cyrilzakka/clinical-trials huggingface dataset:
Resistant Starch Supplementation Effects on the Intestinal Tract Profile and Cardiovascular Markers in Renal Patients

The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

Patients with chronic kidney disease (CKD), especially those who are on dialysis have a high prevalence of cardiovascular mortality and, among the risk factors include inflammation and oxidative stress. Recently this scenario, beyond those alterations found in these patients, it has been suggested that the balance of the intestinal flora in these patients might be a new factor of cardiovascular risk. Some treatment strategies have been studied in order to modulate the gut microbiota as the use of pre, pro or synbiotics. Although few studies, supplementation with prebiotics has been recommended. However, the use of resistant starch as a source of prebiotic for modulation of the intestinal flora in these patients has not yet been evaluated, but the study of Prof. Vaziri the University of California Irvine, USA, with nephrectomized rats showed that the resistant starch was able to attenuating the progression of failure of renal function, inflammation and oxidative stress and minimize the abnormalities of intestinal epithelial barrier. The objective of this study is to assess whether supplementation with resistant starch from the rice-flour coffee developed by EMBRAPA, as well as from an already industrialized product (Hi-Maize of Ingredion®) could modulate the intestinal microbiota of patients with CKD ( both patients under conservative treatment, such as dialysis treatment), as well as exerting a beneficial effect with respect to reducing levels of inflammatory markers of oxidative stress, uremic toxins and in addition, markers of cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients with arteriovenous fistula as vascular access in the upper limb and on maintenance dialysis for at least 6 months;
* Patients under conservative treatment in stages 3a and 3b (30 to 60 mL / min) of chronic kidney disease and receiving nutritional treatment for at least 6 months (adequate supply of energy 30-35kcal/kg/day and hypoproteic 0.6 g/kg/day.

Exclusion Criteria:

* Patients with autoimmune and infectious diseases, diabetes, cancer and AIDS;
* Patients with catheter for hemodialysis access;
* Patients using catabolizing drugs, supplements as antioxidant vitamin, probiotics, prebiotics, synbiotics and antibiotics.
* Patients who exercise are also deleted.
The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease

This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.


Eligibility Criteria:
Inclusion Criteria:

* Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
* receiving no more than 48 hrs of therapy prior to study enrollment

Exclusion Criteria:

* serum creatinine \<2.2 at the time of enrollment
* no prior use of CMV IgG
A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.


Eligibility Criteria:
* Men or women, at least 18 years of age at screening
* Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse
Effect of Need to Void on Gait Speed in Multiple Sclerosis

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. If motor disorders are the most visible disability, urinary disorders are frequent, with prevalence from 32 to 86%. The first ones are due to pyramidal, cerebellar or proprioceptive lesions. The seconds are due to specific lesion in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that walk and urinary disorders are link, because of similar anatomic ways and control process. Effect of bladder filling is well known on motoneuronal excitability. The effect of bladder filling on walk stay unknown, while medullary integration of these two functions is very close, in medullary cone.

Primary aim is to assess the effect of need to void on walk speed in multiple sclerosis with lower urinary tract symptoms. Secondary aim is to identify clinical or urodynamic factor link with major walk impairment when patients need to void.

Patient with multiple sclerosis over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.

History and treatment, high, weigh, symptoms severity by USP score, cognitive impairment by MMSE score and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home.

Walk tests are realized in a specific place, with calm and no passage. A chair is placed at each end of the path. Toilets are just next to the hall where they realize the tests. A 10 Meters Walk Test is done during this condition, 3 times (only the intermediate 6 meters are recorded). They can take 30 seconds of rest between each try if necessary. One Timed up and go is done. Patient can use their habitual walking device. Speed walk asking is comfortable for the two test.

Next, patient can urinate. 3 post void residual volume with portable echography are done, and the higher is recorded.

Patient achieve the same walk tests after urinate, in the same order. They must use the same walking device.

Primary outcome is mean gait recorded for 10 meters walk test.

Secondary outcome is time for timed up and go test.

Individual variability between the 3 10MWT in the two conditions will be study.

Influence of age, EDSS, severity of symptoms, MMSE, detrusor overactivity on speed impairment will be study in secondary analysis.


