cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients

Use of motor imagery, mirror therapy and motor relearning program in rehabilitation of people with stroke is on rise and these are unique and emerging techniques. Motor imagery is a mental rehearsal through visualization while mirror therapy creates a reflection of non-effected limb by using a mirror. Moreover, motor relearning is task-oriented approach, benefacial for balance and motor funCtion in patients with stroke that emphasizes on relearning.The aim of the study is to determine the comparative effects of motor imagery and mirror therapy versus motor relearning program in addition to routine physical therapy on balance, motor function and activities of daily living in subacute stroke patients.

This randomized clinical trial will be conducted at medical centre Fifty stroke patients will be included using convenience sampling technique. The participants in the study will be randomly allocated in to two groups . Twenty five participants will be included in both Groups A d B. Group A (motor imagery and mirror therapy) will receive 60 minutes treatment session that consists of 20 minutes motor imagery, 20 minutes mirror therapy along with 20 minutes routine physical therapy and Group B (motor relearning program) will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes. Both groups will undergo 60 minutes session for 5 days per week for 12 weeks. Berg balance scale will be used to assess balance, Fugl-meyer assessment to assess motor function and Functional independence measure for activities of daily living. Assessment will be carried out at baseline, 4th week, 8th week and at 12th week after the discontinuation of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke patient of both gender.
2. Stroke patient of age 40-65 year .
3. Patient diagnosis of cerebral ischemic stroke .
4. Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.
5. Ability to walk with minimal assistance (functional ambulation category 1 to 3.
6. Patient with score \> 25 on mini-mental status examination.

Exclusion Criteria:

1. Patients who presented with hemiplegic neglect or apraxia
2. Patients with history of global or receptive aphasia
3. Patients with history of psychological or emotional problems
4. Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).
5. Patients with history of artificial joints
Evaluating the Community Drum Circle

Mental health vulnerability due to stress is increased America due to disproportionate effects of social factors such as racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of Persons of African Descent(PAD) or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Component 2c. Drum Circle Study: Investigators will study the impact of participation in drum circles on anxiety and feelings of connectedness.

The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Individuals who attend periodic (i.e. weekly) drum circles will be recruited to join an 8-week paradigm. Drum circle sessions may audio recorded and participants will be informed of this during the consent process. Participants may be asked to undergo Electroencepholography, functional Near Infrared Spectroscopy, and/or other physiological measures before, during, and after the circles. Upon completion of the experiments, participants will be asked to take part in a focus group that will provide valuable feedback on their experience with the mindfulness intervention. Focus groups will last 30-minutes to 1 hour and will occur in-person.

Eligibility Criteria:
Inclusion Criteria:

* ages 16 and older

Exclusion Criteria:

* ages 15 and younger
Electronic Health Record Strategies to Promote Diverse Participation in Research

The purpose of this study is to determine the effectiveness of enhanced features in an online patient portal including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users.

The primary objective is to examine the effectiveness of enhanced online patient portal features including banners, a chatbot, and direct to patient message and traditional mailed letters on increasing interest in research among online patient portal users, as measured by the user's creation of a research profile.

The secondary objective is to examine the effectiveness of two enhanced online patient portal features including banners, a chatbot and direct-to-patient messages and traditional mailed letters on increasing participation in research among online patient portal users, as measured by the user joining a research study.

This study tests the hypothesis that at one year follow-up, various user engagement tools (e.g. messaging, banners) will increase the proportion of research profiles created by online patient portal users over profiles created by online patient portal users in the absence of those interventions.

Eligibility Criteria:
Inclusion Criteria:

* Has an account with the online patient portal
* Has logged into the online patient portal at least once in the past year
* Has not set up a research profile

Exclusion Criteria:

* Currently enrolled in a clinical trial
* Opted out of research
* Has received a direct to patient recruitment message within the past year
* On active cancer treatment
* Active member of the study team
A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy

The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial

* primary objective

  1. complication rate
* secondary objectives

  1. satisfaction rate
  2. pain scale difference

Eligibility Criteria:
Inclusion Criteria:

* age 5\~85 years
* any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
* Patient performance status(PS) with greater than 80 or more on Karnofsky PS
* Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

* Pregnant or lactating
* Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
* History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
* Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.


Eligibility Criteria:
Inclusion Criteria:

Must satisfy A and B and C below:

A. Women aged 45+

B. Postmenopausal

C. Osteoporotic with high risk of fracture

Exclusion Criteria:

* History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system
* Current alcohol or substance abuse
* Major psychiatric disorders
* Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia
* Known congenital or acquired bone disease other than osteoporosis
* Current use or past use in the past 12 months of oral bisphosphonates
* Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin
* Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months
* Any current or previous use of strontium or intravenous bisphosphonates
* Sensitivity to cell-derived drug products or teriparatide
* Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months
* Inability to sit upright for 30 minutes
* Esophageal abnormalities
Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds

Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.

