cyrilzakka/clinical-trials huggingface dataset:
Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels.

Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups.

All patients will also receive a long-acting (24 hours) morphine injection during surgery.

The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.

Data Collection:

Data will be collected from the patient's medical record after discharge

Variables include:

* Age
* Sex
* BMI
* UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit
* Patient's assessment of acceptability of pain
* UPAT score as assessed by physical therapy pre and post therapy sessions
* Duramorph dose
* Time patient arrived on the Orthopedic Unit
* Length of ambulation during physical therapy sessions
* Amount of supplementary opioids (measured in morphine equivalents)
* Use of anti-emetics
* Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event
* Length of hospital stay

The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Written informed consent

Exclusion Criteria:

* Pregnant women
* Creatinine clearance less than 60 ml/min
* BMI greater than 40
* Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
* Receive a unicondylar knee replacement
Telephone Contact Between Hospital and General Practitioner About Medication Review for Older Patients

In this trial, the feasibility of cooperation between clinical pharmacists and physicians by conducting a telephone follow-up conversation between the hospital geriatrician, the general practitioner and the clinical pharmacist is evaluated. During hospital stay the clinical pharmacist and the geriatrician will review older patients' medication and discuss the future treatment with the general practitioner after discharge by telephone or medico-technology.

The first part of the feasibility study will be a qualitative baseline measure of characteristics of the participants and work flow. The second part will be a pilot randomized controlled study where participants will be allocated to either usual care or medication review and follow up contact


Eligibility Criteria:
Inclusion Criteria:

\* 5 drugs or more

Exclusion Criteria:

* Terminal illness
* Not able to speak and understand Danish
Study of the Effects Strengthening Exercises in Individuals With ALS

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease MND) among adults. Motor neurons in the spinal cord, brain stem, and cerebral motor cortex degenerate and create a variety of upper (UMN) and lower motor neuron (LMN) clinical signs and symptoms, with the most frequently presenting symptom being focal weakness beginning in the leg, arm, or bulbar muscles, occurring in more than 70% of patients. Despite the high incidence of muscle weakness in patients with ALS, only two case studies evaluating the effects of specific muscle strengthening and endurance exercise programs in this patient population have been published, and the effects of resistive exercise programs in patients with ALS have not been well studied. Some have discouraged exercise programs in patients with ALS because of fear of overuse weakness. Yet, in patients with other neuromuscular diseases, resistive exercise programs have been shown to be beneficial and have not produced overuse weakness. The purpose of this study is to determine the effects of six months strengthening program on strength, function, fatigue and quality of life in individuals with ALS.

The specific aims of this preliminary, prospective randomized study of individuals with ALS are to determine variability, describe trends over a 6-month time frame and to estimate differences between individuals with ALS who perform an upper and lower extremity strengthening program three times per week and a control group of individuals with ALS with respect to the following outcomes:

1. an increase in muscle strength (maximum voluntary isometric contraction) as measured by quantitative muscle testing.
2. an increase in functional activities as measured by The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)7 and the Schwab and England Rating Scale (SERS).
3. a decrease in fatigue as measured by the Fatigue Severity Scale.
4. an increase in quality of life as measured by the SF-36.Subjects will be randomized into two groups - experimental and control. Subjects in the control group will perform a daily stretching exercise program for a period of six months. Subjects in the experimental groups will perform a strengthening exercise program three times per week for a period of six months. All subjects will be evaluated at baseline and then monthly using the following outcome measures: (1) maximum voluntary isometric contraction; (2) Amyotrophic Lateral Sclerosis Functional Rating Scale; (3) Schwab and England Rating Scale; (3) Fatigue Severity Scale; (4) forced vital capacity; and, (5) the SF-36.

Eligibility Criteria:
Inclusion Criteria:

* definite and/or probable diagnosis of ALS
* early stages of the disease

Exclusion Criteria:

* history of neuromuscular dysfunction not related to ALS
* active, confounding medical conditions
* unwillingness or inability to comply with the protocol
* FVC of less than 90% predicted
* ALSFRS score of less than 30
Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored euthyroidism in Graves' disease is an autoimmune complication. This is a confirmatory study of the biomarkers from ImmunoGraves WP1 in which immunological markers with possible association with mental fatigue in Graves' disease are explored.

In ImmunoGraves WP2, 310 patients with Graves' disease are assessed for symptoms of mental fatigue, quality of life, anxiety and depression, self-evaluated stress, coping strategies, personality traits, eye symptoms and background variables. Participants are examined in hyperthyroidism at inclusion, within three weeks from diagnosis, and in euthyroidism after 15 months. Serum and cerebrospinal fluid (in a subsample of participants) is collected at both visits and will be evaluated for the immunological markers identified in WP1 as well as for thyroid hormones, thyroid autoantibodies and biomarkers indicating organic and structural nerve damage. Significant predictors for mental fatigue will be identified by logistic regression.

To assess functional changes in the brain, magnetoencephalography will be performed in a subset of patients and in healthy controls at inclusion and after 15 to 18 months. Combined with magneto resonance imaging (MRI), magnetoencephalography gives information on neuronal activation during attention testing.


