cyrilzakka/clinical-trials huggingface dataset:
Measuring Adherence to Home Shoulder Physiotherapy With Artificial Intelligence

An important part of recovery for shoulder injuries, is sticking to the exercise regimen that is prescribed by a physiotherapist. Currently, there is no proper way to measure whether patients are correcting doing their prescribed exercises at home. Researchers at Sunnybrook have tested out a Smart Physiotherapy Recognition System (SPARS), which consists of a watch that patients can wear while they are performing their physiotherapy exercises. The watch aims to learn how the exercises are done correctly when worn during supervised physiotherapy sessions, and then to record and compare whether those same exercises are being done correctly in a home setting. The main objectives of this study aims to test whether the SPARS system can effectively measure whether physiotherapy exercises are being done properly when they are done without physiotherapist supervision. Secondly, to examine whether the recovery process after shoulder injuries is improved if patients perform the physiotherapy exercises correctly.

A research assistant will conduct in-person data collection on 120 patients, by recording patients' exercises during their supervised physiotherapy sessions each week using the SPARS smart watch. Each patient will wear smart watch on their affected arm only when performing prescribed exercises, and the watch will start recording inertial sensor data once the patient puts the watch on. The injured worker population will be recruited from referrals made to the Sunnybrook Working Condition Program (WCP) at the Holland Centre for a work-related shoulder injury. The patient population that is being funded by OHIP, will be recruited from referrals Sunnybrook Shoulder and Upper Extremity Program. Data collection will be collected at baseline (at time of informed consent), and at each supervised physiotherapy session during the course of a patient's treatment. A research assistant will be required to attend a minimum of one supervised physiotherapy session for each patient every two weeks, and record exercise type and technique, alongside the inertial data collection, based on feedback from the treating physiotherapist. Follow-up outcomes such as surveys and shoulder testing will be done at 6 weeks, monthly at a maximum of 3 months (OHIP-patients) and 5 months (WSIB) patients, final treatment session (if different than maximum amount), and 1 year after.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females over the age of 18
2. Be diagnosed with rotator cuff tendinosis, shoulder impingement syndrome or a rotator cuff tear
3. Will be undergoing planned conservative management
4. Be able to participate in home physiotherapy exercises

Exclusion Criteria:

1. Upper extremity neurological deficit
2. Have had a previous failed surgery on the shoulder that is currently being treated
3. Undergoing simultaneous treatment for both shoulders
Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

The primary objective of this study is to determine the complete response (no vomiting and no need for other medications to treat nausea) in terminally ill patients suffering from nausea and/or vomiting, who are treated with palonosetron. Another objective is to determine the partial response (relief of nausea and vomiting to the extent that the patient wishes to continue treatment with palonosetron) after being treated with palonosetron. Palonosetron is currently approved by the FDA to prevent nausea and vomiting associated with chemotherapy. The investigators are testing this medication to see if it can help to relieve nausea and vomiting not associated with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be at least 18 years old.
2. Patient must have a terminal diagnosis, with estimated survival of 6 months or less.
3. Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea medications. If the patient is treated with an anti-nausea medication, a minimum of 2 hours should pass to ensure that the medication is given a chance to be effective. If there is no relief after 2 hours, then the patient may be treated with palonosetron.
4. Patient's medications must be reviewed. Any medications possibly causing nausea should be stopped if possible. For example, if an opiate is suspected of causing nausea, another opiate should be substituted. However, if this is not effective, or if a medication change cannot be made, then the patient would be eligible for this study.
5. Patient must be able to understand and sign informed consent
6. Patients who have a bowel obstruction that will not be relieved by surgery may be enrolled. This includes patients whose obstruction is technically unresectable, or who are medically too ill to endure a surgery, or who refuse surgical intervention for any reason

Exclusion Criteria:

1. Patient has received chemotherapy in the past 28 days.
2. Assessment of possible causes of the nausea and vomiting should be done and recorded. If a reversible cause of the nausea is identified, that cause should be treated if possible. If the treatment relieves the nausea, then the patient is excluded from this study. Possible reversible causes of nausea and vomiting that should be excluded are:

   * Other medical conditions such as benign positional vertigo, etc.
Sildenafil Citrate and Intrapartum Fetal Distress

Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy.
2. Pregnant ≥ 37 weeks gestation.
3. Fetus with longitudinal lie and vertex presentation.
4. Healthy fetus with EFW\>2500 gm

Exclusion Criteria:

1. Patients with previous cesarean delivery or uterine surgery.
2. Antepartum hemorrhage.
3. Cephalopelvic disproportion.
4. Category II or III non-stress test.
5. Medical disease as hypertension, cardiac, renal and hepatic disorders
6. Intrauterine fetal death.
7. Fetal growth restriction.
8. Fetuses with major congenital malformations.
9. Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
10. Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices

The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of the first seven days without clinically significant bleeding.


