cyrilzakka/clinical-trials huggingface dataset:
Cholesterol-lowering Effects of Plant Stanol Ester

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.


Eligibility Criteria:
Inclusion Criteria:

* total cholesterol concentration ≥ 200 mg/dL and \< 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and \< 180 mg/dL
* were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
* reachable by phone
* willing to declare written informed consent
* agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.

Exclusion Criteria:

* Pregnant women
* obese
* diabetic subjects or subjects with random plasma glucose concentration \> 200 mg/dL
* hyperthyroidism, a history of metabolic, endocrine and kidney disorders
* acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
* taking lipid-lowering medication or other medications likely to affect lipid metabolism
Lacosamide Versus Propranolol in Migraine

Investigators aim to compare the effect of lacosamide versus propranolol in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily, and the second group will receive propranolol 160 mg per day. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14). HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

* Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,

Exclusion Criteria:

* Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
* patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.
* patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.
* patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure
* patients who received prophylactic treatment for migraine,
* patients with any contraindications to drugs used in the study
* patients with bronchial asthma, chronic obstructive pulmonary disease
Pilot Safety Study of Injectable SIS for Critical Limb Ischemia

This study is intended to collect safety and effectiveness data on the Cook Injectable Small Intestinal Submucosa (SIS)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of critical limb ischemia
* Rutherford 4-5 or Leriche-Fontaine IIIB
* Patient unable to be treated by endovascular or surgical means

Exclusion Criteria:

* Patient's age is \<21
* Patient is pregnant or breast-feeding (or is planning to become pregnant within the next year)
* Patient has had a previous surgery, within 30 days of the study procedure
* Patient has any planned surgical or interventional procedure within 30 days after the study procedure
* Patient has a life expectancy less than 1 year
* Patient has a known allergy to pigs or pig products, or has a religious or cultural objection to the use of pig tissue
* Additional restrictions as specified in the Clinical Investigation Plan
CRPS - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation

This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). The investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and MRI techniques.

rTMS hypothetically disrupts the default networks related to chronic pain and renders the brain more susceptible to drugs, rehabilitation, or cognitive behavioral therapy. In addition, there is experimental evidence that rTMS releases factors that are involved in endogenous top-down modulation of pain and neural plasticity. Thus, the analgesic effect of rTMS may be mediated via enforcing endogenous pain control systems at the brain level, in addition to its effects on neuroplastic effects.

For active, navigated stimulation targets the investigators have the parietal opercular cortex overlying the secondary somatosensory cortex ("S2") and the primary motor cortex (M1).

The investigators randomize participants to first receive nrTMS to the right "S2" or sham stimulation. After ten sessions the investigators follow up the participants up to three months. At three months, if the average pain is ≥5/10 in numeric rating scale (NRS), the participant is offered an active, open nrTMS treatment phase depending on which treatment the participant first received. If the participant benefits from the open label treatment, a maintenance therapy is offered (6 months with gradually reducing nrTMS treatment frequency). The symptoms and quality of life are followed with questionnaires and diaries. After the maintenance period, the RN calls a structured interview at 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* CRPS 1 or 2 of the upper limb
* Duration ≥ 6 months
* Mean pain (NRS) intensity ≥5/10
* Medical and other therapies have failed

Exclusion Criteria:

* Other stimulation therapies apart from transcutaneous nerve stimulation
* psychotic disorder
* severe depression
* use of strong opioids
* epilepsy
* any contraindication for MRI
* abuse of alcohol or drugs
* ongoing insurance or other entitlement cases
Randomized Study of the Safety and Effectiveness of the Sight Sciences VISCO™360 Viscosurgical System Versus SLT in Primary Open Angle Glaucoma (VISCO360 Study)

The purpose of this study is to evaluate the safety and effectiveness of the Sight Sciences VISCO™360 Viscosurgical System in reducing intraocular pressure (IOP) in adult, pseudophakic subjects with open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG) in the study eye.
* Pseudophakic with Posterior Chamber IOL (PCIOL)
* Able and willing to attend follow up visits for two years post-operative
* Able and willing to sign informed consent

Exclusion Criteria:

* Phakia or aphakia
* Previous glaucoma procedure with or without an implantable glaucoma device (including incisional surgery, ALT, iridectomy/iridotomy, etc.) \[Subjects with one prior SLT application (\>3 months prior to screening) or prior ECP (performed \> 12 months prior to screening) can be enrolled\].
* Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
* Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
* Abnormal angle anatomy as determined by gonioscopy (e.g. peripheral anterior synechiae, rubeosis or other angle abnormalities)
* Participation in any clinical trial ≤ 30 days prior to screening
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants

Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years
2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor
3. Scheduled for reconstruction surgery with one of the following implants:

   * MatrixMIDFACE Preformed Orbital Plate
   * Custom-made orbital implant
   * Orbital Floor Mesh Plate
   * SynPOR Titanium Reinforced Fan Sheet
4. At least partial sight in both eyes before the accident
5. Willingness and ability to participate in the study follow-up according to the protocol
6. Ability to understand and read local language at elementary level
7. Signed informed consent

Exclusion Criteria:

1. Bilateral orbital fracture
2. Fractures of the orbital roof
3. Comminuted zygoma fracture
4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure
5. Previous dislocated orbital fractures on either side
6. Vision or diplopia not assessable
7. Injury of the globe
8. Neurological diseases with influence on eye motility or sight
9. Legal incompetence
10. Active malignancy
11. Life-threatening condition
12. Alcohol and drug abuse
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™

This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.

This is a prospective, non-randomized, open-label study evaluating the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.

Up to 200 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to 6 treatments to the face and/or off-face locations with treatment intervals of 4 weeks +/- 2 weeks. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment. Total study duration is approximately 12 months (up to 9 months for treatment and 3 months for follow up).

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age or older
2. Willingness to provide signed, informed consent to participate in the study
3. Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) \>/= 1.
4. Willingness to adhere to study treatment and follow-up schedule
5. Willingness to adhere to post-treatment care instructions
6. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
7. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study

Exclusion Criteria:

1. Pregnant, planning pregnancy during the study, or breast feeding
2. Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed.
3. Active sun tan in the intended treatment area
4. History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
5. History of melanoma
6. History of vitiligo in the intended treatment area
7. History of keloid or hypertrophic scar formation
8. History of Melasma in the intended treatment area per Investigator's discretion
9. Use of systemic retinoid therapy (e.g. Accutane) during the past 6 months
10. Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment
11. Open wound or infection in the intended treatment area
12. History of light induced seizure disorders
13. The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety
14. Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.

This study will investigate how 3 new types of drug formulations are absorbed by the body. This study is termed 'open-label', which means volunteers will be aware of which treatment they are receiving. The study involves all volunteers receiving all 3 different formulations, as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study. Volunteers will also receive a single dose of a formulation used in previous trials (reference formulation), so as a proper comparison with the new formulations can be made. One of the new formulations will also be administered along with food, to assess if the drug performs or is absorbed differently.

The present study will investigate the tolerability and pharmacokinetics of single oral doses of firategrast administered as the existing immediate release tablet formulation and as three modified release tablet formulations designed to release drug over differing relase rates. The range of release rates is expected to give preliminary information on the performance of a matrix modified release formulation for use in future efficacy studies.

Subjects will receive each formulation in the fasted state in a randomised 4-part single dose crossover fashion. Based on the review of pharmacokinetic data from at least the first two study sessions, subjects may also receive a fifth dose of firategrast, administered after a high fat meal. The formulation administered with food will be chosen based upon pharmacokinetic data from previous dose sessions. Doses administered will be different with respect to gender; the doses are expected to result in similar exposures across the genders.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 65 yrs inclusive
* Healthy, as determined by study physician
* Capable of giving informed consent

Exclusion Criteria:

* Positive drugs of abuse result
* Positive for HIV or Hepatitis B and/or C viruses
* History of alcohol consumption in excess of average recommended weekly intake (more than 21 units for males, more than 14 units for females)
* Participation in a clinical trial within 90 days of scheduled first dose
Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases

To study the effect of silymarin against methotrexate-induced liver injury in rheumatic diseases including rheumatoid arthritis, psoriatric arthritis and psoriasis

- Methotrexate was indeed a common and effective treatment for rheumatoid arthritis, psoriatic arthritis and psoriasis. Methotrexate-related hepatotoxicity are common occur 1:1,100 persons. Liver abnormalities varies from asymptomatic liver enzyme elevation to fatal hepatic necrosis and liver fibrosis. Methotrexate was discontinued owing to liver dysfunction in 7.4%

Eligibility Criteria:
Inclusion Criteria:

* Aged \> 20 years
* Diagnosis at least one of the following

  1. Rheumatoid arthritis according to American College of Rheumatology/ The European Alliance of Associations for Rheumatology 2010(ACR/EULAR2010) with at least one joint swelling or tenderness or
  2. Psoriatric arthritis according to CASPAR classification criteria with at least one joint swelling or tenderness, or at least one site dactylitis or enthesitis or Psoriasis by dermatologist with active skin lesion
  3. No previous treatment with methotrexate or treatment with methotrexate within 30 day before randomization
  4. No previous treatment with other conventional synthetic DMARDs other than methotrexate such as sulfasalazine, hydroxycholoquine, leflunomide
  5. No previous treatment with biologic DMARDs such as anti-TNF
  6. Can follow the treatment protocal

