cyrilzakka/clinical-trials huggingface dataset:
Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education (PNE) will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

It will have three arms of which will receive exercise, PNE and/or cognitive training for 8 weeks (Group I - exercise and PNE; Group II - exercise, PNE and cognitive training; Group III - cognitive training).

Participants will be assessed for pain characteristics, psychological, and cognitive aspects at baseline, post-intervention and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* have chronic idiopathic LBP
* report pain intensity of at least 2 out of 10 on the Numeric Pain Rating Scale
* 18 to 64 years old
* Be able to read, write and speak Portuguese
* Asses to personal computer and internet for those receiving cognitive training

Exclusion Criteria:

* individuals receiving any chronic treatment for their pain
* symptoms of peripheral nervous system pathology (e.g., motor weakness and sensory disturbance);
* a diagnosis of an ongoing neurological disease with peripheral or central nervous system involvement or relevant sequela;
* having a diagnosis of ongoing psychiatric disease
* having relevant cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA).
Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

This clinical investigation is a prospective, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses FineVision POD F GF (PhysIOL, Liège, Belgium).

The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.

The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD suspicious eyes (determined by OCT)
* Complicated surgery
Clinical Cardiovascular Outcomes of African-Americans

To examine clinical cardiovascular outcomes of African Americans.

BACKGROUND:

It has been well recognized for years that the survival rates among African-Americans with chronic diseases are reduced compared to their white counterparts. Recently attention has focussed on racial disparities in survival with chronic cardiovascular diseases. Prior to the widespread availability of coronary arteriography, African-Americans were thought to have a very low incidence of coronary artery disease. These findings appear to be inconsistent with the now generally accepted view that the coronary artery disease mortality rate is nearly equal in United States Black and white men and is increased in Black women as compared to white women.

Howard University and Howard University Hospital provided a unique environment for studying the clinical cardiovascular outcomes of African-Americans, in light of its history. That is, due to the influx of blacks into the District of Columbia in 1862, Freedmen's Hospital (which is now known as Howard University Hospital) was established for their care. Howard University Hospital has had an admissions profile with greater than 95 percent African-Americans for the past century

DESIGN NARRATIVE:

The study used previously collected data to: 1) examine the trends in mortality rates at Howard University Hospital, based on discharge status, between 1986 - 1992, for selected cardiovascular diseases; 2) compare cardiovascular mortality rate trends between Howard University Hospital and the National Hospital Discharge data; 3) examine cardiovascular co- morbidity experiences using a severity of illness index at Howard University Hospital compared to National data by race/ethnicity, geographic location and hospital bed size; and 4) identify a cohort of cardiovascular patients retrospectively based on repeated discharge data at Howard University Hospital, to analyze survival data.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Low-frequency Electrical Stimulation of Acupuncture Points

Abstract:

Objective: To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.

Methods: Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (MAX and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

①Diagnostic criteria for upper extremity motor dysfunction after stroke. ②Age 35-75 years and duration of illness is 2 weeks to 3 months. ③ Impaired hand function with Lovett classification ≥ grade 2 and MAS ≤ grade 2. ④No organ dysfunction such as heart, liver, lung, kidney or blood circulation dysfunction. ⑤Clear consciousness, no major impairment in intelligence, hearing or speech, and stable condition. ⑥Patients voluntarily participated in this subject trial and signed the informed consent form.

Exclusion Criteria:

* Presence of neurological or musculoskeletal disorders affecting functional recovery prior to the onset of the disease. ②Brainstem infarction, bilateral cerebral infarction or transient ischemic attack.
Message: Study of Patients' Perception of Physician's Compassion

The goal of this study is to learn what types of conversations patients prefer to have with their doctor about treatment options and how patients view their doctor's compassion.

If participant agree to take part in the study, basic information will be collected (such as date of birth, date of diagnosis, sex, and religion). Participant will also complete questionnaires about any symptoms they may be having, how hopeful they are, how they are accepting the disease, their trust in the medical profession, and how they like information to be delivered to them.

After completing the questionnaires, they will be randomly assigned (as the roll of dice) to one of 4 groups.

Regardless of which group they are in, they will watch 2 short videos that show actors portraying a doctor and patient having a conversation about treatment options in a clinical setting. Both videos will discuss the same material, but the order of the videos and the actors in the videos will be different for each group. Both videos are about 4 minutes long.

After watching each video, the participant will complete 3 questionnaires about the doctor in the video. It should take about 38 minutes to watch both videos and to complete all of the questionnaires.

