is the preferred method. This study evaluates non-surgical and arthroscopic treatment for hip microinstability regarding hip function and adverse events.

This is a prospective cohort study evaluating 26 participants above 18 years of age undergoing non-surgical and surgical treatment for microinstability of the hip joint. Participants with findings on physical examination and imaging suggestive of hip microinstability will undergo six months of physiotherapy aimed at stabilizing the hip joint. If non-surgical treatment fails, a diagnostic hip arthroscopy will be performed, and if hip microinstability is confirmed, the participants will undergo a plication of the hip joint capsule. Participants will be evaluated with Patient-Reported Outcome Scores (PROMs) and strength- and function tests at time of enrollment and at 6-, 12- and 24 months following treatment. The primary outcome is hip function determined by PROMs and strength- and function tests. Secondary outcomes include Health-Related Quality of Life (HRQL), sport activity level and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Hip microinstability
* Minimum 18 years old

Exclusion Criteria:

* Hip osteoarthritis
* Severe hip dysplasia
* Perthes disease or avascular necrosis of the femoral head
* Previous surgery to the hip joint
Comparison of Effect of Different Methods of Cognitive Loading on Gait of Normal Healthy Students

Comparison of effect of different methods of cognitive loading on gait of normal healthy students.


Eligibility Criteria:
Inclusion Criteria:

* Male and female students from colleges of Abbottabad.
* Age limit (17 to 20) According to (FSC admission criteria age of the student should not be more than 18 to enter the college.)
* Healthy individuals without any neurological and MSK disorder. (screening will be done before performing the test on the student, questions regarding the above-mentioned conditions and consent will be signed before starting the test)

Exclusion Criteria:

* Any student with visible physical deformity or MSK disorder will not be included in this research (15)
* Any student with a psychiatric or neurological disorder will not be included (16)
* Any student with cardiac abnormality will be excluded from this research (17)
* Any student who does not fall in this age group will not be included in this research.
* Colleges outside Abbottabad will not be included in this research.
The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women

Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.

This study was conducted in Batıkent Family Health Center of the Ministry of Health between May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal women by the researcher twice a week. No intervention was applied to the postmenopausal women in the control group.

Eligibility Criteria:
Inclusion Criteria:

* able to communicate,
* aged 50 to 65,

Exclusion Criteria:

* taking hormone replacement therapy,
* chronic diseases (such as diabetes, hypertension, and so on),
* psychiatric disease,
* diagnosed with a sleep disorder attributed to other cause
* menstruation for more than one year
* history of alcohol or drug addiction
Apioc Contact Lens Feasibility

This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.

This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.

Eligibility Criteria:
Inclusion Criteria:

1. Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
2. The subject must have ≤ 1.50 D of corneal astigmatism.
3. The subject should have clear, healthy corneas.
4. The subject should have a normal, healthy conjunctiva in both eyes.
5. The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
6. The subject must provide written informed consent.
7. The subject must appear willing and able to adhere to the instructions set forth in this protocol.

Exclusion Criteria:

1. No irregular corneal astigmatism is permitted.
2. No pterygia or corneal scarring that would interfere with contact lens wear.
3. No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
4. The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
Pediatric Hepatic Tumors

Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.


Eligibility Criteria:
Inclusion Criteria:

1. - For inclusion in the clinical database:

   * Children and adolescents (≤18 years at diagnosis) suffering from a primary liver tumor diagnosed after 01/01/1990 and treated in France
   * Informed consent to the computerization of data signed by the patient or by parents or legal representatives if he is a minor.
2. - For inclusion in the biological collection (CRB Paris Sud):

   * Additional criteria:
   * Availability of biological samples (tumor tissue, healthy tissue, plasma and / or serum).
   * Informed consent to the use of biological remains signed by the patient or by parents or legal representatives if he is a minor.
3. - For the inclusion of deceased patients:

   * Obtaining consent or failing this, seeking non-opposition to the computerization of data (for inclusion in the database) and the use of biological remains (for inclusion in the biological collection) of the patient or both parents or the legal guardian if he is a minor.

Exclusion Criteria:

* None
Phase IV Bioseal Study in Brain Tumor Surgery

The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 75 years of age
* Undergoing elective meningioma surgery and having a tumor cavity
* Presence of an appropriate Target Bleeding Site (TBS) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis
* Able and willing to comply with procedures required by protocol
* Signed and dated written informed consent prior to any study related procedures.

Exclusion Criteria:

* Subjects undergoing emergency surgery
* Subjects with any intra-operative findings that may preclude conducting of the study procedures
* Intended use of Fibrin Sealants (including autologous Fibrin Sealants) other than Bioseal on the Target Bleeding Site (TBS)
* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products
* Subjects who have a history of traumatic head injury
* Female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period
* The subject, in the opinion of the investigator, would not be suitable for participation in the study
* Subjects who participated in another trial within 30 days prior to the planned start of treatment.