cyrilzakka/clinical-trials huggingface dataset:
Ketamine Use in Electroconvulsive Therapy

The purpose of this study is to determine whether combination of ketamine plus electroconvulsive therapy improves depressive symptoms decreasing cognitive side effects.

This study will compare the clinical response to brief pulse ECT with infusion of ketamine 0.5 mg/kg versus brief pulse electroconvulsive therapy with infusion of placebo (saline) in major depression. We also will compare levels of cognitive impairment among these groups, compare levels of quality of life among these groups, compare levels of BDNF among these groups. We also will study if levels of 25-hydroxyvitamin D are associated with cognitive impairment in subjects undergoing ECT.

Eligibility Criteria:
Inclusion criteria

- Patients with unipolar and bipolar depression from The Psychiatric Unit of Hospital de Clinicas de Porto Alegre (diagnosis will be established by the Structured Clinical Interview for DSM-IV Axis I)

Exclusion criteria:

* Patients with dementia
* History of addiction / abuse of psychoactive drugs
* Other psychiatric diagnoses
* Refusal to follow the study.
VEGA Prospective Kiel

Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.

For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Patient has received primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:
* degenerative osteoarthritis,
* rheumatoid arthritis,
* posttraumatic arthritis,
* symptomatic knee instability, knee stiffness or deformation of the knee joint
* Age at the time of surgery ≥ 18 years
* Patient signed informed consent

Exclusion Criteria:

* Age younger than 18 years at the time of surgery
* Any prior joint replacement at the index knee
* Patient did not sign informed consent
* All cases not listed under indications (according to IfU)
* All cases showing any contraindication (according to IfU)
The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section

In this study, the investigators aim to investigate if artificial uterine contractions prior to elective caesarean section delivery may have an impact on the respiratory morbidity of term neonates.

Accumulating evidence suggests that the respiratory morbidity of infants is lower if delivered by caesarean section after the spontaneous onset of uterine contractions, or after oxytocin exposure. Moreover, benefits for the mother due to stretching of the lower uterine segment and possible lower blood loss are plausible.

In obstetrics, there is a well described and standardized way to induce artificial uterine contractions in order to predict fetal wellbeing and tolerance of labor, without inducing the labor itself. This is the oxytocin challenge test (OCT). Although the OCT has not been performed previously in the context of planned elective caesarean section deliveries, it is generally considered a safe procedure if appropriate monitoring is granted. Hence evaluation of the role of artificial uterine contractions in perinatal respiratory morbidity of term infants delivered by elective caesarean section is possible and of interest.

Eligibility Criteria:
Inclusion Criteria:

* Term/near-term pregnancy (36+0 - 41+6 weeks of gestation)
* Planned delivery by elective caesarean section
* Absence of any exclusion criteria
* Informed consent obtained

Exclusion Criteria:

* Term premature rupture of membranes (TPROM)
* Spontaneous onset of uterine contractions
* Known serious congenital malformations
* Placenta praevia/vasa praevia
* Abnormal placental attachment
* Intrauterine growth restriction (birth weight below 3rd centile for given gestational age and gender)
Effect of Grapes in Inflammatory Bowel Disease

The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the gut microbiotacomposition in adult patients with the IBD subtype Crohn's disease (CD).

This protocol is designed to investigate the effect of grape powder consumption in Inflammatory Bowel Disease (IBD), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (GM) composition in humans with IBD. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).

The overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the California Table Grape Commission) on the GM composition in adult patients with the IBD subtype Crohn's disease (CD).

An 28 day pilot study in adult CD patients at the Digestive Health Institutes (DHI) of University Hospitals Cleveland Medical Center (UHCMC). table

Participation in this study will last for a maximum of 28 days and will consist of two phases. Phase I (baseline period - 7 days) where all grapes and berries will be removed from the diet, and Phase II (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. The dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. Participants will be asked to avoid consumption of all other grapes/berries during phase II. The investigators will compare the before and after changes in gut microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Crohns disease. CD outpatients in remission
* Harvey Bradshaw-index in remission (\<6 score)
* Capable of providing consent to participate.
* Able to complete daily surveys and take oral nutrition
* Able to record daily meal intake

Exclusion Criteria:

* Short bowel syndrome.
* Hospitalized patients.
* Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
* Known drug abuse.
* Known parasitic disease of the digestive system.
* Symptomatic intestinal stricture.
* Presence of an ostomy.
* Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.
* Well-founded doubt about the patients cooperation.
* Existing pregnancy or lactation.
* History of \<1 natural bowel movements per day.
* Unable to access to technology that permits the daily completion of study related activities.
* Change in IBD medication within past 4 weeks.
* Body mass Index \<16 kg/m or ≥35.
* Documented C.difficile colitis within four weeks of screening.
* Known berry or grape allergy
* No probiotic or antibiotic use for the previous 14 days
Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

The objective of this project is to define the effectiveness and therefore the role of NIR vein finders in adult patients with difficult peripheral venous access. The specific objective of the proposed randomized controlled trial is to test the clinical success rate of placing peripheral venous catheters in 'difficult' access patients using traditional peripheral venous catheter placement compared to two established methods utilizing NIR vein imaging. The investigators hypothesize that the capability to successfully place lasting peripheral venous catheters is increased with the adjunct of the imaging technology, reducing the number of failed needle sticks, reducing the number of peripheral venous catheters placed throughout a patient's hospital stay, and reducing the need for more invasive catheters such as PICC lines.

