cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL with a history of diabetes and will examine whether vitamin D or fish oil prevents the development and progression of diabetic kidney disease.

This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will test whether vitamin D3, omega-3 fatty acids, or both prevent the development and progression of diabetic kidney disease (DKD). Persons with diabetes are at high risk of kidney disease. In 2005-2008, the prevalence of DKD among people with type 2 diabetes in the United States was 34.5%. Moreover, from 1988-1994 to 2005-2008, the prevalence of DKD in the United States grew 34% to 6.9 million people. DKD is both the leading cause of end stage renal disease in the developed world and a potent amplifier of cardiovascular disease risk.

Vitamin D and omega-3 fatty acids are promising interventions for DKD prevention and treatment, based on results of animal-experimental models and early human studies. Because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of DKD in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent progression of albuminuria and loss of glomerular filtration rate, two complementary manifestations of DKD, over 3 years of treatment.

In VITAL, 20,000 participants will be randomly assigned in a 2x2 factorial design to vitamin D3 (cholecalciferol) 2000 IU daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. This ancillary study will identify and recruit a sub-cohort of VITAL participants with diabetes at baseline and ascertain effects of study interventions on albuminuria and glomerular filtration rate in this group. First morning voids will be collected at baseline and year 3 for measurement of urine albumin-creatinine ratio. Blood samples will be collected simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin C) and other relevant biomarkers. This VITAL ancillary study is designed to determine whether vitamin D3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of DKD.

Eligibility Criteria:
Inclusion Criteria: Participants in VITAL (NCT 01169259) with a self-reported physician diagnosis of diabetes are eligible to participate in this ancillary study.

Exclusion Criteria:

* Type 1 diabetes
* Diabetes only during pregnancy
* Known cause of kidney disease other than diabetes
* History of kidney transplantation
Gaze Holding in Cerebellar Patients

The long-term goal of this research is to advance the investigators knowledge of how the cerebellum a) controls gaze holding and compensates for impaired gaze stability and b) modulates vestibular information that is forward-ed from the labyrinth and brought to perception. While gaze holding is stable also at large angles of gaze eccentricity in healthy human subjects, patients with chronic (degenerative) cerebellar disorders are inable to stabilize gaze in eccentric positions, resulting in eye drift towards primary (straight-ahead) position and com-pensatory gaze-evoked nystagmus. When returning to primary position, a compensatory nystagmus into the opposite direction (called rebound nystagmus) can be observed in these patients. Unlike patients with de-generative cerebellar disorders, patients suffering from ischemic of hemorrhagic stroke within the cerebellum present with acute deficits of gaze holding and verticality perception.

While a linear relationship between the amount of eye velocity drift and eccentricity of eye position has been proposed in healthy human subjects, others suggested non-linear behaviour. The strategy of this research is to characterize gaze holding and verticality perception in healthy human subjects and patients with either acute (ischemic or hemorrhagic) or chronic degenerative cerebellar disorders and to relate eye movement findings with structural imaging of the cerebellum. The investigators will therefore analyze key cerebellar structures with regards to loss of volume and relate these imaging findings with the participants' ability to hold gaze and es-timate direction of vertical. The investigators hypothesize that besides the flocculus other vestibulo-cerebellar structures are involved in gaze holding and verticality perception in humans.


Eligibility Criteria:
Inclusion Criteria:

1. ages 18-85
2. informed consent
3. for group 1: acute (i.e. symptom onset \<14 days ago) cerebellar ischemia or hemorrhage as confirmed by clinical examination and brain imaging (CT or MRI)
4. for group 2: chronic cerebellar degeneration as confirmed by clinical examination (presence of downbeat-nystagmus and / or gaze-evoked nystagmus and / or ataxia of gait and stance) in the absence of focal lesions (as previous cerebellar stroke, mass lesion or inflammation) on clinical routine cerebellar imaging
5. absence of exclusion criteria

Exclusion Criteria:

1. has MRI contraindications such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
2. disturbed consciousness
3. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
4. Pregnancy or possible pregnancy if not ruled out by a negative pregnancy test.
Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation

The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project

Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an anticubical vein for blood samples.

At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523" capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order. Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every second minute the first ten minutes, and then every 10 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.

The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored .

Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
* any medial treatment
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia

The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.

Myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in Asian countries including Korea. This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 5 to less than 9
2. Meet the following refractive criteria by cycloplegic refraction

   1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
   2. Astigmatism of 1.50 D or less in each eye
   3. Anisometropia of 2.00 D or less
3. Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
4. Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
5. Subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion Criteria:

1. History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatment of myopia control with low dose atropine within 1 month prior to Baseline)
2. Current or prior use of multifocal lenses (e.g. progressive addition lenses), orthokeratology (Ortho-K, e.g. Dream lens), or Rigid gas permeable (RGP) within 1month prior to Baseline(Visit 2)
3. Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area
4. History of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)
5. History of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery)
6. Down's syndrome or cerebral palsy
7. Within 6 months prior to the Screening visit (Visit 1), has experience of other clinical trial medications or investigational device
8. Clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator may consider inappropriate for participation in the clinical trials
9. Systemic diseases that could impact both vision and visual field
10. History of growth hormone treatment within 1 month prior to Baseline (Visit 2)
11. Other reasons for participation in the trial at the discretion of the investigator
Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.

A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.

Purpose:

to determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators

Method:

We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions.

statistical analysis done using SPSS version 23

Eligibility Criteria:
Inclusion Criteria:

* Female age is ≤ 37 years old with ≥ 8 MII oocytes
* Males with normal semen parameters (WHO 2010).
* We conducted three experiments all with Siblings oocytes splits and all embryos

Exclusion Criteria:

* Oocyte or sperm donation.
* Sever male factor.
* Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement

To evaluate the long-term results after transcatheter aortic valve replacement

Patients with transcatheter aortic valve replacement are followed for 5 years to demonstrate efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* aortic valve stenosis
* transcatheter aortic valve replacement

Exclusion Criteria:

* no written informed consent
The Effects of Jerusalem Artichoke and Fermented Soybean Powder Mixture Supplementation on Glucose Control

The purpose of this randomized, double-blind, placebo-controlled study was to determine whether jerusalem artichoke and fermented soybeans powder mixture is effective in the control of blood glucose level in subjects with prediabetes or newly diagnosed type 2 diabetes.

The objective of this clinical study was to evaluate the effect of jerusalem artichoke and fermented soybean powder mixture supplementation on blood glucose. A randomized, double-blinded, placebo-controlled study was conducted on 60 subjects with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly diagnosed type 2 diabetes. The subjects were randomly assigned to either a group ingesting 40 g jerusalem artichoke and fermented soybean powder mixture supplementation daily or a placebo group for 12-week. We assessed fasting and postprandial levels of glucose.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects were with prediabetes (IFG or IGT) or newly diagnosed type 2 DM (T2DM) no taking medicine. IFG was defined as fasting glucose between 100 and 125 mg/dL and IGT was defined as 2-h OGTTs glucose levels 140-199 mg/dL. Newly diagnosed type 2 diabetes was defined as fasting glucose ≥126 mg/dL or 2-h OGTTs level ≥ 200 mg/dL.

Exclusion Criteria:

1. glucose lowering medications or insulin injections;
2. abnormal liver or renal function;
3. chronic stomach and intestines disease;
4. chronic alcoholism;
5. pregnancy or intending to become pregnant during time of study.
6. complications;
7. an occupation that could be dangerous if hypoglycemia should occur.
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
* Positive anti-delta for at least 3 months prior to screening
* Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
* A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
* Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

Exclusion Criteria:

* Antiviral therapy for CHD within the previous 6 months
* Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* Other medical condition associated with chronic liver disease
* Women with ongoing pregnancy or who are breast feeding
Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease

This research study is designed to investigate a new potential medicine for mobilizing stem cells and apheresis collection in patients with Sickle Cell Disease. MGTA-145, the new potential medicine, will be given with plerixafor.

This Phase 2, multicenter, open-label study will be conducted in 2 parts (Parts A and B). Part A is intended to characterize the efficacy, safety, PK and PD of a single dose of MGTA-145 and plerixafor for HSC mobilization and apheresis collection in patients with SCD. Part B is designed to characterize the efficacy, safety, PK and PD of 2 consecutive days of dosing with MGTA-145 and plerixafor for HSC mobilization and apheresis collection in patients with SCD.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥18 to ≤35 years of age.
* Subject must weigh ≥30 kg.
* Subject must have a diagnosis of Sickle Cell Disease.

