cyrilzakka/clinical-trials huggingface dataset:
ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).

This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or an ExAblate Sham or "fake" procedure. The chance of randomization to Sham is one out of four. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be unblinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an unblinded fashion, as long as they still qualify for ExAblate treatment. All subjects will be followed at 6 and 12 months and for up to 5 years as directed by their doctor.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 22 years and older
* Subjects who are able and willing to give informed consent and able to attend all study visits
* Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
* Subject exhibits a significant disability from their ET despite medical treatment
* Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
* Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria:

* Subjects with unstable cardiac status
* Severe hypertension
* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
* Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
* Significant claustrophobia that cannot be managed with mild medication
* Current medical condition resulting in abnormal bleeding and/or coagulopathy
* Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
* History of intracranial hemorrhage
* History of multiple strokes, or a stroke within past 6 months
* Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
* Are participating or have participated in another clinical trial in the last 30 days
* Subjects unable to communicate with the investigator and staff
* Subjects with a history of seizures within the past year
* Subjects with brain tumors
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"

The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).

This method validation study will endeavour to obtain evidence for:

* Recruitment methodology effectiveness
* The usefulness of the "Canestest" test as a screening tool
* The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
* The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Female gender
* Over 18 years of age
* Have a high probability for compliance with and completion of the study

Exclusion Criteria:

* Hypersensitivity to metronidazole --only applies to Group 2.
* Post-menopausal defined as at least 12 consecutive months without menstruation
* Treatment of BV in last 4 weeks
* Clinically significant menstrual irregularities
* Suspected presence of STDs or other vaginal infection
* Pregnancy
* Breast feeding
* Participation in other clinical studies which could influence genitourinary tract microbiota
* Substance abuse
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Effects of Inspiratory Muscle and Endurance Training in Heart Failure Patients With Pacemaker

It is well-known that not only peripheral muscles, but also respiratory muscles muscle weakness and deconditioning play an important role in low exercise capacity of patients with Heart Failure (HF). Exercise training has been shown to improve exercise tolerance and quality of life in patients with heart disease. However, hearth failure patients with pacemaker such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization pacemakers or defibrillators (CRT-P or CRT-D) have additional specific issues when performing exercise. No study investigated the effects of different inspiratory muscle training protocols. For this reason, we aimed to investigate the effects of inspiratory muscle training on outcomes in hearth failure patients with pacemaker

Heart failure patients with pacemaker will be included. Primary outcome measurement is respiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression, physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with Pacemaker who are clinically stable
* After 12 weeks of pacemaker implantation
* No change in medications over one month

Exclusion Criteria:

Patients with

* Severe cognitive disorders
* Pulmonary, neurological and orthopedic diseases
* Pregnant and lactating patients
* Acute infection or exacerbation
A Study to Investigate Efficacy and Safety of KBL697 in Patients With Mild to Moderate Active Ulcerative Colitis

The study is designed to investigate efficacy and safety of KBL697 in patients with mild to moderate active ulcerative colitis. KBL697 has been developed as a potential new treatment for ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient has an established diagnosis of ulcerative colitis for at least 3 months prior to Screening
* Patient has active mild to moderate ulcerative colitis at Visit 2
* Patient is taking at least one of the following oral medication: 5-ASA, Corticosteroids, Immunomodulators

Exclusion Criteria:

* Patient has a possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
* Patient has a persistent fever of ≥ 38.3°C
* Patient has current signs or symptoms of infection
* Patient has any immunosuppressant condition
* Patient has a known malignancy within 5 years prior to Screening
* Patient who has a medical history of drug abuse or alcohol abuse
* Patient who, in the opinion of the Investigator, has a clinically significant co-morbid disease
* Patient has hepatic failure
* Patient is pregnant or plans a pregnancy within the study period
* Patient has no previous history of treatment for ulcerative colitis (treatment-naïve patient)
* Patient has ongoing or failed treatment for ulcerative colitis with calcineurin inhibitor
* Patient has received biologic medication
* Patient has received antibiotics within 4 weeks prior to Visit 2
* Patient is unable to stop previous antibiotics treatment during study period
* Patient has received probiotics within 2 weeks prior to Visit 2
* Patient with history of major surgery in any region of the gastrointestinal tract
* Patient has received any investigational product or participated in another clinical trial
* Patient has a stool culture or other examination positive for an enteric pathogen
* Patient tests positive for CMV by PCR test at Screening
* Patient tests positive for HIV at Screening
* Exclusion criteria based on results of Hepatitis B at Screening
* Exclusion criteria based on results of Hepatitis C at Screening
Comparison of Floss Band Application and Mulligan Mobilization

This study will investigate the effects of Floss band application and Mulligan mobilization on ankle range of motion, vertical jump, gait and balance in active healthy young adults.

