cyrilzakka/clinical-trials huggingface dataset:
Blended Oil Beneficial for Blood Lipids Management

To investigate the effects of two types of oil blends on blood lipid profile, glucose homeostasis, body composition, gut microflora and other markers of cardiometabolic disease risk in Chinese men and women with borderline hyperlipidemia

The primary aims of this study is to evaluate the effects of consumption of two separate blends of cooking oil, containing rice bran, flaxseed and sesame oils, for a period of 8 weeks, on blood total cholesterol, total triglycerides, low-density and high-density lipoprotein cholesterol and metabolism in borderline hyperlipidaemic, 50 to 70 years old, Chinese, male and postmenopausal female, as compared to refined olive oil. The secondary aims of the study is to evaluate the effect of the two separate blends of cooking oil on markers of cardiometabolic diseases risk (including body composition, glucose homeostasis, markers of oxidative stress and chronic inflammation) and changes in gut microbiota composition and function.

Eligibility Criteria:
Inclusion Criteria:

* Male and post-menopausal female,
* Chinese ethnicity
* Age ≥50 and ≤70 years
* LDL cholesterol (measured) ≥3.06 mmol/l and ≤4.51 mmol/l

Exclusion Criteria:

* Body Mass Index (BMI) \> 27.5 kg/m2.
* Having allergies / intolerances to the foods in the meal accompaniments of the study
* Having undergone bariatric surgery
* Having fasting glucose ≥7.0 mmol/l
* Having heart, kidney (nephrotic syndrome), blood or thyroid dysfunctions
* History of chronic liver diseases including NAFLD, liver cirrhosis or hepatic fibrosis or having history of HIV, Hep-B or Hep-C virus
* Having prescription medication or Traditional Chinese Medicine or supplements known to affect blood lipid metabolism, in the opinion of the study investigators, in the last two weeks prior to screening
* Having diabetes or chronic gastrointestinal disorders
* Following any special diets (for medical or aesthetic reasons)
* Smoking
* Having had diarrhea in the last 3 months
* Having taken antibiotics in the last 3 months
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients with PNAC Who Require More Than Eight Weeks of Omegaven Treatment

This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population


Eligibility Criteria:
Inclusion Criteria:

1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
2. Pediatric patient (\<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks.
3. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.

Exclusion Criteria:

1. Patient has received Omegaven within four weeks before inclusion in the study
2. Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.
3. Patient has known cirrhosis (liver biopsy is not required under this protocol).
4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
5. Patient has previously received a liver-only or liver-inclusive transplant.
6. Patient has hemodynamic instability due to any major cardiac anomaly.
7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
8. Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.
9. Patient has renal failure and requires renal replacement therapy.
10. Patient has a severe hemorrhagic disorder.
11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dL).
12. Patient has a record of EFAD before inclusion in the study
13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
15. Patient is subject to treatment limitation.
16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline

The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.

This is a prospective trial of vaginal preparation (or vaginal cleansing/washing) on late preterm and term pregnancies admitted to Labor \& Delivery unit for cesarean delivery with three arms. Randomization allocation would be performed in 1:1:1 fashion for vaginal preparation with chlorhexidine-alcohol, povidine-iodine, and saline washes. A saline wash group is included to determine if the act of cleansing the vagina with a sponge alone reduces bacterial colony counts.

Eligibility Criteria:
Intervention Group (vaginal preparation)

Inclusion Criteria:

* Pregnant women admitted for cesarean delivery
* Gestational age greater than or equal to 34 weeks

Exclusion Criteria:

* Rupture of membranes or active labor
* Chorioamnionitis (prior to enrollment)
* Recent (within 4 weeks) antibiotic exposure
* Maternal HIV infection or immunocompromised state
* Known allergy to shellfish, iodine, or chlorhexidine
Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents

To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.

Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 and 17 years old (VACC and BNTC groups)
* Age between 18 and 49 years old (ADU group)

Exclusion Criteria:

* Pregnant teenagers;
* History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine;
* Have previously received a vaccine against COVID-19;
* Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C);
* Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant).
Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.

The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.


Eligibility Criteria:
Inclusion Criteria:

* Neonates whose parents and/or guardians have signed the informed consent form.