This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over 19 years of age
2. Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
3. Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing

Exclusion Criteria:

1. A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
2. Those who are pregnant or lactating
REcruitment MAneuvers and Mechanical Ventilation Guided by EIT in pARDS

There is evidence from randomized controlled trials in adult patients with Acute Respiratory Distress Syndrome (ARDS) suggesting that delivering small tidal volumes with adequate levels of Positive End-Expiratory Pressure (PEEP) and a restrictive fluid strategy could improve outcome. However, there are data and common bedside experience that individual patients may or may not respond to interventions, such as escalation of PEEP or positional changes, and there may be a role for a more personalized ventilator strategy.

This strategy could account for the unique individual morphology of lung disease, such as the amount of atelectasis and overdistension as a percentage of total lung tissue, the exact location of atelectasis, and whether positional changes or elevation of PEEP produce lung recruitment or overdistension.

Stepwise Recruitment maneuvers (SRMs) in pARDS improve oxygenation in majority of patients. SRMs should be considered for use on an individualized basis in patients with pARDS should be considered if SpO2 decreases by ≥ 5% within 5 minutes of disconnection during suction or coughing or agitation. If a recruitment maneuver is conducted, a decremental PEEP trial must be done to determine the minimum PEEP that sustains the benefits of the recruitment maneuver.

Electrical impedance tomography (EIT), a bedside monitor to describe regional lung volume changes, displays a real-time cross-sectional image of the lung. EIT is a non-invasive, non-operator dependent, bedside, radiations-free diagnostic tool, feasible in paediatric patients and repeatable. It allows to study ventilation distribution dividing lungs in four Region Of Interest (ROI), that are layers distributed in an anteroposterior direction, and shows how ventilation is distributed in the areas concerned.

EIT measures and calculates other parameters that are related not only to the distribution of ventilation, but also to the homogeneity of ventilation and the response to certain therapeutic maneuvers, such as SRMs or PEEP-application.

Aim of this study is to provide a protocolized strategy to assess optimal recruitment and PEEP setting, tailored on the patients individual response in pARDS.


Eligibility Criteria:
Inclusion Criteria:

* Intubated and mechanically ventilated children, ageing 1 months-5 years and meeting the PALICC definition for pediatric Acute Respiratory Distress Syndrome (pARDS)
* Informed Consent signed

Exclusion Criteria: Patients with one or more of the following characteristics:

* Previous barotrauma (pneumothorax, pneumomediastinum or subcutaneous emphysema)
* Signs of intracranial hypertension
* Cyanotic congenital cardiac disease
* Dorso-lumbar pathologies or other bone pathologies associated with restrictive lung disease (such as scoliosis, kyphosis)
* Implantable devices not compatible with EIT (such as pace-makers and implantable cardioverter defibrillator)
* Controindication to positioning the esophageal catheter (surgery, esophageal stenosis)
Oasys vs. Extreme H20 Xtra 59

To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 19 years of age
* Contact Lens Wearers
* Patients with mild to moderate symptoms of dry eye

Exclusion Criteria:

* male or female younger than 19 years of age
The Learning Effects of Task-priority Strategy on Dual-task Weight Shifting and Brain Plasticity in Patients With Parkinson's Disease

(1) postural and suprapostural performance of a dual task would be differently affected by the strategy of task prioritization and (2) the cortical activation is different according to attentional focus strategies.

These hypothesis would be tested by gait performance, suprapostural accuracy and relative power spectrum of EEG.

Eligibility Criteria:
Inclusion Criteria:

* 1. modified H-Y stage II-III Parkinson's disease 2. No other diseases 3. Non-demented PD 4. Non-tremor PD

Exclusion Criteria:

* None
Safety Study of HBV DNA Vaccine to Treat Patients With Chronic Hepatitis B Infection

The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to reduce hepatitis B disease.

Hepatitis B virus (HBV) is responsible for the most common form of parenterally transmitted viral hepatitis. It is estimated that approximately 350 million people worldwide are persistent carriers of the virus and it is a major cause of acute and chronic infections of the liver, with significant associated morbidity and mortality. Chronic infection occurs in 98% of new-born children infected by vertical transmission from the mother and in 5% of individuals infected after 2 years of age. About 25% of these subjects will progress to cirrhosis and 20% of this subgroup will develop hepatocellular carcinoma - one of the most common cancers world wide. HBV is a non-cytopathic virus and liver injury is mainly mediated by the host immune response against virus-infected liver cells and by the production of inflammatory cytokines. A vigorous, polyclonal and multispecific cytotoxic and helper T cell response to HBV is readily detectable in the peripheral blood of subjects with acute self-limited hepatitis B, but is weak, antigenically restricted (mono- or oligospecific) or undetectable in subjects with chronic infection. A vigorous T cell response is thus believed to be responsible for the elimination of the hepatitis B virus. The aim of a therapeutic vaccine would be to enhance natural responses by boosting the appropriate cellular immune response to HBV. The purpose of this study is to evaluate the safety and tolerability profile of the pPDPSC18 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

Eligibility Criteria:
Otherwise healthy, treatment naïve subjects with chronic well compensated, eAg positive HBV infection
Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.