Exclusion Criteria:

* Pregnancy or planning for pregnancy
* Breastfeeding women
* Ongoing treatment with active malignancy
* GFR \< 30 ml/min/1.73m2
* Previous documented of HIV infection
* Chronic alcohol drinking ≥ 3 times/wk or drug abuse within 6 months prior to randomization
* Positive of HbsAg, anti HCV
* Previous documented of preexisting liver disease such as alcoholic liver disease, liver cirrhosis, autoimmune hepatitis
* AST or ALT \> ULN ( 0-50 U/L )
* WBC \< 3,000/ul or platelet \< 100,000 /ul, ANC \< 1,500/ul
* ILD diagnosed by rheumatologist and pulmonologist from chest X ray and HRCT
* History documented silymarin hypersensitivity or severe adverse effects diagnosed by physician or pharmacist from PMK hospital or from history drug allergy or symptoms such as rash, chest tightness, dyspnea, diarrhea and hypotension
* Cannot follow up on treatment protocal
NPO Before Sedation

Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.

Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).


Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for elective echocardiography
* Aged under 3 years old

Exclusion Criteria:

* Comorbidity other than hear disease or chromosomal disease
* Patients with delayed gastric emptying
* Patients with structural abnormalities of the stomach or esophagus
* Difficult airway management
* Parents refuse to participate in the study
* Unable to achieve sedation
* Neonatal
Effect of Kale Consumption on Human Xenobiotic Metabolizing Enzymes

The primary objective of this study is to determine how daily consumption of kale changes the activity of human xenobiotic metabolizing enzymes. Secondary objectives are to measure absorption and metabolism of kale phytonutrients, and to determine how kale consumption affects gene expression related to metabolism and lipid measures associated with cardiovascular health.

Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely associated with the incidence of several cancers, including cancers of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by a plant enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be the active agent for cancer prevention. Their ability to reduce risk of cancer may derive in part from their ability to modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I cytochrome P450s and Phase II enzymes.

The primary aim of this study is to investigate how daily consumption of kale influences foreign-substance metabolizing enzymes, which in turn may reduce cancer risk. Secondary aims of this study include measuring metabolism of kale nutrients, effect of kale consumption on fecal microbiota, and how kale consumption influences risk factors for cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* 5 years cancer free
* Not a tobacco product user
* Blood glucose less than 126 mg/dL
* Able to voluntarily agree to participate and sign an informed consent document

Exclusion Criteria:

* Brassica vegetable allergy or intolerance
* use of oral contraceptives
* Women who have given birth in the previous 12 months
* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* History of bariatric surgery or nutrient malabsorption disease
* Pregnant, lactating, or intending to become pregnant during the study period
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Adipokine Genetic Variations in predictingNAFLD Progression to NASH in Egyptian Patients

Due to the limited data concerning Egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level


Eligibility Criteria:
Inclusion Criteria:

Egyptian patients confirmed NAFLD diagnosis diabetic

-

Exclusion Criteria:

* Pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, Wilson's disease), drug induced hepatitis, chronic enteropathies, Chronic kidney disease
A Pilot Study to Evaluate the Impact of Dexmedetomidine on Breast Cancer Recurrence After Surgery

Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. The purpose of present study is to examine whether utilization of dexmedetomidine in patients undergoing surgery for primary breast cancer increases breast cancer recurrence and metastasis, and to investigate its effects on the patients' immune system.

Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. Patients of control group will receive same amount of normal saline. Patients will be followed up for 36 months to measure the incidence of cancer recurrence and metastasis. Serum form patients of both groups will be collected at 24 h after surgery. The number of CD3+ , CD4+, CD8+ cells and NK cells in the serum will be compared between the two groups. Serum levels of IFN-γ, IL-12，IL-4 and VEGF will also be measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* ASA grade I-III
* Age range of 18 to75
* Patients diagnosed primary breast cancer
* Patients will have elective mastectomy

Exclusion Criteria:

* with history of breast operation
* Patients diagnosed with inflammatory breast
* Severe mental or physical illnesses(like liver, renal, brain or lung disease)
* with history of opioid addiction
* Patients diagnosed metastatic breast cancer
* Contradictions or an allergy to Dexmedetomidine