Eligibility Criteria:
Inclusion Criteria:

* Recently diagnosed Graves' disease
* Positive thyroid stimulating hormone (TSH)-receptor antibodies (TRAb)
* Thyroid hormones above the upper reference limit
* Inclusion within three weeks after start of antithyroid drugs

Controls: Matched for gender and age

Exclusion Criteria:

* Person unable to follow protocol as with psychosis, dementia or not able to answer questionnaires in Swedish.
* Recidive of Graves' disease
* Pregnancy

Controls: -Thyroid disease

* Neurological disease
Vasoactive Peptides in Portal Pressure

This study is looking at the detection of vasoactive peptides in portal hypertension.


Eligibility Criteria:
Inclusion Criteria:

* HVPG \>= 12 mmHg
Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback

The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of this study are to determine if orthotics, with and without a textured top cover, can alter muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in Parkinson's participants.

The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. Observing gait parameters and muscle activation changes, in orthotics with and without a textured top cover, provides an increased understanding of conservative treatment options available to the Parkinson's population. It is hypothesized that balance and functional mobility in Parkinson's Disease (PD) patients will increase, while decreasing fall risks, when wearing both types of orthotics. Larger improvements are expected with the orthotics with a textured top cover, thus increasing plantar sensory feedback. Male and female participants, aged 55-75, with a diagnosis of idiopathic Parkinson's disease can participate in the study. Two types of orthotic design will be examined: 1) Customizable over-the-counter orthotics and 2) Customizable over-the-counter orthotics with a textured top cover. Five different assessments will be performed during three different testing sessions: 1) baseline testing; 2) 6-weeks post-baseline; and 3) 12-weeks post-baseline. The administered assessments include: 1) Static balance, double limb stance; 2) The Berg Balance Scale (BBS); 3) Timed Up and Go (TUG), 4) Functional Gait Assessment (FGA); and 5) Walking task.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with idiopathic Parkinson' disease

Exclusion Criteria: A pre-screening questionnaire will assess the following:

* peripheral neuropathy, vestibular concerns, cognitive impairment, severe arthritic conditions, or other conflicting medical conditions
* deep brain stimulation
* currently wearing orthotics, or previously worn in the last two years
* decreased plantar sole sensation
* requires the ability to walk 10m unassisted
Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery

The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial.

The aims are:

Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended.

Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]).

Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.


Eligibility Criteria:
Inclusion Criteria:

1. Seeking to undergo MBS at HHC.
2. Be able to give valid informed consent in English. Attending the live, in-person, group TC classes each week is the main component of the intervention. During the classes, the TC instructor will be giving instructions and communicating with the participants in English. It is not practical to having an interpreter during the live classes. Therefore, participation is limited to those who are English speakers.
3. Be 18-70 years of age.
4. Have BMI≥35 kg/m2
5. Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score ≥24 Mini-Mental State Examination.
6. Be physically inactive defined as performing \<150 min/wk of moderate to vigorous intensity PA based on self-report.
7. Be able to ambulate independently without use of an assistive device.
8. Be able to complete questionnaires and view TC instructional videos via REDCap.
9. Be able to commute to one of the HH Medical and Surgical Weight Loss Center clinics to participate in testing sessions and in-person TC classes.

Exclusion Criteria:

1. Having severe psychological or physical conditions that may impair their ability to adhere to the study protocol such as uncontrolled mental health issues, and severe arthritis.
2. Pregnant women.
Effects of a Zinc Oxide Underarm Formula on Normal and Injured Skin in Healthy Volunteers

Bothersome odor from the axilla is in most cases caused by Corynebacterium spp. Anti-microbial effects of zinc oxide (ZnO) are well documented.

The overall objective of this study is to verify that repeated applications of a ZnO containing formulation can be directly linked to reduced growth of Corynebacterium spp. in the axillae.

In the trial the effects of the ZnO formulation on the skin of the forearms and axillae are investigated simultaneously. In both locations the skin is treated daily with the ZnO/placebo formulations.

At day -8 skin areas of the forearms and the axillae are sampled by adhesive tape that is extracted in phosphate-buffered saline (PBS) and PBS extract analyzed on total proteins (BCA) and IL-1α. In the axillae swabs are taken for Corynebacterium spp. semi quantification and pH is measured in the axillae and on the forearm.

At day 0 treated skin areas of the forearms and the axillae are sampled by adhesive tape that is extracted in PBS and PBS extract analyzed on total proteins (BCA) and IL-1α, and compared to adjacent non-treated skin. In the axillae and on the forearms, swabs are first taken for Corynebacterium spp. semi quantification followed by wounding using ablative fractional (10%) carbon dioxide laser at 20 millijoule/microbeam and pediatric lancet. pH is measured in the axillae and on the forearm.

Progress of wound healing is assessed by dermatoscopy at days 3, 4 and 5. At day 5 swabs are taken in the axillae for Corynebacterium spp. semi quantification and pH is measured. Furthermore, skin areas of the axillae are sampled by adhesive tape that is extracted in PBS and PBS extract analyzed on total proteins (BCA) and IL-1α.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Age between 18 and 65 years
* Non-smoking
* Written informed consent

Exclusion Criteria:

* No current or past skin disorder
* Immunosuppressive treatment
* Pregnant and breast feeding women
* Hypersensitivity to zinc and/or other ingredients in the products
Effect of Upper Extremity Rehabilitation Using Immersive Virtual Reality in Chronic Stroke Patients.

