cyrilzakka/clinical-trials huggingface dataset:
High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.

To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous stem cell rescue in the treatment of multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:- received cytoreduction prior to transplant

* adequate organ function Exclusion Criteria:- previous transplant
* smoldering MM or benign monoclonal gammopathy
Evaluation of the Correlation Between the Coronary Stenosis Degree With FFRCT and the Grade of Stable Angina Pectoris

Angina pectoris is the most common clinical manifestation of coronary heart disease（CHD）, which is the main feature of chest pain caused by transient myocardial ischemia. Chronic stable angina pectoris is the degree, frequency, nature and cause of angina pectoris in patients with no significant change in a few weeks. The disease incidence is complex, difficult to diagnosis and treatment, clinical should be combined with various inspection methods for diagnosis and differential diagnosis. Fractional flow reserve of computerized tomographic scanning (FFRCT ) allows computerized tomographic scanning（CT） to scan the determination of coronary blood flow and blood pressure in the heart at rest and hyperemia, but no need to additional check or drugs. This technique has been used for noninvasive fractional flow reserve (FFR) in the calculation, assuming normal artery, calculated by the ratio of the maximum blood flow and blood flow of coronary artery stenosis of an artery. Along with the development and progress of computational fluid dynamics, in the resting state by computed tomographic angiography of coronary artery(CCTA) image data based, simulation of coronary artery maximal hyperemia and according to the 3-dimensional model of the traditional method of reconstruction of coronary arterial tree and ventricular muscle structure, and in order to calculated coronary blood flow and pressure. FFRCT is a novel non-invasive examination method, using computed tomographic angiography of coronary artery image data can be calculated FFR, and preliminary study proved that it has a high degree of correlation with traumatic FFR. Therefore, this study aims to evaluate the correlation between the degree of coronary stenosis and the grading of angina pectoris by noninvasive means --FFRCT, in order to provide a new idea for the diagnosis and differential diagnosis of coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* After computed tomographic angiography of coronary artery (CCTA) for the diagnosis of coronary heart disease patients

Exclusion Criteria:

* First, the patients with hematological diseases, infectious disease, end-stage renal disease and malignant tumor and other diseases. Second, the patients with acute myocardial infarction. Last, the percutaneous coronary intervention(PCI) and coronary artery bypass grafting (GABG) after the operation.
Effects of Vitamin D and Calcium Supplementation on Inflammatory Biomarkers and Adypocytokines in Diabetic Patients

The epidemic of type 2 diabetes is an enormous public health problem in all parts of the world, with 366 million cases by 2030. Chronic inflammation has been postulated to play a role in the pathogenesis of type 2 diabetes. High levels of adiponectin and inflammatory biomarkers are known as a new risk factor for diabetes. There is accumulating evidence suggesting that altered vitamin D and calcium homeostasis affect the development of type 2 diabetes, but it is still unclear whether that effects are through reducing the level of adipocytokines and inflammatory biomarkers or not. This study has been designed to evaluate the effects of vitamin D and calcium supplementations alone and in combination on inflammatory biomarkers and adypocytokines in type 2 diabetic patients.

This study is a single masked, controlled randomized trial with period of 8 weeks. 120 diabetic patients who met the inclusion criteria will enroll in this study. Subjects will randomly assign in to four groups. Randomization will be achieved by permuted blocks with stratification by age, sex, BMI, type of diabetes and dose of medication. Group1 will receive 50000 IU of vitamin D3 per week plus calcium placebo, group2 will received 1000 mg of calcium carbonate per day plus vitamin D placebo, group 3 will receive 50000 IU of vitamin D3 plus 100 of mg calcium carbonate per day and group four will receive calcium and vitamin D placebos. Total cholesterol, HDL, LDL, serum triglyceride, serum glucose, serum insulin, HbA1C, leptin, adiponectin and inflammatory biomarkers such as TNF-alpha, IL-6 and high sensitivity C reactive protein (hs-CRP) will be determine by taking blood samples at the baseline and at the end of intervention. Systolic and diastolic blood pressure and anthropometric measurements (height, weight, hip and waist circumferences) will be measured at the baseline and after 8 weeks of intervention. 3 dietary records and 3 physical activity records will be taken at 2,4 and 6 week of intervention to make sure that all subjects maintain their usual diet and physical activity during intervention.


Eligibility Criteria:
Inclusion Criteria:

* more than 30 years old
* have no history of renal failure, cancer, liver diseases, thyroid diseases or any other inflammatory diseases
* have no allergy
* do not use any tobacco products
* not using corticosteroids
* not consuming any kinds of vitamin D or calcium supplement
* have not more than 4 kilograms weight change during last 3 months

Exclusion Criteria:

* pregnancy
* insulin dependent diabetes
Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female) with hypertension aged between 18-75 yrs.
* Patients not treated with amlodipine or no amlodipine in previous 1 year.
* Post-menopausal females

Exclusion Criteria:

* Patients unable to switch from prior hypertensive medication.
* Severe hypertension.
* Pregnant or nursing females.
* Patients with Type 1 or Type 2 diabetes mellitus
* History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay \[ELISA\] and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria are applied
Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children