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis
* Follow in neuro-urology for lower urinary tract symtpoms
* Able to walk 50 meters without human assistance
* able to hold on void during 3 minutes at least

Exclusion Criteria:

* actual urinary tract infection
* relapse in the last week
* Mini Mental State Examination \< 10
Home Treatment of Pulmonary Embolism

The best management in selected patients of pulmonary Embolism (PE) should be at home. The efficacy and safety treatment´s at home versus at hospital should be similar and quality of life should be better. Our purpose is to demostrate that Low weight molecular heparin (LWMH) at home for PE is at least as effective and safe at home as at hospital

In order to carry out the Cooperative Investigation Plan for home treatment of pulmonary embolism, a network of multidisciplinary groups was built with the participation of 10 groups, distributed in 6 different regions and integrated within the Spanish Society of Pneumology and Thoracic Surgery (SEPAR).

Those groups will share a database integrated in the Spanish Registry on Thromboembolic Disease (RIETE), which is a project already being carried out and in which many of the groups of the network already participate.

The research project will be a study developed in two phases. In the first phase, predictive profiles for a favourable progression of the disease in patients with pulmonary embolism will be studied using the actual management of the disease with the current assistance model.

In the second phase, a randomized study comparing the efficacy and safety of two models of home treatment ( discharge from hospital during the first 72 hours after the diagnosis of PE and discharge from hospital during the first 5 days) in patients previously selected, according to predefined criteria which were modified on the basis of the results of phase I versus the current assistance model will be developed

The results will be measured in terms of efficacy, safety, economic burden, and quality of life in both models (at home and at hospital).

Eligibility Criteria:
Inclusion Criteria:

* The consecutive outpatients subjects diagnosed of PE at 10 different Spanish hospitals.
* A score of 2 or under in our prediction rule (risk score for short-term)
* Signed written Informed consent

Exclusion Criteria:

* A score over 2 in our prediction rule
* Patients with a PE requiring thrombolysis or surgical thrombectomy
* Patients with right ventricular dyskinesia in echocardiography at 48 hours from heparin therapy. (It is not necessary echocardiography for the model of discharge at 5 days)
* Troponin level over 0,1 g/L
* Patiens requiring oxygen therapy or under 93% in oxygen saturation level.
* Patients requiring intravenous analgesic therapy
* Patients with some medical or surgical conditions requiring to stay at hospital
* Patients with advanced chronic cardiovascular diseases (dyspnea III-IV NYHA)
* Patients with advanced chronic respiratory diseases (several COPD criteria of GOLD with FEV1\< 50%)
* Documented congenital or acquired bleeding tendency /disorder (s)
* Documented current ulceration or angiodysplastic gastrointestinal disease
* Hemorrhagic stroke or recent (\< 3 months prior to randomization) brain, spinal, or ophthalmological surgery.
* Recent surgery \< 3 days
* Pregnancy
* Several Obesity (CMI over 30)
* Patients could not complete the treatment at home.
* Exclusion criteria related to study procedures
* Life expectancy \< 3 months
Canola Oil Multicentre Intervention Trial

The purpose of the study is to examine how the consumption of different dietary oil varieties affects a broad range of metabolic responses that are important in the development of cardiovascular diseases. This study will examine the relationship between dietary oil consumption and arterial function, blood fat content, and blood markers of cardiovascular disease risk. Additionally, the efficiency of the body in converting fat from dietary oils into other specific fat compounds with know health benefits will be examined. Also, the correlation between psychosocial parameters and vascular function will be studied.

Although consumption of omega-3 fatty acids favorably modulate circulating lipids and arterial health, there is confusion surrounding the specific health benefits of plant based alpha-linolenic acid (ALA) versus marine derived eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This research will examine the health benefits of ALA from consumption of diets rich in canola oil, novel monounsaturated fatty acid (MUFA) and DHA enriched canola oils, and flax oil compared with a control diet representative of North American diets rich in omega-6 and saturated fats. Treatment oils will be examined for potential influence on endothelial dysfunction, inflammation, oxidation, body composition, and plasma lipoprotein characterization. Furthermore, in an effort to elucidate the genetic factors that promote ALA conversion to EPA/DHA and strengthen the role of ALA in cardiovascular health, a major objective is to correlate common genetic variants in the fatty acid desaturase 1 (FADS1) and fatty acid desaturase 2 (FADS2) gene cluster with ALA conversion to EPA/DHA and n-3 fatty acid composition of serum phospholipids in response to consumption of the treatment oils. Besides, psychosocial predictors of vascular function will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Waist circumference ≥94 cm (males) or ≥80 cm (females)

plus at least one of the following:

