cyrilzakka/clinical-trials huggingface dataset:
Effect of Pomegranate Seed Powder on Markers of Metabolic Syndrome

Metabolic syndrome is a public health concern worldwide and in Pakistan as well. Abdominal obesity, hyperglycemia, hypertriglyceridemia, hypertension, and low HDL cholesterol are its hallmarks while pomegranate seed's unique chemical composition has sparked research into the health benefits in same arena as weight control, blood lipid profile changes, and other metabolic disturbances. It's high time to study therapeutic efficiency of Pomegranate seed powder against metabolic syndrome.

Metabolic syndrome, accumulation of certain metabolic risk factors, such as abdominal obesity, hyperglycemia, hypertriglyceridemia, hypertension, and low HDL cholesterol, has been noted as one of the most important risk factors for the epidemic of type 2 diabetes and cardiovascular disease in the 21st century. It has become a significant public health concern and a global epidemic with a prevalence rate of about 25% among American adults. Multiple researches have demonstrated the effectiveness of pomegranate in the management of diabetes, inflammatory conditions, obesity, and blood lipid levels, and consequently metabolic syndrome. Various pomegranate components have the potential to substitute anti-diabetic medications as well Pomegranate seed's unique chemical composition has sparked research into the health benefits, such as weight control, blood lipid profile changes, and other metabolic disorders.

seed powder can influence the patient's metabolic syndrome-related indicators.

Hypothesis:

Pomegranate seed powder can be effective to treat the individuals with impaired metabolism.

Methodology:

In a clinical trial, patients of metabolic syndrome (n=50) will be given pomegranate seed powder dose for over 8 weeks, twice a day. Biochemical outcomes including blood pressure, FBG, cholesterol, hemoglobin level will be determined before and after the completion of trial in addition to patient's weight. Finally, using one-way ANOVA and T-test, collected data will be analyzed.

Expected outcome: The study will explore the potential of pomegranate seed powder in treating metabolic syndrome's risk factors. Therefore, our findings on the studied parameters of patient will assist future researchers in developing tested, evidence-based recommendations.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25kg/m2
* Dyslipidemia
* Altered blood glucose level
* Age 30-55 ( male and female)

Exclusion Criteria:

* Thyroid disorder
* Liver disease
* Kidney disorder
* Cancer etc
Venous Insufficiency and Neuromuscular Stimulation

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

STUDY AIMS

1. To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.
2. To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.

METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound.

The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground).

ENDPOINTS Primary end-point

* Increase in venous flow Secondary end points
* Improvement in clinical symptoms at 6 weeks, as judged by questionnaire
* Reduction in absolute leg diameter and volume at 6 weeks

Eligibility Criteria:
Group 1

* Inclusion criteria - 18+ years old, 17\<BMI\<30
* Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI\<0.9, active infection, previous leg fracture or metal implant in leg

Group 2

* Inclusion criteria - 18+ years old, 17\<BMI\<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US
* Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI\<0.9, active infection, previous leg fracture or metal implant in leg

Group 3

* Inclusion criteria - 18+ years old, 17\<BMI\<30, clinical diagnosis of deep venous insufficiency (CEAP C2-6) confirmed with duplex US
* Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI\<0.9, active infection, previous leg fracture or metal implant in leg

Group 4

* Inclusion criteria - 18+ years old, 17\<BMI\<30, clinical diagnosis of deep venous obstruction confirmed with duplex US
* Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI\<0.9, active infection, previous leg fracture or metal implant in leg
Is Neutrophil to Lymphocyte Ratio a Prognostic Factor of Sepsis in Newborns With Operated Neural Tube Defects?

We aimed to investigate whether Neutrophil Lymphocyte Ratio is a Prognostic Factor of Sepsis in Newborns with operated Neural Tube Defects?


Eligibility Criteria:
Inclusion Criteria:

* \<28 days diagnosed with with neural Tüpe Defects To be operated

Exclusion Criteria:

* \>28 days
Articaine Versus Lidocaine Buccal Infiltration

assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth


Eligibility Criteria:
Inclusion Criteria:

* medically stable
* 18years or older
* patient with bilateral lower anterior teeth requiring non surgical removal

Exclusion Criteria:

* grade 3 mobility
* neurological disease
* allergy to anethesia
Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis

The purpose of this study is to investigate the efficacy of lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis compared to baby shampoo.

After being informed about the study and potential risks, all patients giving written consent will have a complete ophthalmological examination to determine eligibilty for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of seborrheic blepharitis

Exclusion Criteria:

* Patients with ophthalmological pathologies that may affect the tear film functions including ocular rosacea, contact lens use, history of any ocular surgery, or patients with systemic pathologies or those using systemic medications that may affect the tear film functions
* Patients younger than 18-year-old
* Patients who used any treatment for blepharitis within the 6 months prior to the examination
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye.

