cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)

The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.

Balance alteration is a risk factor for falls in elderly individuals that has physical, psychological and economic consequences. The objectives of this study are to evaluate the usefulness of an intervention utilizing the NintendoTM Wii console in order to improve balance, thereby decreasing both the fear of falling as well as the number of falls, and to evaluate the correlation between balance as determined by the console and the value obtained in the Tinetti tests and the one foot stationary test.

Methods/Design: This is a controlled, randomized clinical trial of individual assignment, carried out on patients over 70 years in age, from five primary care centers in the city of Mataró (Barcelona). 380 patients were necessary for the intervention group that carried out the balance board exercises in 2 sessions per week for a 3 month period, and 380 patients in the control group who carried out their usual habits. Balance was evaluated using the Tinetti test, the one foot stationary test and with the console, at the start of the study, at the end of the intervention (3 months) and one year later. Quarterly telephone follow-up was also conducted to keep track of falls and their consequences.

Discussion: The study aimed to connect the community with a technology that may be an easy and fun way to assist the elderly in improving their balance without the need to leave home or join rehabilitation groups, offering greater comfort for this population and decreasing healthcare costs since there is no need for specialized personnel.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 70 or older, of both genders,
* with the ability to walk, with or without technical assistance
* who are available for a one year period and who agree to participate in the study, signing an informed consent form

Exclusion Criteria:

* Home-bound patients
* individuals who are already receiving rehabilitation treatment on walking
* those with moderate cognitive deterioration (Pfeiffer ≥5)
* terminally ill patients
* individuals who do not have a telephone
* those with communication difficulties: cognitive and/or sensory deterioration, language barriers
Different Approaches to Maternal Hypotension During Cesarean Section

The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.

The supine hypotensive syndrome of pregnancy is induced by compression of the inferior caval vein by the enlarged uterus. It occurs in approximately 8% of pregnant women at term. More patients may develop an asymptomatic variety of this syndrome in the supine position. The hypotensive effect of spinal anesthesia per se may thus be aggravated in a significant number of term parturients. A preoperative supine stress test (SST) before elective cesarean section under spinal anesthesia has been shown to predict severe systolic hypotension with reasonable accuracy.

Different strategies have been proposed for the management of this complication; they can be divided into pharmacological and non-pharmacological ones.

According to pharmacological strategies, vasoactive drugs are used to treat hypotension induced by sympathetic efferent blockade following spinal anesthesia. To this end, α-agonist ephedrine is commonly considered the best choice because of its minimal impact on the fetoplacental circulation. However, excessive use of ephedrine may be detrimental to neonatal well-being because of its vasoconstrictor effect on fetoplacental circulation.

Non-pharmacological treatments may represent a valuable, safer alternative. According to many authors non-pharmacological treatments aimed at removing the cause of aorta-caval compression syndrome are to be preferred because more appropriate from an etiopathogenetic point of view. The use of a wedge-shaped cushion placed under the right hip is a well-known non-pharmacological strategy which allows the uterine left lateral displacement and, consequently, the removing of the compression from the inferior vena cava.

The aim of the present study is to compare, through the evaluation of neonatal well-being, the efficacy of these approaches to hypotension after spinal anesthesia for elective Caesarean section in parturients affected by aorto-caval compression.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing spinal anesthesia for elective Cesarean section
* Patients in ASA Physical Status Class I or II
* Informed written consent to participation
* Positive Supine Stress Test

Exclusion Criteria:

* Any known fetal pathology
* Indication to general anesthesia
* Known allergy to any of the study drugs
Role of Herbs in the Management of Asthma

The aim of this trial is to study the effect of a polyherbal capsule containing four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of bronchial asthma.

A randomized placebo controlled double blind trial. Four herbs that have proven efficacy on bronchial asthma will be given. Equally matched placebo will be given randomly to patients. Each arm active herbs and placebo will be compared against the Formoterol+Fluticasone Single maintenance and reliever therapy(SMART) and conventional therapy. All the parameters of Bronchial Asthma(BA) will be compared between the randomized groups.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 18 years.
* History of asthma documented by a physician for at least 6 months
* Patients on steroid therapy for at least 4 weeks.
* If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy.
* The subject agrees to participate in the study

Exclusion Criteria:

* Any one of the following

  * Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
  * Abnormal hepatic and renal function
  * Pregnant, attempting to conceive, or lactating women
  * Current or former employees of organic India
  * Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  * Physician uncomfortable with patient compliance to treatments or follow up.
  * Non-compliance to tobacco cessation therapy.
Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections

SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in patients with wet age related macular degeneration who have incomplete response with routineranibizumab treatment.


