cyrilzakka/clinical-trials huggingface dataset:
Effects Of Supervised Sensorimotor Training Through Telerehabilitation Monitoring After Total Knee Arthroplasty

Knee Osteoarthritis (OA) along with low back pain, is one of the most frequent rheumatic disorder in the Asian regions. Total Knee Arthroplasty is considered as a gold standard management strategy for relieving symptoms due to degenerative arthritis of knee. Rehabilitation after knee arthroplasty is an essential component among this population and plays a significant role in improving the functional performance and quality of life. However, access to rehabilitation, health care services and follow up is not always possible. One of the possible solution is the utilization of telerehabilitation technology to allow monitoring facilities be delivered to the patients from distance, so that follow up of a patient could be ensured. Secondly, a type of therapeutic exercise followed after knee replacement constitutes muscle strengthening, muscle stimulation with resistance exercises, sensorimotor training and telerehabilitation. Sensorimotor training improves central nervous system function for managing movement and appropriate muscular firing patterns for maintaining joint stability. An important component missing in the treatment regime of a knee replacement patient is the lifestyle modification program which is a combination of education, exercise and diet. So, the aim of current project is to evaluate the effects of supervised sensorimotor training with and without lifestyle modifications through telerehabilitation monitoring on joint position sense, balance, posture, muscle strength, knee joint function and quality of life after total knee arthroplasty. The telerehabilitation system would interaction between clinician at hospital and patients at home. A web based portal will be developed and then utilized to provide the user with personalized information such as guided video and audio instructions about each exercise. The digital rehabilitation solution is well established in developed nations. It is the need of hour to introduce technological advancements in Pakistan. Tele-rehabilitation should be incorporated as it will be helpful for the community and will reduce the dependence on human resources while ensuring better clinical outcomes as standard therapy. Intervention group will receive lifestyle modification manual and follow up will be ensured through telerehabilitation monitoring. Analysis will be done through SPSS 21.


Eligibility Criteria:
Inclusion Criteria:

1. Both male and female
2. Successful Total Knee Arthroplasty surgery
3. Ability to walk (with walking aid or unaided)
4. Aged between 45 to 75 years old,
5. Active knee flexion of 80 degree and active knee extension of -10 degree upon discharge
6. Availability of internet service in the residing area.

Exclusion Criteria:

1. Presence of health related medical conditions that could interfere with tests or the rehabilitation program
2. Neurological conditions that might affect balance
3. Inability to attend rehabilitation services, revised knee arthroplasty
4. Blindness and any condition incompatible with 30 minutes of light to moderate physical activity
Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer

This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.

PRIMARY OBJECTIVE:

I. To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer.

SECONDARY OBJECTIVES:

I. To determine the presence of gastric cancer (GC) associated risk factors amongst the diverse ethnic populations (in greater Orange and Los Angeles Counties).

II. To determine the proportion of high-risk patients who are willing to undergo upper endoscopy.

III. To identify actionable diagnoses on upper endoscopy of high-risk individuals.

EXPLORATORY OBJECTIVE:

I. To assess population-based understanding of gastric cancer.

OUTLINE:

PART I: Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.

PART II: High-risk participants are assigned to cohort I and non-high risk participants are assigned to cohort II.

COHORT I: Participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.

COHORT II: Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.

Participants are followed up annually for a total of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative

  * Assent, when appropriate, will be obtained per institutional guidelines
* Age: ≥ 40 years to ≤ 80 years
* Identify as a racial minority either Asian, Hispanic, or Black American
* Willingness to:

  * Provide blood samples and undergo upper endoscopy

Exclusion Criteria:

* Identify as Non-Hispanic White
* History of gastric cancer
* Known premalignant lesions of the stomach
* History of upper endoscopy within 2 years
* Women of childbearing potential: Pregnant/ nursing
* An employee who is under the direct/indirect supervision of the principal investigator (PI)/a coinvestigator/the study manager
* A direct study team member
Comparison of Different Tourniquet Release Times in Bunion Surgery

Patients listed for hallux valgus/hallux rigidus correction surgery will be randomised to one of two treatment groups. Group 1 (standard care) will have the calf tourniquet released after wound closure. Group 2 will have the tourniquet removed five minutes before wound closure. Participants will have the volume of their operated foot measured pre-operatively and post-operatively at six weeks and three months.

Pneumatic tourniquets provide the benefits of better visualisation and decreased blood loss, but can also cause metabolic changes due to ischemia and compressive damage due to pressure. Surveys of foot and ankle surgeons demonstrates prevalent use of tourniquets in their clinical practice, with various patterns of use differing amongst the surgeons.

Bunion surgery is one of the most common surgical procedures in foot surgery. It involves correcting the hallux valgus deformity through a combination of various osteotomy, fusion, or soft tissue procedures. Swelling after any surgery is common, but particularly so after foot surgery as gravity causes fluid to collect in the foot. With regards to recovery after surgery, patients are advised to expect to be off work for between 6-8 weeks for a sedentary occupation, and between 12-14 weeks for heavy work. Although patients have low pain levels, the foot remains swollen for an average of 3-6 months after surgery. It is usually the swelling that prevents patients from getting in to normal footwear to be able to return to work sooner.

