cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder

This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study.

This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication. Efficacy for treatment of depressive symptoms is not a goal of this study. Fifty subjects will receive study drug for seven days. Thirty subjects will receive ABT-436 and twenty subjects will receive placebo. Blood, urine and saliva samples will be obtained, both before and during study drug administration, to measure ABT-436 pharmacology. Safety will be assessed throughout the study, including at two follow-up visits after completion of study drug administration.

Eligibility Criteria:
Inclusion Criteria

1. Age between 18 to 55 years, inclusive. 2. Body Mass Index is 20 to 35 kg/m2, inclusive. 3. A primary Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of major depressive disorder.

4. Mild-to-moderate depressive symptoms at Screening. 5. A condition of general good physical health. Exclusion Criteria

1. Pregnant or breast-feeding female.
2. Use of any medication within 4 weeks prior to Day -2, unless the dose has been stable for 4 weeks, no dose change is anticipated during the study, and the medication is specifically allowed for this study, OR prior as needed (PRN) use of the medication is specifically allowed for this study.
3. Use of fluoxetine or aripiprazole within 8 weeks prior to Day -2.
4. Positive screen for drugs of abuse/alcohol, recent history of drug/alcohol abuse or smoking.
5. A current or past history of major depressive disorder with psychotic features, bipolar disorder, schizophrenia or other psychotic disorder, mental retardation, or mental disorder due to a general medical condition.
A Study of PRX-03140 in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week double-blind treatment period.


Eligibility Criteria:
* Men or Women with a clinical diagnosis of Probable AD
* MMSE score 12 to 22 inclusive
* Age \>50 and \<90 years
* Received at least 4 months of a stable dose of donepezil 10mg QD for AD
* Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 months
* Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
* No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
* No diagnosis of vascular dementia
* No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible
* No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
* No cognitive rehabilitation within 6 months of the study
* Subject has a regular caregiver willing to attend all study visits
* Signed informed consent by the subject (and legal guardian, if applicable)
* No history of drug or alcohol abuse
* No clinically significant laboratory abnormalities or medical history
* No investigational drug within 30 days of Randomization
* Cannot receive memantine within 2 months of enrollment
* No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment
* No clinically significant ECG abnormalities or cardiac history
* No history of uncontrolled seizure disorder within 12 months of enrollment
* Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
* No history of malignancy within 3 years of randomization
* Women cannot be pregnant or breastfeeding
Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring

The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥18 and ≤75 years of age
* Clinical diagnosis of diabetes
* Diabetes duration ≥ 1 year
* HbA1c ≥7.2%
* Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy

Exclusion Criteria:

* Taken prednisone or cortisone medications in the previous 30 days
* Currently pregnant or planning pregnancy during the study period
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Unable to follow the study protocol
* Unable to speak, read and write in English
The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence

The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

This randomized clinical trial includes 115 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour pad test and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of three treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training and G3: Control Group).

Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 50 and 75 years old;
* Submitted to radical prostatectomy;
* With complaints of urinary incontinence;
* That completed one month of surgery;

Exclusion Criteria:

* History of incontinence;
* Transurethral resection of the prostate;
* Diagnosis of neurological or cognitive impairment;
* Subjects who were unable to attend treatment sessions, due to distance or physical limitations.
The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls

The purpose of this study was to examine the impact of a 12-week jump rope exercise program on blood pressure, arterial stiffness, vasodilating and vasoconstricting factors, inflammatory markers, and body composition in prehypertensive adolescent girls. Forty prehypertensive adolescent girls participated in this study. The girls were randomly divided into the jump rope exercise intervention group (EX, n=20) and control group (CON, n=20). The EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate in any structured or unstructured exercise protocol. Blood pressure, arterial stiffness, plasma nitrate/nitrite levels, endothelin-1, C-reactive protein, and body composition were measured before and after the 12-weeks study.


Eligibility Criteria:
Inclusion Criteria:

* prehypertensive
* sedentary (no regular exercise training or physical activity within the last year)
* no weight loss diet during the last six months

Exclusion Criteria:

* pregnancy
* chronic disease
* daily medication use (including antioxidants and weight loss supplements)
Comparing the Efficacy of Continuous and Pulsed Ultrasound Treatments in Lateral Epicondylitis

Objectives: The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.

Patients and Methods: Fifty one patients diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound, pulsed ultrasound and placebo groups by using closed envelop method. First group received continuous ultrasound treatment. Second group received pulsed ultrasound treatment in proportion as. Third group received of placebo treatment. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).

The purpose of this study was to investigate the efficacy of continuous and pulsed ultrasound treatments in lateral epicondylitis and to compare the efficacy of these two treatments against each other and placebo.

