cyrilzakka/clinical-trials huggingface dataset:
Training Levels Comparison Trial

To determine the effects of high or low intensity long-term exercise conditioning in patients with coronary artery disease.

BACKGROUND:

A vast amount of literature exists on the improvements in work capacity, reduction of risk factors, and an increased feeling of well-being among coronary heart disease patients after physical training programs. Previous observations of short-term training programs which resulted in an increase in physical working capacity have not usually shown a cardiac change. The National Exercise and Heart Disease Project did not show such changes, but the exercise level may have been inadequate. Several other studies suggested that more prolonged and intense training could result in improved cardiac function.

DESIGN NARRATIVE:

Patients were randomized to high intensity or low intensity long-term exercise groups. Compliance was strengthened by randomizing following a sequence of eligibility visits and after a test period of subject reaction to an exercise program. The primary endpoint was change in exercise ejection fraction at one year. Secondary endpoints included changes in lipid levels, body composition, blood pressure and heart rate measurements, glucose tolerance, quality of life measures, compliance, and progression of disease. Patients were classified into one of four strata based on the documented history of myocardial infarction and resting left ventricular ejection fraction. Within each stratum, patients were assigned in equal numbers to the two intensity levels of exercise intervention. All exercise prescriptions were based on exercise testing of patients maintained on their usual medical regimen including drugs. Patients underwent standardized multistage treadmill exercise testing monitored by Doppler echocardiogram at baseline, just prior to randomization and at the three month, six month, one year and two year visits. Patients participated in the structured group exercise sessions three days per week. Each exercise session was preceded by and ended with a five to fifteen minute warm-up and cool-down session. Each patient was given an exercise prescription that included a 30 minute period of walking or of walking and jogging sequences and 15 minutes of arm-leg bicycle ergometer exercise. Recruitment started in May 1987. The last patient was enrolled in March 1990.

Eligibility Criteria:
Men, ages 30 to 67, with documented coronary heart disease.
Treatment Time-frame Guideline for Dry Needling in the Lower Limb

This study evaluates the impact of treating myofascial trigger points with a single session of dry needling on maximal isometric strength in the short term. Two groups will receive dry needling in separate muscle groups and a third group will receive no dry needling.

Dry needling is a effective treatment for myofascial trigger points. It is very common in a sporting environment. Strength is a key aspect of athletic performance. Despite the prevalence of dry needling within a sporting environment, the effects of dry needling on strength remains unknown.

This study will investigate the effects of dry needling on maximal isometric strength with a view to informing clinical practice amongst clinicians working in the elite sport setting.

Eligibility Criteria:
Inclusion Criteria:

* Must have latent trigger points in their rectus femoris and gluteus maximus

Exclusion Criteria:

* Active trigger points in rectus femoris or gluteus maximus
* Participants with current injuries
* History of fibromyalgia or myofascial pain syndrome
* History of blood disorder which prevents dry needling
* Needle phobia
* History of surgery in the last 6 months
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).

Eligibility Criteria:
Inclusion Criteria:

* Patients have given written informed consent
* Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²
* For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
* Estimated glomerular filtration rate (eGFR) ≥ 60 mL/\[min\*1.73m²\]
* Alanine amino transferase (ALT) \> 20 IU/L in females and \> 30 IU/L in males
* Hepatic steatosis (MRI-PDFF ≥ 10%)
* Effective contraception for women of child bearing potential

Exclusion Criteria:

* Evidence of another form of liver disease
* Evidence of liver cirrhosis
* Evidence of hepatic impairment
* Positive serologic evidence of current infectious liver disease
* History of excessive alcohol intake
* Acute cardiovascular disease with 24 weeks prior to screening
* Uncontrolled high blood pressure
* Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
* Use of non-permitted concomitant medication
* Pregnancy or lactation
The Canadian Mitral Research Alliance (CAMRA) Trial CardioLink-2

Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery.

Mitral valve repair has emerged as the preferred surgical treatment for mitral valve prolapse (MVP), a condition wherein the mitral valve does not close properly. One common strategy for mitral valve repair is leaflet resection, which involves removing part of one or both of the mitral leaflets that flop or bulge back (prolapse). Another strategy is leaflet preservation, which involves placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle). While both strategies are routinely used and lead to successful mitral valve repair, there is no clear evidence as to whether one strategy is better than the other in terms of long term outcome. The purpose of this study is to determine if one repair strategy (leaflet resection versus leaflet preservation) leads to better longer term patient outcomes. A total of 88 patients from 6 Canadian centres will be randomly assigned to one of the two strategies. The primary outcome will be functional mitral stenosis (MS) as assessed by 12-month mean mitral valve pressure gradient at peak exercise.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with mitral regurgitation and mitral valve prolapse who are scheduled for elective mitral valve repair by an experienced mitral valve repair surgeon (\>15 degenerative mitral valve repairs per year, with a repair rate\>90%, and able to perform mitral repair with either a leaflet resection or leaflet preservation strategy).
2. Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy

Exclusion Criteria:

1. Patients with anterior leaflet or commissural prolapse
2. Patients with endocarditis or rheumatic mitral valve disease
3. Patients with mitral annular calcification extending beyond the circumference of one leaflet scallop
4. Patients with significant LV dysfunction defined as a LVEF \<40%
5. Patients undergoing concomitant aortic valve surgery
6. Patients unable to undergo bicycle ergometry
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.


