cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.

Hot flashes can be a disturbing symptom of menopause. Prescription medications are commonly used for symptom relief. Several non-prescription therapies are under investigation. This study will examine the use of omega-3 (fish oil) supplements to see if it helps relieve hot flashes and therefore improve the quality of life.

Study Hypotheses:

Menopausal women who take Omega 3 vitamins(fish oils)will show improvement in the severity of their hot flashes.In addition women who take Omega 3 supplements will show improvement in their lipid profiles.

This study requires you to have blood drawn twice, record your hot flashes for a total of 3 weeks, and to take a product every day for 12 weeks. It will also entail 4 visits and up to 4 telephone contacts. The information you provide will be maintained in a database accessible only to the primary investigator and research team. You will be assigned a code number for your blood work and all other information. The key to this code will be maintained in this database.

Overall 60-100 women will be recruited for this study locally. During the course of the study you will get overall two blood draws amounting to up to a teaspoon for measurement of your cholesterol and fat levels.

This project consists of three phases.

Phase I

We will ask you questions about your medical history and your health. You will then be asked to provide a urine sample which will be used to confirm your menopausal status with a FSH level. You will be requested to keep a record of your hot flashes for one week using a symptom diary. Upon completion of the diary, you will return to the study site. If you qualify for participation, you will have blood work done to measure your cholesterol and other fat levels through a lipid panel. You will be provided with these results free of charge at the conclusion of the study.

Phase 2

You will receive the study medication. Half of the participants will receive the actual product we are investigating and half will receive a placebo (inactive/dummy pill). Neither you nor the investigators will not know which one you are given until the end of the study. During the 4th and 12th weeks, you will be asked to keep a diary (similar to the first one) of your hot flashes.

Phase 3

At the end of the 12 week study period, you will return to the study center. The second blood draw will be done to monitor any changes. This will conclude your participation. You will be sent a copy of your cholesterol profiles and FSH levels approximately 2 weeks after you complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal females (no periods for over 6 months)
* Documented Serum FSH level\>20
* Positive urine FSH test
* Hot flashes, on average five a day
* A 2 week pre study washout period of exclusion criteria

Exclusion Criteria:

* No EPT/ET
* OTC supplements: ex; soy, black cohosh, flax, bellergal, primrose oil, vitamin E, red clover
* Excessive smoking \> 1ppd
* Anti seizure medications
* Clonidine
* Effexor
* More than 2 servings of fish per week
Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars

In patients that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period?

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University outpatient clinic. The operator in charge will be DR. The patients in this study will be selected according to different exclusion and inclusion criteria.

Teeth that meet the inclusion criteria will be selected (n=26) and divided into two groups (n=13).

Group (1): NovaProTM Fill Universal Composite (Nanova Columbia.MO. USA).Group (2): Tetric N-Ceram Nano-hybrid (IvoclarVivadent, Schaan, Liechtenstein). Teeth will be cleaned to remove surface stains. Compound proximal cavities will be prepared with rounded internal angles and with non beveled margins. The carious tissues will be removed using diamond burs of the suitable size at high speed under profuse water cooling system. After the cavity preparation and the appropriate shade of resin material selected, all restorations will be performed using a pre-curved metallic sectional matrix associated with a separating ring and a proper sized wooden wedge to establish the anatomical shape and proximal contacts of the teeth. All the restorative materials will be applied according to the manufacturer instructions (n=13)

All participants will be instructed to follow oral hygiene measures (brush the teeth twice a day, floss once a day) to avoid plaque and bacterial accumulation which may negatively affect the performance.

The restorations will be evaluated at baseline (after placement of restoration), after 6, 12, 18 \& 24 months, using Modified United States Public Health Service criteria (USPHS) for the following characteristics: Anatomic Form (Wear), Marginal integrity, Surface roughness, Marginal discoloration, Color match, Recurrent caries, Post-operative sensitivity. The resin composite restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable and Charlie represents a clinically unacceptable situation.