Fifty one patients (33 women, 18 men) diagnosed with lateral epicondylitis were included to the study. Patients were randomised to continuous ultrasound (n=17), pulsed ultrasound (n=17) and placebo (n=17) groups by using closed envelop method. First group received 10 sessions of 1 W/cm2 and 1,5 MHz continuous ultrasound treatment. Second group received 10 sessions of 1 W/cm2 and 1,5 MHz pulsed ultrasound treatment in proportion as 1:4. Third group received 10 sessions of placebo treatment with the same device seemed to be working but without delivering any output. Resting and moving pain levels of the patients were evaluated by using visual analog scale. Muscle strength was evaluated by using dynamometer. For functional evaluation Duruoz's hand index and Patient-Rated Tennis Elbow Evaluation (PRTEE) scales were used. Evaluations were made at baseline, at the end of the therapy, and one month after the therapy. In addition, at baseline and at the end of the therapy, the thickness of the common extensor tendon was measured by using ultrasonic imaging (USG).

Eligibility Criteria:
Inclusion Criteria:

* aged between 18-70 years
* pain on the lateral side of the elbow for less than six months
* tenderness over the lateral epicondyle
* pain during extension of wrist and fingers

Exclusion Criteria:

* upper extremity and neck disorders
* other elbow pathologies
* presence of tendon rupture
* usage of non-steroidal anti inflammatory drugs
* joint limitations due to a previous radius/ulna fracture
* previous elbow surgery
* osteoporosis, malignancy, hemophilia, neurologic deficit(s) in the ipsilateral upper limb
* cognitive disfunction
Pocket Echocardiography System (PES) for Detection of PDA in Neonates

This is a single-center, feasibility study involving all neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents will be approached and provided a description of the study. No written consent will be requested, but parents have the option of opting out. Each patient will have a 5 minute Pocket echocardiography system scan followed by a full echo performed on a traditional full featured echo system. The objective is to assess if the current Food and Drug administration (FDA) approved Pocket echocardiography system (PES) can detect patent ductus arteriosus (PDA) in neonates as comparable to traditional full featured echo systems (FFES) and/or physical exam alone.

All newborns admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation will be included in this study. Parents will be approached and provided a description of the study. No written consent will be requested, but parents have the option of opting out. If parents agree to be part of this study, a 5-minute PES scan will be performed first so as to not bias the sonographer. Then, a full echocardiogram study will be performed on a traditional FFES. The scans will be performed at the bedside. The images will be reviewed and compared by fellow and/or attending and by experienced sonographer. The scans will include short axis view, ductal view and arch view.

The objective of the study is to assess if the current FDA approved PES can detect PDA in neonates as comparable to traditional full featured echo systems and/or physical exam alone. Using PES for PDA diagnosis will be an accessible, economic and effective way of complementing the findings in our physical exam by increasing diagnostic accuracy, and detecting PDA's at the bedside comparable to a full size traditional echocardiographic system.

Eligibility Criteria:
Inclusion Criteria:

* All newborn infants with orders for cardiac echocardiography evaluation in clinically stable condition

Exclusion Criteria:

* Known congenital heart disease.
* Clinically unstable (Meaning by unstable patients: Those patients that need cardiopulmonary resuscitation, or in maximum ventilatory or inotrope support and in immediate need for Extracorporeal Membrane Oxygenation or major surgery or whenever the physician attending responsible for the clinical care of the patient considers that a traditional echo needs to be done urgently)
FLEX Arteriovenous Access Registry

Evaluation of the FLEX Vessel Prep system combined with angioplasty in the treatment of arteriovenous access stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Hemodialysis patient currently scheduled to undergo an intervention of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities.
2. The patient is ≥18 years of age. Patient is legally competent, has been informed of the study, voluntarily agrees to participate, and has signed the inform consent form.
3. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
4. The patient understands the study and is willing and able to comply with follow-up requirements.
5. The patient is willing to provide informed consent.

Exclusion Criteria:

1. The patient has a known or suspected systemic infection.
2. The patient has a known or suspected infection of the hemodialysis graft.
3. The patient has an untreatable allergy to radiographic contrast material.
4. In the opinion of the operating physician, the patient's hemodialysis access is unsuitable for endovascular treatment.
Tissue Glue (Cyanoacrylate) Versus Conventional Suture in Kidney Donors

By means of a prospective, randomised trial the investigators want to examine skin closure in living donors - subjected to laparoscopic, hand-assisted nephrectomy - by tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).

Study hypothesis: (i) Latest generation tissue glue (Cyanoacrylate (Liquiband)) is at least as good as conventional suture regarding wound healing/complications. (ii) Peroperatively, tissue glue is faster than conventional suture.

At Oslo University Hospital Rikshospitalet, the principal investigator have since 1998 been involved in developing minimally invasive techniques for living donor nephrectomy (LDN). Since 2009 all LDN's have been performed by laparoscopic, hand-assisted technique; by means of 'handport' and 3 laparoscopic ports (5/12 mm).