Bunion surgery is usually performed under a calf-tourniquet to create a bloodless surgical field and ensure less surgical bleeding, thereby reducing surgical time. However, use of tourniquets can lead to more swelling, increased post-operative pain and challenges in rehabilitation - all of which may affect recovery after bunion surgery. Prolonged duration of tourniquet use has been shown to cause post-operative wound healing complications, potentially attributable to local inflammation and tissue hypoxia. It is known from the studies for knee replacement surgery that tourniquet use can lead to decreased range of motion after surgery in early stage.

This study will be a randomised controlled trial with two study groups. The control group will have surgery with the tourniquet remaining in situ until the wound is closed. The intervention group will have the tourniquet released after surgery, but closure will be delayed by five minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients having hallux valgus or hallux rigidus
* Able to give informed consent
* Able to return for follow-up

Exclusion Criteria:

* Patients with symptomatic peripheral vascular disease
* Patients with known peripheral oedema from any cause
* Patients who will also require lesser toe correction as part of the procedure
* Active smokers
Continue Glucose Monitoring Before Insulin Pump

The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.

This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.

Eligibility Criteria:
Inclusion Criteria:

1. Males and Females aged 2-24 years
2. Clinical diagnosis of Type 1 diabetes mellitus
3. Duration of diabetes: At least 6 months

   - This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
4. Basal/bolus insulin regimen using long-acting and rapid-acting insulin

   - This will provide a uniform method of insulin therapy.
5. Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
6. Willingness to wear the iPro®2 for 5 days continuously per insertion
7. Participant agrees to comply with the study protocol requirements
8. Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

Exclusion Criteria:

1. Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
2. Glucocorticoid use within 2 weeks of study enrollment
3. Concurrent use of other medications that may affect glycemic control
4. Prior CGM use in the past 6 months
5. The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
6. Non-English or non-Spanish speaking
Estrogen Use in Protection From Cognitive Decline

This study is designed to assess the effects of estrogen therapy among postmenopausal women at risk for cognitive decline.

A total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to continue or discontinue use of estrogen and will be followed for two years.

Participants will undergo PET and MRI scans and neuropsychological assessments initially and at the end of the two-year follow-up period. These procedures will allow us to evaluate brain metabolism and cognitive performance at baseline and two years following continuation or discontinuation of estrogen therapy.

We hypothesize that women who discontinue estrogen will show more evidence of decline than those who continue estrogen. This project will expand current knowledge of effects of estrogen by 1) determining whether estrogen use among postmenopausal women at risk for cognitive decline is protective of brain metabolism, 2) identifying early predictors for cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 45 and 65
* Currently on hormone replacement
* One year or more post complete cessation of menses
* Willing to sign the Human Subject Protection Consent form prior to enrollment in the study
* Willing to be randomized to continue or discontinue estrogen therapy
* Adequately visually and auditorially acute to allow neuropsychological testing
* Beyond 8 years of educational achievement to allow adequate neuropsychological testing
* Willing to undergo brain imaging
* At risk for cognitive decline, as defined by one or more of the following: Personal or family history of mood disorder, Hypothyroidism, Diabetes, Family history of Alzheimer's, APOE-4 allele

Exclusion Criteria:

* Diagnosis of possible or probable Alzheimer's disease or dementia
* Cerebrovascular disease or uncontrolled hypertension (systolic BP \>170 or diastolic BP \>100)
* History of myocardial infarction within previous year or unstable heart disease
* History of significant liver disease, pulmonary disease, or current cancer
* Contraindication for MRI (metal in body, claustrophobia, etc.)
Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility

Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy as one of the routine steps in the fertility workup program has become mandatory before the final diagnosis of unexplained infertility.

Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an initial test without a high degree of suspicion for pathology due to the need for anesthesia in an operating room setting. The basic infertility work-up has included a HSG to evaluate the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final procedure in selected infertile women.

Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity. However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy in most studies.

Eligibility Criteria:
Inclusion Criteria:

* Normal HSG
* Normal Ultrasound
* Normal Hormonal Profile
* Normal Semen

Exclusion Criteria:

* Abnormal findings in different investigations of infertility
Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology

The study is based on the realization of a meditation program associating patients, caregivers and control subjects


Eligibility Criteria:
Inclusion criteria for all participants (patients, caregivers and control subjects)

* Participants aged 18 or over
* Curious and motivated participant to participate in the program
* Participant with no current or previous experience of regular or intensive practice of meditation or a comparable practice. The practice is considered regular and / or intensive if:

  * it occurs more than one day per week for more than 6 consecutive months over the last 10 years,
  * and / or in case of more than 5 consecutive days of intensive practice (internship or retirement) in the last 10 years,
  * and / or more than 25 consecutive days of (cumulative) retirement over the last 10 years.
* Participant available to follow the full meditation program (3 month period)
* Participant agreeing to participate by signing the study information note
* Participant able to understand, speak and read French
* Patient capable of using digital media and having an internet connection

Patient-specific criteria (target population)