The effects of floss band application and mulligan mobilization on ankle range of motion, vertical jump, gait, and balance in active healthy young adults are unclear or limited due to a lack of studies. There are also no other studies comparing the two interventions in healthy young adults. Therefore, this study will investigate the effects of Floss band application and Mulligan mobilization on ankle range of motion, vertical jump, gait, and balance in active healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-24 years,
* Not having any known disease
* Being recreationally active
* Body mass index between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* Presence of cardiovascular, rheumatic, dermatologic, orthopedic or neurologic diseases
* History of injury or trauma in the last 6 months
Clinical and Structural Outcome of Conventional Versus Accelerated Corneal Collagen Cross-linking (CXL).

Compare different corneal parameters and visual outcome of corneal collagen cross-linking (CXL) with conventional versus accelerated ultraviolet-A irradiation using riboflavin with hydroxypropyl methylcellulose.

40 patients with signs of progressive keratoconus are randomized to either corneal collagen cross-linking (CXL) with conventional ultraviolet-A (UVA) irradiation at 3 milliwatt/cm² (mW/ cm²) or accelerated ultraviolet-A (UVA) irradiation at 9 mW/ cm². In both groups riboflavin with hydroxypropyl methylcellulose was used. The objectives of this study are to evaluate and compare different corneal parameters (maximum corneal curvature, depth of collagen cross-linking, endothelial cell density) and clinical outcomes of uncorrected visual acuity (UCVA) and best spectacle corrected visual acuity (BSCVA)) after CXL with conventional and accelerated UVA irradiation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with increase of minimum of 1,0 diopter in maximum keratometry.
* Patients with increase in corneal astigmatism of minimum 1,0 diopter.
* Patients with in spherical equivalent of min 0,5 diopter.
* Patients living in Eastern Norway.

Exclusion Criteria:

* Minimum pachymetric corneal thickness (Pentacam)\<360 µm.
* Central corneal scar.
* Chemical burn, serious corneal infections and ocular surface diseases.
* Pregnancy.
* Lactation.
Human Epilepsy Genetics--Neuronal Migration Disorders Study

The purpose of this study is to identify genes responsible for epilepsy, brain malformations and disorders of human cognition.

Epilepsy is responsible for tremendous long-term healthcare costs. Analysis of inherited epilepsy conditions has allowed for identification of several key genes active in the developing brain. Although many genetic abnormalities of the brain are rare and lethal, rapidly advancing knowledge of the structure of the human genome makes it a realistic goal to identify genes responsible for other epileptic conditions, related brain malformations and disorders of cognition.

The purpose of this study is to identify genes responsible for epilepsy and disorders of human cognition (EDHC). The Walsh Laboratory at Boston Children's Hospital is looking for genes involved in brain development. Conditions that we study include brain malformations, such as polymicrogyria, lissencephaly, pachygyria, heterotopias, microcephaly and cerebellar hypoplasia, and inherited disorders of cognition, such as familial intellectual disability and familial autism. People with these conditions also often have epilepsy. The structural brain abnormalities are usually diagnosed by brain MRI or sometimes CT scans. Adults and children with these conditions, and their family members, are invited to participate in our study. By comparing the DNA of individuals or families that carry EDHC to the DNA of people in the general population, it may be possible to learn more about the genetic bases of certain forms of EDHC.

Study participants must have a brain malformation or disorder of cognition, such as familial intellectual disability or autism, in order to take part in this research.

Eligibility Criteria:
INCLUSION:

* Males and females of any age.
* Persons with a brain malformation or disorder of cognition (familial intellectual disability \[previously known as mental retardation\] or autism).

EXCLUSION:

* Persons without a brain malformation or disorder of cognition (familial intellectual disability (previously known as mental retardation\] or autism).
Validating the Use of Frailty Measurements to Predict Care & Quality of Life

The aim of this research program is to validate frailty measurements as a risk stratification tool to predict deteriorations in patient-reported outcomes, to gain a better understanding of patient preferences for care within varying degrees of frailty, and to assess differences in frailty measurement between patients and their clinicians.

This work will provide a foundation in the development of customized interventions for people with COPD and varying degrees of frailty, with the goal of improving quality of life and optimizing health system service delivery for patients and their care givers.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients of The Ottawa Hospital Respirology clinic
* Chronic Obstructive Pulmonary Disease diagnosis confirmed by pulmonary function testing.
* English or French speaking

Exclusion Criteria:

* patients with a known diagnosis of severe cognitive impairment
Multicentre ObseRvational Study in Posterior mecHanical thrombEctomy: conscioUs Sedation vs General aneSthesia

The association of conscious sedation vs. general anesthesia in ischemic stroke with posterior circulation occlusions undergoing endovascular therapy, is istill unknown.

No prospective or clinical trials have studied this effect on posterior circulation strokes.

The choice of anesthetic regimen is ussually depending on local stroke-team protocols or neurointerventional preference.

