cyrilzakka/clinical-trials huggingface dataset:
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4

Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.

Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.

This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 18 years of age at start of screening
* CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
* Not expected to start dialysis for 8 months
* Serum intact PTH \< 500 pg/mL during screening period
* On a stable ACE inhibitor/ARB regimen for 30 days prior to screening

Exclusion Criteria:

* History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
* Currently receiving erythropoiesis stimulating agent or IV iron therapy
* History of inflammatory/autoimmune disease
* History of polycystic kidney disease
* HIV positive or AIDS
* Pregnant or breastfeeding
* Receiving activated Vitamin D analogs, nutritional vitamin D agents \> 2,000 IU/day, or calcimimetics with in the last 3 months
* Significant GI disorder
* Proteinuria \>3.5 g/24 hours
Drug Interactions From Simultaneous Administration Of Metformin And GSK189075 To Subjects With Type 2 Diabetes

GSK189075 is intended for use as a single treatment or in combination with other treatments for tye 2 diabetes mellitus (T2DM). Metformin is widely used in Europe and the USA for the treatment of T2DM. This study will evaluate the effect of GSK189075 on metformin levels in the blood in T2DM subjects. The rationale is to look for any safety problems that may result when the 2 drugs are given together.


Eligibility Criteria:
Inclusion criteria:

* Have Type 2 diabetes mellitus.
* Have a Body Mass Index within range 22 to 35kg/m2 inclusive.
* Females who meet above criteria must be physiologically incapable of becoming pregnant (i.e., surgically sterilized, or post-menopausal per protocol definition).

Exclusion criteria:

* Are currently taking insulin therapy.
* Have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer).
* Have a history of stomach, liver, kidney, or other disease that with interfere with taking the study drug.
* Are currently using diuretics, oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or other medications that would cause you to deplete your fluid balance in your body; currently taking stable regimens for heart conditions; currently using prescription or non-prescription drugs within 7 days of starting the study that may interfere with the study drug.
* Would donate more than 450 ML of blood over a 2 month period.
* Physician does not think it is a good idea for you to participate in the trial. - Had a urinary tract infection or bladder infection in the last month. - Are currently drinking more than 2 beers, 1 glass of wine, or 1 glass of spirits daily.
* Have a positive urine drug screen test.
* Plan to change your smoking habits during the course of the trial.
* Have Hepatitis C, Hepatitis B, or HIV. - Have a lab or EKG abnormality. - High or low blood pressure.
* Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
* Are a male subject unwilling to abstain or use protection during intercourse.
Testing the Application of Mepitel Film During Radiation Therapy to Reduce Radiation Related Redness and Peeling in Breast Cancer Patients Following Mastectomy

This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

I. To determine the ability of Mepitel Film to reduce the severity of radiation dermatitis in patients undergoing post-mastectomy radiotherapy for breast cancer when compared to the institutional standard of care.

KEY SECONDARY OBJECTIVES:

I. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a centralized, blinded provider assessment review of photographs.

II. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a non-blinded institutional provider assessment.

III. To determine the ability of Mepitel Film to prevent radiation-induced dermatitis based on a combined patient and non-blinded institutional provider assessment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care skin management during radiation therapy for up to 6 weeks.

ARM II: Patients receive Mepitel Film applied to breast or chest wall every week before radiation therapy for up to 6 weeks.

