cyrilzakka/clinical-trials huggingface dataset:
Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.

This study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, this work has important implications for improving the overall health of this population.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* BP 120/80 or higher \*(bps will be checked weekly first 4 weeks to ensure \< 130/80 - IF bp remains \> 130/80 we will administer other bp meds per JNC VII guidelines)
* CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

* Known significant CVD (history of Myocardial infarction (MI), recurrent stroke, or New York Heart Association (NYHA) class III or greater).
* Serum potassium \> 5.2 meq/L
* Known allergy or hypersensitivity to ACE inhibitor or ARB
* Female of childbearing age not practicing contraception
* Current treatment with an Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (ARB) (Note: can participate if on ACE-I after 6 week washout period)
* History of ACE-I induced angioedema
* History of angioedema, hereditary or idiopathic
* Persons lacking consent capacity

  * 500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
* Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.

Exclusion Criteria:

* Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
* Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.
Prevention of Micro-architectural Bone Decay in Males With Non-metastatic Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

Less than 20% of men in whom prostate cancer is diagnosed early die from it. Cardiovascular disease is the most common cause of death in men with early prostate cancer. A commonly used form of treatment for prostate cancer is androgen deprivation therapy (ADT). ADT, while effective for the treatment of prostate cancer, has been linked to undesirable side effects, such as an increased risk of bone fractures and diabetes. Bisphosphonates, a class of drugs that prevent bone resorption, have been show to reduce the loss of bone mineral density that occurs as a consequence of ADT, but the effects of bisphosphonates on preservation of bone architecture is unknown.

This project has two main goals:

To assess prospectively, in men with prostate cancer receiving ADT, the effect of:

1. the intravenous bisphosphonate zoledronic acidon ADT-induced microarchitectural decay of bone structure.
2. ADT on insulin resistance and glucose metabolism. We will recruit 100 ambulatory men with non-metastatic prostate cancer who are about to commence a three year course of ADT as per routine clinical practice at Austin Health. Men will be randomised to receive either intravenous zoledronic acid (Aclasta, Novartis Pharmaceuticals) or placebo at baseline and after 12 months of ADT. Men with contraindications to zoledronic acid will be excluded from the study. All 100 study subjects will have clinical and laboratory assessment at baseline, and at 3, 6, 12, 18 and 24 months (study end), and imaging studies at baseline and at 6, 12 and 24 months.

The study protocol is outlined in more detail below (Please see flow chart included in the in

PICF):

Clinical and laboratory assessment:

Full medical history, physical examination and quality of life assessment using the SF-36 questionnaire. Laboratory studies will include: oral glucose tolerance test (3, 12 and 24 months Commercial-in-Confidence only) and measurements of measure total testosterone, fasting glucose, C-peptide, HBA1c, bone turnover markers.

Imaging studies:

1. Bony micro-architecture by high resolution quantitative computed tomography
2. Bone mineral density and body composition by DEXA This project will have no direct benefit for the subjects involved in this study; however, it will improve our understanding on the effect of zoledronic acid on bone microarchitecture in men with prostate cancer receiving ADT. It will also help us to better understand the effect of ADT on insulin resistance and glucose metabolism.

Not desired

Eligibility Criteria:
Inclusion Criteria:

* Men with prostate cancer receiving ADT

Exclusion Criteria:

* Contraindications to Zoledronic acid
Insulin Resistance and Insulin Secretion

This is a pilot study to examine the prevalence of metabolic risk factors (impaired insulin release and impaired insulin sensitivity) for type 2 diabetes mellitus in children and adults from a population that is at high risk for this disease. We hypothesize that at least one of these pre-diabetic traits will be evident in a large proportion of relatives of known type 2 diabetic children as compared to a control group of subjects without a family history of type 2 diabetes. By isolating these traits, it will be possible to determine the relative contributions of genes and environment to each trait and to identify those at risk for subsequent development of type 2 diabetes by virtue of having one trait. Ultimately, those individuals at risk, especially those with impaired insulin release, would hopefully benefit from intervention to prevent the weight gain that will 'unmask' their underlying pancreatic dysfunction and thus prevent or retard the development of type 2 diabetes.


Eligibility Criteria:
Ascertainment criteria for probands:

* age 10-20 years and
* obesity (BMI \>85% for sex and age)
* diabetic criteria as described above or family history (first or second degree relative) with type 2 diabetes
TK-based Suicide Gene Therapy for Hepatocellular Carcinoma

The purpose of this study is to determine whether activation of a prodrug after intratumoral gene transfer is safe in humans, and to determine dose levels for further clinical development.