The efficacy of NIR vein finders beyond the first line approach, particularly in patients that have failed conventional peripheral venous access methods or in patients that are expected to be a "difficult stick", is not established. Conflicting results have been reported in the pediatric literature regarding the subjective benefit of NIR light devices in patients with perceived difficult peripheral intravenous access. In addition, knowledge about the efficacy of these devices in the adult inpatient setting is mostly unknown. The aim of the present study is to address these knowledge gaps.

Eligibility Criteria:
Inclusion Criteria:

* non-pediatric in-hospital patients (≥15 years of age, inpatient and outpatient setting)
* willing to provide research authorization
* scheduled and consented to undergo peripheral venous cannulation of one of the upper extremities to be performed by one of the members of the Vascular Access Team
* determined to be a difficult peripheral venous access defined by one of the following criteria in alignment to the A-DIVA scale to be assessed by one of the members of the Vascular Access Team \[8\]:
* failed inspection for more than one visible or palpable suitable vein through conventional methods
* failed at least one attempt of peripheral venous cannulation through any methods
* history of difficult peripheral venous access
* greatest diameter of target vein less than 3mm determined by conventional methods

Exclusion Criteria:

* clinical contraindication for placement of peripheral venous catheter, including:
* severe bilateral upper extremity edema
* severe bilateral upper extremity skin burn
* severe bilateral upper extremity cellulitis
* history of bilateral axillary lymphadenectomy
* known severe cardiovascular or pulmonary compromise demanding minimization of procedure time, such as:
* severe shock with severe cardiovascular instability
* active CPR
* major uncontrolled hemorrhage
* any condition for which the primary healthcare provider is requesting emergent venous access
* scheduled PICC or midline catheter placement
* non-English-speaking patients if an interpreter is not available
* prisoner and any individual involuntarily confined or detained in a penal institution
* impaired capacity to make informed medical decisions
Antibiotic Resistant Bacteria Among Patients With Severe Intraabdominal Infections

The objectives of the study were:

1. To study risk factors for colonization and infection with antibiotic resistant bacteria among patients with severe IAI before and after antibiotic treatment and surgical intervention.
2. To study species changes in the rectal flora among patients with severe IAI before and after antibiotic treatment and surgical intervention.
3. To review guidelines for antibiotic use in participating units.
4. To evaluate surgical antibiotic prophylaxis and treatment in relation to risk for colonization and infection with antibiotic resistant bacteria among patients with severe IAI
5. To use the results from the study in the process of a more appropriate use of antibiotics in participating units and care of patients with severe IAI.
6. To study the dynamics of extended-spectrum beta-lactamase producing and wild-type Enterobacteriaceae in patients with suspected severe intra abdominal infections before, during and after antibiotic treatment.

In order to evaluate if standard empirical treatment was adequate in relation to resistance pattern among most prevalent species at admission we need another 70 patients to be included with at least data and cultures from admission.

Eligibility Criteria:
Inclusion Criteria:

* Patients with evidence of intra-abdominal infections that require surgical intervention will be eligible.
* In addition will patients with intra-abdominal abscess confirmed with CT/ultrasound be eligible, but not treated with surgical intervention if estimated to require at least 5 days antibiotic treatment, with a severity needing initial intravenous administration of antibiotics.

Exclusion Criteria:

* Age under 18 years
EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS

Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* individuals who fill a (incident or prevalent) prescription for inhaled corticosteroids (either monotherapy or in combination inhaler with long-acting beta-agonists) who have been diagnosed by a doctor as having asthma
* possessing a cell-phone with ability to send/receive text messages
* residing in British Columbia (BC), Canada and planning to reside in BC for the next 12 months
* registered with the medical services plan (MSP, the provincial insure of medically-required services) in the past 12 months, and planning to remain registered for the next 12 months
* designated pharmacy being the main drugstore for patient
* not participating in another interventional study
* consent to participate in the study.

Exclusion Criteria:

* Unable to communicate in English
* Under 14 years of age
Ear Acupuncture Reducing Pain and Improving Balance

The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain.

We hypothesize that:

I) The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain.

II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment.

III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.


