cyrilzakka/clinical-trials huggingface dataset:
Post-operative Cognitive Dysfunction and the Change of Regional Cerebral Oxygen Saturation in Elderly Patients Undergoing Spinal Surgery

Post operative cognitive dysfunction (POCD) is a well-recognized complication of patients undergoing cardiac surgery. Previous studies reported near-infrared spectroscopy provides information on the occurrence of cerebral desaturation resulted in POCD. But evidence of POCD after general surgery has been lacking. Especially, the prone position is used primarily for surgical access to the posterior spine, if there is any significant lowering of the legs or tilt of the entire table, venous returns may be decrease or augmented accordingly. The purpose of this study was to examine the relationship between POCD and intra-operative cerebral oxygen saturation after spine surgery in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* the patient undergoing the lumbar spine surgery in severance hospital

Exclusion Criteria:

* Patients who had previous cerebral disease, dementia, severe problems in hearing and understanding, or who were unable to provide informed consent were excluded.
Neutrophil-to-Lymphocyte Ratio in Predicting Outcomes of Patients With Aneurysmal Subarachnoid Hemorrhage in a Tertiary Care Hospital in Nepal

This study uses Neutrophil-to-Lymphocyte Ratio to Predict Outcomes of Patients with Aneurysmal Subarachnoid Hemorrhage which will be beneficial in taking early decisions for surgery , patient counselling etc


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age, of either genders, ethnicity and location who presented to the emergency department within 72 hours of the onset of symptoms who underwent surgical or interventional treatment for SAH caused by a ruptured intracranial aneurysm

Exclusion Criteria:

* excluded patients with traumatic SAH, history of infection or stroke within eight weeks, underlying cancer, severe kidney or liver disease, history of auto-immune or hematologic disorder lost to follow-up within three months and individuals declining informed consent.
The Use of tDCS in the Orofacial Pain

The trial´s main goal is to explore the use of transcranial direct current stimulation (tDCS) as a treatment option for persons suffering from orofacial pain. The aim of the trial is to further investigate the efficacy and longevity of tDCS in treating chronic pharmacoresistant orofacial pain.

A prospective, randomized, double-blinded, two-arm, sham-controlled design will be utilized. Primarily, the analgesic effect's intensity and duration will be assessed. Secondarily, the associated reduction of symptoms of anxiety and depression will be investigated, as well as the impact on the general quality of life. Anodal stimulation (6 sessions in 2 weeks, 2mA, 20 min, cathode over the opposite Fp area) of M1 contralateral to the pain location will be employed. Washout periods of 48-72 hours will be kept between applications to improve neuroplasticity changes' induction, which is estimated to reflect in the effect retention. Eight major evaluation points will be employed in 26 weeks, and a daily numeric rating scale (NRS) self-assessment.

The trial will potentially improve the quality of life, reduce the health burden caused by chronic orofacial pain, and provide further data on the use of tDCS in this setting, thus, enabling an additional route to manage the symptoms of pain in the future.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Orofacial Pain by a pain medicine specialist according to ICOP (International classification of orofacial pain) and ICHD3 (International classification of headache disorder)
* Stable analgesic therapy one month before the stimulation series

Exclusion Criteria:

* Changes to the analgesic therapy in 6 months following the stimulation series
* Non-compliance with the follow-ups
* General contraindications to tDCS - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses
Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis

This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.

The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40-65 years
* Diagnosed with sub-acute adhesive capsulitis
* Pain range of 3 to 8 on NPRS
* SPADI score of \>40
* Presence of myofascial trigger point in subscapularis muscle

Exclusion Criteria:

* History of fracture
* Rheumatoid arthritis
* Shoulder osteoarthritis
* Any malignancy
* Shoulder dislocation
* Subacute adhesive capsulitis with impingement syndrome
Proactive Treatment of Tacrolimus Ointment for Adult Facial Seborrheic Dermatitis

The purpose of this study is to determine whether proactive use of 0.1% tacrolimus ointment once or twice weekly can keep adult facial SD in remission and reduce the incidence of exacerbation.

Seborrhoeic dermatitis (SD) is a common chronic papulosquamous dermatosis, affecting 2% to 10% of the adult population, mainly those between the ages of 20 and 50 years with a male bias. The affected skin appears erythematous and oedematous, covered with yellow-brown scales, and is often accompanied by pruritus. It typically affects areas containing sebaceous glands, particularly the scalp, ears, face, chest, and intertriginous areas. SD has a chronic course, and relapse is common. Therefore, therapy is directed toward reducing the symptoms or aggravating factors of SD, such as loosening and removal of scales and crusts, inhibition of yeast colonization, control of secondary infection, and reduction of erythema and pruritus. Standard topical treatments for SD include corticosteroids and anti-mycotic medications. However, the chronic use of topical corticosteroids particularly on the face could result in undesirable outcomes, such as telangiectasia, atrophy, striae, peri-oral dermatitis, or tachyphylaxis, and early relapse after discontinuation of treatment. SD relapse prevention strategies have not yet been established, so the investigators suspected that intermittent use of tacrolimus ointment can be effective in preventing SD relapse.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age with a diagnosis of facial seborrhoeic dermatitis