Exclusion Criteria:

* Subject must not have had a vaso-occlusive event (VOE) requiring a visit to a healthcare facility within 30 days of screening.
* Subject must not have undergone or attempted and failed previous hematopoietic stem cell (HSC) collection.
* Subject must not have had a prior autologous or allogeneic transplantation, inclusive of gene therapy.
* Male subject must be willing or able to use a highly effective method of contraception for 3 months during and after treatment.
* Female subject must not be pregnant or breastfeeding. If sexually active, female subject must be willing or able to use a highly effective method of contraception for 3 months during and after treatment.
Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

In 2012, more than 14 million cases of cancer were diagnosed worldwide, with the forecast for 2025 exceeding 20 million. Pain is the most critical symptom that accompanies cancer. The development of disease generates the need for oncological palliative care and adequacy of the structure by Public Health Care System. In this context, this study aims to evaluate an alternative to the treatment plans provided for in the Brazilian's Public Health Care System table. The objective is to carry out a cost-effectiveness analysis of the epidural administration of morphine and ropivacaine in patients with abdominal neoplasia, and pain that is difficult to clinically control, which leads to an improvement in the quality of life, functional conditions and survival of patients, and that reduces the cost to the Brazilian's Public Health Care System. This is a randomized clinical trial. Patients will be divided into two groups: control and intervention. The control group will receive oral treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of the Brazilian's Ministry of Health: morphine, pregabalin and duloxetine. The intervention group will receive an anesthetic solution containing morphine and ropivacaine for epidural administration through a surgically implanted catheter. Pain, quality of life, functional capacity and survival will be evaluated using the following instruments: Visual Analogue Scale; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire "Core" 30; Karnofsky Performance Scale; Eastern Cooperative Oncology Group Scale; Palliative Performance Scale; and Palliative Prognosis Index. It is expected that, at the end of the study, the intervention group will represent a significant savings for the Public Health Care System, due to the decrease in the number of hospitalizations/day and the possible complications due to the lack of effectiveness of the oral treatment. It is expected that the results found will produce scientific support to disseminate the proposed treatment plan for Brazilian's Public Health Care System patients in palliative care.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years,
* both sexes
* diagnosed with abdominal neoplasia and with PPI \< 2.0, which indicates a survival of at least 90 days
* have full cognitive conditions
* Patients must also have a caregiver with cognitive conditions.

Exclusion Criteria:

- Patients with technical incapacity to implant the catheter will be excluded, namely: patient refusal, infection at the puncture site and hemodynamic instability.
Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients

Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).

Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were first diagnosed be heart failure with left ventricular ejection fraction less than 40%.
* Received one of ACEIs,ARBs,ARNI drugs.

Exclusion Criteria:

* Electronic medical records was not complete enough to analyse.
* Patients who had history of heart transplantation or had heart transplantation plan in last 12 months.
Clinical Trial Comparing Continuous Versus Intermittent Hemodialysis in ICU Patients

The mortality of acute renal failure (ARF) remains to be high (around 60-70%) despite manifold improvements in ICU care. At present, it is not clear if the method chosen for renal replacement therapy, i.e. intermittent haemodialysis (IHD) or continuous haemofiltration (CVVH), might impact on the outcome of these patients. For this purpose, a prospective randomised clinical study of the effect of continuous versus intermittent renal replacement therapy on the mortality and outcome of acute renal failure will be performed.

please see above

Eligibility Criteria:
Inclusion Criteria:

* all ICU patients requiring renal replacement therapy

Exclusion Criteria:

* patient denies informed consent
* patient not requiring intensive care therapy
* kidney transplanted patients
* chronic renal failure (serum creatinine \> 3mg/dl)
Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

The present study is a pilot study aiming to compare the variation in core temperature (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.

In this study the investigators will select 20 patients scheduled for orthopedic surgery of the knee or foot with neuraxial anesthesia (subarachnoid or sequential blocks). Sedation for these procedures with midazolam or propofol is daily practice in the investigators' department.

So the patients will be randomized, through the envelope method, in 2 groups with 10 patients each: "midazolam group" and "propofol group".

In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.

In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol target-controlled infusion (TCI) pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.

The neuraxial block will be performed inside the operating room and preferentially in lateral decubitus. The choice of drug and dosage used for the block will be left to the anesthesiologist, to mimetize day-to-day practice. The limit dermatome of sensory block will be noted.

The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).

Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead. Room temperature will be kept at 17 degrees Celsius (ºC). Patients will be warmed with a underbody forced-air blanket (BairHuggerTM3MTM) set at 38ºC and maximal flow, initiated after performing the neuraxial block and stopped right before leaving the operating room.

Data will be analyzed with the Statistical Package for the Social Sciences (SPSS) program.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for orthopedic surgery of the foot or knee
* Indication to neuraxial anesthesia
* Surgery duration \> 30 minutes

Exclusion Criteria:

* Preference for deep sedation
* Preference for no sedation
* Kidney failure
* Hepatic failure
* No signed informed consent