* Patients with cancer,
* State of health compatible with the study meditation program
* Patient affiliated to a social Health sytem

Caregiver-specific criteria

* All medical and / or paramedical staff of the sponsor Center in contact with patients (doctors, nurse, caregiver, radiotherapy manipulator MERM)

Criteria specific to the control population - Any voluntary person not belonging to the two categories above

Exclusion Criteria:

For all participants

* Participant with significant vulnerability factors dependence on alcohol and drugs, severe depression, severe social anxiety, recent mourning etc.).
* Participant who cannot submit to the follow-up of the trial for geographic, social or psychopathological reasons

For patients

* Very advanced stage of cancer disease with life-threatening commitment,
* Participant deprived of liberty or under guardianship

For control subjects

- Nursing staff, regardless of their place of practice
Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia

This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.


Eligibility Criteria:
Inclusion Criteria:

* good health
* no history of allergy to the components of the local anesthetic formulations tested
* maxillary canine, lateral incisor, and first premolar responsible to electric stimulation

Exclusion Criteria:

* intake of any medication that would alter pain perception
* history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
* systemic disease
Effects of Hatha Yoga on Chronic Neck Pain

Hatha Yoga is a traditional system of exercises, used in India for the relief of painful condition since centuries and gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with chronic low back pain, no studies regarding chronic neck pain are available until now. The purpose of this study is to determine if Hatha Yoga can ameliorate chronic neck pain and related restrictions.

Hatha Yoga is a traditional system of exercises, used in India for the relief of painful condition since centuries and gaining more and more interest in Europe and the US. The efficacy of Hatha Yoga for relieving chronic low back pain has been repeatedly demonstrated in clinical trials, while there are no studies in the literature regarding chronic neck pain. The aim of this study is to investigate, whether a 9 weeks-course of Hatha Yoga reduces subjective pain ratings and disability in patients suffering from chronic neck pain. Furthermore, as neck pain patients have been shown to suffer from impaired sensory processing and proprioception, along with restricted range of motion, the study aims to test if Hatha Yoga can improve these variables. Therefore, tests regarding cervicocephalic proprioception, active range of motion and the processing of mechanical, vibration and pain stimuli will be included.

58 patients with chronic nonspecific neck pain will be randomized to either Hatha Yoga group or control group, receiving information regarding exercises for chronic neck pain. The control group will be offered to take part in a Yoga class after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic mechanical neck pain, at least 40 mm on the 100mm visual analog scale.
* Pain for at least 3 months.

Exclusion Criteria:

* radicular symptoms
* congenital spine deformity
* pregnancy
* rheumatic diseases
* oncologic diseases
* other severe psychiatric or somatic comorbidity
* recent invasive or surgical treatment of the spine
* regularly yoga practice participation in other studies
Relationship of Cerebral Perfusion Pressure Variability to Sepsis-associated Encephalopathy

The purpose of the study is to evaluate whether variability of CPP (cerebral perfusion pressure) is related to sepsis-associated encephalopathy and outcomes of patients with sepsis.

Encephalopathy is a common complication of sepsis, impaired cerebrovascular autoregulation (AR) in patients with sepsis is considered related to Sepsis-associated encephalopathy (SAE). As AR is important in stabilizing the cerebral perfusion pressure, whether greater variability of CPP is related to SAE and mortality or not remains unclear. We conduct this study to evaluate the relationship between them.

Eligibility Criteria:
Inclusion Criteria:

* clinical symptoms of sepsis, severe sepsis and septic shock
* age over 18 years

Exclusion Criteria:

* preexisting Neurological diseases
* traumatic brain injury
* intracranial infectious disease
* severe hepatic or renal dysfunction
* ICU discharge Within 72 hours
* pregnancy
Evaluation of InnoLIA HTLV I/II Score

The InnoLIA HTLV I/II Score is an in vitro diagnostic test for confirmation of antibodies to human T-cell lymphotropic virus (HTLV) type I and type II in human blood samples. It is intended as a supplemental test for blood donor samples that are reactive in routine anti-HTLV screening tests. This study will determine if the test is useful for donor counseling purposes.

The InnoLIA HTLV I/II Score study consists of three sub-studies. The first sub-study will determine the sensitivity, specificity and accuracy of HTLV type assignment using well-characterized samples from the NIH-funded HTLV Outcomes Study (HOST). The second sub-study will compare automated reading and interpretation of test results with manual reading and interpretation using a sub-set of samples tested in the initial study. The third sub-study allows for use of the InnoLIA HTLV I/II Score as a supplemental test for whole blood and HCT/P donors testing repeatedly reactive with an FDA-approved donor screening test for anti-HTLV-I/II.

Eligibility Criteria:
Inclusion Criteria:

* Subjects completing a health history evaluation for routine donor screening
* Subjects willing and able to provide informed consent
* Subjects testing repeat reactive on a licensed screening test for HTLV antibodies

Exclusion Criteria:

* Subjects not meeting health history criteria for routine donor screening
* Subjects unwilling and unable to provide informed consent
* Subjects testing negative on a licensed screening test for HTLV antibodies