Exclusion Criteria:

* Neonates connected to invasive mechanical ventilation.
* Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
* Neonates who have received sedation.
* Neonates presenting withdrawal syndrome.
Pulsatile Cupping in Low Back Pain

The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, 18-65 years
* Chronic low back pain (disease duration \> 3 months)
* Pain intensity on visual analogue scale at inclusion \> 40 mm (0-100 mm scale)
* Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
* Undersigned informed consent form

Exclusion Criteria:

* Use of anticoagulants (Phenprocoumon, Heparin)
* Coagulopathy
* Cupping in the last 6 weeks
* Other CAM therapies in the last 12 weeks (e.g. acupuncture)
* Physical therapy in the last 12 weeks (e.g. massage, osteopathy)
* participation in another study in the last 3 months
* Paracetamol allergy or intolerance
* Pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
* Known renal and / or hepatic diseases
* Intake of central nervous system-acting analgesics in the last 6 weeks
* Applying for early retirement due to low back pain
* Severe disease that does not allow participation
* No undersigned informed consent form
Artificial Root-End Barriers

This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.

The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. The purpose of this retrospective study was to determine the clinical success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. Patients were recalled and evaluated for clinical signs and symptoms and osseous healing. Immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the Periapical Index (PAI).

Eligibility Criteria:
Inclusion Criteria:

* a tooth with a single canal and presence of an open apex by radiograph
* Ca(OH)2 treatment for at least one week prior to obturation
* use of MTA to produce an artificial apical barrier
* placement of a final restoration
* radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth
* patients ages 5-40 years old

Exclusion Criteria:

* patients younger than 5 and greater than 40 years old
* patients unable to be contacted for recall during the study
* patients with a medical condition whose health would be jeopardized by participation in the study
A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis

This is a randomized, observer-blinded, Aqueous Gel-controlled trial examining the safety and efficacy of daily application of DBI-001 Gel vs. DBI-002 Gel vs. Aqueous Gel for 24 consecutive weeks in subjects with onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 50 years of age, inclusive, at Screening
* Willing to abstain from all cosmetic activities involving the toenails during the entire course of the study
* Distal subungual onychomycosis defined as a great toenail with onycholysis and thickening of the nail bed with keratinous material
* Willing to have his/her treatment-targeted great toenail(s) clipped to remove onycholytic nail plate at each visit
* At least one treatment-targeted great toenail must have at least 6 mm of clear nail from the proximal nail fold to the proximal limit of disease and, after trimming to within 1mm distal nail groove, have at least 3mm of involved nail from distal nail groove to proximal limit of disease
* Confirmed presence of microorganisms of interest by KOH and qPCR at Screening
* The affected treatment-targeted great toenail(s) is capable of re-growth as documented by subject self-reported history of clipping nails at least monthly

Exclusion Criteria:

* Positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study
* Any dermatological conditions that could interfere with clinical evaluations
* Great toenails with only superficial white onychomycosis, any evidence of subungual mycetoma as evidenced by yellow or white spikes, or any evidence of proximal onychomycosis
* Any underlying disease(s) or other dermatological condition(s) that requires the use of interfering topical or systemic therapy, with the exception of certain protocol-specified that require a defined washout period for eligibility
* Treatment of any type of cancer within the last 6 months, with the exception of superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma
* History of any significant internal disease which contraindicates the use of live microbiome
* History of failing oral or prescription topical treatment for onychomycosis
* A history of current episode of onychomycosis present for more than 3 years
* Nail or anatomic abnormalities of the target great toenail(s)
* AIDS or AIDS-related complex by medical history
* History of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year
* Subjects known or suspected to be taking immune suppressive medications or subjects who are immunosuppressed
* Subjects with poorly controlled diabetes mellitus requiring medical intervention/treatment
* Subjects with peripheral vascular disease based on medical history
* Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
Endocardial Stem Cells Approach Efficacy

The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone


Eligibility Criteria:
Inclusion Criteria:

* Men and women who are not of childbearing potential
* Age 21-75 years.
* Patients with CAD, NYHA and CCS angina III-IV functional class
* LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
* Unsuitable for initial or repeated conventional revascularization (CABG or PCI)

Exclusion Criteria:

* Failure to provide informed consent.
* Plan for PCI or CABG.
* Non-cardiac illness with a life expectancy of less than 3 year.
* Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
* Previous heart, kidney, liver, or lung transplantation.
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
* Recent acute myocardial infarction (AMI) within 90 days of study entry
* Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
* History of moderate to severe aortic stenosis or prosthetic aortic valve
* Permanent atrial fibrillation
* Thrombosis in LV, based on echocardiography data
Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients

to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

Thirty-four patients with lumbar disc prolapse The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), ) multidirectional reach test, McGill pain Questionnaire, time up and go test and Oswestry Low Back Pain Disability Questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 30:45
2. sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI).
3. Body mass index (18.5 to 29.9) Kg/m2.