Eligibility Criteria:
Inclusion Criteria:

Included in the study were patients with proven bleeding from esophageal varices due to liver cirrhosis:

* with a minimum age of 18 years,
* with bleeding symptoms (hematemesis, melena, hematochezia, hypotension, tachycardia) that had lasted not longer than 48 hours prior to hospital admission,
* who were expected to be hospitalized for at least seven days,
* who agreed to participate in the study.

Randomization did not take place if another therapy was medically indicated for any reason.

Exclusion Criteria:

Patients were excluded from the study:

* in whom introduction of an endoscope was not possible for technical reasons,
* who had received an alternative endoscopic treatment to eradicate varices during the last three months (sclerotherapy, ligation),
* who had proven additional fundus bleeding from varices or bleeding from a hypertensive gastropathy,
* who had end stage tumor disease or end stage liver cirrhosis (Child Pugh class C with organ complications, such as hepatonephric syndrome, infected ascites etc.),
* who were pregnant or breast feeding,
* who had a known pulmonary disease combined with restricted lung function or right ventricular failure,
* who had congenital or acquired coagulopathies of non-hepatic origin,
* who were currently participating or had participated in another study during the past 30 days or had already been included in this study once,
* who were treated with drugs to decrease portal vein pressure (somatostatin, somatostatin analogs, terlipressin, glycylpressin, except β-blockers and nitrates),
* who had shown an allergic reaction to thrombin or aprotinin,
* who had a heparin-induced thrombocytopenia Type I or Type II.
Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation

Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

Eligibility Criteria:
Inclusion Criteria:

* Planned continuity interrupting mandible resection
* Planned mandible reconstruction with free fibula flap
* Informed consent
* Procedure performed at University Medical Center Hamburg Eppendorf

Exclusion Criteria:

* Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
* Musculosceletal pain at the time of study enrollment
Evaluating the Effect of Surgical Drain Securement on Patient Quality of Life and Postoperative Drain-related Complications

The objective of this study is to evaluate whether surgical drain securement with a novel sutureless device (K-LOCKTM) will improve patient quality of life and reduce postoperative drain-related complications compared to drain securement with traditional suture-based methods. The K-LOCK™ Device is a novel sutureless drain securement device that may improve patient experiences with surgical drains.

Patients will be identified as potential subjects where the study team will speak with them, determine eligibility, and obtain consent prior to surgery. On the day of surgery, patients will be randomized to either A) drains being secured with the K-Lock device or B) drains being secured with the suture-based technique. All drains will be secured according to randomization.

Postoperatively: The study team will follow the subjects weekly via the electronic medical record documenting (in REDCap) calls made to the triage nurse, visits to the emergency department, requests for additional pain medications, unexpected drain removal, need for additional drain placement, etc. Subjects will return to clinic at their regularly scheduled follow-up appointments with no additional study related activities and will be followed by the study team weekly, via chart review for a total of 3 months from their surgery date. When the subjects return to clinic to have their final drain removed they will be asked to complete a survey asking about their experience with their drains and drain securement. We will also have a blinded evaluator complete a short survey evaluating the skin around the drain insertion site. Photos will be taken of the drain site upon drain removal and again at the 3 month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient of the Department of Plastic and Reconstructive Surgery
* Able to sign English language Consent form
* Undergoing a surgical procedure where placement of one or more surgical drains is anticipated

Exclusion Criteria:

* Unable to sign English language consent form
* Incompatible drain size placed
* Allergy or sensitivity to skin adhesives
Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain

The goal of this observational study was to better understand the impact of increased plasma volume on later exercise in hypoxia. Investigators examined young, healthy, males who regularly participated in aerobic exercise.

