cyrilzakka/clinical-trials huggingface dataset:
NHF vs NIV in Patients With Acute Exacerbation of COPD

Although non-invasive ventilation (NIV) usage has increased significantly over time in COPD exacerbation, a great percentage of patients (\~30%) present contraindications to NIV or cannot tolerate it. Nasal high flow (NHF) has been introduced for the management of hypoxemic respiratory failure in adults with favorable effects on ventilation and respiratory mechanics. The above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

The use of non-invasive ventilation (NIV) in COPD exacerbation has increased significantly over time since it has been shown to improve acute respiratory acidosis (increases pH and decreases PaCO2), decrease respiratory rate, work of breathing, severity of breathlessness and therefore reduce mortality and intubation rates.

Despite all these favorable effect, a great percentage of patients (\~30%) present contraindications to NIV or cannot tolerate it increasing thus the possibility of NIV failure and consequently intubation rates.

Over the past decade, nasal high flow (NHF) oxygen therapy has been introduced for the management of hypoxemic respiratory failure in adults. NHF can generate high flow rates up to 60 L·min-1 and through this mechanism exerts its positive effects on respiratory mechanics, carbon dioxide washout, patient's respiratory rate and work of breathing. Although the above mentioned NHF positive effects has been observed also in stable COPD patients with or without chronic hypercapnia, NHF use in COPD exacerbation is questionable and only a few case reports studies have been published showing favorable effects of NHF on COPD exacerbation.

In this study, the investigators hypothesize that NHF is not inferior to NIV for respiratory support in patients with COPD exacerbation and acute or acute on chronic hypercapnic respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

* Patient with mild to moderate COPD exacerbation and the following characteristics persisting after initial medical therapy with bronchodilators and controlled oxygen therapy

  * 7,25\<pH\<7,35
  * PaCO2\>45mmHg
  * RR\>23
* Ability to obtain written informed consent by the patient or patient's next of kin

Exclusion Criteria:

* severe facial deformity
* Facial burns
* Fixed upper airway obstruction
* Criteria for imminent intubation and invasive mechanical ventilation (any of the following)

  * respiratory or cardiac arrest
  * gasping respiration
  * pH \<7.15
  * depressed consciousness (Glasgow Coma Score \<8)
  * psychomotor agitation inadequately controlled by sedation
  * massive aspiration
  * persistent inability to remove respiratory secretions
  * heart rate \< 50 ·min-1 with loss of alertness
  * severe hemodynamic instability without response to fluids and vasoactive drugs
  * severe ventricular arrhythmias
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia

This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment in Study URO-901-3005 (NCT03902080).


Eligibility Criteria:
Inclusion Criteria:

* Participant has completed participation of the 24-week double-blind treatment period in Study URO-901-3005 (NCT03902080) and demonstrated compliance with the study procedures and study medication schedule in the opinion of the investigator.
* Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Participant has the ability to continue to receive a stable dose of Benign Prostatic Hyperplasia (BPH) treatment with either a) alpha blocker monotherapy or b) alpha blocker +5-ARI.
* In the opinion of the investigator, the participant is able and willing to comply with the requirements of the protocol, including completing study questionnaires and the Bladder Diary.

Exclusion Criteria:

* Participant experienced any Serious Adverse Event in Study URO-901-3005 that was reported as "possibly or probably related" to study treatment by the investigator.
* Participant is using any prohibited medications
* Participant has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 milligrams per deciliter \[mg/dL\] or 8.33 millimoles per Liter \[mmol/L\] and/or non-fasting blood glucose \>200 mg/dL or 11.1 mmol/L) based on most recent available lab results in Study URO-901-3005 or uncontrolled in the opinion of the investigator.
* Participant has uncontrolled hypertension (systolic blood pressure of ≥180 millimeters of mercury \[mmHg\] and/or diastolic blood pressure of ≥100 mmHg) or has a resting heart rate (by pulse) \>100 beats per minute.
* Participant has systolic blood pressures ≥160 mmHg but \<180 mmHg, unless deemed by the investigator as safe to proceed in this study and able to complete the study per protocol.
* Participant has current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstances that might, in the opinion of the investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
Effects of Animation Therapy on Children With ADHD

The aim of the study is to determine the effects of animation therapy on the main symptoms of Attention Deficit - Hyperactivity Disorder; hyperactivity, inattention and impulsivity.

Attention Deficit and Hyperactivity Disorder (ADHD) is the most frequent childhood disorder, that is characterized with three main symptoms: inattention, hyperactivity, and impulsivity. Animation Therapy is the use of a stop-motion movie production process for therapeutic purposes. This new approach may have promising effect on attention because of its flow effect. Also, there is only one study on the effectiveness of Animation Therapy in literature. This study is planned to investigate the effects of Animation Therapy on the main symptoms of the disorder.

