cyrilzakka/clinical-trials huggingface dataset:
Pain Education vs. Self-management Associated With Movement Control Exercises for Chronic Low Back Pain

The primary aim of this study is to compare the effects of an exercise program based on movement control exercises associated with self-management advice (SME) or pain neuroscience education (PNE) on the outcomes of pain intensity and pain disability in patients with chronic non-specific low back pain (CLBP).

Participants: One hundred and four volunteers (104) aged 18-50 years with chronic non-specific low back pain.

Interventions: The volunteers will be randomized into two treatment groups: self-management education and movement control exercises or pain neuroscience education and exercises based on movement control exercises. Two workshops of 40 minutes each will be administered as education approach and the exercise program along 2 months ( and 12 sessions distributed over 2 months.

Main outcome measures: Primary outcomes will include pain intensity and low back disability, and secondary outcomes will be pain catastrophizing, pain self-efficacy, kinesiophobia, exercise adherence and global perceived effect. These will be measured pre- and post-intervention and at the 1-month follow-up. Statistical analysis will be conducted following treatment intent principles, and treatment effects will be calculated using a mixed linear model, considering intervention groups as a factor and assessments over time as repeated measures.

Eligibility Criteria:
Inclusion Criteria:

(1) non-specific chronic low back pain with a mechanical constituent caused by certain postures, activities, and movements, in addition to having at least 3 months of pain and/or episodes for at least half the previous 6 days, located between T12 and the gluteal folds; (2) pain intensity scores greater than 2 and greater than 14% on the Oswestry Low Back Disability Index and (3) positive results in 2 or more of the 6 tests to determine movement control impairment.

Exclusion Criteria:

(1) red flags such as tumors or neoplastic diseases in the spine, inflammatory diseases, infections, and fractures; (2) central and peripheral, psychiatric, rheumatologic, and cardiac neurological diseases; (3) acute and symptomatic radiculopathy, lumbar stenosis, and spondylolisthesis; (4) pregnant women; and (5) individuals submitted to physiotherapeutic treatment during the last 6 months. Finally, volunteers will be advised about the non-use of pain medications 24 hours before the evaluations.
Arm Motor Rehabilitation, Entertainment and Cognition System for the Elderly

The research project is intended to provide information pertaining to the feasibility of the BrightArm Compact robotic rehabilitation system for patients early sub-acute post Cerebral Vascular Accident. The aims are to: a) determine clinical benefit to motor and cognitive function as well as mood; 2) to ascertain technology acceptance by patients and therapists. The experimental training consists of 12 integrative arm/hand and cognitive training by playing therapeutic games. Participants are evaluated pre-and post-intervention and provide subjective evaluation of the system.

This study targets participants, who had suffered a first stroke recently, and who may or may not have been diagnosed with mild cognitive impairments or dementia (including Alzheimer's disease). It is important to find out if these improvements can be obtained with the computer game-based integrative (motor-cognitive) bilateral rehabilitation developed by Bright Cloud International Corp, and if these gains transfer to daily activities.

Specific aims are:

* BAC technology acceptance;
* improvement in motor function for the upper extremity;
* strengthening of shoulder and fingers;
* increased active (self initiated) range of motion for shoulder, arms and fingers;
* improved independence in activities of daily living;
* improvement in cognitive areas of memory, attention and decision making;
* improved mood (as in reduced depression severity);

Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 85;
* diagnosis of first-time CVA that occurred more than 5 days prior and less than 21 days prior
* English speakers;
* UE unilateral or bilateral involvement (from new bilateral CVA)
* motor involvement (FMA score 20 to 45);
* ability to actively move UE more than 10 degrees for shoulder and elbow flexion/extension;
* ability to actively extend fingers at least 5 degrees
* cognitive skills to participate (Montreal Cognitive Assessment (MoCA) \[Nasreddine et al 2005\] score 10-30).
* Subjects may have normal cognition, MCI or dementia

Exclusion Criteria:

* being younger than 50 or older than 85 years of age
* previous stroke
* Stroke that occurred more than 20 days prior to enrollment
* Inability to actively extend fingers at least 5 degrees;
* Fugl-Meyer scores of 19 or less;
* severe visual neglect or legally blind
* severe hearing loss or deafness
* receptive aphasia or severe expressive aphasia;
* severe spasticity (Modified Ashworth Scale 4/4)
* contractures of the upper limb joints
* uncontrolled hypertension (\>190/100 mmHg)
* severe cognitive impairment determined by Montreal Cognitive Assessment (MoCA) \[Nasreddine et al, 2005\] test of 9 and below;
* No chemodenervation or nerve block to upper limb involved during the experimental period (e.g., botulinum toxin injection)
* inability to speak English;
* a history of violence or drug abuse;
* paranoia and psychotic behavior;
* inability participate in the neuropsychological pre-study assessment for reliable scores (e.g., cognitive impairment, communication disorders).
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility for Duodopa/Duopa therapy in accordance with the approved local Duodopa/Duopa label in the participating country.
* Duodopa/Duopa naïve participants
* Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
* Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.
* For Arm B: Participant and caregiver must be motivated to use the PKG, understand the instructions and be able to handle the device.
* For Arm B: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the Parkinson's disease diary following training at enrollment visit 1/V1 with concordance on at least 1 time interval of "Off", concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.

