cyrilzakka/clinical-trials huggingface dataset:
Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes

This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes OR healthy control (no type 2 diabetes)
* BMI\<32

Exclusion Criteria:

* heart disease
* pregnancy or birth within 3 month
* smoking
* Kidney disease
* beta-blockers
* insulin treatment (for type 2 diabetics)
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: Health Outcome

This study is a retrospective review of the data collected in a previously completed randomized, controlled trial (RCT) entitled "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" (NCT00120874). As part of the previously completed RCT, participants with Alzheimer's Disease (AD) were randomly placed into one of two groups: memantine, or memantine plus an individualized management program consisting of home visits, educational sessions for caregivers, and a caregiver support group. Participants received the study intervention for 28 weeks; study follow-up lasted for 52 weeks.

The collected data from the existing study books from the 28 week treatment portion of the RCT will be carefully examined with respect to each of the research questions for the present retrospective study.


Eligibility Criteria:
Inclusion Criteria:

* Previously participated in the "Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial" study.
Ziprasidone and Sertraline in PTSD

Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.

A current problem in the pharmacotherapy of PTSD is that the medication of choice, serotonin re-uptake inhibitors, take several weeks before they show considerable effects on PTSD symptoms. Addition of typical neuroleptics, such as ziprasidone, offers a potential strategy to bring about a faster symptomatic relief, because they display anxiolytic properties without the risk of dependence. Therefore, in addition to standard sertraline therapy (at least 8 weeks), we will give ziprasidone vs. placebo over the first four weeks in a double-blind randomized design.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Post-Traumatic Stress Disorder

Exclusion Criteria:

Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone
The Role of Probiotics in the Eradication of Helicobacter Pylori

All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.

The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).

Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.

The probiotic contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).

Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting).

All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.

Eligibility Criteria:
Inclusion Criteria:

* Established Helicobacter Pylori Infection

Exclusion Criteria:

* Pregnancy
* Lactate
* Previous eradication therapy for HP.
* Course of antibiotics and/or probiotics one month prior to stydy entry
* Course of PPI's, H2- antagonst and antacids two weeks prior to study entry
* Known allergy to antibiotics that will be used in study
* Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment
Study of Bone Disease in Older HIV-infected Adults

This study will look to see if there are changes in the blood cells that are associated with bone disease and sort out effects that are due to the HIV virus itself, the medications and see if faster aging occurs in the cells of HIV infected persons. Bone disease will be measured by a special X-ray called a DEXA scan. A DEXA scan is used by doctors to see if someone has normal bone mass for their age or if there is thinning of the bones.

The purposes of this study are:

* to learn how common bone disease is in HIV infected patients over the age of 50 years that receive their care at the CORE Center
* to see what are the common causes of bone disease in older HIV infected persons
* to see if there are differences in blood cells and levels of cytokines in patients who do or do not have bone disease, as this may help researchers determine the cause of bone disease.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection documented by ELISA and confirmed by western blot
* Treatment with antiretroviral drugs for at least 12 months
* Age 50-70 years
* CD4 count \> 350 cells/mm3 for at least 6 months
* HIV-RNA undetectable (\< 75 copies/ml for at least 6 months)

Exclusion Criteria:

* Known bone disease (primary or metastatic malignancy, osteomalacia)
* Treatment for bone disease (bisphosphonates, calcitonin, strontium, sodium fluoride, synthetic PTH, or high-dose vitamin D \[\> 800 IU daily\]).
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

The aim of the study is to evaluate the safety and efficacy of "AIC316 (pritelivir)" 100 mg once daily compared to valacyclovir 500 mg once daily for the prevention of HSV-2 genital shedding.

Enrolled patients with Mucocutaneous genital HSV, will be randomized to receive either AIC326 or Valacyclovir first and then will be crossed over to receive the opposite Intervention. The study will consist of two treatment periods of 28 days separated by a washout period of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult, immunocompetent men and women in good health of any ethnic group
* Seropositive for Herpes Simplex Virus Type 2 (HSV-2)
* History of recurrent episodes (\>=4 to \<=9) of genital herpes for at least 12 months and willingness to obtain 4 swabs per day.

Exclusion Criteria:

* Present episode of genital herpes at time of randomization
* Clinically relevant acute or chronic infections (excluding HSV-2)
* Known intolerance to valacyclovir, acyclovir, or any component of the formulation
* Documented HSV resistance to acyclovir, valacyclovir, famciclovir or penciclovir
Non-Interventional, Multicenter Bicontact® E PMCF Study

Prospective observational (non-interventional) cohort study, multi-centric in 5 study Centers in Japan to collect short term clinical and radiological results of the cementless Bicontact® E stem in a standard patient population used in routine clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Indication for Bicontact E prosthesis THA
* Patients ≥ 18 years
* Patient not pregnant
* Written informed consent

Exclusion Criteria:

- Patients receiving a bipolar implantation
Thyroid Hormones Treatment in Asthma Exacerbation

This study will explore whether supplementation with thyroid hormones in the set-up of asthma exacerbation could improve the clinical outcomes.