Eligibility Criteria:
Inclusion Criteria:

* Being at the age between 6-12 years.
* Being diagnosed with ADHD by a psychiatrist.
* Taking prescribed medication for treatment of ADHD.
* Having no physical, visual or mental problems.

Exclusion Criteria:

* Absence in pre- and post-intervention evaluations
* Not completing 10-weeks of re-animation approach intervention process.
* Discontinuation of medical treatment for ADHD.
Neuronal Responses to Social Feedback in Major Depressive Disorder

The overall goal of the proposed project is to investigate the neuronal pathways regulating the effects of social acceptance and rejection in healthy controls and patients with Major Depressive Disorder (MDD). Social acceptance and rejection are defined as the explicit declaration that an individual is liked or not liked. Social acceptance can boost one's self-esteem and mood, whereas rejection can lower them. The neurological relationship between social acceptance/rejection and depressive symptoms is not known. Using functional magnetic resonance imaging (fMRI), it is hypothesized that social feedback will activate a specific interconnected neuronal pathway involved in social separation and reward. Executive functioning and response to monetary reward will also be assessed during fMRI using two additional tasks (monetary incentive delay, parametric go no-go) to determine how these cognitive brain functions regulate responses to social feedback.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between 18 and 55 years of age
* No use of psychotropic medications in the past 4 weeks
* No regular tobacco use, and who are able to make decisions for his or her self -Patients who meet criteria for (DSM-IV) Major Depressive Disorder or Depressive Disorder Not Otherwise Specified, with Hamilton Depression Rating Scale scores ≥ 10, and may be on monotherapy (treatment for MDD with a single SSRI)
* MDD patients will be matched with healthy controls for age and education.

Exclusion Criteria:

* No serious medical illnesses or major physiological disturbance during the past three months (e.g., serious infections or pregnancy) or anemia Any other Axis I psychiatric disorder
* Pharmacological exclusion criteria include the use of psychoactive substances during past 3 months (e.g., barbiturates, anticonvulsants glutethimide, alpha-methyl dopa, corticosteroids \[oral or topical creams\], opiates or codeine, cyproheptadine, opioid analgesics, antipsychotic drugs)
* History of DSM-IV alcohol or drug dependence within the past 5 years
* Drug or alcohol abuse in the past 2 years or a CAGE Alcohol Screening Inventory score of \>3
* Regular alcohol use during the past 6 months equal to or greater than 16 cans of beer per week or equivalent; use of street drugs during the past 2 years
* Regular tobacco use, since nicotine stimulates cortisol secretion even in smokers;
* Major chronobiological disruption or phase shift during the preceding month (e.g., total sleep deprivation, reversal of sleep-wake cycles or trans-meridian travel)
* Childbirth or miscarriage within 6 months
* Breastfeeding within 6 months of recruitment
* Progestin-only birth controls (e.g., Cerazette, Ovrette)
* No contraindications to MRI scan including neurostimulators, metal in the body, weight over 250 pounds, and girth size incompatible for MRI scanner bore
* No non-right-handed subjects
* For healthy controls, subjects will have no history of psychiatric problems in themselves or any first-degree relatives
Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia

The aim of the study is to confirm the efficacy of eplivanserin 5mg/day on sleep maintenance of patients with primary insomnia using night polysomnography recordings over a 6-week treatment period corresponding to a stabilization of improvement of sleep.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for at least one month preceding the study visit.
* Disturbance of sleep maintenance:

  * Based on patient' s information:

    * Patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks,
    * Patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month,
    * Patient must report impact on daytime functioning associated with sleep maintenance insomnia

Inclusion will be based on the nocturnal polysomnography (NPSG) recordings performed at the sleep laboratory during the two screening nights.

Exclusion Criteria:

* Females who are lactating or who are pregnant, or of childbearing potential not using an acceptable form of contraception
* Patients presenting with acute or chronic pain resulting in insomnia
* Patients with current psychiatric disturbances
* Body mass index \> 32
* Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety
* Clinically significant and abnormal electrocardiogram (ECG) (including QTc B \> 500ms),
* A positive test for hepatitis B (hepatitis B surface \[HBs\] antigens) or C (hepatitis C virus \[HCV\] antibodies)
* Positive qualitative urine drug screen at screening
* Consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day
* Use of any over-the-counter or prescription sleep medication, or of any substance with psychotropic effects or properties known to affect sleep/wake, within one week or five half-lives (whichever is longer), prior to screening
* Night shift workers, and individuals who nap 3 or more times per week over the preceding month
* Based on medical history and/or NPSG:

  * primary hypersomnia
  * narcolepsy
  * breathing-related sleep disorder (apnea-hypopnea index \> 10/hour of sleep)
  * circadian rhythm sleep disorder
  * parasomnia (e.g. somnambulism)
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
* Naïve to growth hormone therapy

Exclusion Criteria:

* Known or suspected allergy to the trial product or related products
* Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
* Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
* Pregnancy or the intention to become pregnant
* Breast-feeding
* Administration of other growth-altering medication
Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome

The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy.

Surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called Anterior Resection Syndrome (ARS) with varying degrees of severity.

Among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used.

The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (LARS) and therefore on the quality of life of patients undergoing this type of intervention.

Therefore, treatment with PNTS is currently established for the management of LARS symptoms. Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS. It is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment.

The investigators´ hypothesis is: Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery (scheduled, non-urgent) who underwent anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the Hospital Álvaro Cunqueiro in Vigo after the start date of the study.
* Anastomotic tightness (absence of dehiscence).
* Patients older than 18 years old.
* Acceptance to participate in the study.

Exclusion Criteria:

* Inability to understand the study instructions and recommendations.
* Dementia or any type of mental disability.
* Palliative surgery.
* Patients with pacemakers.
* Anti-coagulated patients.
* Patients with trophic lesions on the skin of the ankles.
Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

This study prospectively selects the patients to examine the effectiveness of the investigators' current standard of prophylaxis prior to vascular surgery and to compare the effectiveness of vancomycin and daptomycin plus cefazolin in reducing infections in vascular surgical patients.

According to Medqic.org (site for the Surgical Care Improvement Project) the current recommended drug of choice for prophylaxis prior to vascular surgery is Cefazolin (Ancef). The exception would be to allow the use of Vancomycin as an acceptable antibiotic for patients undergoing cardiac, vascular or orthopedic surgery due to the increasing risk of methicillin-resistantStaphylococcus aureus (MRSA). The significance of the study is to demonstrate that MRSA coverage is needed in vascular surgery with prosthetic graft placement in areas of the body that is at high risk for infection. By decreasing post surgical site and prosthetic infections, we could significantly reduce vascular surgery mortality and morbidity. Cost and amputation rates we feel could also be reduced. patients will be randomized in three groups such as cefazolin,vancomycin and cefazolin, daptomycin and cefazolin and then patients will be monitored per usual post-operative course (30 days and 90 days follow-up) with wound and incision evaluation. Outcome measures include hospital length of stay, the presence of a graft infection, skin infection at incision site, vascular procedure failure secondary to infection, cost, thirty day readmits, amputation, and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 18 years of age undergoing vascular surgery including carotid procedures and a vascular access procedure (Fistula or Graft).

Exclusion Criteria:

* Patients with an allergy to daptomycin or vancomycin.
* Patients with chronic wounds.
* Prior colonization of MRSA.
* Increased MRSA rate facility wide.
* Continuous inpatient stay \>27 hrs prior to surgical procedure.
* Patients with active infection requiring antibiotics preoperatively.
* Patients with a history of MRSA colonization or infection, HIV, admission for \>3 months in an acute care center or long-term care center, penicillin allergy or penicillin allergy and on dialysis.
* Dialysis patients.
Flexible Reaching Control in Parkinson Disease

Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.


Eligibility Criteria:
Inclusion Criteria:

* Ability to perform the task (assessed during the experiment)

Exclusion Criteria:

* Inability to perform the task (motor) or to understand the task requirements (cognitive)
Effectiveness of a Website and Telemonitoring in Patients With Heart Failure.

The number of people with heart failure is increasing in the western world. Mainly due to better treatment of myocardial infarctions and ageing of the population. The amount of health care workers is unfortunately not increasing. We want to investigate how two electronic devices (a website and an interactive web-based platform) influence the self-care, quality of life, hospitalizations and mortality by delivering care from a distance. We also want to investigate if a higher quality of care is delivered despite of less frequent visits to a nurse and/or doctor. The study takes place in the Netherlands and is a randomized trial. Patients with heart failure, registered by an outpatient heart failure clinic or general practitioner can take part. They will be randomized to 3 groups: group 1 receives standard care, group 2 receives standard care with the website, group 3 receives an adjusted care pathway, with both the website and the interactive web-based platform connected to a telemonitoring system. In this group all routine consultations with heart failure nurses and general practitioner will be substituted by this device.


Eligibility Criteria:
Inclusion Criteria:

* heart failure established according to the guidelines of the European Society of Cardiology, and confirmed with echocardiography at least three months earlier. The three month period is used to allow for enough time for essential education and initiation of treatment.
* Sufficient cognitive and physical function to understand the aim of the study and perform or undergo the required measurements and sign informed consent.
* Aged 18 years or over.

Exclusion Criteria:

* Non-availability of internet and e-mail.
* Inability to work with internet and e-mail.
* Inability of the patient and his/her family or care takers to read and understand Dutch.