Eligibility Criteria:
Inclusion Criteria:

* Patient ages 18 to 55 years
* Male or Female patients
* Patients with good oral hygiene
* Patients with good recall availability

Exclusion Criteria:

* Patient who are allergic to products' ingredients used in the study
* Patients with poor oral hygiene
* Patients with history of bruxism and parafunctional habits
* Patients with high caries index or high plaque index.
* Pregnant or lactating women.
* History of severe medical complications such as xerostomia
A Study of LY3885125 in Participants with Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)

The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests will be performed to check how much LY3885125 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a total of approximately 111 weeks.


Eligibility Criteria:
Inclusion Criteria:

Parts A \& B

* Males, or females of not of childbearing potential,
* On a stable diet for the 3 months prior to randomization and willing to continue the same stable diet during the study.

Part A

* Dyslipidemia with the following fasted blood levels at screening: 150 mg/dL ≤ triglycerides \<500 mg/dL, AND LDL-cholesterol ≥100 mg/dL,
* Body mass index (BMI) in range of 18.5 to 45.0 kg/m2. Part B
* NAFLD with liver fat content ≥8% as determined by magnetic resonance imaging proton density fat fraction (MRI-PDFF),
* BMI in range of 27 to 45.0 kg/m2

Exclusion Criteria:

Parts A \& B

* History or presence of medical illness including, but not limited to, any cardiovascular, thromboembolism or bleeding disorder, hepatic, respiratory, hematological, endocrine, immune, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the Investigator, indicate a medical problem that would preclude study participation,
* Uncontrolled hypertension with a resting blood pressure ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at visit 1,
* Alanine transaminase (ALT) or aspartate aminotransferase (AST) \>3.0 × ULN for the reference range,
* Alkaline phosphatase (ALP) \>1.5 × ULN for the reference range,
* Total bilirubin (TBL) \>1.5 × ULN for the reference range,
* Taken drugs associated with hepatic steatosis (e.g., amiodarone, valproic acid, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening visit,
* Type 1 diabetes mellitus (T1DM) or any other type of diabetes mellitus other than T2DM,
* Poorly controlled T2DM with glycated hemoglobin (HbA1c) of \>9.0%,
* Treatment with GLP-1 RA and GIP/GLP-1 RA and approved or experimental agents that target PCSK9 within 9 months prior to screening visit.

Part B

* Evidence of other forms of chronic liver disease,
* Initiated treatment with, or changed dose of, medications that may cause significant weight gain or weight loss, within 3 months prior to the screening visit,
* Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening visit
Epidemiologic, Laboratory, and Clinical Characterization of Individuals With Ocular Diseases

Environmental and genetic factors may play a role in the progression of ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). The goal of this project is to establish a series of case-control studies to evaluate risk factors of ocular diseases in China.

This study is designed to investigate the epidemiologic, genetic, laboratory and clinical characterization of individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.). We will accrue approximately 800 patients as experimental group. The control group consists of age/sex frequency-matched subjects who will be confirmed without ocular diseases. We will explore the environmental (including family history, life style, diet, physical activity, neuropsychological functioning，plasma levels of oxidative stress and angiogenic factors, etc.) and genetic (including oxidative stress and angiogenic factors, etc.) risk factors. We will study the association between various environmental risk factors with the clinical characterization and correlation between the genetic polymorphisms and the presence of various ocular diseases.

Eligibility Criteria:
Inclusion Criteria:

* This is a study only of Chinese.
* Subjects will be allowed to participate if they self-identify as Chinese.
* Individuals with ocular diseases (cataract, retinopathy, age-related macular degeneration, glaucoma, retinal detachment, ocular tumor, etc.) will be allowed to participate. To participate in the study as the control, subjects should be confirmed without ocular diseases.
[KSR-001-P02] Phase 2b/3 Study, Evaluate the Efficacy and Safety of KSR-001 in Patients With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of KSR-001 in patients with Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female who over 19 years old
2. Those who have had symptoms of dry eye for at least 6 months (foreign body sensation, dryness, glare, pain pain, blurred vision, etc.) and Those whose symptoms do not improve with conservative treatment such as artificial tears
3. Those who meet below criteria at least one of two eyes