Exclusion Criteria:

* Any condition included in the contraindications section of the approved local Duodopa/Duopa label in the participating country.
* Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites for Arm A).
* Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
* Mini-Mental State Examination (MMSE) score \<24
* Participation in a concurrent interventional clinical trial.
* Lack of motivation or insufficient language skills to complete the study questionnaires
Quality of the Detection & Treatment of Osteoporotic Fractures in a Swiss Trauma Center

As a tertiary hospital the Traumatology department at the Kantonsspital Aarau looks after about 500 fracture patients hospitalized with an age over 50 years a year. First, we were interested in the effective rate of osteoporotic fractures in this cohort. As to this objective we offered subsequent diagnostics in suspected patients. 2012 we introduced a diagnostic pathway for every patient over 50 years of age with a fracture, including dual energy x-ray absorptiometry (DXA), a questionnaire about risk factors concerning osteoporosis and risk of fracture, the WHO Fracture Risk Assessment Tool (FRAX) and a laboratory workup focusing on this topic. Considering all these information we sent a detailed therapy-plan to the responsible General practitioner.

The main goal of this study is to verify the persistence and compliance of the osteoporosis therapy 12-15 months after fracture and to clarify any obstacles potentially impeding therapy (prejudice, adverse events, contraindication overlooked, financial problems etc.). The investigators use a postal questionnaire provided to the patient and the general practitioner. Data collection is undertaken by a study nurse, in addition phoning for missing data by phone-call. With the aim to ameliorate the implementation of treatment, patients and general practitioners will be provided with the specifically tailored information found to be missing.


Eligibility Criteria:
Inclusion criteria:

* age over 50 years
* any peripheral fracture, which led to hospitalisation in Kantonsspital Aarau, traumatology department

Exclusion Criteria:

* no informed consent
* age under 50 years
* not treated by traumatology department
Regional Changes in Upper Limb Perfusion Following Brachial Plexus Block: A Pilot Study

Ultrasound-guided regional anesthesia is increasingly being used in the modern surgical environment to provide specific intraoperative anesthesia and postoperative analgesia. Infiltration of local anesthesics around peripheral nerves firs blocks sympathetic, then sensory, then motor nerve function. Sympathectomy-induced vasodilation following brachial plexus block results in increased skin temperature and arterial flow within minutes.

Although it has not been shown to reliably increase diameter or cross-sectional area of distal arteries, brachial plexus block does change the pattern and quantity of blood flow to the hand. Given that the magnitude of change of flow cannot be attributed to vessel radius, the investigators suspect that the more laminar fluid dynamics are due to vascular tone.

The investigators study aims to quantify alterations in physiology and peripheral vasodilator response. The investigators anticipate that axially block will significantly improve regional blood flow.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I, II, III
* BMI less than or equal to 39
* Presenting for elective upper limb surgery
* Does not meet any exclusion criteria

Exclusion Criteria:

* Age over 80
* ASA physical status IV or V
* BMI greater or equal to 40
* Language barrier precluding ability to give informed consent
* History of coagulopathy
* INR \< 1.4
* Platelet count \< 100
* Allergy to local anesthetics
* Known peripheral vascular disease of the upper limbs
* Amputation of one or both upper limbs, not including digits
* Peripheral neurological disease
* Does not consent to participate in study
Advance Care Planning at London Health Sciences Centre

All patients admitted to London Health Sciences Centre (LHSC) are asked to indicate their preferences for CPR (cardiopulmonary resuscitation) and other life-sustaining treatments that necessitate an Intensive Care Unit (ICU) admission.

Complex, high-risk patients at LHSC require multiple admissions to the hospital towards their end-of-life (EOL). Documentation of their resuscitation status should be a part of a broader dialogue with patients around their goals of care (GOC) and advance care planning (ACP), but rarely is this the case.

The innovation will involve the use of trained nurse facilitators to have meaningful conversations with patients and their families in an effective way that bridges the gap between resuscitation status, GOC discussions and ACP across the continuum of care.

1. On admission, the usual LHSC process will be followed whereby the patient's wishes for resuscitation are documented on the resuscitation record in the patient's chart. This constitutes the "original" resuscitation status.
2. After referral or screening and written consent, the RA will conduct semi-structured, face-to-face interviews with the patient and or SDM as appropriate. If the RA has concern about a discordance, he/she will then provide verbal feedback to the health-care team (Attending Physician or the Senior Medical Resident (SMR)) immediately and request them to communicate with the patient/SDM again. A case of discordance shall be recorded ONLY if the health-care team (Attending Physician or Senior Medical Resident) confirms that a change in resuscitation status is needed. The output of this intervention will be the "revised" resuscitation status. This "standardized" process for determining this outcome has worked well in our pilot study. Any disagreements between RA and SMR on patient/SDM preferences will be reported to Team#1 Attending and recorded. It will be up to the team to reconcile the "revised" resuscitation preferences on official records (Resuscitation status can only be filled in only by an MD as per hospital policy).

