cyrilzakka/clinical-trials huggingface dataset:
The Impact of Citrus Products on Cardiovascular Health

Epidemiological studies have indicated that the consumption of citrus fruit is inversely associated with the risk of cardiovascular disease. However, clinical data regarding the effects of blood orange juice upon endothelial function is scarce. This randomised, crossover study investigates whether blood orange juice compared to a control drink improves blood vessel function and other cardiovascular health indicators (such as blood pressure and blood lipids). All the subjects will be asked to consume blood orange juice and a control drink in a randomised order, each over a 2-week period, divided by a 1-week wash out period.

Endothelial function measured via flow mediated dilation (FMD), blood pressure, anthropometric measures, lipid profile, high-sensitivity C-reactive protein (hsCRP) and endothelin 1 (ET-1), cyclic guanosine monophosphate (cGMP) will be evaluated in healthy overweight/obese Caucasians prior to and following 2-week consumption of blood orange juice and a control drink. Evaluation of endothelial function as measured by FMD will be conducted on specific days of the menstrual cycle to minimise the fluctuation in oestrogen levels in premenopausal women, which will be monitored in serum samples.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Caucasians (of European origin)
* BMI \> 25 kg/m2

Exclusion Criteria:

* Presence of cardiovascular diseases
* Smoking
* Use of medications or dietary supplements (vitamins, antioxidants)
* On a special diet and/or a training program to change weight
The Effect of Enneagram on Midwifery Students Communication, Self-confidence and Emotional Intelligence

This research was planned to evaluate the effects of Enneagram training on the communication skills, self-confidence and emotional intelligence levels of midwifery students. In this study, planned as a quasi-experimental randomized controlled research, with pre-test-post-retention(permanence) test will be used. Enneagram training will last 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the research,
* Midwifery department 2nd-3rd-4th grade student.

Exclusion Criteria:

* Having experienced an acute traumatic event (loss of parents, divorce, accident, etc.),
* Having a psychological disorder,
* Having received training on Temperament or Enneagram.
* Requesting to withdraw from the study at any stage of the study,
* Not attending more than one training session.
The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Eligibility Criteria:
Inclusion Criteria:

* All students in grades 1 to 4
* Can cooperate with the examination of students

Exclusion Criteria:

* Obvious strabismus and amblyopia
* Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
* History of ocular surgery
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients

The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients

Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke

Eligibility Criteria:
Inclusion Criteria:

* Computed tomography confirmed ischemic or hemorrhagic stroke
* Duration since stroke onset more than 3 and less than 12 months
* Age between 18 and 75 years old
* Persistent neurological deficits more than 4 points in NIHSS stroke scale
* Signed informed consent

Exclusion Criteria:

* The history of previous stroke
* Seizures
* Thrombophilias or primary hematological diseases
* Malignancy
* Hepatic or renal dysfunctions
* Hemodynamic or respiratory instability
* Autoimmune disease
* HIV or uncontrolled bacterial, fungal, or viral infections
* Pregnancy
* Participation in other clinical trials
Bronchial Thermoplasty in Severe Asthma With Frequent Exacerbations

The purpose of this study is to demonstrate the effectiveness of bronchial thermoplasty in a severe asthmatic population with frequent exacerbations.

This will be a single center randomized and controlled study. Thirty subjects with severe asthma (Gina 4 and 5) with frequent severe exacerbations (four or more bursts of systemic corticosteroids \>3 days each in the previous year) will be randomized 1:1 to either the thermoplasty group (bronchial thermoplasty and medical management) or control group (medical management only).