Eligibility Criteria:
Inclusion Criteria:

* Complaints of back pain lasting more than 12 weeks
* Pain referred larger than 4 according to the 11-points pain scale

Exclusion Criteria:

* No other musculoskeletal injury,
* Individuals diagnosed with structural damage
* Individuals who performed a spine surgery
* Individuals who have sensory abnormalities or dizziness.
* Individuals may not be in physical therapy for reducing low back pain.
* Painkillers or anti-inflammatories use 24 hours before the experimental procedure.
Stroke Rehabilitation Outcome During COVID-19 Lockdown

COVID-19 has a big impact on individuals and society as a whole. Especially persons with (multiple) comorbidities such as stroke are affected. The impact of COVID-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.

With 16'000 patients hospitalized and with new permanent disability in approximately 7'000 individuals every year in Switzerland, stroke has a major impact on quality of life and is an enormous socioeconomic burden. Virtually all patients receive inpatient rehabilitation in the sub-acute phase poststroke. However, also in the later phases poststroke, patients receive rehabilitation interventions in outpatient rehabilitation clinics and private practices, with goal to improve or maintain their functional capacity.

Currently, Switzerland finds itself in an extraordinary situation. The Federal Council has issued a series of measures aimed at the population, organizations and institutions, and the cantons. The aim is to curb the spread of the coronavirus and assure the provision of healthcare. The people are invoked to stay at home and only leave the home if absolutely necessary. If they are over the age of 65 or have an underlying medical condition, the Federal Council strongly recommend that you stay at home under any circumstances unless you have to go to the doctor.

With the recommendation of the Swiss Federal Council almost all stroke patients belong to the group who should stay home. Furthermore, all outpatient rehabilitation clinics have reduced the interventions to a minimum. It is unknown how a sudden stop of rehabilitation influences the stroke patients' functional capacities and their perceived quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic or haemorrhagic stroke, confirmed by MRI-DWI and/or CT
* Participating in a stroke research project before the Lockdown (ESTREL - BASEC Nr. 2018-02021/ RE-USE - BASEC-Nr. 2017-01070)
* Age 18 years or older
* Verbal and written informed consent of the patient after participants' information

Exclusion Criteria:

* Severe communication or cognitive deficits, that cause inability to follow the procedures
Education of Parents About Discipline in a Way That is Culturally Sensitive

To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.


Eligibility Criteria:
Inclusion Criteria:

* Parents presenting with their children to a pediatric clinic.

Exclusion Criteria:

-
Postural Responses to External Perturbation in Post-Stroke

To maintain stable body balance in daily activities, the ability to respond to external perturbations is an essential factor. Such capacity is limited in pathological conditions, such as in stroke, in which postural control is impaired due to lesions to the central nervous system. Impairment to postural control increases body sway during upright posture and leads to augmented frequency of falls. In this sense, the identification of mechanisms involved in body balance disorders after stroke is particularly important in situations of postural perturbation. The purpose of this project is to evaluate reactive postural responses to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to different brain areas as a result of stroke, and test principles of dynamic body balance rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are as follows. Healthy participants: absence of detectable neurological or physical malfunction which might affect postural control, no use of drugs affecting body balance and preserved mental capacity. Stroke patients: capacity to sustain independently orthostatic posture for at least 5 min. and preserved mental capacity.

Exclusion Criteria:

* Exclusion Criteria are: no orthopedic malfunction, no clinical instability associated with systemic disease, no use of drugs affecting body balance and presence of "pusher syndrome".
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery

The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.

Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.

Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).

This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
* age \< 79 years old
* left ventricular ejection fraction \<= 40%
* informed patient's consent

Exclusion Criteria:

* age \< 18 years old
* emergency surgery
* medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
* any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
* need for valvular replacement surgery
* redo surgery
* serum creatinine \> 2 mg/dl
* history of malignant cardiac arrhythmias
Cast or Functional Ankle Orthosis After Ankle Fracture Surgery

The goal of this randomized clinical trial was to compare the effect of 6-week casting versus 2-week casting followed by 4-week ankle bracing in adult patients with surgically treated ankle fractures.

The primary outcome measures used were the functional results 3 months after surgery evaluated using two functional outcome measures (Olerud and Molander score and Kaikkonen score) and the patient return to work.

In the casting group, the traditional plaster was changed to a fiberglass one at 2 weeks and the cast treatment continued until 6 weeks. In the functional treatment group, the traditional plaster cast was changed to an reusable semi-rigid plastic orthosis (Aircast) at 2 weeks after surgery and its use was continued as an ankle support for up to 6 weeks. Follow-ups including subjective and objective evaluations were at 2, 6, 12 and 52 weeks and at 2 years postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Weber A or B type ankle fracture
* uni-, bi- or trimalleolar injury and/or fibular displacement of \>2 mm in any plane on the radiographs

Exclusion Criteria:

* Weber C injury necessitating syndesmotic fixation
* Pilon injury
* Inadequate co-operation
* Other severe concomitant injuries