Eligibility Criteria:
Inclusion Criteria:

* Is of American Society of Anesthesiologists (ASA) 1 - 4;
* Is above or equal to the age of 18;
* Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
* Scheduled for surgical procedure in supine position;
* Given written informed consent.

Exclusion Criteria:

* Participants in whom a difficult intubation because of anatomical malformations was expected;
* Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
* Is known or suspected to have a (family) history of malignant hyperthermia;
* Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
* Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
* Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Had already participated in a sugammadex trial;
* Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
* Females who are pregnant:
* Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
* Females who were breast-feeding.
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Huntington's Disease

The primary purpose of the study is to evaluate the safety and tolerability of SAGE-718 softgel lipid capsule in participants with Huntington's Disease (HD)


Eligibility Criteria:
Inclusion Criteria:

For all participants:

* Completed 718-CIH-201 (NCT05107128) or 718-CIH-202 (NCT05358821) studies or meet eligibility criteria for the de novo cohort.
* Agree to refrain from drugs of abuse for the duration of the study and from alcohol during the 48 hours preceding each study visit.
* Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.
* Be able to travel to the study center, and, judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.

Additional inclusion criteria for the de novo cohort (Cohort 3):

* Be at least 25 years old, but not older than 65 years of age at Screening.

  * Genetically confirmed disease with cytosine-adenine-guanine (CAG) expansion ≥40
  * No features of juvenile HD
* CAG-Age-Product (CAP) score ≥90, as calculated using the CAP formula: AGE × (CAG - 30) / 6.49.
* At screening, scores of either: a) Unified Huntington's Disease Rating Scale (UHDRS) -Total Functional Capacity (TFC)=13 and Montreal Cognitive Assessment (MoCA) ≤25 score, or b) UHDRS-TFC ≤12 and MoCA \>25

Exclusion Criteria:

For all participants

* Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to, Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.
* Had gastric bypass surgery, has a gastric sleeve or lap band, or has had any related procedures that interfere with gastrointestinal transit.
* Is known to be allergic to any of SAGE-718 excipients, including soy lecithin.
* Receive any prohibited medications within 30 days of screening and during participation in the study.

Additional exclusion criteria for the de novo cohort (Cohort 3):

* Have previous exposure to gene therapy, or have participated in any other HD investigational drug, biologic, or device trial within 180 days or a non-HD drug, biologic or device trial within 30 days or 5 half-lives (whichever is longer). Additionally, participants who have received treatment with antisense oligonucleotides or a messenger ribonucleic acid (mRNA) splicing modifier will be excluded.

Note: Participants with confirmation of enrolment in the placebo arm of these investigational trials would not be excluded.

Additional exclusion criteria for 718-CIH-201/202 completers (Cohorts 1 and 2):

* Have one or more ongoing serious adverse events (SAEs) from the parent study.
* Have ongoing, unresolved AE(s), which in the opinion of the investigator or sponsor, is likely to interfere with study conduct or compliance.
Effect of an Integrated Care Pathway on Asthma Care in Hospital

Integrated care pathways (ICP) coalesce medical and nursing work practices, unifying and directing care in line with current best practice and guidelines. We wish to examine the introduction of an ICP for children with wheeze/asthma admitted to our hospital. We will determine whether more rigid, but guided care results in faster recovery, quicker discharge with better education and fewer prescribing errors, but also determine whether staff feel alienated by the rigidity of practice, and parents perceive any benefit to the changes introduced.This will be a cluster randomised trial (random weeks) of standard or ICP care in 180 patients admitted to Sick Kids with wheeze/asthma. Parents will be asked to complete a questionnaire on admission and contacted at 10-14 days post discharge and asked to recall education provided at discharge; no other patient or parent intervention will be required.It is expected to take 40 weeks to recruit 180 patients.

Children admitted to hospital with wheeze/asthma are provided with care by a large number of clinicians with varying levels of skills and experiences. Providing a uniform, safe level of care, according to evidence based guidelines is challenging given the levels of experience within each hospital. Integrated care pathways are a multidisciplinary document incorporating medical, nursing, pharmacy and observational charts within a single chronological document. The study is to assess whether such documents can speed recovery and discharge, with care adhering more closely to evidence based guidelines for treatment and education. In addition we wish to assess patient safety (through prescribing errors) and parental and staff attitudes to the ICP introduction. Children arriving at the emergency department will be provided with care by either intergrated care pathway or standard care in 7 day clusters, randomised in 8 week blocks.

Comparison: We will compare the time from arrival at hospital to discharge from the ward as our primary outcome.