Eligibility Criteria:
Inclusion criteria:

* Age 18-65 years
* Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5
* Four or more bursts of systemic corticosteroids \>3 days each in the previous year
* Willingness and ability to give written informed consent

Exclusion criteria:

* Current smoker and former smoker \> 10 pack years total smoking history
* Participation in another clinical trial within the prior 4 months
* Omalizumab therapy within the prior 4 months
* Allergic bronchopulmonary aspergillosis
* Patient having had severe exacerbation of their asthma requiring high doses of oral corticosteroids (\> 60 mg equivalent prednisolone) more than one month in the previous year
* Post-bronchodilator FEV1 of less than 30%
* Past diagnosis of COPD and chronic respiratory insufficiency
* Known coagulopathy or platelet dysfunction
* Use of anticoagulants
* Use of an internal or external pacemaker or internal cardiac defibrillator
* Contraindication to perform bronchoscopy
* Contraindication to perform general anesthesia
* Significant cardiovascular disease
* Current or recent respiratory tract infection resolved less than 4 weeks
* Known cancer or cancer history less than 12 months
* Pregnancy and nursing mother
Development of Child With Equinus Deformity Idiopathic

Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

The main objective of this study is to define the frequency of developmental abnormalities in children with "Equinus Deformity Idiopathic" compared to the general population

The secondary objective is to identify the prenatal and / or neonatal characteristics that could be predictive of the occurrence of developmental abnormalities in

Prenatal and postnatal follow-up data are derived from the child's medical file. To complete these data and after inclusion, parents of children carrying "Equinus Deformity Idiopathic" will be sent a questionnaire that assesses overall psychomotor development and lists the medical events since the birth of their child (scoliosis, epilepsy ...).

Eligibility Criteria:
Inclusion Criteria:

* Children born between January 2002 and August 2015
* Prenatal or postnatal diagnosis of idiopathic or syndromic Equinus Deformity
* Followed by the pediatric orthopedic service of Rennes University Hospital
* Parent having received the information on the protocol and having not expressed their opposition.

Exclusion Criteria:

* Parents opposing the study
Dynamic ASPECTS of Internal PRE-ACTIVATION of Effects Sensors of Voluntary ACTION in PARKINSON's Disease

The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years and older
* Parkinson's disease

Exclusion Criteria:

* Other pathology or neurological or psychiatric history
* Known pregnancy or breastfeeding
* Absence of affiliation to social security or universal health coverage (CMU)
* Person under legal protection
* Patient's opposition to participate
LCI-GER-NOS-TAB-001: Tablet for Geriatric Assessment

The Self Geriatric Assessment Measure \[SGAM\] is based on a standard diagnostic tool used to evaluate geriatric cancer patients in order to determine the appropriateness of cancer directed therapy at LCI. This questionnaire has sections that matches portions of a self-administered geriatric assessment in patients aged 70 or older with malignancy. The prolonged duration of time needed to complete the assessment makes its performance less feasible in standard practice settings.

In previously published studies the Cancer Specific Geriatric Assessment (CSGA) has been provided both via written questionnaire and by personal computer in subjects 70 years of age or older. With improvements in technology, the goal is to evaluate the feasibility of administering the SGAM via an iPad tablet and compare results to both gold standard paper format and prior desktop computer data.

This study proposes the use of an iPad tablet to administer the SGAM may help:

Improve the completion rate of the SGAM assessment Reduction in the time of completion Improvement in the accuracy of reporting

Primary Objective

Assess and compare the proportions of subjects completing, defined as recording responses for at least 70% of actionable questions of the Self Geriatric Assessment Measure (SGAM) in subjects aged 70 years or older with malignancy using an iPad tablet versus written questionnaire.

Secondary Objectives

To assess and compare the proportions of subjects completing the SGAM without assistance using an iPad tablet versus written questionnaire.

To evaluate and compare the total times of interaction with the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

To evaluate and compare the distributions of percentages of recorded responses on actionable questions (from 0% to 100%) on the SGAM using an iPad tablet versus written questionnaire in both all evaluable subjects and the subset of evaluable subjects completing the SGAM.

To describe the rate of technical issues experienced by iPad survey users.

To assess and compare the completion rates and times to completion of the gold standard written format.

