cyrilzakka/clinical-trials huggingface dataset:
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia

The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.

The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.

Eligibility Criteria:
Inclusion Criteria:

* age 8 to 18 years
* positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease
* elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L
* entered in the National Cholesterol Education Program Step II diet for at least 6 months

Exclusion Criteria:

* patients with secondary causes of hyperlipidemia
* history of major illness or surgery 3 months or less prior to enrollment
* taking lipid-lowering medications
* history of gastrointestinal problems
* allergies towards flaxseed
Study of CM313(SC) Injection in Systemic Lupus Erythematosus(SLE)

To evaluate the efficacy and safety of CM313(SC) injection in systemic lupus erythematosus(SLE)


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 to 65 years.
2. Voluntarily signed the informed consent form (ICF).
3. Patients were diagnosed with systemic lupus erythematosus(SLE) according to the diagnostic classification criteria of the European League against Rheumatism (EULAR)/American College of Rheumatology (ACR) in 2019.
4. Systemic Lupus Erythematosus Disease Activity Index - 2000(SLEDAI-2K) score ≥6 during screening, and SLEDAI-2K clinical score (except for low complement and/or positive anti-dsDNA antibodies) ≥4 during screening and at baseline.
5. Positive antinuclear antibody and/or anti-dsDNA antibody results defined in accordance with the laboratory reference value range of the Central laboratory during the screening.
6. ≥1British Isles Lupus Assessment Group-2004 (BILAG-2004) organ system rated as A or ≥ 2 organ system rated as B, and Physician's Global Assessment(PGA) score ≥1.0 during screening.
7. Maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product.

Exclusion Criteria:

1. Kidney disease: Severe lupus nephritis within within 8 weeks prior to randomization.
2. Patients with systemic lupus erythematosus(SLE) or non-SLE related central nervous system disease within 8 weeks prior to randomization.
3. There were non-SLE inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period.
4. History of clinically significant diseases.
Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.

The hypoxic adaptive response is a form of acquired tolerance that occurs by activating internal cellular protective mechanisms and enhancing immune function.This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia. This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia.

Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Intermittent hypoxia has been shown in our team's work to effectively inhibit colorectal cancer tumor progression in mice by enhancing immune cell function. This study aims to explore the safety and efficacy of IH in patients with colorectal cancer using a non-randomized self-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal cancer between ages of 18 and 65 years.
* Colorectal cancer stage Ⅰ,Ⅱ.
* Subjects or their legally authorized representative can provide informed consent.

Exclusion Criteria:

* History of cardiovascular, cerebrovascular, dermatological, and hematological diseases.
* History of pulmonary, hepatic, kidney, dermatologic and hematologic diseases.
* History of pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
* History of substance abuse.
* Participating in other drug or medical device studies.
* History of organ transplantation, including allogeneic stem cell and immune cell transplantation.
* Recent severe infection within 4 weeks.
* Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
* Underwent major surgery within 28 days.
The Effects of Scapular Muscles Training Using a Suspension System in Patients With Non Spacific Chronic Neck Pain and Scapular Dyskinesia

The study aimed to investigate the effect of scapular muscle training using a suspension system in patients with non spacific chronic neck pain with scapular diskinesia


Eligibility Criteria:
Inclusion Criteria:

* Patients age between 20-35 years.
* Patients with non spacific pain(pain \> 3 month).
* pain must have been present for at least the previous 12 weeks.
* Patients with non spacific chronic neck pain with scapular dyskinesia.
* Patient BMI\<30.

Exclusion Criteria:

* History of previous neck surgery.
* Recent or old fractures.
* Cognitive impairment and inability to understand the scale.
* Systematic inflammatory disease e.g., rheumatoid arthritis and ankylosing Spondylitis.
* Neck pain with radiculopathy or neuropathy.
* Scapular dyskinesia due to other pathology such as shoulder impingement
The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin

The risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. This is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (\>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (ASA) use. Eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily ASA or placebo 7 days before and 14 days following polypectomy. The primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. The secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.

Patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. Meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and The Patient Diary to fill (Visit 1). The patient will be admitted to the Study Center in 6-7 days taking on the aspirin/placebo and prepared for the study (Visit 2). Patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (Visit 3). 30 days after polypectomy will be the second control visit by phone (Visit 4). Patients will be monitored by looking at the end points.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 years or older
2. Daily aspirin for primary or secondary prophylaxis
3. Candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger
4. Signed written informed consent
5. Written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period

Exclusion Criteria:

1. Lifelong anticoagulant therapy with warfarin, acenocumarol
2. Concurrent antiplatelet treatment with clopidogrel or ticlopidin
3. Coagulation disorders INR \> 1,5, APTT 2xnorm
4. Known hemorrhagic disorder
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in participants with solid cancers that are advanced or have spread.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

For Part 9 (only arm open for enrollment):

* Stage IV metastatic or unresectable triple negative breast cancer (TNBC) with zero or one prior systemic therapies in the advanced metastatic setting
* Participants with \< 12 months from receipt of last curative-intent chemotherapy are allowed; curative chemotherapy will be considered first-line therapy
* Prior receipt of chemotherapy in the (neo)adjuvant setting is acceptable, as long as completed greater than 6 months from start of treatment
* Tumor biopsy samples (mandatory pre- and on-treatment biopsies) are required for all participants enrolled
* Must have histologic or cytologic confirmation of a malignancy that is advanced (metastatic, recurrent, refractory, and/or unresectable) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Must be immunotherapy treatment naïve, including no prior therapy with T cell immune checkpoint blocker (anti-PDL1, anti-PD1). Prior receipt of intralymphatic cytokine therapy (IRX-2) is acceptable (Part 9 only)
* Other active malignancy requiring concurrent intervention
* Prior therapy with any agent specifically targeting T-cell co-stimulation pathways such as anti-OX40 antibody, anti-CD137, anti- glucocorticoid-induced TNFR-related gene (anti-GITR) antibody, and anti-CD27
* Known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the investigator or Sponsor, could make the administration of study drug hazardous to the participant or could adversely affect the ability of the participant to comply with or tolerate the study

Other protocol-defined inclusion/exclusion criteria apply
Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients

Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients

Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin.

The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients.

In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).


Eligibility Criteria:
Inclusion Criteria:

* signed inform consent

Exclusion Criteria:

* pregnant women
Impact of Nocturnal Hypoxemia on Glucose in High Altitude Sleep Disordered Breathing

Sleep disordered breathing is associated with impaired glucose tolerance and incident diabetes. Nocturnal hypoxemia is a potential stimulus of glucose intolerance. It is especially severe and highly prevalent in high altitude residents. Intervening on nocturnal hypoxemia may therefore improve glucose control and decrease the public health burden in high altitude populations.

The objective of this study is to examine the impact of hypoxemia on glucose homeostasis in high altitude residents. The investigators will address this objective by examining the effect of supplemental oxygen on glucose in a randomized cross-over study.


Eligibility Criteria:
Inclusion Criteria:

* Permanent residents of Puno, Peru

Exclusion Criteria:

* Recent travel to low altitude (\<3000 m)
* Oxygen use
* Pregnancy
* Morbid obesity (BMI \> 40 kg/m2)
* Current smoking
* Diabetes
* Other sleep disorders (e.g. circadian rhythm disorder or insomnia)
* Use of open fires in the home (i.e. for cooking or heat)
* Chronic Mountain Sickness (CMS) as defined by a daytime oxyhemoglobin saturation \< 85%, Qinghai CMS \>10 or excessive erythrocytosis as defined by hemoglobin \>19 g/dL in women or \>21 g/dL in men.
the Evaluation of the Efficacy of TCI66207 on the Skin.

The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged above 20 years old
2. Subject has dull skin.

Exclusion Criteria:

1. .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.
4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
5. Subjects who have large spots (area \>3 square centimeter) or abnormal acne.
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy

The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.


Eligibility Criteria:
Inclusion Criteria:

* 1-3 years of age
* Lives in study villages

Exclusion Criteria:

* Unable to drink 100 mL of sugar water
* Demonstrating evidence of severe acute malnutrition, WHZ \< or = -3, presence of bi-pedal pitting edema
* Apparent need for acute medical treatment for an illness or injury
* Parent refusal to participate and return for 7-week follow-up
Strategies to Improve Bone Health in Men on ADT

This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).