The study will include adults admitted to Rambam health care campus for moderate to severe Asthma exacerbation.

The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the peak expiratory flow (PEF) rate to normal values or personal base line.

Study population: The study will include adults admitted to Internal Medicine B (IMB) department, Internal Medicine H (IMH) department or medical intensive care unit (MICU) in Rambam-Health Care Campus for moderate to severe Asthma exacerbation. The severity of the exacerbation will be based on several acceptable clinical and laboratory criteria, including breathless, alertness, pulse rate, respiratory rate, partial pressure of oxygen in arterial blood (PaO2), partial pressure of carbon dioxide in arterial blood (PaCO2), oxygen saturation, peak expiratory flow (PEF). Study protocol: The study is a prospective, randomized, double-blind, placebo-controlled, clinical trial. Patients will be randomized on admission to receive treatment with intra-venous thyroxine (100mcg once on admission and additional 100mcg after 12 hours) or placebo. The study treatment will be given only after the initial bronchodilator therapy, oxygen and informed consent are given. The primary endpoint is the time to return of the PEF rate to normal values or personal base line. PEF rates will be examined first after initial bronchodilator therapy and then, every 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Known Asthma
* The exacerbation is defined as moderate or severe.
* Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.
* The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy

Exclusion Criteria:

* 60 years of age or older
* Known thyroid disorders
* Subject where thyrotoxicosis is suspected
* Known heart disease
* Heart rate \> 140
Thoracic Specimen Registry

The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases.

The primary objective of this proposal is to develop a Thoracic Specimen Registry at Mayo Clinic. The purpose of the registry will be to support ongoing research in the etiology, early diagnosis, clinical management, and prognosis of lung cancer and other cancers and diseases of the thorax by developing a complete repository of specimens from patients with thoracic disease including but not limited to suspected lung cancer, mediastinal and pleural tumors, lung transplants and from patients at a very high risk of developing other thoracic cancers or other thoracic diseases. Collected specimens will include peripheral blood, bronchoalveolar lavage (BAL) fluid, pleural fluid, tissue (surgical resections \& biopsies) and touch prep samples. The specimens will be stored in a central location at Mayo Clinic and managed by the Mayo Clinic Thoracic Specimen Registry Steering Committee. The registry will be a foundation for the development and implementation of research protocols and clinical trials that will enhance current knowledge of etiology and detection, discovery of new molecular and biochemical markers for screening, early diagnosis, and develop state-of-the-art therapeutic and preventive interventions for managing patients with, or at risk for, thoracic cancers or other thoracic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \> 18 years of age
* Presumed or known or screening of Thoracic Diseases (which includes but not limited to the following: thoracic neoplasms (masses/nodules) malignant or benign, interstitial lung diseases (ILD), chronic obstructive pulmonary disease (COPD), thoracic infections, thoracic malignancies metastatic to other organs, other cancers metastatic to the thoracic cavity.
Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance

The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml

Eligibility Criteria:
Inclusion Criteria:

* Stage IIA and IIB breast cancer treated with radical mastectomy
* Obtaining informed consent
* Total amount of lymph in postoperative day 1 \<150ml

Exclusion Criteria:

* Stage I, III-IV breast cancer
* History of benign breast neoplasm or malignant disease of any origin
* Any breast surgery in the past
* Weight \<50kg
A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants

Aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by USH2A retinitis pigmentosa (USH2A-RP), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. All the procedures will be performed according to normal clinical practice. In addition, a novel quantitative profiling of serum microRNAs will be carried out in order to analyze the clinical importance of microRNA biomarkers in the clinical setting of the disease.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* genetically confirmed diagnosis of USH2A-RP
* availability of genetic tests to assess the pathogenic variants

Exclusion Criteria:

* inability to understand and sign the written informed consent form
* any inflammatory, infectious or degenerative eye disease
* media opacities resulting incompatible with good imaging quality
* uncontrolled systemic, metabolic, autoimmune neuroinflammatory and neurodegenerative disease
* ophthalmologic surgery within the previous six months
Comparison of Two Under Knee Lower Limb Bypass Types:Endothelialised Prosthesis Versus Autologous Vein Graft

The aim of this project is to improve the hemocompatibility of vascular prosthesis with a complete covering of its endoluminal surface with autologous endothelial cells. The objective is to obtain a better bypass permeability with arterial prosthesis replacing low diameter vessels in lower limbs

Physiological vascular endothelium is an hemocompatible and thrombus resistant surface and none of the materials used for revascularisation owns these properties. The aim of this project is to improve the hemocompatibility of vascular prosthesis with a complete covering of their endoluminal surface with autologous endothelial cells. This strategy, that plans to associate an artificial component of synthetic origin and cellular component is a bioartificial vascular substitute concept. First results obtained by an austrian team are really encouraging (with more than 100 patients during last 10 years). Thus, the main objective of this study is to compare efficacy in terms of grafts with endothelialised PTFE prosthesis with great saphenous autologous vein graft for under knee arterial popliteal revascularisation of lower limbs.