Eligibility Criteria:
Inclusion Criteria

Subjects must meet all of the following criteria:

* At least 70 years of age
* Histologically or cytologically confirmed malignancy within the past 1 year
* Ability to read and understand English
* Willingness to complete either tablet or paper based assessment independently and without assistance from caregiver, if applicable
* Willingness and ability to understand and sign a written informed consent document

Exclusion Criteria

Subjects must not meet any of the following criteria:

* Any prior history of whole brain radiation therapy for known brain metastasis
* Known cerebrovascular event within the last 4 weeks from enrollment
* Known to be legally blind or has a history of severe hearing loss that could impair ability to complete questionnaire in the opinion of the investigator
Effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis

this study will be conducted to investigate the effect of Graston Technique on Planter Thickness in Patients With Planter Fasciitis

Plantar fasciitis (PF), generally a self-limiting condition, is identified as one of the most common causes of heel pain in adults. It affects both sedentary and athletic populations .

It may be considered that PF emerges due to excessive and prolonged standing or running, which causes an acute inflammation or micro-tears, and degenerative changes plantar fascia. The persistence of these risk factors inhibits the regular repair process thus collagen degeneration occurs, causing the structural changes of the plantar fascia. Numerous interventions have been described for treatment of PF, which include: Stretching calf or plantar region which is performed with the patient stands with staggered legs facing toward a wall, with both hands stretched out .The Graston technique can break up scar tissue and restore soft tissue. The Graston technique is a type of manual therapy in which patented stainless-steel instruments are used to restore soft tissue motion by breaking up scar tissue. fifty patients with planter fasciitis will be assigned randomly to two equal groups; first one will receive graston technique in addition to exercise program, the second one will receive exercise program only for six weeks

Eligibility Criteria:
Inclusion Criteria:

* patients that Clinically diagnosed cases of plantar fasciitis not less than 6 weeks.
* patients willing to precipitate in the study and take treatment for 6 successive weeks.
* Heel pain felt maximally over the plantar aspect of heel
* Pain in the heel on the first step in the morning
* No history of rest pain in the heel

Exclusion Criteria:

* Subjects with clinical disorders where therapeutic ultrasound is contraindicated such as infective conditions of foot, tumor, calcaneal fracture, metal implant around ankle.
* Subjects with a clinical disorder where myofascial release is contraindicated as dermatitis.
* Subjects with impaired circulation to lower extremities
* Subjects with referred pain due to sciatica and other neurological disorders.
* Arthritis
* Corticosteroids injection in heel preceding 3 months
Clinical Study With Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol

To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol on lipid profile

To evaluate the effects of a nutraceutical containing Berberine-based Food Supplement, Artichoke Extract, Phytosterols, Fenugreek and SelectSIEVE® OptiChol compared to placebo on lipid profile in patients with LDL cholesterol \> 115 and \< 190 mg/dl.Patients were allocated to receive 1 or 2 tablets of the nutraceutical for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* LDL Cholesterol \> 115 mg/dl and \< 190 mg/dl
* primary prevention

Exclusion Criteria:

* patients with neoplastic and liver diseases, renal failure and diabetes mellitus
* pregnant or breastfeeding women
* hypersensitivity to any of the ingredients
* therapy with lipid-lowering drugs
Antioxidants Vitamins and Muscle Damage

Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E) influences the muscle damage and fatigue caused after an acute session of eccentric training.

A randomized, single-blind, placebo-control parallel trial will be conducted. In a previous session volunteers will be interviewed to determine if they meet the inclusion criteria.

Participants should avoid ingesting of foods that contain high amounts of antioxidant compounds: more than two juices of fruits, more than four cups of coffee or tea. Juices with high antioxidant content should be avoided. Alcoholic beverages should also be avoided. Participants will be divided in to groups and will performance one resistance exercise sessions. Prior to exercise, one group will intake supplementation VitC (1000 mg) + VitE (235 mg) and the other supplementation with placebo.