The study is a phase I clinical trial evaluating the intratumoral injection of defective adenovirus containing HSVtk (the thymidine kinase of herpes simplex virus), in patients with advanced hepatocellular carcinoma that were not amenable to curative therapy. The study was conducted in a single center in Spain. Five consecutive cohorts of two patients received increasing doses of the vector by intratumoral injection and equal doses of either intravenous ganciclovir or oral valganciclovir. The dose received by each consecutive cohort of patients was progressively higher according to a prefixed scale.

Eligibility Criteria:
Inclusion Criteria:

* Unequivocal diagnosis of hepatocellular carcinoma according to histological confirmation or EASL-AASLD criteria
* Contraindication for surgical treatment of the disease
* Detectable disease by imaging
* Ability to give informed consent and to express the willingness to fulfill protocol requirements during the study

Exclusion Criteria:

* Current pregnancy or breast-feeding
* Acute infection
* Positive anti-HIV antibodies
* Hematologic alterations not attributable to hypersplenism, or in any case, intense neutropenia and thrombocytopenia, defined as neutrophil count lower than 0,5/pL or platelet count lower than 20/pL
* Participation in other clinical trial during the previous month
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
Low Versus High PEEP in Noninvasive Ventilation for Hypoxemic Respiratory Failure

Current study aimed to explore the effect of high PEEP during noninvasive ventilation among hypoxemic patients with acute respiratory failure.

This was a 1:1 randomized control trial to explore the effect of high versus low PEEP in noninvasive ventilation hypoxemic patients with acute respiratory failure. Several ICUs in China performed this study. In the high PEEP group, the PEEP maintained at 10-15 cmH2O, the inspiratory pressure maintained at 15-20 cmH2O. In the low PEEP group, the PEEP maintained at 5 cmH2O, the inspiratory pressure maintained at 10-20 cmH2O. The primary outcome was incidence of noninvasive ventilation failrue.

Eligibility Criteria:
Inclusion Criteria

* age between 16 and 85 years
* use of dedicated noninvasive ventilator
* PaCO2 ≤50 mmHg
* PaO2/FiO2 ≤300mmHg
* expectation of noninvasive ventilation \>12 hours
* consciousness (Kelly score ≤3 or GCS≥13)

Exclusion Criteria

* use of noninvasive ventilation before randomization \> 24 hours
* use of noninvasive ventilation due to heart failure, asthma, acute excerbation of COPD
* presence of contraindication of noninvasive ventilation such as malformation, rencent pulmonary or esophageal surgery et al.
* end stage disease (expectation of life \< 6 months)
* pneumothorax
* noninvasive ventilation intolerance
* refusal of paticipation
* pregant woman
* requirement of emergency intubation
Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries.

The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery

Exclusion Criteria:

* chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient,
* Patients with allergies to one of the drugs used in the study.
The Role of Vitamin D in the Pathophysiology of Chronic Failure

Patients will undergo at baseline and regular intervals:

* clinically indicated bloodwork/urine and echocardiogram testing
* biomarker studies

Upon enrolment in the study patients will be divided into 4 groups normal, mildly deficient and severely deficient. Normal and mild vitamin D levels will receive no treatment while severe Vitamin D deficiency will be randomized (50/50) to receive no treatment or vitamin D treatment. They will be seen in the heart failure clinic every 6 months. The patients will be followed for 26 months.

The inclusion criteria for the study is:

* an EF ≤40% within the last 12 months before recruitment
* established diagnosis of heart failure
* \>18 years of age
* patients will vitamin d levels of sufficient, mild deficiency and severe deficiency

The exclusion criteria is:

* hypercalcemia
* known hypersensitivity to Vitamin D
* patient unwilling to comply with study requirements
* any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
* women of child bearing potential
* a patient currently taking vitamin d
* severe renal impairment estimated glomerular filtration rate (eGFR) \<30

Eligibility Criteria:
Inclusion Criteria:

* an ejection fraction (EF) ≤40% within the last 12 months before recruitment
* established diagnosis of heart failure
* \>18 years of age
* patients with Vitamin D levels of sufficient, mild deficiency and severe deficiency

Exclusion Criteria:

* hypercalcemia
* known hypersensitivity to Vitamin D
* patient unwilling to comply with study requirements
* any other disease other than heart failure that can alter the patients quality of life over a period of 6 months
* women of child bearing potential
* a patient currently taking vitamin d
* severe renal impairment eGFR \<30
Sustained Attention Abilities in Schizophrenia

Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60 years (include)
* men or women volunteers, hospitalized or not
* subject affiliated to an health insurance
* subject having signed an informed consent (for patients):
* presence of DSM-IV TR criteria for schizophrenia (American Psychiatric Association, 1994)

