cyrilzakka/clinical-trials huggingface dataset:
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial

Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing are at risk for poor outcome. The clinical trial is designed to determine if a pain coping skills training intervention delivered by physical therapists and supervised by psychologists is more effective at reducing pain and improving function and is more cost effective than arthritis education or usual care.

Approximately 25% of patients following knee arthroplasty have disabling pain following apparently successful surgery. Recent research suggests that pain catastrophizing plays a key role in determining which patients with knee arthroplasty have a poor outcome. In addition to this evidence, a substantial literature suggests that pain coping skills training is effective for patients with chronic pain but the intervention has not been studied for surgical patients with severe arthritic knee pain. We designed the Knee Arthroplasty pain coping Skills Training (KASTPain) trial to address this research need. This Phase III three-arm randomized clinical trial seeks to combine a strong and diverse group of researchers to examine an important and understudied area in the joint arthroplasty literature. The KASTPain trial will be the first to examine the utility of a perioperative pain coping intervention for this substantial population of patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults 45 years and older and capable of providing informed consent
* Diagnosis of osteoarthritis as determined by participating orthopaedic surgeons
* Scheduled for an elective unilateral total or unicompartmental knee arthroplasty no sooner than 1 week and no later than 8 weeks from the time of recruitment
* Score of greater than or = to 16 on the Pain Catastrophizing Scale
* Score of greater than or = to 5 on the WOMAC Pain Scale
* Able to read and speak English

Exclusion Criteria:

* Scheduled for revision arthroplasty surgery
* Underwent contralateral knee arthroplasty surgery or hip arthroplasty surgery within 6 months of currently planned surgery
* Unable to or declines study participation
* Self-reported diagnosis of rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, ankylosing spondylitis
* Arthroplasty surgery scheduled because of fracture, malignancy or infection
* Scheduled for bilateral arthroplasty surgery
* Scheduled to undergo hip or knee arthroplasty within 6 months of current knee arthroplasty
* Score of 20 or greater on the PHQ-8 depression scale
* Score of less than 3 on the six-item cognitive screener
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer Survivors

The hypothesis behind our study was that patients after BC surgery, who underwent quadrantectomy or mastectomy, may present a different disability respect to the upper limb on the operated side. Accordingly they could have a different functional recovery patterns after rehabilitation.

The aim of our study was to compare the recovery of the fluidity of the reaching movement (Jerk) as the primary outcome, the reduction of shoulder pain and improvement of disability for the upper limb respect the operated side as secondary outcomes, before and after a specific rehabilitation protocol treatment.

Surgery is usually the first line of attack against breast cancer (BC). The decisions about surgery depend on many factors based on the stage, the type of cancer and patient acceptability, in terms of her long term peace of mind and survival prospects. Typically, breast reconstruction takes place during or soon after mastectomy, to avoid psychological distress for the patient, and in some cases, also after lumpectomy or quadrantectomy; furthermore breast reconstruction can be done many months or even years after surgery too.

Today, breast cancer rehabilitation can help survivors to obtain and maintain the highest possible physical, social, psychological and vocational functioning, within the limits created by cancer and its treatments. After BC surgery, is common to detect disorders as shoulder dysfunction, postmastectomy syndrome, chemotherapy-induced peripheral neuropathy, axillary cording, lymphedema and a host of others as postural imbalance.

Also, alterations in muscle activation and restricted shoulder mobility, which are common in BC patients, have been found to affect upper limb function and alterations in muscle activity patterns differed by breast surgery and reconstruction type: rehabilitation and in particular mobilization stretches and shoulder and scapula exercises after breast surgery are an effective resource to improve upper limb range of motion and decrease chest tightness and pain.

This study was prompted by the lack of literature about the quadrantectomy versus mastectomy intervention, considering the disability of the upper limb from the operated side, especially if in relation to the rehabilitation pathway, currently recommended in BC care.