The aim of the study is to verify if the periodic flush with normal saline 0.9% NaCl causes a longer or equal duration of patency of peripheral venous catheters, compared with heparin solution 50 U / ml flush, in children from 2 years to 14 years. Only 22 and 24 gauge catheters Will be included in the study.The study will assess in particular:

* the difference of permanence in situ of the device
* the difference in incidence of complications (in detail: obstruction, phlebitis, thrombocytopenia, systemic anticoagulation)
* the difference in costs between use of saline normal saline 0.9% NaCl solution and heparinized 50 U / ml.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 years and 14 years old
* Medical prescription of intravenous antibiotic therapy for at least 2 doses on the day
* Presence of informed consent to participate to the study provided by the parents
* No known hypersensitivity to heparin
* No known hypersensitivity to the patch fixing materials (polyurethane and / or glue)
* Absence of diseases buoyancy coagulation (haemophilias and / or thrombophilias)
* No antecedents trombopenie dued to the use of any type of heparin or a pentosan polysulfate
* No existing treatment based on corticosteroids and / or anti-inflammatory

Exclusion Criteria:

* age outside the range 2 - 14 years
* children for which there is no prescription of intravenous antibiotic therapy for at least 2 times a day
* children for which the parents have not consented to the study
* children with known hypersensitivity to heparin
* children with known hypersensitivity to the patch fixing materials (polyurethane and / or adhesive)
* children with disease-causing buoyancy coagulation (Hemophilia and / or thrombophilia)
* children with antecedents of trombopenie occurring by the use of any type of heparin or of a pentosan polyphosphate
* children in treatment with corticosteroids and / or anti-inflammatory
NI-0801 in Allergic Contact Dermatitis

The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 and ≤ 70 years
* Either male or a female lacking childbearing potential
* Previously documented nickel allergy

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
* Known or previous diagnosis of malignancy
* Known current active tuberculosis or a history of active TB within 12 months of screening
* Known infection with HIV, Hepatitis B or C
Defining the Normal Human Response to Probiotics

The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells

The study includes 3 visits. The first visit serves to check inclusion/exclusion criteria/complete questionnaire/give information about the study and receive consent. At visit 2 and 3 the included individuals will drink a placebo blend or a drink containing Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper intestine during endoscopy while under nurse administered propofol sedation (NAPS). There will be four weeks between visit 2 and 3.

At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will be collected, and one blood sample will be collected.

The down stream analysis will include a combination of gene expression analysis, microbiome analysis and classification of the individuals based on analysis of blood samples.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men or women
2. No medication
3. Age between 18 and 35 years
4. BMI below 30
5. Provided voluntary written informed consent

Exclusion Criteria:

1. All clinical diagnoses and disorders requiring medicine
2. Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.
3. Pregnant and women who are breast-feeding
4. Patient with known blood clothing disorders
5. Patients with clinical psychiatric diagnoses (including dementia)
6. Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy
7. Individuals with high blood pressure (≥140 mmHg /90 mmHg)
8. Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months
9. Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening
10. Usage of medications, except oral contraceptives, during the 14 days prior to screening
11. Lactose intolerance
12. Participation in other clinical trials in the past three months
13. Regular use of probiotics in the last 6 weeks
14. Smoking
15. Planned changes to current diet or exercise regime
16. Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening
17. Use of immunosuppressant drugs within last 4 weeks prior to screening
18. Ulcer or malignancy in the intestine which is discovered during second visit
Metabolomic Study in Huntington's Disease (METABO-HD)

The purpose of this project is to study Huntington's disease by metabolomic approach.


Eligibility Criteria:
Inclusion Criteria:

For all groups:

* age between 20 and 70 years
* signature of the informed consent
* covered by social security

For presymptomatic group:

* positive genetic test with CAG repeat length ≥ 37 in HTT gene
* Unified Huntington Disease Rating Scale ≤ 5

For symptomatic group:

* positive genetic test with CAG repeat length ≥ 37 in HTT gene
* The Unified Huntington's Disease Rating Scale motor score ≥ 6
* The Total Functional Capacity score ≥ 11

Exclusion Criteria for all groups:

* participation in another therapeutic trial (3 months exclusion period)
* pregnancy and breastfeeding
* persons deprived of their liberty by judicial or administrative decision
Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis

This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.

The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.

