cyrilzakka/clinical-trials huggingface dataset:
Bromocriptine in the Treatment of Peripartum Cardiomyopathy

Peripartum cardiomyopathy (PPCM) is a rare, but significant heart disease affecting young women in the puerperal period. Thus far, no specific treatment has been approved to treat this disease. PPCM has a wide spectrum of clinical manifestations ranging from mild heart failure to severe cardiomyopathy, cardiogenic shock and death. A significant proportion of survivors have persistent chronic heart failure leading to disabling symptoms and decreased quality of life.

Animal studies have suggested that prolactin is central to the development of PPCM. Prolactin has pro-inflammatory and anti-angiogenic effects that may promote PPCM. Bromocriptine, a central dopamine agonist known to decrease prolactin levels, might thwart its deleterious effects in women suffering from PPCM. Following this rationale, bromocriptine should improve myocardial function in women suffering from PPCM and thus, improve cardiovascular outcomes and healthcare outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Peripartum cardiomyopathy defined by the following criteria:

   * Development of heart failure in the last month of pregnancy or within 5 months of delivery;
   * Absence of an identifiable alternative cause of heart failure;
   * Absence of recognizable heart disease prior to the last month of pregnancy;
   * Left ventricular systolic dysfunction demonstrated by classic echocardiographic criteria, such as depressed ejection fraction;
3. Recent onset of PPCM ( 1 month);
4. Written informed consent.

Exclusion Criteria:

1. Hypersensitivity or contraindication to bromocriptine;
2. Patients already taking bromocriptine for PPCM or for another indication;
3. Cardiogenic shock before enrolment;
4. Survival expected to be less than 1 year due to non-cardiovascular causes (eg. cancer);
5. Participation to another investigational drug or investigational device study within 30 days prior to randomization (participation to registries is allowed);
6. Patients who in the opinion of the investigator will not comply with specified drugs, or follow-up evaluation.
INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients

Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed by surgery. These wounds have a very high rate of wound complications and infection (30%), resulting in more surgeries, longer hospital stays and complex nursing care. Previous research shows that negative pressure (vacuum) dressings applied to the incision at the end of surgery can reduce these complications. The Investigator and his team across Canada will perform a clinical trial comparing standard dressings to these vacuum dressings. The results of this study have the potential to immediately improve the quality of life of soft tissue cancer patients. It can also decrease the amount of time required in hospital and reduce the cost to the Canadian healthcare system.

This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older and are able to provide written consent.
* Patients with lower extremity soft tissue sarcoma confirmed by tissue pathology.Each patient must have local cross sectional imaging (CT or MRI) and a staging CT chest.
* Patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery.
* Patients for which a primary closure must be attained at the time of surgery.
* Patient must be available for postoperative follow-up at the treating center.

Exclusion Criteria:

* Patients who are less than 18 years of age.
* Patients with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans).
* Patients who underwent surgical amputation
* Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts).
* Patients with a life expectancy less than 120 days.
* Patients who have an allergy or sensitivity to adhesive dressings.
Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin Temperature.

A randomised controlled pilot study on the feasibility of introducing a skin temperature device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have had a foot ulcer in Norway.

Diabetes mellitus is linked to late complications from kidneys, eyes, nerves, feet, and an increased risk of cardiovascular disease.

Approximately 170 000 people in Norway suffer from diabetes, and diabetic foot disease is one of the most common complications.

It is estimated that between 400 and 500 amputations are performed yearly in Norway, and most of the amputations are due to non-healing diabetic foot ulcers.

Efficient prevention in high-risk individuals includes follow-up in specialist foot clinics including training in self-care, adaptation of preventive footwear and insoles.

A randomised trial testing the use of skin temperature measurement in addition to routine foot care for preventing new foot ulcers showing a highly significant reduction in recurrent foot ulcers in the temperature measuring group, has previously been performed in USA (Lavery et al. Diabetes Care 2007;30:14).

This study is planned as an open, randomised pilot study of minimum 40 patients testing the feasibility of implementing the use of skin temperature measurement for prevention of recurrent diabetic foot ulcers in a specialist clinical setting in Norway.

If this is the case, we are planning a larger study to examine if these measurements can contribute to reducing the number of recurrent ulcers in clinical practice in Norway.

We are in addition using a cognitive motivational method to examine if this model can increase the use of the temperature measuring device.