   * Those who have over than score 4 in corneal staining test
   * Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
4. both eyes, the corrected visual acuity is 0.2 or more
5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. During this clinical trial period, When Rebamipide treatment is expected due to gastrointestinal disorder or gastritis
2. Within 90 days of the screening visit, if systemic steroid steroids or systemic immunosuppressants were used
3. Within 90 days of the screening visit, If there is a history of other ophthalmic surgeries including the use of punctum plugs or puncture closure surgery
4. If it is a clinically significant ophthalmic disease that is not caused by dry eye syndrome and may affect the interpretation of the results of this clinical trial
5. Within 90 days of the screening visit, Those who have undergone vision correction surgery such as LASIK or LASIK
6. Those with intraocular pressure (IOP) exceeding 21 mmHg or with glaucoma undergoing drug treatment
7. Those with hypersensitivity to the ingredient of this clinical trial drug
8. Patients planning to wear contact lenses during the clinical trial period
9. In the case of one of the following

   * Creatinine level more than twice the upper limit of normal range
   * AST or ALT levels greater than twice the upper limit of normal range
10. History of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery)
11. Within 1 year before screening, Those who have been diagnosed with alcohol or drug abuse and are receiving treatment
12. In the case of women of childbearing potential, those who do not consent to contraception by a medically accepted method of contraception during the clinical trial period (IUD, Intrauterine device or IUS, Intrauterine system), tubal ligation, double blocking method (male condom, female condoms, cervical caps, contraceptive diaphragms, and Combination of blocking methods such as contraceptive sponges)
13. Pregnant or lactating women
14. within 30 days before participating in the clinical trial, Those who have applied other clinical trial drugs or medical devices
15. Patients judged by other investigators as unsuitable to participate in this clinical trial
Carbon Monoxide Measurement to Screen for Sickle Cell Disease

Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).

Increase the temperature operating range of ETCO measurements to 5 to 45°C. The signal output-to-CO (carbon monoxide) concentration correlation of the CO sensor is dependent on temperature. The new algorithm will be a different approach because the current algorithm is at the limits of its capability. We will establish the new specifications by determining performance in a bench model under simulated temperature conditions. We will then determine the ability of the modified device to distinguish between SCD and healthy controls. During this initial testing, we will examine the validity of ETCO measurements under regulated room temperature in the hospital setting. We will enroll 20 subjects, 10 each in the SCD arm and control arm to determine the mean and variance of the ETCO values.

Eligibility Criteria:
Inclusion Criteria:

* Parental / legal guardian consent
* Subject assent for participants ages 7 and above
* Male and female children ages 1-18 years old
* For Hb SS (Homozygous sickle cell anemia) subjects, hemoglobin baseline hemoglobin ≤10 g/dL based upon average hemoglobin value in past year

Exclusion Criteria:

* Subjects must not meet any of the following exclusion criteria to be considered eligible for study enrollment:
* Had a red blood cell transfusion within 8 weeks prior to enrollment
* Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment
* Exposed to second hand smoke within 24 hours prior to breath sample collections
* Have current upper respiratory infection or symptomatic asthma
* For healthy subjects, known to have the sickle cell trait by electrophoresis or genetic testing
Cardiac Magnetic Resonance Imaging for Detecting Endothelial Dysfunction

The goal of this research study is to demonstrate that Cardiac Perfusion MRI with Vasomotor Stress may serve as a non-invasive and less risky imaging technique for detecting non-obstructive perfusion deficits and/or abnormalities in myocardial blood flow (MBF) in patients with endothelial dysfunction.

This is a controlled study, which will enroll approximately 60 subjects (30 diabetics and 30 non-diabetics to serve as healthy controls), and will include male and non-pregnant females, between the ages 18-50 years.

All eligible participants will sign an informed consent and will complete a Lifestyle Questionnaire. They will undergo blood work which includes:

* 2-hour Oral Glucose Tolerance Test and Fasting Labs for Glucose, Insulin, C-Peptide, HbA1c, Creatinine, and Lipid Panel.
* Urine Albumin to Creatinine ratio for microalbuminuria.
* Serum inflammatory markers: E-selectin, homocysteine, ADMA, VCAM, IL-6, TNFalpha, hs-CRP and PAI-1.