Eligibility Criteria:
Inclusion Criteria:

* total mastectomy with breast prostheses or tissue expanders performed or quadrantectomy
* age from 18 to 60 years
* body mass index (BMI) \< 30
* no cognitive dysfunctions ( Mini Mental State Examination MMSE \> 24)
* mild lymphedema

Exclusion Criteria:

* presence of lymphangitis or mastitis
* presence of metastasis
* surgical complications of the intervention, neurological deficits and complications
* important shoulder joint problems before the intervention for BC
* severe-moderate lymphedema and web axillary syndrome
* visual problem not corrected by lenses
* other or previous physiotherapy
Effects of Oral Nicotine and Caffeine Pouches on Anaerobic Performance, Autonomic Function, Cognition, and Behavior

The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40.

Accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of

* anaerobic performance
* cognition
* cardiovascular and autonomic function
* appetite and food intake.

Researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of

* physical performance,
* cognition,
* cardiovascular and autonomic function
* appetite and food intake.

On four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. After each trial, participants will complete a 24-hr food record.


Eligibility Criteria:
Inclusion Criteria:

* Being 21 to 40 years of age
* Being biologically male
* Having a body mass index (BMI) of \< 30 kilograms/meter-squared
* Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month

Exclusion Criteria:

* individuals who are younger than 21 or older than 40
* missing any limbs or part of a limb
* having any neuromuscular/musculoskeletal injury or impairment that would prevent performing any exercise/functional measures for this study
* having a pacemaker or any other electrical implant
* a diagnosis (defined as the presence of disease of or using medication to treat the disease) of heart failure, cardiomyopathy (dilated or hypertrophic), valvular disease, type I or type II diabetes
* taking insulin injections
* any history of severe or mild traumatic brain injury within the last two years
* kidney, liver, thyroid, or heart disease
* treated or untreated American Heart Association stage 2 hypertension (\>140 millimeters of mercury / \> 90 millimeters of mercury)
* any diagnosed neurological or neurodegenerative diseases
* having donated blood or plasma in the last 20 days prior to blood collection procedures
* taking any supplements/medications that may interfere with the results of the study
* any surgeries that would impact swallowing and/or digestion
* currently smoking, vaping, using e-cigarettes, or using any other combustible/smokeless tobacco products
* using smokeless tobacco-free nicotine products on more than 2 days/week
* daily caffeine use of more than 250 milligrams/day or use of any oral caffeine pouches
* have allergies or are regularly taking medications that would impact this study and/or negatively interact with caffeine or nicotine.
Efficacy Study in Phytotherapy of an Association of Plants in the Improvement of Psychological Well-being

The objective of the study is to compare the effect of a 6-week supplementation with a dietary supplement based on plant extracts to the effect of placebo, in patients with a moderate depressive episode (F32.1 by ICD10 definition) and with moderate symptoms (score HAM-D ≥ 16 and ≤ 23).

Longitudinal, comparative, randomized, placebo-controlled interventional study in 2 parallel groups, double-blind, monocentre, aimed at demonstrating the superiority of the combination of plants over placebo on depressive symptoms.

Each patient will be followed for a maximum of 6 weeks, with 3 visits to the doctor.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years old ;
* Patient with a moderate depressive episode (F32.1 by ICD10 definition) ;
* Score HAM-D ≥ 16 and ≤ 23 at inclusion, corresponding to moderate symptoms ;
* Recent depression (less than 6 months), not managed by antidepressant or psychotherapeutic treatment ;
* Depressive disorder not requiring, in the opinion of the investigator, initiation of antidepressant drug therapy ;
* Patient able to understand the study information, read the information leaflet, and willing to sign the consent form ;
* French speaking patient.