Eligibility Criteria:
Inclusion Criteria:

* Previous neuropathic diabetic foot ulcer

Exclusion Criteria:

* Ankle/brachial index \< 0.7. Osteomyelitis, active Charcot
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups.

The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.


Eligibility Criteria:
Inclusion Criteria:

* Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
* Renal calculi;
* Normal renal function;
* Any stone composition;
* Single or multiple stones(planned treatment of all stones at this surgery);
* Age \> 18 years;
* Able and willing to return treatment centre for follow-up visits; AND
* Signed study consent

Exclusion Criteria:

* Ureteric calculi distal to the level of the iliac vessels/iliac crest;
* Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable);
* Bilateral ureteroscopy;
* If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary);
* If in the investigators opinion, enrollment would be not be appropriate; OR
* Pregnancy
Field Implementation of the autoRIC Device in STEMI

This is a "before and after" observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC® Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada for this use under the direction of a health care professional. Paramedics in the Peel and Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and study data will be collected from existing patient records.

The 'before' group will include up to 900 patients who were treated before autoRIC implementation in the services and hospitals. These patients would have had a STEMI and undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to 900 eligible patients who have had RIC treatment with the autoRIC device at the two participating sites following implementation in the services and hospitals.

The primary analyses will compare the short-term and long-term outcomes of eligible patients who have received completed primary PCI for STEMI in the time period before the implementation and following the implementation of this RIC strategy. In addition, a health economic analysis will be conducted to determine the cost-effectiveness of the therapeutic strategy to treat STEMI patients with RIC prior to PCI.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older;
* patients diagnosed with STEMI in the prehospital environment by responding paramedics from Peel Regional Paramedic Services or Halton Emergency Medical Service and transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health Partners;
* walk-in patients diagnosed with STEMI in the ED of either of these two facilities.

Exclusion Criteria:

* left-bundle branch block;
* Lymphedema on either arm
* PICC Line on either arm
* AV fistula or no palpable pulse on either arm;
* patient has a known bleeding disorder or known abnormality of blood flow to the left arm;
* patient has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre- existing traumatic injury to the limb to be treated (left-arm).
Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients

This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.

The main question it aims to answer are:

What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* planned CABG surgery
* volunteer to participate in the study

Exclusion Criteria:

* limb amputations
* stroke-related sequela
* hearing problems
* clinically unstable
Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)


Eligibility Criteria:
Key Inclusion Criteria:

1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at screening; the duration of the subjects illness must be ≥ 1year
2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response too current standard of car base on the YBOCS score.
3. Determined by the investigator to be medically stable at baseline/ randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trail as designed.

Key Exclusion Criteria:

1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results.
3. Previous treatment in a study with troriluzole
Early Characteristics of Autism

This study will identify factors that distinguish children with autism from children with developmental delay and those with normal development and study the efficacy of intensive behavioral therapy in children with autism.

Children with autism often suffer from social, educational, and functional problems. By understanding the social, linguistic, psychological, and physiological differences that distinguish between autistic children, developmentally delayed children, and children with typical development, researchers may be able to recognize autism early in life so that children with autism can be helped as early as possible and their long-term outcome can be improved.

Children in this study will be enrolled for 2 years. They will receive annual evaluations throughout the two-year period. They will undergo a magnetic resonance imaging (MRI) scan and will complete various activities to determine brain functioning. In addition, children with autism will take part in intensive behavioral therapy at least 4 hours every day for the duration of the study. Communication and social behavior scales, an early development interview, observations of parent/child interaction, and neuropsychological, cognitive, and adaptive behavioral measures will be used to assess participants.

Eligibility Criteria:
Inclusion Criteria for Autistic Participants:

* Diagnosis of autism

Inclusion Criteria for Developmentally Delayed Participants:

* Exhibiting current delays in development

Inclusion Criteria for Participants with Normal Development:

* Exhibiting normal development

Inclusion Criteria for All Participants:

* Overall good health
Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.

Infants often experience undesirable gastrointestinal effects, such as constipation, flatulence. These symptoms are often perceived by the parents as being related to the diet (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of the most commonly encountered problems within the first three months of life. The etiology of the disorder remains unknown however, three main theories have been proposed to explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's milk protein or other food constituents. e.g. the protein source, the iron content, hydrolyzation of the protein, or the fat source.

It has been reported that infants receiving a casein predominant formula had less unformed stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein formula have shown more liquid stools.