Eligibility Criteria:
Inclusion Criteria:

Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study

1. Age \>50 years
2. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein Angiography in the study eye
3. Presence of intra or sub retinal fluid on SDOCT in the study eye
4. Current treatment with uninterrupted routine (q35 +/- 7 days) ranibizumab started at least 3 months before Baseline (Week 0), having received at least 3 consecutive ranibizumab injections and no more than 24 injections maximum, with all ranibizumab injection intervals being 35 +/- 7 days apart
5. ETDRS BCVA 20/30 and 20/320 (letter score of 78 to 25) in the study eye

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. Presence of purely serous pigment epithelial detachment in the study eye
2. Any scarring or fibrosis involving the center of the fovea in the study eye
3. Prior ocular or systemic treatment/surgery for wet AMD other than ranibizumab IVI monthly (in study the eye)
4. Prior prn or treat and extend treatment with ranibizumab IVI between 3 to 24 months before Baseline (Week 0) in the study eye
5. Prior treatment with systemic anti-VEGF therapy within the last 6 months in the study eye
6. History of vitreous hemorrhage within the last 6 months in the study eye
7. Prior vitrectomy in the study eye
8. History of retinal detachment in the study eye
9. History of macular hole of stage 2 and above in the study eye
10. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
11. Any intraocular or periocular surgery/invasive procedure during the previous 6 months except lid surgery in the study eye
12. Prior trabeculectomy or other filtration surgery in the study eye
13. Uncontrolled glaucoma (≥ 25mmHg despite treatment with anti-glaucoma medications) in the study eye
14. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.
15. Scheduled for intraocular surgery during the study period in the study eye
16. Concurrent retinal disease (i.e. diabetic retinopathy, retinal vein occlusion, retinal detachment, uveitis) in the study eye
17. History of ocular or periocular infection/inflammation in the study eye within the last 4 weeks of screening
18. Pregnant or breastfeeding
Global Physiotherapy in ICU Patients With High Risk Extubation Failure

This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.

The extubation failure rate is 15% on average in intensive care units, but can reach 30% within 48 hours after extubation in high risk patients. Their characteristics are : age \> 65 years, respiratory disease, body mass index \> 30 kg / m², intubation for more than 7 days, first extubation failure, and patient with ineffective cough associated with bronchial obstruction. The main reason for reintubation in these patients is acute respiratory failure with an ineffective cough, a bronchial obstruction, and neuromyopathy. On these three components, the physiotherapist can apply specific techniques. Even though scientific literature recommends the presence of a physiotherapist before, during and after extubation in patients intubated for more than 48 hours, the benefits of physiotherapy in this context remains poorly explored.

The main objective of this study is to compare the rate of acute respiratory failure within 7 days post-extubation in high-risk intensive care patients. The secondary objectives are to compare the ROX index, the reintubation rate for acute respiratory failure within 7 days after extubation, the rate of pneumonia at 7 days, time spent on respiratory and mobilization care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spontaneous ventilation weaning test.
* Consent form signed by the person support.

Exclusion Criteria:

* Patients with a self-extubation,
* Patients with a tracheostomy,
* Patients with acute respiratory failure for acute lung edema (OAP),
* Patients with decision to limit or stop Active Therapeutics (LATA).
PowerAssert Radio-Frequency (RF) Guidewire Coronary In-Stent Chronic Total Occlusion (CTO)

A single center Pilot Clinical Registry Study of the" Acute Procedural" Safety and Efficacy of Stereotaxis PowerAssert(TM)RF Coronary Total Occlusion System assisted Angioplasty in the Treatment of Refractory Coronary Total Occlusions

Determine the safety and efficacy of the Stereotaxis PowerAssert™ 18 RF Wire System:

Primary - of recanalizing (crossing) coronary total occlusions within a stent.

Secondary - facilitated angioplasty at hospital discharge represented by

* Event free survival
* Anginal status, and
* Target vessel patency
* minimal luminal diameter (MLD).