The purpose of this study is to appraise if various concentration of adrenaline containing tumescent has any significant role in bleeding at skin graft donor site bleeding through photographic assessment.

Tumescent solutions will be prepared by adding 30cc of Ringer's lactate and 10cc of lignocaine 2%, with 1cc of adrenaline of 1:200,000 (which will be prepared by adding 1cc of adrenaline of 1:1000 conc. with 200ml of normal saline marked as solution "A" and without adrenaline marked as solution "B" to form the two different tumescent solutions. Both solutions with be topically applied in soaked gauzes for around 10 minutes. Solution A will be applied over the anterior side of thigh while solution B will be applied over lateral side of thigh.

Tumescent solutions will be prepared around 10 minutes before applying. After 10 min Split-thickness skin graft donor sites will be harvested with a Dermatome adjusted on with a randomized setting to harvest a fixed depth of wound depth. After harvesting skin graft the donor site wound will be photographed.

The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons. At last photographs will be compared with pre-infiltration records in each side. Skin graft donor and recipient site will be inspected on the 5th post-operative day

Eligibility Criteria:
Inclusion Criteria:

* age above 18 years

  * both genders
  * non hypertensive patients
  * Hemoglobin levels more than 10 g/dl
  * Platelet count above 150 x 10E9/L
  * Wounds for more than 6 weeks

Exclusion Criteria:

* • Hypertensive patients,

  * Bleeding tendencies (Disorder),
  * Immune-compromised,
  * Familial history of bleeding
Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from a manic or mixed episode.

Exclusion Criteria:

* Patients who have not provided personal informed consent,
* Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
* Involuntary admittance/detainment.
Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR)

The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica.

The study will consist of an up to 4-week screening period, an up to 2-year Treatment Period which includes two Treatment Periods, and a 16-week treatment-free follow-up period (20 weeks post last dose of secukinumab).

Treatment period:

There will be two Treatment Periods (TPs): TP1 will be from the first dose administration of secukinumab (Baseline) to Week 24, where visits will occur every 4 weeks, and TP2 will be from post Week 24 visit (post-dose) to up to 2 years. Participants will return to the study site every 4 weeks from Baseline until Week 24 (Weeks 16 and 20 visits are optional on-site visits and needed when participants are unwilling/uncomfortable to self-administer study treatment at home/offsite), then every 12 weeks afterwards in TP2 for resupply of study medication but may return earlier if needed (i.e., those participants who are unwilling/uncomfortable to self-administer study treatment can continue to visit site every 4 weeks for drug administration if they wish to do so).

Follow-up period: An EoS visit (20 weeks after last administration of secukinumab) will be done for all participants, regardless of whether they complete the entire study as planned, or they discontinue prematurely.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have completed 52-week Treatment Period as per protocol in a Novartis study of secukinumab in PMR patients (the "core study" - Study CAIN457C22301), AND

  * who have experienced a relapse during the treatment-free follow-up period of the core study, AND
  * who have not been on rescue treatment.
* The participant would potentially derive benefit from secukinumab, and the benefit outweighs the risk, based on the investigator's judgement.

Exclusion Criteria:

* Use of prohibited medications, as specified in the protocol
* History of ongoing, chronic or recurrent infectious disease (i.e., human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV), active tuberculosis infection (TB))
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
* Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to Baseline
* Subjects whose participation in the extension study could expose them to an undue safety risk
Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin

Preoperative anemia is present in more than 50% of patients undergoing cardiac surgery, which is associated with increased risk of transfusion, increased length of stay in the intensive care unit, and increased incidence of renal failure and mortality.

To date, clinical research on perioperative anemia has been focused on finding and treating other underlying causes of anemia, lowering the threshold for transfusion, and performing careful transfusion.

However, recently, it was known that hepcidin and erythroferrone are related to iron metabolism and absorption, vitamin D has an inverse correlation with the development of anemia, and is related to hepcidin concentration control.

Therefore, in this study, the relationship between vitamin D, hepcidin concentration and perioperative hemoglobin level in patients with off-pump coronary artery bypass graft surgery was investigated together.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 20 years of age undergoing off-pump coronary artery bypass graft

Exclusion Criteria:

1. Emergency operation
2. Minimal invasive coronary artery bypass graft
3. Cooperative operation with other surgery
4. Patients who need a mechanical ventricular assist device
5. Patients with chronic kidney disease (eGFR \< 30)
6. Patients who have a end stage renal disease and need a hemodialysis
7. Patients with a low hemoglobin (Hb \< 10) before surgery
8. Patients who have a some disease(leukemia, myeloma, aplastic anemia, sickle cell anemia, etc) affecting hematopoiesis
9. Patients with a liver cirrhosis
10. Patients who receive vit. D, iron supplements, erythropoietin within 6 months
11. Patients who cannot understand the informed consent (eg. Foreigner, patients with cognitive dysfunction, etc)
12. Patients who disagree this study