The following sequence will be performed in each session: 1) baseline assessment (analysis of the composition body, blood draw and parameters of performance) prior to exercise session ; 2) administration of vitamin or placebo supplementation 2 hours before exercise session ; 3) post-exercise assessments (blood biomarkers and performance parameters) immediately after the session and after 24 hours. DOMS will also be assessed 48 h and 72 h after training. The training session implemented will be designed by a Sport Scientific

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Physically active

Exclusion Criteria:

* Injuries
* Supplementation or drugs
* Smokers
A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer

This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.


Eligibility Criteria:
Inclusion criteria:

1. Patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens
2. Tumour sample available for KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses.

Exclusion criteria:

1. Prior treatment with Epidermal Growth Factor Receptor (EGFR) targeting small molecules or antibodies.
2. Biological treatment (including Bevacizumab or any other antiangiogenic agents) during the trial is not allowed.
3. Known pre-existing interstitial lung disease.
4. Planned major surgical procedures during the trial period.
Exploring the Effects of Sonic Augmentation Technology in Music

Brief Summary:

It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which Sonic Augmentation Technology in music can influence emotional health, embodiment, and autonomic functioning. The main goals of the study are:

* To examine the immediate effects of listening to the music.
* To examine whether the participants who received the augmented theme reported more improvements than the participants who received the nonaugmented theme.
* To identify individual characteristics that influence the effectiveness of listening to the music.

Participants will be asked to:

* Listen to 15-minutes of music
* Complete a pre-music and post-music online survey
* Attend the lecture/discussion with Dr. Porges and Anthony Gorry on theory and science underlying sonic augmentation technology and the experiences it aims to evoke.

Detailed Description:

It is the specific intent of this proposal to experimentally explore the possible benefits and mechanisms through which Sonic Augmentation Technology (SAT) in music can influence emotional health, embodiment, and autonomic functioning. This will be accomplished by our team by using well-validated self-report measures of mental health and autonomic reactivity.

Specific Aims:

Specific Aim 1: To examine the immediate effects of SAT in music

•The researchers will explore whether SAT in music leads to improvements in the functioning.

Specific Aim 2: To identify individual characteristics that influence the effectiveness of listening to the music.

* The researchers will explore the impact of specific vulnerability and resiliency factors (e.g., prior mental and medical adversity) on how well participants benefit from listening to the music.
* The researchers will explore the impact of wearing headphones on how well participants benefit from listening to the music.

Experimental design:

Participants will be randomly assigned to either a Sonic Augmentation Technology-enhanced music condition or a control condition featuring the same musical theme without the enhancement. Participants will be asked to attend one virtual session via Zoom where they will:

* Listen to 15-minutes of music
* Complete a pre-music and post-music online survey
* Attend the lecture/discussion with Dr. Porges and Anthony Gorry on theory and science underlying sonic augmentation technology and the experiences it aims to evoke.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 89
* Proficient in English

Exclusion Criteria:

* Under the age of 18
* Over the age of 89
* Limited English Proficiency
Effect of Early Eating and Stair Climbing on Body Composition

To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against eTRE with Brief Intense Stair Climbing (BISC) directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.


Eligibility Criteria:
Inclusion Criteria:

* sedentary- lightly physically active (\<7,500 steps daily)
* BMI \> 25 • 18-39 years old

Exclusion Criteria:

* Have diabetes (self-reported)

  * Have history of smoking (self-reported)
  * Have history of cardiovascular disease (self-reported)
  * Have BMI of \<24.9
* Are pregnant or become pregnant during the study (self-reported)
* Take medication for weight loss (self-reported)
* Physical activity level \> 7500 steps/day
* Unstable weight for 3 months prior to commencement of study (\>4kg weight loss/gain) • Employed in a shift work position
An Evaluation of the Nighttime Retention of Effect of an Investigational Lubricant Eye Drop (FID 115958D)

The purpose of this study is to describe the night-time use of an investigational lubricant eye drop.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of dry eye
2. Current use of an eye ointment or tube gel

Exclusion Criteria:

1. No nighttime contact lenses wear throughout the study period
2. Must not have had punctal plugs inserted within 30 days preceding enrollment