After they have watched both videos, they will be asked to choose which doctor they preferred and to briefly explain the reasons why they chose that doctor.

Length of Study:

Participant will be off study after they have completed the last questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
2. Patients treated as outpatients by the Supportive and Palliative Care team.
3. Age \>/= 18 years-old
4. English speaking
5. Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.

Exclusion Criteria:

1) Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation, as determined by the Principal Investigator or by the attending palliative care physician.
Ocrelizumab Access by Socio-Economic Status

The primary aim of this project is to determine whether there are differences in access to, efficacy and tolerability of Ocrelizumab in men and women of different racial and ethnic origins and socio-economic backgrounds with RRMS and PPMS in two large academic MS Centers with a high volume of patients on Ocrelizumab. The study is a retrospective analysis of multiple sclerosis patients cared for at Brigham and Women's Hospital and Boston Medical Center who were treated with Ocrelizumab during the 4 year study period.

This study will be a two-center retrospective/observational analysis with data collected from the Research Patient Data Registry (RPDR), Brigham Multiple Sclerosis Center Patient Database (Oracle), and Boston Medical Center MS Clinic Database (BMC-MS).

Using the Oracle database, BMC-MS database and electronic medical records (EPIC), the investigators will capture all MS patients who satisfy inclusion criteria. This study will collect age, sex, race, socio-economic status by residence zip code, disease duration, previous treatment, current treatment status, the reason for discontinuing or switching to another treatment, expanded disability status scale (EDSS), and functional systems scores (FSS) where available.

Additionally, the investigators will collect the date, dose, and interval between each ocrelizumab infusion, as well as any pertinent laboratory values and MRI scan results.

Eligibility Criteria:
Inclusion Criteria:

* All MS patients at the Brigham MS Center and Boston Medical Center MS Clinic who have been diagnosed with RRMS or PPMS, ages 18 or older, on Ocrelizumab for at least one year and have received at least 3 treatments (two loading treatments of 300mg each, and one full dose treatment of 600 mg), who have been followed at these institutions for clinical care and brain and/or spinal cord MRI, and who have received Ocrelizumab infusions at these institutions for the duration of the study period.

Exclusion Criteria:

* Simultaneous use of high dose monthly IV steroids,
* Secondary progressive MS (SPMS) disease category,
* Additional serious medical or neurologic co-morbid diseases,
* Additional concomitant immunosuppressive therapy of any kind,
* Additional concomitant MS-specific therapy (DMT) of any kind,
* Change of infusion or care site and absence of neurologic or imaging follow-up.
Economic Impact of Dropless Therapy Versus Usual Care for Cataract Surgery: A Real-World Study.

This real-life Health Economics and Outcome Research (HEOR) study will enable to evaluate the economic impact of Dropless therapy for the prophylactic treatment of inflammation and infection after routine cataract surgery. This prospective randomized controlled crossover open-label study will estimate resource utilization and cost attributable to patients' management following a cataract surgery and until last follow-up visit and adherence, satisfaction and preference between usual care and Dropless in a real-life setting.

Data collected will include patients' characteristics and demographics, medical information, cataract surgery information, healthcare resource utilization, patients' adherence to topical ophthalmic medications as well as patients' satisfaction to both treatment and preference between usual care and Dropless. Patients will fill a set of questionnaires at their recruitment in the study and at their last follow-up visit for their two cataracts surgery.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older;
2. Undergoing delayed sequential bilateral cataract extraction with intraocular lens implantation;
3. Delayed sequential bilateral cataract surgery performed in a day surgery setting;
4. Second cataract surgery planned within 3 months following the date of the first cataract surgery;
5. Ability to read and understand English or French;
6. Signature of ICF.

Exclusion Criteria:

1. Patients with other ophthalmic conditions such as glaucoma, corneal disease, agerelated macular degeneration, and active uveitis\* (\*In line with current clinical practice in Canada, uveitis should be inactive for 3 months to be included in the study);
2. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation;
3. Participation in any investigational ophthalmic-related drug or device trial within the 30 days prior to the start date of this trial or participation in any current investigational ophthalmic-related drug or device trial;
4. Patients with any history of allergy to the usual care post-operative eye drops or the components of Dropless.
Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect

Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2

This study is a combined, open label, prospective, comparative single-center study.