* Triglycerides ≥1.7 mmol/L
* High density lipoprotein (HDL) cholesterol \<1 mmol/L (males) or \<1.3 mmol/L (females)
* Low density lipoprotein (LDL) cholesterol ≥3.5 mmol/L
* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
* Glucose ≥5.5 mmol/L

Exclusion Criteria:

* Thyroid disease
* Diabetes mellitus
* Kidney disease
* Liver disease
* Smoking
* Heavy drinking
* Use of medication known to affect lipid metabolism during the last 3 months(cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors)
Histologic Evaluation of Bone Formation After Alveolar Augmentation by "Sandwich Osteotomy" Procedure for Dental Implants Insertion

The purpose of this study is to evaluate histologic bone remodeling after interpositional bone graft ("sandwich osteotomy" technique) using xenograft to fill the gap of the bone after moving and fixation it in the proper place.

Dental implant use for partially edentolous jaw is a predictable procedure with high success rate. However, implantation procedure requires sufficient bone support both vertically and horizontally, and sometimes there is bone defect that requires bone augmentation prior to dental implant insertion.

There are some bone augmentation techniques known and used for this purposes, including: guided bone regeneration (GBR), distraction osteogenesis, split osteotomy, onlay bone graft, and interpositional bone graft.

One of the techniques is the interpositional bone graft using "sandwich osteotomy" technique, in which a cut is made in the bone (one horizontal and two vertical) separating a mobile bone portion which is fixed (using bone plate) in its new "ideal" position. The gap between the moved bone and the remaining bone is filled with xenograft ("bio-oss"). There is no documentation in the literature about histological evaluation of the bone after this well known clinical procedure. Four months after the bone augmentation procedure - the fixating plate is moved out and dental implants inserted. The first bur of the implantation (the smallest in the diameter) will be a trephine from which a histologic slide will be taken for check. The continuous dental implants insertion is the normal protocol for dental implantation (widening the recipient hole with bur, and insertion of the implant), followed by rehabilitation by prosthodontics.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* partially edentulous patients
* insufficient bone height (recipient site)
* interested in fixed dental rehabilitation using dental implants

Exclusion Criteria:

* smoking
* unbalanced diabetes
Oxidative Stress, Inflammation, and Lipoprotein in Metabolic Syndrome

Obesity is associated with general low grade inflammation and, consequently, of oxidative stress that affects properties and functionality of lipoproteins. Metabolic syndrome exacerbate low grade inflammation. The intentional weight loss of at least 5% of the initial weight can modulate the pro-inflammatory state and reduce the oxidative stress related to the metabolic syndrome, thus diminishing the cardiovascular risk.

Metabolic syndrome is a clustering of risk factors for the development of cardiovascular disease and type 2 diabetes mellitus. Patients with metabolic syndrome have an increased general low grade inflammation and, consequently, of oxidative stress that affects properties and functions of lipoproteins (Dandona et al 2005). Intentional weight loss can improve or prevent many of the metabolic syndrome-related risk factors and these benefits are often found after weight loss of at least 5% of initial weigh.

Aim: i) to investigate the structure and functionality of plasma lipoproteins, oxidative stress and the inflammatory condition in subjects with BMI between 25kg/mq and 35 kg/mq and with or without metabolic syndrome; and ii) to test the effects of weight loss of at least 5% of initial weigh promoted by an hypo-caloric balanced diet on these parameters.

Methods: Eighty overweight and moderately obese subjects (BMI: 25 - 35 kg/m2) with or without metabolic syndrome were recruited for the study. Fasting blood samples were taken and analyzed for routine laboratory analysis, lipoprotein isolation and analysis, and oxidative stress and inflammation markers measurements. The subjects received an hypo-caloric balanced diet. Fasting blood samples were taken from subjects who had lost at least 5% of their initial weight at the end of the intervention period and analyzed for same markers determined at baseline.

Eligibility Criteria:
1. Inclusion Criteria.