4. Advanced Clinical Notes: These will be typed by the RA and a note be made of the "revised" resuscitation preferences along with GOC and ACP discussions.

5. A pilot study related to this work started in August 2016 and has allowed the research team to evaluate barriers and facilitators of conducting this intervention on Internal Medicine patients.

Eligibility Criteria:
Inclusion Criteria:

Patients admitted to internal medicine teams at or after hospitalization day 2 with:

1. Age ≥55 years with ≥1 diagnoses: Chronic lung disease, Coronary artery disease, Congestive heart failure, Cirrhosis, Renal failure, Diabetes, Peripheral vascular disease, Cancer, Dementia (inability with ADLs) or
2. If none of these criteria were met, any patient whose death within the next 1 year would not surprise health-care team members.

Exclusion Criteria:

1. Lack of written consent
2. Patients who do not speak English; hard of hearing
3. Expected to die or be discharged ≤ 24 hours
4. Referral to or having an established palliative care plan
Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar fusion surgery will be randomized 1:1 into one of two treatment groups:

1. Group 1 (n=10): Active tAN + standard care
2. Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar fusion surgery will be randomized to receive either active or sham tAN treatment according to the following time points:

* Pre-operative: 30 minutes in the hour prior to surgery
* Intra-operative: 30 minutes before the end of surgery
* Post-operative: 30 minutes at 3 and 6 hours after surgery
* Inpatient: Four 30-minute sessions on Day 2

Blood Draws

Participants will have blood samples collected at the following time points:

* Day 1 (Day of Surgery)
* Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit.

Eligibility Criteria:
Inclusion Criteria:

1. Medically cleared to undergo a lumbar fusion surgery
2. 18-85 years of age
3. English Proficiency
4. Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

1. Current evidence of an uncontrolled and/or clinically significant medical condition
2. History of bleeding disorders or coagulopathy
3. History of seizures or epilepsy
4. History of neurological diseases or traumatic brain injury
5. Use of illegal recreational drugs
6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators
7. Use of acupuncture within 4 weeks of surgery
8. Grossly abnormal external ear anatomy or active ear infection
9. Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study
10. Females who are pregnant or lactating
11. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Rapid and Easy Evaluation of Cardiac Systolic Function by Means of Mitral Valve Movements in the Emergency Department

Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to the patients, admitted to the emergency department with shortness of breath. The investigators aimed to investigate correlation between LVEF and 4 different mitral valve movements which alternate to the classical LVEF assessing methods and evaluate these methods can be used or not in the emergency department.

A prospective observational study was conducted in an acutely dyspneic patients with receiving echocardiagraphy by the chief physicians. Measurements were performed before echocardiography lab by the physician who conducted the survey in the emergency department. In parasternal long axis view mitral valve E-Point Septal Separation (EPSS) M-Mod measurements and mitral valve anterior leaflet and septal distance (P-ALSS) B-Mod measurements and in apical four chamber view mitral valve anterior leaflet and septal distance (A-ALSS) B-Mod measurements and distance between mitral valve anterior and posterior leaflets (MVLS) B-Mod measurements were acquired as the minimum distance in diastole. LVEF of patients were measured by cardiologist. Correlation of the all values between LVEF and sensitivity, specificity, and likelihood probabilities were calculated.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* nontraumatic acute dyspneic patients

Exclusion Criteria:

* sigmoid septum
* septal hypertrophia
* mitral stenosis
* mitral valve prothesis
* aortic regurgitation
* regional wall motion defect
Taperloc Versus Taplerloc Microplasty

This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Eligibility Criteria:
Inclusion criteria:

* Patients with primary osteoarthritis of the hip scheduled for THA.
* Suitable anatomy for both stems
* Willingness and ability to follow study-protocol

Exclusion Criteria

* Malignancy or metastatic bone disease.
* Any other disease severely affecting bone and mineral metabolism
* Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
* Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
* Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
* Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
* Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
Sour Taste Intensity Matching With Fatty Acids Taste

Investigators are trying to find the concentrations of fatty acids ( a part of the fat and flavor typically found in normal foods) that have a taste intensity similar to that to the sourness of vinegar solutions.

Participants will first taste 5 sour solution containing acetic acid for sour compounds, sucrose esters, and xanthan gum to help them stay dissolved). Then rate them for their taste intensities. Next, participants will taste 5 butyric acid solutions, 5 hexenoic acid solutions, 5 caprylic acid solutions, 5 lauric acid solutions, 5 palmitic acid solutions, 5 oleic acid solutions, and 5 linoleic acid solutions (all will also contain the sucrose esters and xanthan gums.) and rate them for their taste intensities. This should take no longer than 1 hour. Participants will spit all samples into a cup after tasting them. They will not swallow any samples.

Eligibility Criteria:
Inclusion Criteria:

* male and female age 18 to 65

Exclusion Criteria:

* taste abnormalities