The Hyper-CL™ Therapeutic soft contact lenses for short-term wear (up to 7 days) are indicated for therapeutic use to promote corneal healing and relieve corneal pain by protecting the cornea during the treatment of acute or chronic pathologies, such as corneal edema, corneal erosions, entropion, bullous keratopathy, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18-86 years old
2. Subject with Bacterial keratitis in one eye only
3. Subject with Bacterial Keratitis of at least grade 2 score in Average length of infiltration and in Average length of epithelial defect (1mm or above)
4. Best-corrected visual acuity of 6/60 or better in the uninvolved eye
5. No prior antibiotic treatment for current Bacterial Keratitis
6. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

Exclusion Criteria:

1. Perforation or imminent perforation of cornea
2. Subject with glaucoma shunts (e.g. Ahmed valve) and or bleb
3. Sign of inflammation in both eyes
4. Severe itching suggesting viral infection or allergy reaction
5. Subepithelial infiltrate suggesting viral infection
6. Dendrite like ulcer or suspecting of Herpes keratitis
7. Previous penetrating keratoplasty
8. No light perception in the affected eye
9. Pregnancy
10. Other active ocular infection
11. Any infiltration suggesting other than bacterial infection e.g. parasite, fungal
12. Any corneal transplant
13. Post refractive surgery
14. Corneal inlays
15. Any other condition which in the opinion of the investigator would place the patient at undue risk for participation.
16. Participation in another clinical study within the past 30 days
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men

Dietary consumption of fructose has increased by nearly 50% since 1960.

A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.

The protocol will assess the following outcomes:

1. The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
2. The effect of a high fructose vs. glucose diet on liver ATP stores
3. The effect of a high fructose vs. glucose diet on markers of oxidative stress
4. The effect of a high fructose vs. glucose diet on cardiovascular status

Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.

32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.

The sugars will first be taken in an energy balanced and then an overfeeding setting.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index 25-32
2. Waist \> hip circumference
3. Age 18-50 years
4. Male

Exclusion Criteria:

1. Reported weight change \> 3 kg in prior 3/12
2. Active health problems
3. Contraindications to MRI scanning
4. Symptoms of functional bloating or irritable bowel syndrome
5. Abnormal liver or renal function tests
6. Random glucose greater than 11.0 mmol/L
7. Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin.
8. Alcohol intake \> 21 units per week
9. Vegetarianism
10. Normal daily fructose intake from drinks greater than that in 500ml of coca cola
11. Abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the National Diet and Nutrition Survey 2002 data
Building Community Living Labs in Black Communities to Advance Prostate Health Equity and Reduce Prostate Cancer Disparities in Black Men

This clinical trial the possibility of establishing a Community Living Labs (CoLLab) Learning Health System to facilitate access to prostate health Risk, Education, and Assessment in the Community with Help (REACH) services in Black men and compares the impact to American Legion Posts with no CoLLab set up at the individual and community levels. Cancer is the second leading cause of death for Black men and Black men are less likely to receive prostate cancer screening. CoLLab Learning Health System utilizes community health workers (CHW) that are well-trained to form a bridge between communities and clinicians. In fact, Black men who work with CHW's typically have better access to health services, gain knowledge about cancer, cancer prevention, treatment and may have better overall health outcomes. Establishing a CoLLab Learning Health System at American Legion Posts may improve access to clinical trials and prostate cancer services in Black men.

PRIMARY OBJECTIVES:

I. Co-create real-life user centric CoLLab Learning Health System at three American Legion Posts, compared to an American Legion Post with no CoLLab set-up. American Legion Post 197 will serve as the hub and Post 244 and Post 194 as the spokes.

II. Assess and evaluate the impact of the CoLLab Learning Health Systems compared to the comparison Post at the individual and community levels.

III. Explore the feasibility of replicating the CoLLab Learning Health System in Black communities nationally.

OUTLINE:

Participants access CoLLab Learning Health System to use any of the services at least twice monthly for up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

* AIMS 1 AND 3: Participants must be one of the following key personnel:

  * Community PI (n=1),
  * CoLLab Program Manager (n=1)
  * CoLLab Site Managers (n=3)
  * CoLLab CAB members (n=21)
  * 2 Community Health Workers (CHWs) per Post site (n=6)
* AIMS 1 AND 3: Between the ages of 21 and 80.
* AIMS 1 AND 3: Able to complete the survey in English.
* AIMS 1 AND 3: Reside in the Jacksonville, FL and/or surrounding counties.
* AIMS 1 AND 3: Willing and able to consent to the study.
* AIM 2: Black adult of any gender.
* AIM 2: Must be between the ages of 30 and 80.
* AIM 2: Able to speak English.
* AIM 2: Reside in the Jacksonville, FL and/or surrounding counties.
* AIM 2: Willing and able to consent to the study.

Exclusion Criteria:

* AIMS 1 AND 3: Younger than 21years or older than 80 years.
* AIMS 1 AND 3: Not a resident of NE Florida. Unwilling or unable to consent to the study.
* AIM 2: Younger than 30 years or older than 80 years.
* AIM 2: Not a resident of NE Florida.
* AIM 2: Unwilling or unable to consent to the study.
A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).


Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
* Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
* Subject is being newly initiated on Xtandi treatment (Enzalutamide).
* Subject has an estimated life expectancy of ≥ 6 months.
* Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

* Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
* Subject participating or planning to participate in any interventional drug trial during the course of this trial.
* Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
* Subject has any condition which makes the subject unsuitable for study participation.
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality

The general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD.


Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of ASD
* All participants were required to have estimated FSIQ of 80 or above

Exclusion Criteria:

* using any stimulant or non-stimulant medication that affects the central nervous system
* having an identified genetic disorder
* having vision or hearing problems
* suffering from chronic or acute medical illness
* presence of epilepsy