In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically \<15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.

Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.

Eligibility Criteria:
Inclusion Criteria:

Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy \>6 months

Exclusion Criteria:

Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years
Fixed Dose Combination of Bisoprolol and Amlodipine in the Treatment of Hypertension

This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC over monotherapies).


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension not controlled at 5 mg bisoprolol or 5 mg amlodipine at least 4 weeks (definition of not controlled: SBP greater than or equal to (\>=) 140 millimeter of mercury (mmHg) with or without DBP \>= 90 mmHg)
* Male or female subjects \>=18 years of age, without limitation on race
* Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
* Subjects who have signed the informed consent form before any trial related assessment

Exclusion Criteria:

* General contraindications of beta-blockers and/or calcium channel blockers

  * Previous and concurrent acute heart failure or during episodes of heart failure decompensation requiring intravenous inotropic therapy
  * Concurrent cardiogenic shock
  * Previous and concurrent second or third degree atrioventricular (AV) block (without a pacemaker)
  * Previous and concurrent sick sinus syndrome
  * Previous and concurrent sinoatrial block
  * Concurrent symptomatic bradycardia
  * Concurrent symptomatic hypotension
  * Previous and concurrent severe bronchial asthma or chronic obstructive pulmonary diseases
  * Previous and concurrent severe peripheral arterial occlusive diseases and Raynaud's syndrome
  * Untreated pheochromocytoma
  * Concurrent metabolic acidosis
  * Known hypersensitivity to bisoprolol, amlodipine, dihydropyridine derivates or to any of the excipients
* Seated pulse rate less than 60 beats per minute (bpm) at screening
* Any other anti-hypertensive drugs (other than bisoprolol and amlodipine) are used within 4 weeks prior to the screening visit
* Use of any enzyme-modifying drugs acting on cytochrome P450 (CYP) 3A4 enzymes via inhibition (such as ketoconazole, itraconazole, ritonavir) or induction (such as rifampicin or hypericum perforatum) within 28 days before Day 1 of the trial
* Other significant disease that in the Investigator's opinion that would exclude the subject from the trial, such as uncontrolled diabetes mellitus, severe liver and/or kidney dysfunction, decompensated cardiac failure
* Any other condition or therapy which in the Investigator's opinion would pose a risk to the subject or interfere with the trial objectives
* Concurrent alcohol and/or drug abuse
* Known hypersensitivity to the trial treatments
* Pregnancy and lactation period. All female subjects with reproductive potential must have a negative pregnancy serum test within the 7 days prior to enrollment
* Known lack of subject compliance
* Legal incapacity or limited legal capacity
* Participation in another clinical trial within the previous 30 days
* Persons directly involved in the execution of the protocol
Macular Hole Surgery With and Without Internal Limiting Membrane Peeling：A Systematic Review and Meta-analysis

Since Kelly and Wendel first reported successful closure of idiopathic macular holes (MH) by vitrectomy in 1991, many surgical modifications have been made to improve the anatomical and visual outcomes of this surgery. Recently, internal limiting membrane (ILM) peeling has become used widely as an adjunctive procedure during MH surgery because the removal of ILM is thought to reduce the tangential traction on the macula, a major factor in the pathogenesis of idiopathic macular holes. However, the role of ILM peeling in macular hole surgery is not yet well defined. To the best of our knowledge, there is no meta-analysis on comparison of the efficacy of ILM peeling and suture for MH surgery. This study reviewed the published literature comparing surgical results with and without ILM peeling and and performed a meta-analysis to determine whether there is any benefit or detriment anatomically and/or visually.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants are those with idiopathic FTMH in stages 2-3, of less or equal than 18 months duration (based on symptoms reported by the patient) and with a visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria:

* Patients with idiopathic FTMH stages 2-3 but longer than 18 months duration or with other causes of decreased vision (e.g. corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects are present) and
* Those with FTMH related to high myopia (\> 6 dioptres) or trauma will be excluded from the study.