The study aimed to investigate the effect of exergames using virtual reality with head mounted device on motor recovery of upper extremities in chronic stroke patients.

This is a crossover study for comparing conventional occupational therapy and exercise with game format using virtual reality (virtual reality exergame). The virtual reality exergame is designed to maximize the movement of upper extremities, primary to the shoulder and elbow. Thirty-six chronic stroke patient will receive conventional occupational treatment and virtual reality exergame in random order with a two-week-washout period. Outcome measures will be evaluated within two days before and after each treatment, conventional treatment and virtual reality exergame.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke patients who have passed 6 months or more without additional stroke after the first stroke
* Patients with upper extremity dysfunction due to stroke (ischemic, hemorrhagic)
* Patients who can move the upper extremity against gravity with a manual muscle test of grade 3 or higher in the affected shoulder and elbow, respectively
* Patients who can stably maintain a sitting position
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Patients with moderate or severe cognitive impairment with a score of 18 or less on the Mini-Mental Status Examination (K-MMSE)
* Patients with other causes of upper extremity dysfunction, such as peripheral nerve damage, joint disease, etc.
* Patients with a history of severe vertigo or epilepsy
* Patients with medical reasons such as medical conditions that make it difficult to participate in research
* Patients who may be pregnant or who are pregnant or lactating
Emotional Freedom Technique (EFT) Effect on Nurses

It has been planned to determine the effect of EFT, which effectiveness has been determined by the studies, on the covid-19 fear and anxiety experienced by the nurses working in the emergency department. The study was designed as a randomized controlled study with pre-test and post-test control group.

Although it has been a year since WHO declared an emergency, the covid-19 virus has mutated and the number of cases has started to increase again as of February 2021. The emergence of uncertainties in the risk of transmission of the mutant virus together with the simultaneous management of both the care process of pandemic patients and the patients who apply for emergency care and treatment in the emergency services increases the fear of the virus. The feeling of fear causes the person to become distracted and increase anxiety by focusing on the fact that he or she is under the threat of the virus. Recently, non-pharmacological techniques are widely used to reduce anxiety and fear. One of them is EFT. It is to examine the effects of EFT, which effectiveness has been determined with the studies carried out in this challenging process, on the covid-19 fear and high anxiety of emergency room nurses.

Eligibility Criteria:
Inclusion Criteria:

* Not taking any courses about coping with anxiety and stress,
* Volunteering to participate in the study,
* The absence of infection, wound, scar in the tapping area

Exclusion Criteria:

* Having any psychiatric diagnoses
Effects of Intermittent Exercise Training Programs in Patients With Myocardial Infarction

Cardiovascular diseases are a leading cause of death worldwide. According to the World Health Organization (WHO), cardiovascular diseases constitute 1/3 of all causes of death.

Myocardial infarction (MI) is an irreversible myocardial necrosis due to prolonged ischemia.

Patients with MI are candidates for cardiac rehabilitation (CR). American Heart Association (AHA) guidelines recommend exercise-based cardiac rehabilitation and suggest exercise to add to patients' routine treatment. When the literature on patients with MI is examined, various exercise programs are seen. The aims of present study is investigating and comparing the effectiveness of intermittent exercise training and aerobic exercise training programs in patients with MI.

Cases are divided into two groups as exercise (control) and control group by closed envelope randomization method. All patients are informed about risk factors and risk factor management. All patients are trained 3 days in the first week under the supervision of a physiotherapist to learn individual exercise programs. Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Participants of the experimental group are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Having had MI at least 3 months ago
* Stable clinical status for at least two weeks
* Walking independently
* Volunteer for research study

Exclusion Criteria:

* Having unstable angina
* Having uncontrolled hypertension
* Having hemodynamic instability
* Participating in any exercise program in the last six months
* Having a major orthopedic or neurological problem that limits functionality
Patients With Chronic Obstructive Pulmonary Disease at Altitude - Effect of Nocturnal Oxygen on Exercise Performance

The purpose of this study is to investigate the effect of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with chronic obstructive lung disease.

Patients with moderate to severe COPD living below 800 m, will be recruited to participate in a randomized cross-over field trial evaluating the hypothesis that exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy via a nasal cannula. Outcomes will be assessed during 2 days in Zurich (490 m, low altitude baseline), and during 2 days at St. Moritz Salastrains (2048 m).

Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease (COPD), GOLD grade 2-3
* residents at low altitude (\<800 m)

Exclusion Criteria:

* unstable condition, COPD exacerbation
* mild (GOLD 1) or very severe COPD (GOLD 4)
* requirement for oxygen therapy at low altitude residence
* hypoventilation
* pulmonary hypertension
* more than mild or unstable cardiovascular disease
* use of drugs that affect respiratory center drive
* internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* previous intolerance to moderate altitude (\<2600m).
* exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* pregnant or nursing patients