1.a Group "Obese with MS":

* BMI between 25 e 35 Kg/m2
* presence at least three of the following:1) waist circumference \>102 cm for males or \> 88 cm for females; 2) triglycerides: ≥ 150 mg/dL;3) HDL-cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females; 4) hypertension (systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg or antihypertensive intake); 5) glycemia: ≥ 110 mg/dL
* Alcohol consumption \< 25 g/die
* No smoking or smoking less that 5 cigarettes/die
* No use of antioxidant based supplements
* Absence of hormonal treatments
* Informed consent signature

  1.b Group "Obese without MS":
* BMI between 25 e 35 Kg/m2
* Alcohol consumption \< 25 g/die
* No smoking or smoking less that 5 cigarettes/die
* No use of antioxidant based supplements
* Absence of hormonal treatments
* Informed consent signature

  2. Exclusion Criteria
* Presence of major disease
* Receiving hypoglycemic treatment
* Receiving treatments that alter lipoprotein metabolism
* Receiving hormonal treatments
* Use of antioxidant supplement
* Alcohol consumption \> 25 g/die
* Smoking \> 5 cigarettes/die.
* For women:pregnancy
Studies With 1,25-Dihydroxycholecalciferol

Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients suffering from disorders with Vitamin D resistance are unable to absorb calcium from food. Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin D3). Patients will be monitored and observed throughout the study to avoid experiencing side effects from the medication.

Patients with extreme resistance to 1,25-dihydroxyvitamin D will be evaluated and treated with high doses of 1,25-dihydroxyvitamin D3.

Plan: In previously untreated patients the study will be divided into a control and one or more treatment periods. During the control period, parathyroid status will be assessed by parameters nos. 1\& 2 (below). In previously treated patients maintenance vitamin D will be gradually replaced with 1,25(OH)2D3. This will be accomplished by withdrawal of vitamin D and institution of 1,25(OH)2D3 when the serum calcium shows a downward trend.

1,25(OH)2D3 as 0.25 or 0.5 ug capsules (though IND 20,889) or as a solution of I microgram per ml will be administered orally. In most cases, because of consideration of time and expense, the cooperation of the patient's local physician will be enlisted. The following will be monitored:

1. Serum calcium, phosphorus,alkaline phosphatase,creatinine at twice weekly intervals. After a maintenance dose has been established, this will be decreased to a monthly, and subsequently 3-6 monthly interval.
2. Urine calcium, phosphorus,creatinine and cAMP before therapy and, when appropriate, during therapy.

The dose of 1,25(OH)2D3 will be 0.125 to 50.0 ug/day. Serum calcium will not be allowed to rise above the normal range (2.0 -2.4 mM at NIH). Should hypercalcemia occur, appropriate treatment will be initiated and the drug dosage will be decreased.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients with hereditary resistance to calcitrol.
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients

The purpose of this research is to evaluate the impact of a microarray PGx test on prescribing/dosing of drugs and cancer treatments in patients with cancer who are currently eligible for single-gene DPYD testing.

This is a prospective, non-randomized, Phase 2 study. The target population is adults ≥18 years of age who have received or will be receiving standard of care single-gene DPYD (dihydropyrimidine dehydrogenase) PGx testing to help guide dosing for their cancer treatment. Pharmacogenes that will be reported back to participants and providers from the microarray test are expected to take approximately one week and will be evaluated by the PGx team and uploaded to the participant's electronic medical record (EMR). Only clinically actionable results per CPIC and FDA guidelines will be included in the participant report. Participants will be followed on study for approximately 6 months to collect data on the number of drug prescriptions with known drug-gene interactions and potentially actionable results, BPAs fired, and actions taken due to BPAs.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and HIPAA authorization for release of personal health information.
* Age ≥ 18 years at the time of consent.
* Eligible for standard of care single-gene DPYD testing (i.e., receiving or expected to receive a fluoropyrimidine-based chemotherapy regimen). The potential participant meets inclusion criteria if the standard of care single-gene DPYD test is planned or previously ordered. If previously ordered, consent must occur no later than 60 days from the date the DPYD results were available.
* Willing to provide additional buccal swabs if residual DNA from previous DPYD testing is inadequate for microarray testing.

Exclusion Criteria:

• History of prior allogeneic hematopoietic cell transplantation or liver transplantation