Other comparisons to be made for: Speed of recovery of heart rate and respiratory rate Time to require no supplemental oxygen Time to achieve 4 hourly spacing of bronchodilator Number and degree of prescribing errors Provision of education to parents Provision of care adhering to asthma guidelines (accurate discharge dose of prednisolone from emergency dept, use of multidose salbutamol rather than nebuliser) Number of clinical contacts required with patients Staff opinion of ICP before and after introduction Parental opinion of care in different groups Parental recall of advice/education provided to them during admission Possible Hawthorne effect during period of the study

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-16 years (inclusive) arriving at the Emergency Department with acute wheeze/asthma

Exclusion Criteria:

* Children requiring high dependency care
* Children with significant neurological or cardiac disease
Fixed Lingual Mandibular Growth Modificator

The current trial was designed to investigate the possible initial net skeletal and dental effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1 malocclusion subjects. The null hypothesis stated that there were no significant differences in dentofacial changes between FLMGM group and control group.

The study was prospective controlled clinical trial conducted at the department of Orthodontics, between May/2009 and June/2011. The protocol of study was approved by the council of scientific research and postgraduate studies.

The original study sample included 43 patients (25 treated, 18 untreated). Of the 43 patients initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated, 1 untreated) were excluded . All patients and parents gave prior informed consent to their inclusion in the investigation.

Patients of both groups were followed on a parallel basis during a period of 8 months and included in the trial regardless of achievement of a Class I incisor relationship. All patient of treatment group (n=21) were treated with FLMGM, and treatment was continued beyond this time point if the Class II malocclusion was not fully corrected and clinical objectives were not achieved. On the other hand, no orthodontic treatment was performed during that duration for the subjects of control group (n=17), and most of control subjects were offered suitable treatment at a later date.

For each patient, a direct digital lateral cephalogram was taken pre- and post- treatment/observation using PAX 400 (VATECH CO., Korea) with the same settings. Cephalograms were digitized on screen and analyzed in a blind manner by the same orthodontist using a cephalometric software (Viewbox, 3.1.1.13, Kifissia). . All linear measurements were reduced to life size (enlargement: 7.54%).

Pretreatment equivalence, changes occurring during the examination period in each group and comparison of changes observed in both groups were tested for significance with t-tests using SPSS . P values of less than 0.05 were considered statistically significant. To assess the method error, twenty cephalograms were randomly picked from both groups and redigitized and analyzed by the same orthodontist after 1 month, and the method error was calculated by Dahlberg's formula.

Eligibility Criteria:
Inclusion Criteria:

Before treatment, each patient fulfilled the following criteria:

1. Cl II/1 malocclusion with an overjet greater than 4 mm.
2. Mild to moderate Class II Skeletal pattern (A-N-B \> 4°) with retrognathic mandible (S-N-B \< 76°).
3. Growth potential. Fishman skeletal maturation indicator (SMI) method28 was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7,29 at the beginning of the treatment/observation period were invited.

Exclusion Criteria:

-
Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer

The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) \<10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Clinical stage T1c-T2aN0M0
* Gleason score \<= 3+3=6
* prostate specific antigen (PSA) \<10 ng/ml
* \<= 2 cores positive out of a minimum of 12 cores sampled
Evaluation of Pain Quality in Young Swimmers Suffering From Myofascial Pain Syndrome Using Lidocaine Phonophoresis

To evaluate pain quality by pain quality assessment scale (PQAS) using lidocaine phonophoresis on myofascial pain syndrome (MPS) in athletic children.

Forty five males athletic swimmer children (10 to 14 years old) with MPS in the upper trapezius muscle were evaluated before and after treatment. They were randomly divided into three groups, n=15 children each. A (control), B and C (study groups). The three groups received spatial designed physical therapy program. The two study groups received pulsed ultrasound and lidocaine phonophoresis repectively. The duration of treatment was 40 minutes, three times / weeks for three successive months.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 10 to 14 years.
* All children have regional neck pain complaint.
* Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I )
* The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005):
* Patients suffered from active MTrPs in the upper trapezius.
* Tender spots in one or more palpable taut bands.
* A typical pattern of referred pain distributed in the ipsilateral, posterolateral cervical paraspinal area, mastoid process or temporal area
* Palpable or visible local twitch response on snapping palpation at the most sensitive spot in the taut band.
* Restricted range of motion in lateral bending of the cervical spine to the opposite side.
* Palpation of a trigger point elicits a stereotypic zone of referred pain specific to that muscle.
* Identification of a palpable taut band, as well as a palpable, and exquisitely tender spot along the length of that taut band.
* All children allowed to practice their regular sport activities.

Exclusion Criteria:

* Neurological disorders.
* Dermatological disorders.
* Acute trauma prior to the study.
* Fibromyalgia, systemic disease and drug allergy history were excluded from the study.
* Having myofascial trigger points injection.
* Chronic pain in both sides of the body.
* History of findings of cervical injury whether orthopedic or soft tissue injury
Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Be of non-childbearing potential.
* Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
* BCVA of 20/320 or better in the worst eye.

Exclusion Criteria:

* Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
* Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
* Diagnosis or recent history of clinically significant cerebrovascular disease.
* Uncontrolled hypertension.
* Uncontrolled Type 1 or Type 2 diabetes mellitus.