MORPHEUS Stroke Registry is a prospective multicentre observational study that investigates the association between anestheisa and functional outcome in patients with posterior circulation large vessel occlusion treated endovascularly.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged ≥ 18 years
* Evidence of posterior arterial occlussion (basilar artery, intracranial vertebral artery and posterior cerebral artery)
* Patients eligible for mechanical thrombectomy

Exclusion Criteria:

* Patient's refusal to participate
* Arterial recanalization prior to endovascular thrombectomy attempt
* Patient unable to present or be available for follow-up
Pain After Strabismus Surgery

At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.

Main hypothesis:

Children ages 4-12 years will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (surgery to correct misaligned eyes) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery.

Primary Objective At Lurie Children's, the current standard practice is for patients to be prescribed oral acetaminophen as needed every 4-6 hours after strabismus surgery. However, making the acetaminophen "as needed" leaves room for error for parents to be underdosing their children and, thus, leads to increased pain felt by these pediatric patients. To date, there have been no studies comparing patient satisfaction outcomes between a group taking a course of scheduled acetaminophen every 6 hours and to a group instructed to take as needed. The investigators plan to study the differences between these two groups by using the Parent's Post-operative Pain Measure (PPPM) questionnaire to survey parents and the Faces Pain Scale-Revised to survey children at their post-operative appointment.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4-12 years old
* Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL
* ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.

Exclusion Criteria:

* ASA classification 3 or higher (patient has severe systemic disease or worse)
* Contraindication to toradol (anesthesia)
* Contraindication to acetaminophen
* Previous strabismus surgery
Comparison of Progressive Muscle Relaxation and Stretching Exercises in Diabetic Population

The goal of this clinical trial is to compare the effects of Progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale. The main questions it aims to answer are, Will there be a significant difference between the effects of Progressive muscle relaxation and stretching exercises in the diabetic population? Can stress mediate the effects of Progressive muscle relaxation and stretching exercises in the diabetic population?

Researchers will compare the effects of Progressive muscle relaxation and stretching exercises mediated by stress on heart rate variability, cortisol level, galvanic skin response and perceived stress scale.

Participants will:

Be given session of Progressive muscle relaxation or stretching exercises or no physical therapy treatment 3 sessions per week for 2 weeks and visit the clinic once every 3 days for 2 weeks for intervention. Measurements will be taken before and after every session. Perceived Stress will be assessed at the start of the intervention at baseline and then after 2 weeks.

The subject of this research is individuals with type 2 diabetes who also experience depression. Progressive muscle relaxation (PMR) has the potential to reduce blood sugar levels in type 2 diabetes patients. This reduction is linked to the stress, both physical and psychological, experienced by the patients.

When stressors are assessed, muscle tension is created, which signals the brain and creates a feedback. PMR works to interrupt this loop by stimulating the parasympathetic nervous system and influencing the hypothalamus through focused concentration, promoting a positive mindset and reducing stress on the hypothalamus. Stretching can also be easily integrated into a diabetic's daily routine promoting both physical and mental wellbeing.

Most studies focus on PMR or stretching exercises separately in managing stress, but comparing these two interventions in terms of stress reduction and physical outcomes in diabetics is limited.

Understanding which intervention provides better stress relief could lead to more targeted recommendations in diabetic care.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-65 years Females Uncontrolled Diabetes Mellitus Sedentary Lifestyle Has never undergone progressive muscular relaxation before.

Exclusion Criteria:

* Unstable Angina Cardiac arrhythmia Postural deformities Left ventricular ejection fraction \< 45%
Changes Induced by Early HABIT-ILE in Pre-school Children With Uni- and Bilateral Cerebral Palsy

Studying in two randomized controlled trials (RCT) the changes induced by early HABIT-ILE in functional, neuroplastic and biomechanical assessment in children with unilateral and bilateral CP.

This study aims to evaluate the effect of two weeks of early Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) on bimanual performance in pre-school children with unilateral cerebral palsy (CP) and on gross motor function in those with bilateral CP, compared with two weeks of usual motor activity including usual rehabilitation (control group). We will assess further changes in unilateral performance tests, daily life activities questionnaires and executive function tests. Neuroplastic changes will be assessed using brain imaging (magnetic resonance imaging, MRI) and biomechanical changes will be assessed by using optoelectronic motion capture system with electromyography (EMG), to determine the effect of HABIT-ILE on movement pattern and quality.

Eligibility Criteria:
Inclusion Criteria:

* children with unilateral or bilateral cerebral palsy (spastic or dyskinetic)
* age 1 to 4 years inclusive (corrected age if preterm birth)
* ability to follow instructions and complete testing according to the age.

Exclusion Criteria:

* active seizure
* programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
* severe visual impairments
* severe cognitive impairments
* contraindications to perform MRI assessments (Metal implants, etc.)