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have provided written informed consent
* Have dry eye in both eyes

Exclusion Criteria:

* Use of contact lenses
* Have an uncontrolled systemic disease
* Have an uncontrolled psychiatric condition, or substance or alcohol abuse
* Women who is pregnant, nursing or planning a pregnancy
Stress and Insomnia

Insomnia is characterized by rumination and worry over stressful events affecting nighttime sleep. Emotional reactions while stressful events are ongoing have not often been investigated in insomnia. In the current study stress reactions will be measured during a real-life simulation experiment with stressful events and investigate not only how previous sleep patterns affect emotional reactivity to the event but also how the emotional events affect sleep patterns the following night.

Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects of either neutral or stressful events during driving. Through questionaires and intake polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep medication use and alternative sleep disorders than insomnia. Stress levels will be measured through skin conductance and heart rate variability during events and through nighttime polysomnography (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime PSG.

Investigators hypothesize that subjects with insomnia, compared to subjects without sleep complaints, show stronger emotional reactions to stressful events and stronger effects of stress on sleep quality the following night. Results will facilitate a model for emotional reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption converting into chronic insomnia and aid in developing customized insomnia treatment.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia group: patients with insomnia (DSM-V criteria): sleep complaints, of more than 3 nights a week, more than 3 months, affected daytime functioning
* Control group: no self-reported sleep problems
* 20-50 years old
* Female
* Having given written informed consent to participate in the research project
* Driving license

Exclusion Criteria:

* Night and shift-workers,
* Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder,
* For insomnia group: all sleep disorders other than persistent insomnia,
* For control group: all sleep disorders
* Progressive neurological diseases that include restless legs syndrome,
* Cardiovascular disease other than treated hypertension,
* Unstable respiratory or endocrinological diseases,
* Reporting symptoms of menopause and/or taking hormone replacement therapy for menopause symptoms,
* Drug addiction, alcohol addiction during the previous 6 months (smoking is allowed),
* Having undertaken trans-meridian travel (± 3H) in the previous 1 month,
* Pregnant or lactating women.
* Chronic pain.
* Having simulator-sickness during the first practice session
* Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0.
* A change in skin conductance of less than 0.05 microSiemens after an auditory stimulus.
* Left-handedness
* Patient participating to any other interventional study
COVID-19 in Osteoarthritis Patients

While the coronavirus pandemic has spread rapidly around the world, it has generated a considerable degree of fear, concern and anxiety among the population in general and among certain groups in particular, such as older persons. Initial findings from studies in China indicated the presence of moderate to severe psychological impact in a significant proportion of individuals and an increased prevalence of post-traumatic stress symptoms. It should also be noted that other types of symptoms, such as anxiety and depression, appeared to persist over time and to a greater extent.

Osteoarthritis can develop in any joint, but most often affects the knees, hands and hips. People with osteoarthritis are often older and sometimes more frail than the general population. The main recommendations for non-drug treatment of osteoarthritis include education, physical activity and structured exercise programmes with or without weight reduction. Due to the confinement associated with COVID-19, many patients have had to stop exercise/physical activity and postpone prosthetic surgery. Apart from the context of delay in surgery, there is little data available on the impact of the pandemic on people with arthritis. Several questions are therefore still pending concerning the impact of the pandemic on these patients.

The investigators hypothesise that the following therapeutic modalities have been disrupted during this period: access to care, scheduling of prosthetic surgery, consumption of painkillers or NSAIDs, recourse to physical activities, recourse to physiotherapy sessions, weight changes, level of pain.... Our objective is to evaluate the physical, social, psychological and behavioural consequences of the COVID-19 pandemic in a cohort of osteoarthritis patients.


Eligibility Criteria:
Inclusion criteria:

- OA patients

Exclusion criteria:

* active or passive opposition of the patient and / or its legal representatives to participate in the study.
Abdominal Functional Electrical Stimulation to Reduce Hyperinflation in Chronic Obstructive Pulmonary Disease Patients

This is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. As part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Post-bronchodilator FEV1/FVC ratio of less than 0.7 and post-bronchodilator FEV1 between 30 and 80 % predicted.
* Current or former smokers with at least a 20 pack year smoking history
* Over the age of forty

Exclusion Criteria:

* Female subjects who are pregnant
* Subjects unable to give informed consent
* Subjects unable to perform required activities of the study (e.g. Six minute walk test)
* Subjects with an implanted electronic device (e.g. a cardiac pacemaker)
* Subjects who have had a chronic obstructive pulmonary disease exacerbation within 30 days prior to enrollment
* Considerable arthritic changes that limit exertion
* Patients on oral prednisone
* Patients with a hernia
* Patients with a history of pneumothorax within the last 5 years
* History of epilepsy
* History of Abnormal electrocardiogram suggestive of cardiac disease
Pilot Simulation RCT of Telemedical Support for Paramedics

This study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. Half of the paramedic teams will use a video telemedicine platform for communication with a physician, while the other half will use an audio-only platform.