The investigators consider use of tissue glue instead of suture as another small step towards less invasive surgery.

Since 2000 there has been many reports, and even Cochrane reviews on the use/safety of tissue glue for skin closure. However, very few randomised studies have been performed with the latest generation tissue glue; Cyanoacrylate, with a critical mixture of octyl-:butyl-acrylate. And in Norway there has been no research in this field.

On this basis, the investigators intend to examine skin closure in living donors, a very healthy/homogenous study population, subjected to laparoscopic, hand-assisted nephrectomy, by a prospective, randomised trial: Tissue glue (Cyanoacrylate (Liquiband)) versus conventional, intracutaneous suture and dressing (1 : 1; 30 + 30 donors).

Primarily, the investigators will examine wound healing/complications by wound observation at postop. days 2 + 4 + 'at departure', with numerical scales for secretion, gaps, edema, rubor - as well as infection/bacteriology and complications/ reinterventions. In addition, the donors' self-satisfaction with the wound handling will be registered. Furthermore, the investigators will look at time consumption during surgery, price, stay in hospital and cosmesis judged at 2-3 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Living kidney donor with informed consent
* Approved comprehensive work-up/evaluation at local hospital

Exclusion Criteria:

* Allergy towards acrylate or similar chemicals
* Unable to communicate in norwegian language
Validation of PINI Score in ICU

Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU

Main objective: to evaluate the relationship between PINI score and biomarker related to PINI, and 28 days mortality in ICU

Secondary objectives:

* to evaluate the relationship between PINI score (and biomarkers related to PINI) and morbidity in ICU : SOFA score, duration of ventilation, duration of antibiotherapy, duration of extra renal epuration, length of stay
* to evaluate the relationship between PINI score (and biomarkers related to PINI) and nutrition in ICU (type of nutrition, calorie content)

Eligibility Criteria:
Inclusion Criteria:

* Both patient in ICU

Exclusion Criteria:

* minor patient
* No possibility to calculate PINI score
* Pregnant woman
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study

The objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age;
* Patient has proven informed consent;
* Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
* Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;
* Stable medical situation;
* Stable geographical situation;

Exclusion Criteria:

* Permanent or paroxysmal AV block ≥ II;
* Permanent Atrial fibrillation/Atrial flutter;
* Device Replacement;
* Patient with a poor echocardiographic window;
* Patient already implanted with the right ventricular lead not in the apical position;
* Subjects with a dual chamber pacemaker, implanted later than six months;
* Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
* Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
* VpS or IRSplus algorithm contraindications;
* Age \< 18 years;
* Life expectancy \< 12 months;
* Cardiac surgery planned within the FU period;
* Participation to another clinical investigation;
Efficacy of Splinting, Exercise and Electrotherapy on Hallux Valgus

The aim of this study was to investigate the effects of splinting, exercise and electrotherapy on the hallux valgus (HV) angle, and foot-specific health-related quality of life. Sixty women (120 feet) with bilateral HV deformity were randomly assigned to one of three groups - an HV night splint (SP) group, an exercise (EX) group, and a high-voltage galvanic stimulation (EL) group. Angular degrees (hallux interphalangeal, HV, and intermetatarsal angles expressed as angles A, B and C, respectively) were determined before enrollment (t0) and three months after treatment (t2). Foot-specific quality of life was assessed using the Manchester-Oxford Foot Questionnaire (MOFQ) at t0, after one month (t1), and at t2. All groups exhibited significant changes in the A, B, and C angles and outcome measures (p ≤0.001). Decreases in the A and C angles, and MOFQ-Pain subscale scores, were higher in the SP group than in the other two groups (p\<0.05). C angle at t2, MOFQ-Walking score at t1 and t2 and MOFQ-Pain subscale score at t1 were lower in the SP group (p\<0.05).


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of HV confirmed by an orthopedist experienced in foot surgery
* female gender
* bilateral HV deformity
* aged 18-60 years.
* Patients were then selected based on an HV deformity degree of '2' or '3' on the Manchester scale before randomization

Exclusion Criteria:

* Patients with HV deformity degrees less than '2' or more than '3' according to the Manchester scale
* Patients with systemic disease, cognitive or mental disturbance, a history of surgery to the lower extremity, or previous use of any foot splints were excluded.
Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.

This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.

Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.

Eligibility Criteria:
Inclusion Criteria:

* Age:6 months-7 years.
* ASA, American Society of Anesthesiology, II and III .
* Patients undergoing cardiac surgeries with midline sternotomy incision.

Exclusion Criteria:

* Patients whose parents or legal guardians refusing to participate.
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy.
* Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
* Elevated liver enzymes more than the normal values.
* Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).