Exclusion criteria

* a major somatic disorder or non stabilized
* medical history likely to affect cerebral anatomy or to be linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)
* any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)
* sensory disabling impairments, and specifically visual acuity \< 8
* general anaesthesia during the 3 months before the study
* pregnancy (declared by the subject)
* persons in an emergency situation
* persons deprived in any way of their liberty
* persons in period of exclusion in an other protocol
* use of psychotropic substance during the 3 weeks before the study
* use of benzodiazepines
Clareon PanOptix Pro vs. Clareon PanOptix - Study A

The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Eligibility Criteria:
Key Inclusion Criteria:

* Understand and sign an ethics committee-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
* Other protocol-defined exclusion criteria may apply.
Effects of Bowen's Therapy and Post Isometric Relaxation Techniques in Patients of Temporomandibular Joint Disorder

the aim of this study to compare effects of Bowen's therapy and post isometric relaxation techniques on pain, range of motions and function in patients with TMJ disorder.

Temporomandibular joint disorder is a very common and serious problem of mouth and face pain related condition that mostly effect in quality of life and compromise the daily functional activities of a patient. It can be caused by any trauma, biomechanical, neuromuscular and psychologically related problems. Patient may come in acute and chronic phase. Patient condition mostly vary and worsen day by day, it thoughts that TMJD going interval throw out the life span of patient. Medicine, physical therapy interventions and surgical procedures are use in treatment of TMJ disorder. This study will conducted the comparative effects of Bowen's and post-isometric relaxation techniques on pain, ROM and functions in TMJ patients.

The study would be randomized clinical trial. Total 24 subjects will be assigned randomly into two groups by using lottery methods. Baseline treatment will be same (ultrasound, tapping) in both groups. Group A will be treated by Bowen's therapy and Group B will be treated by post-isometric relaxation technique for 30 min session (2 sessions/week and total 4 weeks). Numeric Pain Rating Scale, maximum mouth opening inter-incisal rural and jaw functional limitation scale-20 would be used as an outcome measurement tool for pain, range of motion and function respectively. Measurement will be taken at Baseline and at the end of the 4th week's treatment session. After assessing the normality data will be analyzed by using parametric / nonparametric test.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female Participant aged 20-50.
* Pain on function.
* Restricted jaw movement.
* Clicking, popping sound.
* Tenderness in muscle of mastication.
* Joint tenderness.
* With a restricted mandibular range of motion 40mmor less measured interincisal.

Exclusion Criteria:

* Systematic arthropathy such as.
* Rheumatoid arthritis
* Fracture of jaw or TMJ.
* Malignant history of face and jaw.
* Prevent history of jaw or TMJ surgery.
* Subject has/ had dental/ orthodontic treatment within the past 14 days
Bilateral Bispectral Index (BIS) Study

The purpose of this study is to assess real time changes in raw and processed EEG in relation to the clinical and radiological evidence of cerebral vasospasm.

Subarachnoid hemorrhage (SAH) is a prevalent and morbid condition (45%-30 day mortality). One of the major causes of reduced cerebral blood flow (CBF) after initial SAH is cerebral vasospasm. Early treatment of cerebral vasospasm (\< 2 hr) is necessary for improved neurologic outcome. Hence, there is significant interest in development of a monitor. The most common bedside diagnostic tool is Transcranial Doppler (TCD) which is controversial given its low sensitivity and specificity. TCD is not a continuous monitor and is user dependent. Many centers rely on Cerebral Angiography for diagnosis of vasospasm; however angiographic spasm does not correlate with outcome. EEG can detect changes in cerebral blood flow which precede clinical decline but is technically difficult to perform and not practical for continuous monitoring.

Processed EEG monitors have become somewhat popular in the operating setting for assessment of depth of anesthesia. The recent introduction of bilateral 4 channel disposable probes presents to opportunity to use EEG as a non-invasive continuous monitor for vasospasm. We propose a prospective observational study to assess real time changes in raw and processed EEG which we will correlate with clinical and radiologic evidence of vasospasm. Our primary clinical endpoint will be the determination of delayed cerebral ischemia. This modality could prove to be a significant clinical advantage for patients suffering from SAH.

Eligibility Criteria:
Inclusion Criteria:

* Adult men or women of any age and ethnicity within 48 hours of subarachnoid hemorrhage (SAH)

Exclusion Criteria:

* Age \< 18 years
* Greater than 48 hours past the initial hemorrhage
* Previous history of stroke of any etiology
* Inability to consent for themselves or have a proxy to consent for them (implied consent)
Physiopathological Study of Autonomic Failure in Parkinson's Disease

The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease
* ages 45 to 80 years, both genders
* patients who signed informed consent

Exclusion Criteria:

* autonomic function modifying treatment
* pre-existing neuropathy or risk factors for neuropathy
* dementia
* colonic disorders
* coagulation disorders (may be due to treatment)