In the United States, the current standard of pre-hospital (out-of-hospital) emergency care for children with life-threatening illnesses in the community includes remote physician medical direction for paramedics providing life-saving therapies while transporting the child to the hospital. Most pre-hospital emergency medical service (EMS) agencies use radios systems for audio communication between paramedics and physicians. This communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.

The purpose of this pilot study is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life-threatening illnesses. Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction.

Because real pediatric life-threatening illnesses are rare, high-stakes events and involve a vulnerable population (children), this pilot randomized control trial will provide early data on the efficacy of this intervention in simulated cases of pediatric medical emergencies. The primary outcome is "paramedic resuscitation performance" measured by a checklist of observable critical actions by independent reviewers during live observation and video review. The results of this study will provide important pilot data to estimate the clinical effect of this intervention and the sample size needed for a future definitive trial with children, a vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* Certified paramedics from three EMS systems in the Boston metropolitan area (Boston EMS, South Shore EMS, and Lahey Medical Center EMS)
* Attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (Boston Medical Center and Boston Children's Hospital)

Exclusion Criteria:

-Prehospital providers without paramedic level certification (e.g. BLS certification only)
Post Market Clinical Follow Up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry

Commercially pure (CP) titanium is the gold standard to produce dental implants because it has a huge volume of scientific publications over a period of more than 50 years, it is cheap and simple to produce (i.e., making dental implants economically "affordable") and comes in numerous specific designs of screws for various indications. That is why more than 95% of the implant market is dominated by titanium.

However, there is an innovation trend to manufacture implants from more inert and biocompatible materials. Ceramic implants represent a valuable alternative for expanding the patient base of clinicians, especially in cases with challenging aesthetic demand. Furthermore, there has been a significant increase in the number of patients requesting metal-free dentistry or bio-holistic implant treatments.

In the past, ceramics were often branded as "inferior" quality due to its reputation as being brittle but the growing volume of scientific publications specifically on zirconia are demonstrating that it is comparable in fracture-strength with titanium implants. There is a clear market niche for zirconia implants, especially in cases of:

* Aesthetic reconstructions in the anterior region, especially in patients with a thin gingival biotype
* Gingival recessions where a white colored implant is a great advantage
* For patients with a titanium intolerance/sensitivity
* For patients who prefer a bio-holistic/metal-free dental approach.

Today, clinicians are asking for long-term clinical results of zirconia as a dental implant material. Therefore, Z-Systems AG is conducting this zirconia dental implant registry. A registry design was chosen because it will capture long-term benefits/risks from clinical routine without patient selection.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥ 18 years) was or will be implanted with up to 5 implants of the Z-Systems Z5-BL or Z5-TLproduct group
* Patient has signed Informed Consent.

Exclusion Criteria:

* None
Do People With Insomnia Sleep Better After Psychological Treatment?

The principal aim of the study is to evaluate if CBT for insomnia is associated with improvement in the PSG sleep of patients treated in primary care. Furthermore,the relationship between subjectively-assessed sleep and PSG sleep are investigated(at pre-treatment, at post-treatment, in relation to treatment change.


Eligibility Criteria:
Inclusion Criteria:

Meets clinical/RDC criteria for primary insomnia Healthy Adult (18+ years)

Exclusion Criteria:

Evidence of sleep disorders other than insomnia Use of sleeping pills Major Psychopathologies
Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality of Life

The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.

Further investigations studies are needed to determine the efficacy of psychological interventions for people with hidradenitis suppurativa.

The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.

This is an experimental randomized trial with control group. Quality of life, symptoms: pruritus, odor and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects.

The investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in Visual Analog Scale (VAS) for pruritus, odor and pain. The Dermatology Quality of Life Index (DQLI) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in Hospital Anxiety and Depression Scale (HADS). The experimental group scores will be less than the control group for quality of life, symptoms and distress.

Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years old at the time of selection.
* Subjects diagnosed with hidradenitis suppurativa.
* Subjects that are in dermatological treatment.
* Patients should be able to understand and communicate with the investigator.

Exclusion Criteria:

* Subjects suffering from a serious concomitant illness.
* Subjects with a mental illness.
* Subjects who are performing psychiatric treatment.
* Subjects who are performing psychotherapy sessions both individual and group.
* Patients who have alcohol dependence or drug abuse.
* Subjects that present legal incapacity or limited legal capacity.
* Subjects presenting illiteracy or language barriers.