Investigators first measured participant's response to exercise in hypoxia (simulated \~7,500 feet above sea level). The investigators then had participants either 1) undergo 1 bout of high intensity interval exercise or 2) undergo 1 bout of moderate, continuous exercise.

48 hours after the exercise, participants were again examined in hypoxia.

A crossover design was utilized to assess the effects of exercise-induced plasma volume expansion on cycling performance in hypoxia. All participants completed a high intensity (HI) bout and control (CON) intervention in a counterbalanced order. The HI bout consisted of 8x4min cycling bouts at 85% of VO2peak with 4 min rest between intervals. CON consisted of cycling at 50% VO2peak. Two 15 km, self-paced cycling time trials (TT) were performed before and after each training intervention. The first TT occurred 5 days before the training intervention (HI or CON) and the second TT occurred 48 hours post intervention. Interventions were separated by 14 days to ensure sufficient washout of any training effect as data have suggested retention of expanded plasma volume may last for 7-14 days. During washout, participants were instructed to continue their normal exercise routine.

The investigators hypothesized that a single HI session would increase plasma volume and attenuate cardiovascular strain during exercise in hypoxia, as evidenced by reductions in HR and elevations in SV and Q. Furthermore, the investigators hypothesized that these changes would contribute to a reduced time-to-completion in a 15 km, self-paced cycling TT.

Eligibility Criteria:
Inclusion Criteria:

* Males age 18-38
* Exercise at least 3 times/week for at least 30 minutes/day for the past 3 months.

Exclusion Criteria:

* Frequent hot bath or sauna users
* Resided at altitude greater than 2,500 meters for \>14 days.
* Cardiovascular or metabolic disease
Treatments for Depression: Drug Versus Psychotherapy

This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.

MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo.

Participants are evaluated on 2 occasions, 1 week apart, before they are randomly assigned to receive either supportive-expressive psychotherapy, sertraline (Zoloft) (followed by venlafaxine \[Effexor\] if patients do not respond to sertraline), or placebo. The active phase of treatment lasts 4 months. The frequency of patients' visits depends on the assigned treatment.

Patients who are randomized to receive medication or placebo are initially seen on a weekly basis, then less often, depending on the rate of symptomatic improvement. Patients who are randomized to psychotherapy are seen twice a week for the first 4 weeks, then once a week for the remaining 12 weeks. Outcome is monitored at week 2,4,6,7,8, 12, 15 and 16. At the end of the first 16 weeks of treatment, patients are thoroughly evaluated. Those who have responded to treatment are assigned to a continuation phase and are seen once a month for another 16 weeks. At the end of the 16-week continuation phase, patients are again evaluated and all treatments are stopped. Follow-up continues every 3 months for up to 2 years to ensure that the patients' depression remains under control.

Eligibility Criteria:
Inclusion criteria:

* Major Depressive Disorder diagnosis

Exclusion criteria:

* Psychotic or bipolar disorder diagnosis
* Substance dependence in the last 6 months
Plaque Burden and Ischemia in MINOCA

The goal of this clinical trial is to assess coronary artery plaque burden, perivascular inflammation and extent of myocardial ischemia in patients presenting with acute myocardial infarction and non-obstructive coronary artery disease. The main question it aims to answer are:

* Identify coronary artery anatomy, plaque burden, composition and high-risk plaque features by CT coronary angiography in MINOCA
* Assess presence, extent and severity of myocardial ischemia in MINOCA

Participants will examined by CT coronary angiography and stress \[12N\] NH3 PET-MR.


Eligibility Criteria:
Inclusion Criteria:

* Acute chest pain
* Elevated troponin
* Non-obstructive coronary arteries by coronary angiography

Exclusion Criteria:

* Obstructive coronary artery disease
* Contraindications against CT coronary angiography or stress \[12N\] NH3 PET-MR
* Not able to give informed consent
NHLBI Type II Coronary Intervention Study

To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.

BACKGROUND:

There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease.

DESIGN NARRATIVE:

A randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years.

Eligibility Criteria:
Men and women with angiographically demonstrated coronary artery disease.
Pilot Feasibility Study of Laryngeal Ultrasound in the Paediatric Population - ECHO LARYNX

Nasofibroscopy is the gold standard for laryngeal pathology diagnosis. However, this examination is invasive and can be poorly tolerated in the pediatric population. Laryngeal ultrasound appears to be a better tolerated alternative. However, few data exist in the pediatric population in the literature. The aim of this study is to evaluate the feasibility of laryngeal ultrasound in a larger pediatric population of pathological and non-pathological subjects.