A reduction of crying hours was also described in infant receiving an hydrolyzed formula. Some probiotics were reported with potential benefit on the gut comfort.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, 0-1 month old at point of enrollment
* Birth weight \< 2500g and \> 4500g
* Gestational age \< 37 weeks and \> 42 weeks
* Infants who cannot be breastfed because of the maternal status
* Willing to exclusively consume the assigned study formula with whey protein
* Are likely to be compliant
* Mother/caregiver demonstrates an understanding of the given information and ability to record the requested data

Exclusion Criteria:

* Congenital illness or malformation
* Significant pre-natal and/or post-natal disease
* Receiving systemic antibiotic treatment at time of enrolment
* Infant with symptoms of allergy to cow's milk
* Infant's family cannot be expected to comply with treatment (feeding regimen)
* Subjects who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last month
To Evaluate Clinical Outcome and Injection Compliance of Scilin

This is a prospective, multi-center, open-label, non-interventional, 12-week study in people with type 2 diabetes mellitus who are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice. The term study insulins will be used in this protocol for these drugs and combinations.


Eligibility Criteria:
Inclusion Criteria:

* Based on physicians' clinical judgement, subjects who are treated with SciLin N, SciLin R and SciLin M30 ( alone or in combination) will be eligible to be included in this clinical study.

Exclusion Criteria:

Subjects with one of the conditions listed below will be excluded:

Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months Subjects who have to be treated with other insulins simultaneously Subjects who are participating in other diabetes clinical studies at the same time
VR Headset for Pain During Pregnancy Termination

The goal of this randomized control study is to see if virtual reality headsets (VRHS) are useful in women undergoing surgical pregnancy termination. The main questions it aims to answer are:

Do VRHS decrease the pain associated with surgical pregnancy termination Participants will wear the VRHS during the surgery and take a pain survey before and after the procedure. The pain assessment will be compared to placebo headset which will be randomly assigned.

Use of virtual reality headsets have been employed in cancer and behavioral medicine fields with moderate success in controlling anxiety stress and pain. The decision to terminate a pregnancy can create significant stress and anxiety. In the US, there are over 900,000 pregnancy terminations each year with many patients undergoing dilation and evacuation with minimal anesthesia. We plan to assess virtual reality headset's ability to decrease pain associated with surgical termination of pregnancy.

Patient's will be recruited from a single outpatient family-planning center. Inclusion criteria include all patients over the age of 18 that are undergoing a surgical termination of pregnancy in the first and second trimester under local and/or conscious sedation anesthesia. Patients under the age of 18 with significant medical comorbidities will be excluded. Patient demographics including age, BMI, obstetric/ gynecology history, and prior terminations will be collected. Patients will be given pre- procedure survey to assess anxiety and stress. The survey will be self-administered with assistance from study personnel. Patients will then be randomized to either the virtual reality headset or no headset. The procedure will be then performed with the headsets on the patients. Amount and type of local anesthesia employed will be recorded. After the procedure (within 1 hour), the individuals will be resurveyed for both stress and anxiety, with the addition of a visual analog scale to assessing pain associated with the procedure. Pre and post vital signs will also be extracted from the chart. The patient as well as the clinician performing the procedure will be masked as to the intervention. We will require 50 patients per arm assuming a 30% reduction in the pain scale (power 80%, 95% CI, with SD of 0.70). Logistic regression will be performed for those comorbidities that may be influence our outcome, such as age, BMI, prior terminations.

Eligibility Criteria:
Inclusion Criteria:

* all healthy patients undergoing a first or second trimester pregnancy termination

Exclusion Criteria:

* pregnancy patients requesting a termination under the age of 18
Post-operative Corticosteroid Treatment After Mitral Valve Surgery

The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.

Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.

Eligibility Criteria:
Inclusion Criteria:

* open mitral valve surgery
* patients agrees to participate in the study
* adult (minimum 18 years of age)

Exclusion Criteria:

* atrial fibrillation onset before first postoperative morning
* prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day)
* patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability
* diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment
* systemic mucous infections
* known allergy or oversensitivity to hydrocortisone
* Cushing syndrome
* history of psychosis
* history of ulcus or active ulcus
* chronic atrial fibrillation or atrial flutter
* corticosteroid or immunosuppressive treatment in use for any reason
* active tuberculosis infection
* severe renal impairment (serum creatinine 200 umol/l or over)
* history of deep or superficial venous trombosis
* Herpes simplex -ceratitis