Exclusion Criteria:

* The patients will be excluded if they have one of the followings:

  1. lumbar myelopathy.
  2. Patients with previous spinal surgery.
  3. Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
  4. Any other neurological or musculoskeletal disorders of the spine or upper extremity.
  5. Patient with cardiopulmonary disease or diabetes mellitus
Strategic Use of New Generation Antidepressants for Depression

The purpose of the study is to establish the optimum treatment strategy for first-line and second-line antidepressants in the acute phase treatment of major depression.


Eligibility Criteria:
Inclusion Criteria:

* non-psychotic unipolar major depressive episode (Diagnostic and Statistical Manual, Fourth Edition \[DSM-IV\]) in the preceding month
* age 25-75
* starting treatment with sertraline clinically indicated
* tolerability to sertraline 25 mg/d ascertained
* can understand and sign informed consent form
* can be contacted by telephone for symptom severity and adverse events

Exclusion Criteria:

* have received antidepressants, mood stabilizers, antipsychotics, psychostimulants, electroconvulsive therapy (ECT) or depression-specific psychotherapies in the preceding month
* history of schizophrenia, schizoaffective disorder or bipolar disorder
* current dementia, borderline personality disorder, eating disorder or substance dependence
* physical disease interfering with sertraline or mirtazapine treatment
* allergy to sertraline or mirtazapine
* terminal physical illness
* currently pregnant or breast-feeding
* high risk of imminent suicide
* requiring compulsory admission
* expected to change doctors within 6 months
* cohabiting relatives of research staff
* cannot understand Japanese
Validity and Reliability Study of the Motor Accuracy Test

The Motor Accuracy-Revised Test's validity and reliability in Turkey was studied in this paper.

The study sample group consists of 100 children who are studying in a primary school registered to Hatay Provincial Directorate of National Education. The children's ages range between 6 years and 8 years 11 months.

Eligibility Criteria:
Inclusion Criteria:

* not having any physical, psychological or mental disabilities,
* to be aged between 6 years and 8 years and 11 months,
* to have the consent of both the child and the parents.

Exclusion Criteria:

* identified as having any kind of physical, visual or hearing disabilities,
* having mental retardation, or possessing a learning disability.
The Oh Happy Day Class - Digital Connections (OHDC-DC): A Pilot Study

The goal of this clinical trial is to see if a mobile phone app can deliver depression treatment to African Americans who are depressed. The main question it aims to answer is if this treatment is effective in reducing symptoms of depression.

Participants will attend six 90-minute weekly classes via an app on their phone, and will be asked to complete surveys every week. Participants can expect to be in the study for four months.

The Oh Happy Day Class-Digital Connections (OHDC-DC) is designed for African American adults experiencing clinical depression (CD). OHDC originally comprised of 13 treatment modules focused on culturally relevant strategies to increase knowledge of depression and healthy coping behaviors aimed at reducing symptoms of clinical depression and improving health outcomes.

The Oh Happy Day Class-Digital Connections (OHDC-DC) comprise of 5 core elements of the OHDC-DC:

1. 90-minute-weekly cognitive behavioral psycho-education classes over a 6-week period.
2. Six classes will be offered and facilitated online in the computerized OHDC-DC.
3. Participants will be encouraged to stay engaged between classes by digitally connecting on the app with the class content. On the app they will receive reminders and messages from staff and participants to stay digitally connected and engaged.
4. Embedded in the classes and content is psychoeducation with an emphasis on educating participants about depression, raising awareness of mental illness with the goal of normalizing it and reducing stigma, and increasing healthy coping behaviors, and.
5. The intervention will be delivered by a licensed mental health clinician.

Eligibility Criteria:
Inclusion Criteria:

* African-American
* Age 18 and older
* Experiencing depression (as evidenced by a score of 5 or higher on the PHQ-9)
* Own a mobile phone

Exclusion Criteria:

* Individuals who are currently receiving psychotherapy
* Individuals who are presently experiencing suicidal ideation
* Individuals who started psychotropic medication less than three months prior to the start of the OHDC will be excluded from the study
* Participants scoring 25 or higher on the PHQ-9 will be screened out
OCS Heart Perfusion Post-Approval Registry

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Multi-center, observational post-approval registry to:

1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

Eligibility Criteria:
Inclusion Criteria:

* Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.

Recipient Exclusion Criteria:

* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant.

Donor Exclusion Criteria (for DCD Donor Hearts only):

* Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).