This is a phase III, randomised equivalent trial. It is open labelled, with 2 parallel well balanced groups. Forty patients will be randomised. A short segment of the cephalic vein will be cut and some blood will be sampled in patients randomised in the ePTFE group. Endothelial cells of the cephalic vein will be isolated, cultured, with autologous serum, and then amplified before sowing of the internal face of PTFE prosthesis, previously covered with a biological glue clinically validated. Before prosthesis implantation, systematic quality controls will be performed. Implantation will be planned 3 weeks after venous sampling. Eventual failure of cellular culture or prosthesis covering will lead to an autologous vein graft. People randomised in the second group will receive an autologous saphenous vein graft.

The primary outcome is to demonstrate the equivalence of time dependent permeability rate between endothelialized PTFE and autologous vein graft. Equivalence between both technics would allow to preserve autologous saphenous vein for later distal bypasses (where it is the best technic) or for coronary bypasses.

Eligibility Criteria:
Inclusion Criteria:

Age above 18, male or female, II to IV arteritis level with intermittent limping, under knee femoro popliteal bypass indication.

Available saphenous vein, no major trophic trouble, no contra indication to the use of prosthesis.

-

Exclusion Criteria:

-
Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the following criteria were considered for enrollment into the study :

·Ambulatory, healthy postmenopausal women with :

* Natural menopause and more than 5 years after their last menstrual period.
* Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).

Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).

Exclusion Criteria:

Subjects with any of the following criteria were not considered for enrollment into the study :

·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
Effects of Apelin on the Lung Circulation in Pulmonary Hypertension

The purpose of this study is to determine the effects of Apelin on the lung circulation. The investigators hypothesise that Apelin will relax the lung blood vessels and improve the pumping ability of the heart.

Apelin is an endogenous peptide with physiological actions in the cardiovascular system and is abundantly expressed in the pulmonary vasculature. Pre-clinical models and preliminary clinical data indicate that Apelin deficiency may mediate or contribute to the pathogenesis of pulmonary hypertension and heart failure. Apelin causes peripheral vasodilatation and increased cardiac contractility. The investigators will determine the effects of Apelin on the pulmonary circulation in 3 groups; healthy control, people with pulmonary arterial hypertension and people with pulmonary hypertension due to heart failure. Each subject will receive both Apelin infusion and saline placebo infusion in a crossover design. The infusions will be given in a random order which the subject and the investigator will be blinded to. The investigators hypothesise that Apelin will have more marked pulmonary haemodynamic effects than that observed in the systemic circulation. Moreover, the investigators propose that Apelin will have a marked vasodilatory effect on the human pulmonary vasculature and reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension or pulmonary hypertension due to left heart disease.

Eligibility Criteria:
PULMONARY ARTERIAL HYPERTENSION

Inclusion Criteria:

* Pulmonary Arterial Hypertension which is Idiopathic, Heritable, associated with connective tissue disease or associated with drugs/toxins
* mean pulmonary artery pressure \>/= 25mmHg
* pulmonary capillary wedge pressure \< 15 mmHg
* normal/reduced cardiac output
* stable
* WHO functional class II - IV

Exclusion Criteria:

* significant left ventricular dysfunction
* chronic lung disease (FEV1 \< 60% or abnormal CT)
* chronic thromboembolic pulmonary hypertension

HEART FAILURE

Inclusion Criteria:

* stable on treatment for 3 months prior to study
* NYHA grade II - IV
* ejection fraction \<35%, left ventricular end-diastolic diameter \> 5.5 cm and/or shortening fraction \< 20%
* Tricuspid regurgitant velocity \>/= 3.0 m/s

HEALTHY VOLUNTEERS

Inclusion Criteria:

* mean pulmonary artery pressure \< 25 mmHg
* tricuspid regurgitant velocity \< 2.5 m/s

Exclusion Criteria:

* obstructive coronary artery disease

ALL SUBJECTS

Exclusion Criteria:

* bleeding diathesis
* women of childbearing potential without pregnancy test
* systolic blood pressure \> 190 mmHg or \< 100 mmHg
* malignant arrhythmias
* renal or hepatic failure
* haemodynamically significant valvular heart disease
* severe or significant co-morbidity
* pacemaker
* already taking part in another trial
* lack of informed consent