According to current knowledge, the gold standard for diagnosing laryngeal pathologies is flexible fiberoptic laryngoscopy (FFL), as it allows visualisation of the motricity of the laryngeal structures and the appearance of the mucous membranes. However, this is an invasive examination, which can be poorly tolerated in the pediatric population. This poor tolerance can make it difficult to obtain an accurate diagnosis because of the child's movements. With the aim of improving patient comfort without compromising diagnostic performance, some studies describe laryngeal ultrasound (LUS) as an alternative to FFL. This imaging examination appears to be better tolerated than FFL because it is less invasive for the patient. However, there are few data available in the infant population. The main limitations of LUS are obtaining a satisfactory ultrasound window and inter-rater reproducibility. For these reasons, the aim of this study is to assess the feasibility of LUS in the pediatric population and to obtain reference frame enabling the different laryngeal structures to be visualised. We will include around one hundred patients treated in the pediatric ENT unit, with or without laryngeal pathology. An ultrasound record will be performed during the consultation in addition to the usual examination. The record will be analysed by a blinded assessor. A single consultation will be required and no follow-up is planned.

Eligibility Criteria:
Inclusion Criteria:

* patients treated in the pediatric ENT unit at Bordeaux University Hospital, aged between 0 and 15 years

Exclusion Criteria:

* intubated patient,
* haemodynamic
* respiratory instability
* opposition to participation expressed by parents or patient
Use of Platelet-enriched Plasma During Auricular Reconstruction

In this study investigators are trying to determine the benefits of using platelet enriched plasma during the second stage of auricular reconstruction. The intervention will be blinded to the surgeon and the surgical team. The main outcome will be the evaluation of the integration rate of the skin full thickness graft used to coat the auricular frame.


Eligibility Criteria:
Inclusion Criteria:

* Microtia Tanzer II-A
* patients aged 8-12 years
* Haemoglobin \> 10 gr/dL
* History of first stage of auricular reconstruction

Exclusion Criteria:

* associated endocrinopathies
* desnutrition (\<2.5 gr/ dL)
Salt Reduction on Blood Pressure and Cardiovascular Organ Damage

The purpose of this study is to determine the effect of a modest reduction in salt intake on blood pressure in white, black and Asian individuals with hypertension or prehypertension, and also to determine whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease.

The average salt intake for adults in the UK is approximately 10-12 g/day. The current recommendations are to reduce salt intake to 5-6 g/day or less. Many randomised trials have shown that this reduction in salt intake has a significant effect on blood pressure, however, most previous trials were carried out in white individuals, fewer in blacks, and none in Asians.

Increasing evidence from epidemiological studies in humans and experimental studies in animals suggest that that our current high salt intake may have other harmful effects on cardiovascular health e.g. a direct effect on stroke, left ventricular hypertrophy, progression of renal disease and proteinuria independent of and additive to salt's effect on blood pressure. However, no well-controlled trials have studied whether a modest reduction in salt intake has beneficial effects on the surrogate markers of target organ damage in cardiovascular disease.

We propose to carry out a double-blind randomised trial to study the effects of a modest reduction in salt intake, as currently recommended, on blood pressure and target organ damage assessed by the measurements of 24 hour urinary albumin excretion, left ventricular mass, left ventricular diastolic function, pulse wave velocity and capillary density, in white, black and Asian individuals with hypertension or prehypertension.

Comparisons: Usual salt intake compared to reduced salt intake.

Eligibility Criteria:
Inclusion Criteria:

* Patients with untreated essential hypertension or prehypertension (sitting systolic blood pressure between 120 and 170 mmHg and/or sitting diastolic blood pressure between 80 and 105 mmHg)
* Age 18 - 75 years.

Exclusion Criteria:

* Individuals younger than 18 or older than 75 years
* Individuals with severe hypertension i.e. blood pressure \> 170/105 mmHg
* Individuals with any secondary cause of hypertension
* Individuals with impaired renal function with plasma creatinine greater than 150 umol/L
* Individuals with diabetes mellitus
* Individuals with malignancy or liver disease
* Individuals with ischaemic heart disease or heart failure
* Females who are pregnant or breast feeding or on the oral contraceptive pill.