cyrilzakka/clinical-trials huggingface dataset:
Plant-based Dietary Intervention for Treatment of Acne

The purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.

Acne is the most common skin disorder in the United States. Although many cases are transient, the condition is often chronic, causing self-consciousness and social stigmatization over the short term and physical scars and damaged self-esteem over the long term. Patients and clinicians have frequently attributed acnegenesis to diet; studies of varying quality have been published on the topic since the 1830s. Recently, well-designed, controlled, prospective studies suggest an acnegenic effect of specific dietary factors, including high-glycemic-index foods and dairy products. Limited evidence also suggests an acnegenic effect of foods containing saturated fats. More well-designed, randomized, controlled trials are needed to further establish dietary effects on acne. Based on epidemiologic observations and results of prior clinical trials, we are conducting a pilot study to determine if a low-fat, low-glycemic-index vegan diet affects the number of acne lesions and acne severity.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female gender
2. Mild, moderate, or severe acne, as indicated by an Evaluator Global Severity Score (EGSS) score of 2, 3, or 4
3. Presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face
4. Presence of acne for at least 3 months (by volunteer's history)
5. Age at least 18 years
6. Ability and willingness to participate in all components of the study
7. Willingness to be assigned randomly to a low-fat, vegan diet or a control group
8. Intention to remain in the Washington DC area for the 16-week study period.

Exclusion Criteria:

1. Change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period.
2. Use of depot medoxyprogesterone contraception
3. Use of oral retinoids in the last 6 months
4. Use of high doses of vitamin A in the last 3 weeks (≥ 10,000 IU)
5. Use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month
6. Presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest.
7. Use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides
8. History of alcohol abuse or dependency followed by any current use
9. Current or unresolved past drug or alcohol abuse
10. Facial hair that would interfere with making acne assessments
11. Pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months
12. History of severe mental illness within the past 3 years
13. Unstable medical status
14. Current dietary pattern that is low-fat and vegan
15. Anticipated difficulty attending or participating in group sessions
16. Inordinate fear of blood draws
17. Diabetes treated with insulin or any other medications.
Quantification of Elastin Markers Synthesis in Williams-Beuren Syndrome and 7q11.23 Micro-duplication Syndrome

Introduction: Williams-Beuren syndrome is a rare genetic disorder caused by a 7q11.23 microdeletion. The phenotype associates vasculopathy (arterial stenosis, hypertension), dimorphism and intellectual disability. Microdeletion includes several genes: ELN encodes for elastin and the haplo-insufficiency (only 1 functional copy) causes vasculopathy.

The primary objective is to quantify plasma and urinary levels of elastin peptides in Williams-Beuren patients and 7q11.23 micro-duplication syndrome patients in order to correlate the levels of these markers with the number of copies of ELN gene (proportional positive relationship "gene copy number - circulating levels of markers) Materials and Methods: This prospective study will be carried out in Lyon at the "Hôpital Femme-Mère-Enfant" for 2 years. 3 groups of patients will be studied: Williams-Beuren patients (N=20), micro-duplication 7q11.23 syndrome patients (N=10) and healthy patients (N=60). Subjects will be followed for 1 day.

Clinical examination (weight, height, blood pressure) and biological sample collection (blood and urine sample) will be carry out for Williams Beuren and micro-duplication 7q11.23 patients group. A large majority of visits will be part of patients' usual care. A large part of patients are systematically seen in consultation once a year. For healthy group, only biological sample collection will be carry out. The PE concentrations will be assessed and compared between the three groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age : from 3 months to 60 years old
* Williams Beuren group : Diagnosis confirmed with FISH
* Micro-duplication 7q11.23 group : Diagnosis confirmed with CGHarray
* Healthy Group : no cardiovascular and neurological medical history
* Informed consent

Exclusion Criteria:

* No social insurance
* Subject under judicial protection
* Subject participating in another research including an exclusion period still in progress
Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.

Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.

This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.

Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.

In this study, the cell cycle regulatory message RNA and protein from patients' and healthy volunteers' bone marrow and peripheral blood will be extracted and quantified by real time polymerase chain reaction and western blot. The different level of cell cycle regulatory gene between patients and volunteers and the relationship between the level and patients' clinical characteristics such as age, gender, type of disease will be analysed by SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) or chronic myeloid leukemia (CML) as defined by the World Health Organization (WHO) diagnostic criteria

Exclusion Criteria:

* Have received treatment
Omega-3, Nigella Sativa, Indian Costus, Quinine, Anise Seed, Deglycyrrhizinated Licorice, Artemisinin, Febrifugine on Immunity of Patients With (COVID-19)

The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc.

COVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment.

Based on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection.

Natural supplementations have many reported effects on the human health ranged from immunity boosting to effective antiviral effect. Omeg-3 as an example affect the human health by many mechanisms e.g. Anti-oxidant, immunity boosting agent. Moreover, Omega-3 exerts an antiviral effect on Flu virus by inhibiting influenza virus replication 1. On the other hand, black seed supplementation exerts a chelation effect on sickle cell anemia patients and inhibits Human Heme Metabolism 2. Moreover, black seed exerts an antiviral effect on the replication of old coronavirus and the expression of (TRP-genes) family 3. In addition, Omega-3 regulates the human immunity against bacterial and viral infections 4. During the past years, many natural sources exerts an antimalarial effect with perfect reported results 5.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic with respiratory or systemic symptoms
* Positive nasopharyngeal swab for COVID-19
* CT imaging showing viral pneumonia
* Temperature 38°C
* Respiratory rate \< 25 /min
* Oxygen saturation (pulse oximetry) \>95%

Exclusion Criteria:

* Pregnant or breast feeding
* Hepatic failure Child-Pugh C
* Negative swab test of (SARS)-(CoV-2)
* Expected life is less than 24 hours
* End-stage lung disease
A System and Process to Improve the Satisfaction With Hearing Health Products

Innovative Design Labs Inc. (IDL) and its collaborators, proposes to create a cloud-based system which integrates advances and techniques from Health and Wellness Coaching (HWC) into the Hearing Aid (HA) fitting and trial process.

As of 2015, 28.8 million U.S. adults could benefit from using hearing aids and the prevalence of hearing loss in the United States is predicted to rise significantly due to an aging population and the growing use of personal listening devices. However, only 28.5% of individuals who could benefit from a HA actually wears one. The non-use of hearing aids by people with hearing loss has many far-reaching implications for their physical health, mental health, and their social life. As the market moves towards a, direct-to-consumer distribution model following the 2017 FDA directive, more patients will be receiving therapy for hearing loss. While in traditional practice, an audiologist assists the patient with support adjusting to their new therapy, there is no person fulfilling that role in the direct-to-consumer model. Hypothesis: The investigators hypothesize that the integration of Health and Wellness Coaching, aided by cloud-based tools, into this process will increase patients' satisfaction and usage of hearing health products. Specific Aims: 1) Create patient/coach interaction protocol and training; 2) Develop a cloud-based Health Coaching Interface; 3) Evaluate system effectiveness through a clinical trial.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Significantly reduced cognitive ability (assessed using the Montreal Cognitive Assessment MoCA)
* Lack of proficiency communicating in English
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018
* Subject who has agreed to the use of his data for the purpose of this research
* Subject presenting an untreated neuroma

Exclusion Criteria:

* Subject having expressed his opposition to participating in the study
* Subject followed for neuroma of other cranial pairs,
* Subject followed in the context of type II neurofibromatosis
* Subject with a treated neuroma (radiotherapy or surgery)
Levobetaxolol Hydrochloride Eye Drops for Treatment of Primary Open-angle Glaucoma or Ocular Hypertension

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with glaucoma.

To evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Agreed to participate in this clinical trial and informed consent;
* Aged 18 to 70 years of age, male or female;
* In line with primary open-angle glaucoma diagnostic criteria, IOP ≥18mmHg;
* or in compliance with ocular hypertension diagnostic criteria, intraocular pressure\> 21mmHg

Exclusion Criteria:

* Known or suspected to be allergic to investigational drugs and materials
* has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma.
* merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa.
* merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients.
* During the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment.
* Need systemic β-blocker therapy during the study.
* with severe kidney disease, or abnormal liver function tests (ALT, AST≥ 1.5 times the upper limit of normal, SCr\> upper limit of normal).
* merge sinus bradycardia, over Ⅰ degree atrioventricular block, cardiogenic shock, heart failure, symptomatic hypotension or other serious heart, lung diseases (such as bronchial asthma or a history of bronchial asthma, chronic obstructive lung disease, bronchospasm, respiratory failure, etc.).
* merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems.
* associated with neurological and psychiatric disorders
* suspect or indeed alcohol, drug abuse history.
* pregnancy, lactation or recent fertility planner.
* The researchers believe other circumstances were not involved in this trial.
* participate in other clinical trials within three months.
Efficacy Study of GLYC-101 to Evaluate Outcomes After Post-laser Ablation

Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).

Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the following criteria will be considered for admission to the study:

* Patients giving informed consent for retro-auricular laser ablation between 25 and 55 years old.
* Retro-auricular area is free of any irritation, scars or dermatologic conditions which might interfere with the study.
* Willing and able to participate in the study and follow all study directions.
* Able to read, understand and sign the consent form.

Exclusion Criteria:

* Pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
* Systemic or cutaneous disease that may interfere with the study results.
* Presence of irritation or dermatologic skin conditions in the retro-auricular area.
* Known allergies to materials within the test formulations.
* Systemic or cutaneous therapy with medication that impacts wound healing (steroids, immune modulators, immune suppressants).
Improving Surgical Outcomes in Patients With Low Grade Gliomas Using Advanced Pre- and Intra-operative MRI

This aim of this study is to improve the outcomes for patient with gliomas undergoing neurosurgery by maximising the extent of resection whilst minimising neurological morbidity. This will be achieved through the use of advanced MRI, fMRI and DTI, performed at two stages of the patients' clinical management.

Low grade gliomas are often located near to and infiltrate into important parts of brain which are involved with language and motor function. During surgery to remove these tumours, there is a fine balance between trying to remove as much of the tumour as possible and limiting any damage to these functionally important parts of the brain which, particularly in a young patient, may result in impairment for the rest of their life.

Functional MRI (fMRI) can be used to identify these functionally important cortical areas and diffusion tensor imaging (DTI) can be used to identify the important subcortical and deep white matter tracts connecting these regions. The use of these advanced imaging techniques performed pre-operatively to plan surgery is now commonplace however their role in guiding the actual operation itself is limited because of the occurrence of 'brain shift', this being deformation in the contour of the brain parenchyma which occurs as the tumour is resected. This can result in inaccuracies if the pre-operative advanced MRI data is being used in the neuronavigational system to guide surgery.

The main aim of this study is to determine the optimal method of providing updated, spatially accurate data on the location of these functionally important areas of the brain to the neurosurgeon intra-operatively. In this study, two different techniques will be compared. The first is the acquisition of real-time fMRI and DTI acquired intra-operatively during tumour resection. The second is to use intra-operatively acquired structural and diffusion sequences to perform non-rigid co-registration of fMRI and DTI data which has been acquired before surgery. The feasibility and then the accuracy of these two techniques will be evaluated.

The second aim of this study is to better understand the effect that the tumour and surgery have on language function as this will have important implications on the planning of the surgical approach, the counselling of patients of the possible risks of surgery and in helping to decide long term treatments. This will be achieved by performing advanced MRI scans, in particular an extensive language fMRI paradigm pre-operatively and post-operatively in patients with gliomas undergoing surgery. This will be combined with clinical testing of language function. Greater understanding of the neural plasticity in this functionally important system could allow for a greater, maximal resection.

Eligibility Criteria:
Inclusion Criteria:

* Intrinsic brain tumour requiring resection
* Aged 18 years or over

Exclusion Criteria:

* Inability to give consent
* Contraindication to MRI
* No English language comprehension
Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques.

The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery
* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 60 months of follow-up

Exclusion Criteria:

* The patient is participating in another study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* Patient has a stage-1 prolapse (POP-Q classification)
* Patient has asymptomatic prolapse
* The patient has a prolapse recurrence (i.e. this is not the first case of prolapse)
* The patient is not available for 60 months of follow-up
* Patient has a vaginal or urinary infection
* Patient has poorly-adjusted diabetes
* Patient on long-term corticotherapy
* Patient has previously had pelvic radiotherapy
* Patient has contraindication for anesthesia
* Patient has an intestinal inflammatory disease
Effects of Montelukast on Airway Regulatory T Cells in Asthma

Montelukast is one of anti-inflammatory agents and a good controller for the patients with asthma. The hypothesis of the study is that the Montelukast will have airway anti-inflammatory effects and up-regulated regulatory T cells functions in asthma.


Eligibility Criteria:
Inclusion Criteria:

* asthma
* mild status
* stable status
* nonsmoker
* Positive of airway hyperresponsiveness (Methacholine-PC20\<16mg/mL)

Exclusion Criteria:

* taken other asthmatic medications such as oral, injective, and inhaled steroids, leukotriene antagonists, oral, inhaled, and transdermal beta-agonists, theophylline, anti-histamine agents, anti-IgE antibodies and long acting muscarinic receptor antagonists.
* respiratory tract infections within 4wks
* moderate to severe other organ disorders
* active malignancies
* past histories of side effects of leukotriene antagonists
* psychological disorders
* pregnancy or nursing