Exclusion Criteria:

* taking other systemic or topical treatments for facial seborrhoeic dermatitis within the previous 4 weeks
* a known allergy to the components of tacrolimus ointment
* malignant neoplasm; immunologic abnormality
* active infection
* other definitive cutaneous findings such as erythroderma, acne, and psoriasis
Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acquired haemophilia
* Treated with activated recombinant human factor VII as first line treatment
* Treated with activated recombinant human factor VII after January 2011

Exclusion Criteria:

* Patients with first diagnosis before january 2010 and having a relapse after january 2011
* Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.

Exclusion Criteria:

* Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
* Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
A Phase 2 Study to Assess the Pharmacokinetics of Bevirimat 100 mg Tablets Given to HIV-1 Positive Patient for 15 Days

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.


Eligibility Criteria:
Inclusion Criteria:

* Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable).
* Have a CD4+ lymphocyte count \>/= 100 cells/mm3.
* Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of \<400 copies/mL.
* Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study.
* Be informed of the nature of the study and provide written informed consent.
* Be legally competent and able to communicate effectively with study personnel.
* Be able and willing to comply with outpatient visits.

Exclusion Criteria:

* Presence of any acute illness within 14 days prior to study entry.
* Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry.
* Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
* Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis).
* Patients with systolic blood pressure \< 90 mmHg or \> 160 mmHg or diastolic blood pressure \< 50 mmHg or \> 110 mmHg.
* A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medication for the indication of seizures or seizure-related conditions.
* A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
* Patients who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to first dose of study drug.
* Patients who have received treatment with immunomodulating agents such as IL-2, alpha-interferon, beta-interferon, or gamma-interferon within 4 weeks prior to first dose of study drug.
* Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication.
* Bupropion-containing products require at least a 14-day washout period and will not be approved for co-administration.
* Rifampin or other rifamycin products require at least a 28-day washout period and will not be approved for coadministration.
Comparison of the Efficacy of Ultrasound-Guided Corticosteroid Injection and Paraffin Therapy in Carpal Tunnel Syndrome

The aim of this study is to compare the efficacy of paraffin therapy, a physical therapy modality, and ultrasound-guided corticosteroid injection in the treatment of carpal tunnel syndrome, the most common entrapment neuropathy. By doing so, the study will evaluate the effectiveness and feasibility of these two alternative, low-side-effect treatments for managing this frequently encountered condition.

A total of 46 patients, aged 18-65, diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies, will be included in the study.Pain levels will be assessed using the Visual Analog Scale (VAS), and functional impairment will be measured with the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Electrophysiological evaluations will be performed by a neurology specialist at the 1st and 3rd month follow-ups outside of working hours and without being billed to the Social Security Institution (SGK). VAS, BCTQ scores, and electrophysiological parameters will be evaluated at baseline, and at the 4th and 12th-week follow-ups post-treatment. Electrophysiological measurements will include median nerve distal motor latency (MMNDL), median nerve distal sensory latency (MNSDL), sensory nerve conduction velocity (SNCV), compound muscle action potential (CMAP), and sensory nerve action potential (SNAP) amplitudes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65.
* Diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological studies.
* Received either ultrasound-guided corticosteroid injection or paraffin therapy.
* Symptoms persisting for at least 3 months.

Exclusion Criteria:

* Diagnosis of other conditions causing neuropathic symptoms (e.g., polyneuropathy, brachial plexopathy, thoracic outlet syndrome).
* History of previous injection or surgery for carpal tunnel syndrome.
Effects of Stress on Observers and Their Subsequent Performance During High Fidelity Simulation-based Training.

This randomized controlled trial aims to determine if the stress response and performance of trainees who are observers in simulation training is similar to trainees who are actively participating in simulation training in the 'hotseat' during 3 consecutive simulation sessions.

We hypothesize that trainees experience less stress when they are observers in the first 2 simulation sessions. However, when they are placed in the 'hotseat' during the third session, their stress response, as well as their performance, will be similar to trainees who spend all 3 simulation sessions in the 'hotseat'.

Background: High fidelity simulation-based training (SBT) using sophisticated manikins instead of real patients for medical teaching is now commonly practiced worldwide. We previously showed that SBT causes significant stress in the trainees, as evidenced by a rise in their heart rate and salivary cortisol(; and that repeated exposure to SBT was associated with the same level of stress, despite performance improving. From our studies, participants in the 'hot-seat' actively managing the clinical crisis experience the highest levels of stress but benefit the most from the learning experience. However, the stress experienced by observers (who are in the same room but not actively managing the crisis) and their learning outcomes have not been studied.