The study is separated in 3 consecutive study parts. The first 2 study parts include 16 patients each. In the third study part 16 additional patients will be enrolled. Study part 1 and 2 will be used for optimization and validation of the measurement algorithms of the Vital USA biosensor. During the third study part with enrolment of 16 additional patients, the precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The visit schedule for all participants of all 3 study parts will be exactly the same. In all groups of participants, the Vital USA non-invasive monitoring biosensor will be individually introduced and assigned. During the experimental study visit, a standardized meal will be given to the participants. Before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the pO2 using a patient monitor will be compared to the device readings.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetic or healthy subject (50 % from each)
* Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
* 18 years old and above;
* Anatomically suitable finger in discretion of the investigator

Exclusion Criteria:

* Does not meet inclusion criteria;
* Any conditions that may hamper good visual contact between the finger or wrist and sensor, such as raised birthmarks, scars, tattoos;
* Pregnancy;
* Nursing mothers;
* Any skin scratch(es), damage, over dry, long nails on the measured finger;
* Unsuitable finger with the device might be excluded if recognized during the trial;
* Medication containing nitrates
PGD2 Formation in Vascular Injury

To investigate the biosynthesis of PGD2 during percutaneous transluminal coronary angioplasty (PTCA) procedure.

A) To determine whether biosynthesis of PGD2 is altered in response to vascular injury in humans

B) Patients will be grouped base on their aspirin using status. Three groups of no aspirin but an alternative anti-platelet medicine, low dose (81 mg) aspirin, high dose 325 mg aspirin will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients with existing CAD admitted for elective PTCA:

  1. Treated with any dose of aspirin daily for at least 5 days, with special interest in those treated with 81 mg aspirin daily or
  2. Treated with an alternative antiplatelet therapy, such as clopidogrel, due to aspirin hypersensitivity or PMDs preference or
  3. No aspirin therapy at all
* Patients presenting to the ER with Acute Coronary Syndrome(ACS)who will have a PTCA
* Patients with stable angina or positive stress tests scheduled for a cardiac catheterization

Exclusion Criteria:

* History of unstable diabetes (hgb A1c\>8 or FBS\> 200)
* Uncontrolled hypertension (SBP \> 180, DBP \>100)
* History of an acute confounding disease as judged on clinical screen that according to the investigator may interfere with interpretation of the study results, or compromise the safety of a potential subject.
* Patients who have taken NSAIDS or COX-2 inhibitors other than aspirin, for at least 10 days prior to PTCA
Efficacy of Serratus Anterior Plane Block Mastectomy

Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .

The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.

Patients and methods nclusion criteria:

-ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion criteria:

* Patient refusal
* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
* Allergy to the drugs used in the study
* Chronic pain therapy,
* BMI more than 30 kg/m2

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II female patients, age 25-60 undergoing breast cancer surgery

Exclusion Criteria:

* -Patient refusal
* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)
* Allergy to the drugs used in the study
* Chronic pain therapy,
* BMI more than 30 kg/m2
Telehealth System to Improve Quality of Life in Breast Cancer Survivors

Background: Cancer is increasingly viewed as a chronic disease and therefore there is a growing need for long-term treatments. Breast cancer survivors suffer physical impairment after oncology treatment. This impairment reduces quality of life (QoL) and increases the prevalence of conditions associated to unhealthy life-style.

Objective: The overall objective of e-Cuidate telerehabilitation will be to evaluate short and long-term effects telehealth program.

Methods: Seventy-two breast cancer survivors (age range: 18-65 years) will be recruited through oncology and breast units at the Virgen de las Nieves Hospital and San Cecilio Hospital and associations of breast cancer patients in Granada. Patients will be randomized to receive the online rehabilitation group (n=36) or usual care (control) group (n=36). Telerehabilitation group will receive an eight-week online intervention and control group receive recommendations about usual care.

Discussion: The investigators study attempts to increase the level of fitness and reduce musculoskeletal disorders in breast cancer patients through a strategy for care based on telerehabilitation to promote therapeutic exercise.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage I, II, or IIIA breast cancer
* Medical clearance of participation
* Without chronic disease or orthopaedic that would interfere with ability to participate in a physical activity program
* Access to Internet
* Basic ability to use the computer or living with a relative who has this ability
* Completion of adjuvant therapy except for hormone therapy
* No history of cancer recurrence
* Have interest in improving lifestyle: fitness/stress level
* Have signed informed consent
A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

The study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (T2D). Participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. Participants need to take one injection of semaglutide once a week, on the same day of every week. Participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening.
* Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose.
* HbA1c of 7.0-10.5 percentage (%) \[53-91.3 millimoles per mole (mmol/mol)\] (both inclusive).

Exclusion Criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.