Exclusion Criteria:

* Patient with a depressive disorder of another nature or any other mental illness (schizophrenia, bipolarity, alcohol or drug addiction, etc.);
* Patient at risk of suicide (noted by the investigator, or HAM-D item 3 score \> 2) or having attempted suicide in the last 5 years;
* Depression felt for more than 6 months ;
* Patient under psychotropic treatment (current or in the month preceding inclusion) (neuroleptic, anxiolytic, hypnotic);
* Patient on beta-blocker therapy ;
* Patient on dialysis ;
* Patient using products containing piperine or St. John's wort, or having a known effect on mood in the last 30 days ;
* Woman who is pregnant or breastfeeding, or has plans to become pregnant in the next 8 weeks ;
* Patient with an allergy or contraindication to one of the components of the product under study (rhodiola or saffron) ;
* Patient unable to understand information related to the study (mental or linguistic disability) ;
* Patient participating or having participated in the previous 3 months in another clinical trial ;
Effects of Inspiratory Muscle Training in Patients With Post COVID-19

Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.

Dyspnea is one of the most common long-term symptoms in COVID-19 patients. It has been determined that dyspnea that persists three and six months after hospital discharge is associated with peak oxygen consumption in hospitalized and discharged COVID-19 patients, while peak oxygen consumption decreases in patients with dyspnea. Inspiratory muscle training may be an effective treatment modality in the treatment of dyspnea in patients with dyspnea after COVID-19. The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity, and quality of life, and decreased fatigue and dyspnea.

The aim of this study is to investigate the effects of inspiratory muscle training on oxygen consumption, muscle oxygenation, physical activity level, respiratory muscle strength and endurance, peripheral muscle strength, functional exercise capacity, dyspnea, fatigue and quality of life in patients with COVID-19.

Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).

Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-75
* Diagnosed with COVID-19
* COVID-19 Polymerase Chain Reaction (PCR) test result negative
* Volunteer to participate in the study

Exclusion Criteria:

* Body mass index \>35 kg/m2
* Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
* Aortic stenosis, complex arrhythmia, aortic aneurysm
* Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
* Cognitive impairment that causes difficulty in understanding and following exercise test instructions
* Participated in a planned exercise program in the last three months
* Bulla formation in the lung
* Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
* Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of combined oral contraceptive (COC) ethinyl estradiol and drospirenone in the blood stream in postmenopausal female participants who are overweight or obese. The safety and tolerability of LY3437943 when administered with COC will also be evaluated. This study will last up to approximately 29 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal female participants
* Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have an unstable disease or a disease constituting a risk when taking the study intervention.
* Have significant renal insufficiency
* Have an important gastro-esophageal reflux disease, pyloric stenosis, gastroparesis or a history of gastric bypass surgery.
* Have a history or presence of chronic or idiopathic acute pancreatitis.
* Have a history of severe clinically significant multiple or severe drug allergies.
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
* Have had any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years
* Have any form of diabetes mellitus other than type 2
* Have type 2 diabetes with HbA1c greater than or equal to 10% at screening
* Have received an oral or transdermal patch hormone replacement therapy (HRT) within the last 1 month prior to screening or depot injectable HRT within the last 6 months
* Have received any investigational drug within the last month or 5 half-lives of this drug, whichever is longer, prior to screening. If the half-life of the previous investigational drug is unknown, the washout period should be at least 3 months before screening
* Show evidence of HIV infection or positive HIV antibodies
* Have evidence of, or test positive for, anti-hepatitis C virus antibody unless a confirmatory test for hepatitis C virus RNA is negative
* Test positive for hepatitis B surface antigen. In case a hepatitis B virus DNA test was also performed recently and is positive, the participant should be excluded independently of the hepatitis B surface antigen test result. The hepatitis B core antibody test is not used to assess eligibility
* Have acute or chronic hepatitis, or signs and symptoms of any other liver disease, or with significant abnormalities in laboratory liver tests
* Have a fasting triglyceride level greater than 500 mg/dL at screening
* Used any nicotine product including tobacco or nicotine replacement products within 1 month prior to screening or a positive cotinine test at screening. Are unable or unwilling to refrain from using such products during the study
* Have donated at least 450 mL of blood within 8 weeks before screening or intend to donate blood during the study
Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia

The aim of this study is to investigate the effects of the sole of foot sensory education and electrical stimulation on proprioceptive and cortical senses in patients with acute hemiplegia.