After completion of study, patients are followed up at 7-14 days, 3 months, 6 months, 1 year, and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of breast malignancy with TNM staging.
* Patients must have undergone a mastectomy with or without reconstruction within the past 120 days if not receiving adjuvant therapy, or within 60 days after completion of the last dose of chemotherapy.
* No prior radiotherapy to any portion of the planned treatment site.
* No documented history of adhesive or tape allergy.
* Patients must be scheduled to receive conventionally fractionated photon-based radiation. Patients planning brachytherapy within the treatment field, and patients scheduled to receive bilateral radiation or hypofractionated radiation are not eligible.
* No active rash or pre-existing dermatitis within the treatment field.
* No co-existing medical conditions resulting in life expectancy \< 2 years.
* No active collagen vascular diseases (i.e. lupus erythematosus, scleroderma, dermatomyositis).
* No concomitant cytotoxic chemotherapy. Endocrine therapy and HER2 directed therapies are allowed.
* No current inflammatory breast cancer, or gross dermal involvement at initiation of radiotherapy.
* No previous history of organ or bone marrow transplant.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* In order to complete the mandatory patient-completed measures, participants must be able to speak and read English.
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or non-pregnant, non-lactating female, age 2 to 35 years, inclusive as of the day of the Screening Visit.
* Clinical diagnosis of Lennox-Gastaut syndrome, where seizures that result in drops are not completely controlled by current antiepileptic treatments.
* Onset of seizures at 11 years of age or younger.
* Abnormal cognitive development.
* Must be receiving at least 1 concomitant AED and up to 4 concomitant anti-epileptic treatments.

Key Exclusion Criteria:

* Etiology of seizures is a degenerative neurological disease.
* History of hemiclonic seizures in the first year of life.
* Subject only has drop seizures in clusters, where individual seizures cannot be counted reliably.
* Pulmonary arterial hypertension.
* Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
* Receiving concomitant therapy with: centrally-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine.
* Taking felbamate for less than 1 year prior to screening and/or does not have stable liver function and hematology laboratory tests, and/or the dose has not been stable for at least 60 days prior to the Screening Visit.
* Currently receiving an investigational product.
* Institutionalized in a general nursing home (ie, in a facility that does not specialize in epilepsy care).
* A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* At least 18 years of age at screening
* HbA1c ≥ 8% and ≤ 12% at screening
* Fasting plasma glucose (FPG) ≤ 270 mg/dL (15mmol/L)
* Stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks
* estimated glomerular filtration rate (eGFR) \&lt; 60 ml/ml/1.73m2
* Body Mass Index ≤ 45.0 kg/m2

Exclusion Criteria:

* Clinical diagnosis of Type 1 diabetes
* History of ketoacidosis
* Renal, hepatic or pancreatic disease
* Impairment of renal function (defined as creatinine clearance \[CrCl\] \< 60 mL/min
* Cardiovascular or vascular diseases identified within 3 months of participationImpairment of renal function (defined as creatinine clearance \[CrCl\] \< 60 mL/min
Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke causing arm weakness within 5-15 days
* no other neurological or psychiatric disease, who are able to perform study tasks

Exclusion Criteria:

* patients younger than 18 or older than 80 years
* patients with more than one disabling stroke
* Patients with bilateral motor impairment
* Patients with poor motivational capacity, history of severe alcohol or drug abuse
* Patients with severe language disturbances, particularly of receptive nature
* Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
* Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
* Patients with unstable thyroid disease
* Patients with increased intracranial pressure
* Patients with unstable cardiac arrhythmia
* Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
* Patients who are not available for follow-up at 3 and 12 months
* Pregnancy
* Patients with contraindication to MRI will not participate in MRI
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Adults and Children in a Malaria Endemic Area

The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children and adult volunteers in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in The Gambia.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents.

Exclusion Criteria:

* Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
* Severe malnutrition.
* Hypersensitivity to HDCRV.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
* History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator
* Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
* Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
* Blood transfusion within one month of enrolment.
* History of vaccination with previous experimental malaria vaccines.
* Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
* Current participation in another clinical trial, or within 12 weeks of this study.
* Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
* Likelihood of travel away from the study area.
* HIV positive.
* Positive malaria antigen test
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease

The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated withBioresobable Vascular Scaffold for coronary disease

Exclusion Criteria:

* History of allergy to contrast
* Serum Creatinine \> 2.0 mg/dl
* Severe arrhythmia
* Pregnancy or breast feeding
Low Dose Radiation to Improve T-Cell Infiltration in Pancreatic Cancer

Principal purpose of the study is the determination of an active local external beam radiotherapy dose leading to a maximum number of tumor infiltrating T-cells.


Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis of resectable pancreatic carcinoma is required prior to treatment. Potentially resectable is defined as no extrapancreatic disease, no evidence (on CT) of involvement of the celiac axis or superior mesenteric artery, no evidence (on CT or MRI) of occlusion of the superior mesenteric vein or superior mesenteric-portal venous confluence.
* No evidence of metastatic disease as determined by chest CT scan, abdominal CT scan (or MRI)
* 18 years of age or older
* American Society of Anesthesiologists (ASA)- Performance status of 1 to 3
* Women of child bearing potential must practice adequate contraception and refrain from breast feeding. Female patients must have a negative pregnancy test within 7 days of treatment
* Informed consent

Exclusion Criteria:

* Locally irresectable pancreatic cancer
* distant metastases
* medically unfit for surgery
* Pregnant or lactating women
* prior chemotherapy or radiation treatment
* Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
* Unwillingness to participate or inability to comply with the protocol for the duration of the study
* Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
* Participation in other interventional trials
Improving Discharge Communication in the Emergency Department Through Information Structuring

The goal of the proposed study is to assess the potential of information structuring for improving discharge communication. Specifically, the investigators aim to examine the advantages of an information-structuring skills training for physicians (compared to an empathy skills training) on discharge communication and associated patient outcomes, such as patients' information recall and adherence to physician recommendations. The investigators hypothesize that patients receiving structured discharge information from their trained physicians will be able to recall more information and show higher adherence to recommendations relative to controls (i.e., patients receiving discharge information from doctors trained in empathy skills).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with chest pain
* Outpatients with abdominal pain

Exclusion criteria:

* Patients younger than 18 years of age (limited ability to provide informed consent)
* Patients with limited ability to communicate in German, the default language at the hospital (confounder related to language proficiency)
* Patients with dementia (confounder arising from pathological memory deficits)
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176

The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from the body.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight \>50 kg

Exclusion Criteria:

* Creatinine clearance as calculated by the Cockroft-Gault formula of less than 60 mL/min
* Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator or the sponsor medical monitor. Reticulocyte count, haemoglobin and platelet counts must not be less than the lower limit of normal for the subject.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, GI, haematological, neurological, endocrinological, immunological, musculoskeletal disease or any uncontrolled medical illness (eg active infection) or psychiatric disorder, as judged by the investigator or medical monitor.
* Clinically significant abnormal electrocardiogram (ECG) findings
Sensory Symptoms in Active Vitiligo

This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin \[neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)\] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.

Study Design: Case-control study Population: 45 patients with active vitiligo and 45 patients with stable vitiligo

Inclusion criteria:

Age: 18 years old and older Sex: both sexes

Exclusion criteria:

Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - Cases who received treatment (systemic or topical) in the last 3 months before sampling. - Neurological or other diseases that cause itching. - Medical history of DM, HTN, or other systemic diseases, history of associated autoimmune diseases.

Assessment will be carried as follows: • History of itching or other abnormal neurological sensations as paresthesia and numbness. Aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching Type of vitiligo (segmental, unilateral, vulgaris). • Assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • Assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • Clinical assessment: the vitiligo area score index (VASI), vitiligo extent scores (VES), vitiligo disease activity score (VIDA) (Feily, 2014) will be assessed in every participant and demographic data

Eligibility Criteria:
Inclusion Criteria:

* Active and stable vitiligo

Exclusion Criteria:

* Diabetic or other associated disease
remedē System Therapy Study

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. Approximately 225 subjects will be enrolled and implanted at approximately 50 sites in the United States and Europe.

Eligibility Criteria:
1. Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is strongly recommended that a patient have a diagnostic PSG within 12 months of the expected implant date documenting moderate to severe CSA.
2. Age 18 years or older
3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
4. In the opinion of the investigator, subject is willing and able to comply with the protocol.
5. Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
6. In the opinion of the Investigator, life expectancy exceeds one year.
7. The subject is not pregnant or planning to become pregnant.