After blood work, all participants will undergo cardiac MR perfusion imaging procedure with Cold Pressor Test and Adenosine Stress Test.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 50 years
* Should be able to sign an informed consent and HIPAA Agreement
* 30 healthy, non-diabetic individuals
* 30 diabetic individuals without documented coronary artery disease
* Diagnosed diabetics less than 5 years
* HbA1c less than 8.0

Exclusion Criteria:

* Children under 18 years and adults above 50 years
* Type 1 DM
* Lactating and Pregnant females
* BMI less than 35
* Contraindication to MRI such as pacemaker, defibrillator implants, etc.
* Allergy to MR (paramagnetic) contrast
* History of Angina, MI, or documented Coronary Artery Disease
* Previous history of CHF, CABG, Angioplasty and Stenting
* History of Valvular Heart Disease and Congenital Heart Disease
* History of Peripheral Vascular Disease
* History of Cardiac Arrythmias and anti-coagulation therapy
* History of Cerebro-vascular accidents or TIA
* History of active diabetic retinopathy and nephropathy
* Uncontrolled hypertension (systolic \> 170 and diastolic \>100 mm Hg
* End Stage Renal Disease and patients on dialysis
* HbA1c of 8.0
* Creatinine greater than 1.7 mg/dl
* History of active gastrointestinal bleeding
* History of IV drug use
* Chronic or current steroid treatment
* Growth hormone treatment
The Effect of Solving Jigsaw Puzzles on Visuospatial Cognition in Older Adults: Jigsaw Puzzles As Cognitive Enrichment

Meta-analyses indicate beneficial effects of cognitive training and cognitively challenging video games on cognition. However, cognitive effects of solving jigsaw puzzles - a popular, visuospatial cognitive leisure activity - have not been investigated, yet. Thus, the primary aim of this study is to evaluate the effect of solving jigsaw puzzles on visuospatial cognition. As secondary aims, effects on psychological outcomes (self-efficacy, perceived stress, well-being) and visuospatial everyday functioning (instrumental activities of daily living and self-reported cognitive failures in everyday life) are examined.

see References section below for the study protocol article

Eligibility Criteria:
Inclusion Criteria:

* No cognitive impairment (Mini-Mental State Examination ≥ 24)
* Commitment to minimum jigsaw puzzle time (1 hour/day, 6 days/week, 5 weeks)
* Interest in jigsaw puzzles
* Low jigsaw puzzle experience (less than 5 completed puzzles within the last 5 years)

Exclusion Criteria:

* Cognitive impairment (Mini-Mental State Examination \< 24)
* Participation in another interventional study
* Self-reported psychiatric, neurologic or other disease, which could affect cognitive change over time
* Self-reported, severe visual impairment or motoric impairment of the upper extremity which significantly affects ability to solve jigsaw puzzles
The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery

The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery

The study was designed as a double-blind, prospective randomized controlled trial.

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know whether the superficial cervical plexus block is applied to the patients. Randomization of the patients was planned using computer aided. It is envisaged that 20 participants will be included in the patient group that will have a superficial cervical plexus block and will not have a superficial cervical plexus block. The current pain status in the postoperative period in the patient groups that will or will not have a superficial cervical plexus block is determined by NRS (Numerical rating scale) at rest and in motion at certain hour intervals ( 30.min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered, and the number of bolus doses with PCA in the first 24 hours will be recorded. The quality of recovery (QoR-40) scoring system will be evaluated at the postoperative 24th hour of both patients with and without superficial cervical plexus block. In addition, the hemodynamic values of the patients will be recorded in these intervals.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing lumbar spinal surgery under elective conditions
* ASA I-III
* Between 18-75 ages

Exclusion Criteria:

refuse during registration

* request to be dismissed from study
* failure to give informed consent
* emergency surgery
* bleeding diathesis
* Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)

All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25.0-35.0 kg/m²
* Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance

Exclusion Criteria:

* Previous bariatric surgery
* Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
* Cancer or cancer that has been in remission for less than 5 years
* Major psychiatric illness
* Inflammatory gastrointestinal disease
* Pregnant or lactating women
* Use of medications that are known to affect the study outcome measures
* Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
* Bowel movements less than 3 times per week
* Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
* Persons that are not able to grant voluntary informed consent
* Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.