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for elective revascularization of a native coronary vessel
* Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent
* Written Informed Consent obtained

Exclusion Criteria:

* Under 18 years of age
* Current participation in another study with any investigational drug or device

  -\>TIMI 0 flow at target lesion site
* Lesion \>40mm. in length
* Factors making follow-up or repeat angiography difficult or unlikely
* Acute myocardial infarction less than 1 month before angioplasty
* Contra-indication to emergency coronary artery bypass surgery
* No access to cardiac surgery
* Contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin
* Angiographic evidence of thrombus (filling defect proximal to or involving the occlusion)
* Occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion
* Totally occluded bypass graft as target vessel
* Occlusion in an unprotected left main coronary artery
* Ejection fraction less than 30%
* Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse
* Lesion within a bifurcation with a significant sidebranch \>1.5mm in diameter
Comparing Pericapsular Nerve Group Block with Lumbar Erector Spinae Plain Block in Total Hip Arthroplasty Surgery

Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.

Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .

The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.

Total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty.

Beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity .

The primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (PENG) block with lumbar erector spinae plain block.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old, undergoing total hip arthroplasty surgery

Exclusion Criteria:

* Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.
Bladder Training in Radical Prostatectomy

Radical prostatectomy is the gold standard in the treatment of patients with localized prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality of life of men negatively. There are various attempts to prevent and treat urinary symptoms after radical prostatectomy.The aim of this study is to evaluate the effect of the structured bladder training program on lower urinary tract symptoms and quality of life in patients undergoing radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 40 years
* Being male
* Being with localized prostate cancer
* Undergoing open radical prostatectomy
* No preoperative urinary incontinence
* Being body mass index\> 30 kg/m2
* Agreeing to participate in the research
* Being literate

Exclusion Criteria:

* Having a congenital disorder of the urinary system
* Having neurological disorders
* Having a history of transurethral resection of the prostate
* Having communication and mental impairment
* Inability to do pelvic floor muscle exercises
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study

This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI of 18.0 to 40.0 kg/m2, inclusive
* Agree to use an acceptable method of contraception for the duration of the study
* Have an MDD primary diagnosis
* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply

Exclusion Criteria:

* Have a current primary Axis-I disorder other than MDD
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during their lifetime
* Have attempted suicide within the past 2 years
* Have a positive test for drugs of abuse
* Are pregnant, planning to become pregnant, or breastfeeding
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation within 60 days
* Additional criteria may apply
Observational Study of an Automatic Detection of Patients at Risk of Chronic Postoperative Pain ("Alerte Douleur")

Following surgery, some but not all patients develop persistent (or chronic) postoperative pain CPSP. Several risk factors for this persistent pain have been confirmed in previous studies, but neither surgeons nor anesthesiologists have or take the time to systematically screen patients for this risk. However, hospital information systems often contain the data already, entered during preoperative consultations (e.g. chronic opioid medication) or obtained during the postoperative period (e.g. pain scores).

Here the investigators test an automatic detection algorithm which alerts the analgesia team when a patient at risk of CPSP is or has been operated.

The primary aim of the study is to confirm that the sensitivity of the automatic alert is at least 80%, i.e. that 80% of patients with the primary outcome had an automatic alert.

The secondary aim of the study is to develop an algorithm (combination of risk factors) with which the specificity of the alert can be improved.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* elective surgery
* perioperative use of the hospital information system
* surgery of the following types: endoprosthesis of the knee or shoulder, amputation other than toe or finger, spinal surgery, cardio-thoracic thoracotomy, laparotomy, inguinal hernia repair, breast surgery

Exclusion Criteria:

* inability to read and understand the consent form or the questionnaires
* emergency surgery
* having already participated in the study for another surgery
Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)

The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

1. conventional oxygen therapy (O2 conventional)
2. high flow nasal oxygen therapy (O2-HFN)
3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).


Eligibility Criteria:
Inclusion Criteria:

* Hypoxemic and no hypercapnic acute respiratory failure :
* severe dyspnea at rest with a respiratory rate \>25 breaths/min
* PaO2/FiO2 \<300
* PaCO2 \<45 mmHg,

Exclusion Criteria:

* age \<18 years
* NPPV contraindications
* past history of respiratory chronic disease (COPD, cystic fibrosis...)
* cardiac pulmonary edema
* Pre-defined intubation
* other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
* profound aplasia (white cells count \<1000/mm 3)
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion Criteria:

* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
* Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.
* Subjects with a history of steroid-induced IOP elevation in either eye.
* Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.