Objectives: We aim to determine: 1) If observers of SBT experience less stress when compared to the trainees in the 'hot-seat' and; 2) if trainees who were observers in prior SBT sessions perform as well as trainees who were in the 'hot-seat' during subsequent SBT sessions.

Methodology: Thirty-six trainee anaesthetists are randomized into 2 groups to undergo three SBT scenarios. 18 Trainees randomized to the Observer group will first undergo two SBT scenarios as observers followed by a third session in the 'hot-seat'. 18 Trainees in the Control group will undergo all 3 sessions in the 'hot seat'. For each session, stress response is measured by salivary cortisol and amylase while performance is measured using the Anaesthetists Non Technical Skills (ANTS) score.

Clinical Significance: If we find that trainees who are observers of the first 2 SBT scenarios experience less stress than the 'hot-seat' trainees but yet achieve similar level of performance during the third SBT session, we can potentially make SBT less stressful and reduce the total number of simulation required, thus improving the efficiency of simulation training.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthesia residents in their 2nd or 3rd year of training

Exclusion Criteria:

* Hypertension
* Cardiac disease
* Endocrine disorder
* Use of beta-blockers
* Recent stressful or traumatic life events
* Pregnancy
Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series

Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth. Although empirically supported psychosocial and pharmacological treatments for OCD exist, many children and their families are not able to adequately access these treatments or derive only partial benefit from them. Such findings highlight the importance of developing more effective treatment options which have the potential to be widely accessible to OCD youth.

The investigators are proposing to test a computerized attention modification program, AMP, in six youth with OCD in an open case series to gather information regarding protocol acceptability, feasibility and preliminary efficacy. This phase includes the development and refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP parameters for use with children.

Following ascertainment of study eligibility, participants will undergo a baseline assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention bias assessment, and self report questionnaires. Study participants will then receive 12 sessions of AMP treatment over the course of three weeks. All youngsters and their families will be reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours over the course of six weeks. Participants who are treatment responders may be asked to return approximately 3 months after completing treatment for a follow-up assessment.

Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom severity.


Eligibility Criteria:
Inclusion Criteria:

* Youth ages 8 - 17
* Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule (ADIS-IV) Child/Parent version
* Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score \> 15
* Medication free or on stable medication for six weeks prior to study entry
* Informed parental consent and child assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.

Exclusion Criteria:

* DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
* Concurrent psychosocial treatment for OCD
* IQ \< 80
* Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate treatment initiation.
Characterization of Dyschromic Hypertrophic Scar

Currently, there are limited prevention or treatments available for dyschromia in burn hypertrophic scars (HTSs). The limited available techniques involve transferring melanocytes from unaffected areas to the scar to adjust pigment. These techniques involve the creation of a donor site and do not utilize the cells that may already be present in scars. This study aims to confirm melanocyte presence in regions of hypo- and hyper- pigmented HTS. If melanocytes can be found in regions of hypopigmentation, these scars may be able to be treated in the future by pigmentation stimulators without the need for surgery. Additionally, if pigmentation specific molecules of interest can be found to be up-regulated in hyperpigmented scar, these may be able to be altered by a pharmacotherapy.

Subjects with burn scars that are lighter and/or darker than their normal skin will be asked to participate in this study. It is being done to obtain more information about why some people develop scars that are different in color to their normal skin after trauma to the skin such as a burn.

Participants who wish to participate will have scar measured with a ruler, and study sites identified and photographed.

Additionally the following procedures will be done:

Non-invasive measurements: Each area of scar will have multiple non-invasive measurements done. These include:

* scar scales - subjective measures of color, itching, pain, height, etc.
* elasticity - a probe is briefly placed on top of the skin to measure its ability to stretch
* induration - a probe is briefly placed on top of the skin to measure how firm it is
* color - a skin probe in briefly placed on top of the skin to measure its color

Biopsies: Based on the measurement of the scars, several small 3mm punch biopsies will be done. Subjects with light colored scars and total scar greater than 500cm2 are eligible to participate in an optional sub-study. For this sub-study, an additional excisional biopsy 1 cm by 2 cm in the shape of an oval will be obtained from the lighter colored scar.

Blood collection: Blood will be collected for correlating blood characteristics to scar outcome. Approximately 20 mL of blood will be collected, which is less than 2 tablespoons. A portion of this blood might be used in the future for genome sequencing of pigmentation or hypertrophic scar-related gene sequences. Whole genome sequencing will not be performed.

Interview: Personal information, medical history, health behaviors, and scar history will be reviewed.

Data collection: Information about initial burn injury, hospitalization, and outpatient visits will be requested from the medical record.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Skin trauma resulting in a dyschromic scar

Exclusion Criteria:

* Dyschromic scar dole to face, genitals, fingers, or toes
* Known Lidocaine allergy
* Pregnancy
* Prisoner Status