Hemiplegia is a syndrome characterized by disorders of motor and sensory functions, speech and mental abilities. Hemiplegia is a common neurological problem in the world and is the third most common cause of death.

In addition to motor loss in patients after stroke, sensory problems are accompanied and close to 60% of stroke patients experience sensory problems. In a limited number of studies in the literature, it is stated that sensory impairment in the lower extremity negatively affects standing, walking speed, balance during ambulation and symmetrical gait. At the same time, it has been proven that the sole of the foot sense plays an important role in the balance of sitting, standing up and performing independent daily living activities. After a stroke, sensory training increases functionality, patients with sensory training recover faster, mobility, balance and daily life activities become better, and daily life improvement is expressed. The purpose of sensory training is to maximize the patient's learning through the connection between environment and repetitive activities.

The aim of this study is to compare the effects of neurodevelopmental physiotherapy program combined with sensory training or electrical stimulation on the sole of the foot proprioceptive and cortical senses in individuals diagnosed with hemiplegia.

There is no study on how proprioceptive and cortical sensations will be affected in acute hemiplegic patients if sensory training and electrical stimulation are added to the classical treatment program. By finding and comparing the effects of active (sensory training) and passive treatment (electric stimulation) with this study, it was planned to propose an effective treatment protocol for developing the sole of the foot senses to the experts working in this field.

As a result, purpose of the study is to prevent inadequate sensory input in hemiplegic patients from adversely affecting quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Participating to the study in a voluntary basis
* Patients with 50-80 years old
* A stroke diagnosis by a neurologist
* A stroke attack within 6 months
* Minimum 18 points from Mini Mental Test
* Medically stable

Exclusion Criteria:

* Unstable condition
* Other neurological or orthopaedic problems that will affect function other than stroke
* Uncontrolled hypertension
* Diabetic foot ulcers
* Part/total foot amputation
Masticatory Side Change and Masticatory Function.

The primary objective of this study is to establish the effect of the frequency of masticatory side switches on masticatory performance. We also want to know the effect of the frequency of masticatory side switches on the masticatory rhythm. Twenty-eight healthy volunteers will undertake masticatory tests, following a series of instructions given at the moment. These volunteers will take a re-test in two-weeks time. The sequence of these tests will be randomized in such a way that, each participant will initially perform an established sequence of "freestyle, only-right, and only-left" masticatory tests, and then will carry out one of the 6 possible combinations of "A1, A3, and A5". These tests will be recorded on video to assess, on slow playback, the change of the chewing side, and the masticatory rhythm.Masticatory performance will be determined by sieving the silicone particles.

This crossover intervention study aims to assess the effect of the degree of alternance of the chewing side on various aspects of masticatory function, including masticatory performance and rhythm. Twenty-eight volunteers will take part, recruited for convenience, among friends and relatives of the teachers and students of the Degree of Dentistry of the Faculty of Medicine and Health Sciences of the University of Barcelona. These individuals will perform masticatory tests and, after a period of two weeks, will repeat them as a re-test. Each participant will perform 6 tests, each consisting of 5 assays, chewing a small latex bag containing a few silicone tablets (2 g) during 20 masticatory cycles. One test involves freestyle mastication in which the participant will be asked to chew the latex bag naturally. Two tests involve chewing the bag unilaterally (i.e., right-hand side in one and left-hand side in the other) and the order of their assays will be varied. For the last three tests, the participant will change the chewing side 1 (A1), 3 (A3), or 5 (A5) times respectively; the sequence of the assays will be randomized. The masticatory performance will be determined by the "median particle size" (MPS), and the masticatory rhythm will be assessed through the masticatory frequency as the ratio of masticatory cycle number to masticatory time. The control variables will include age and sex.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old.
* Natural dentition (minimum 24 teeth).

Exclusion Criteria:

* Active orthodontics treatment.
* Intraoral pain.
* Temporomandibular joint pain.
* Masticatory muscle pain.
* Large dental restorations.
* Dental prosthesis.
Sun Protection Factor Assay (317/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.