cyrilzakka/clinical-trials huggingface dataset:
Arthrocentesis Followed by Prolotherapy

we will do tmj joint lavage and followed by dextrose injection

Two groups of patients one group will receive lavage with saline and other group will receive lavage then dextrose injection

Eligibility Criteria:
Inclusion Criteria:

* tmj painful joints patients healthy patients disk displacement with reduction

Exclusion Criteria:

* patients previously treated males young age group
'Ai Pono Cooking Demonstrations

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

In Years 1 - 5, the investigators will hold quarterly cooking demonstrations and cultural lessons for a total of 36 events. The lessons will be aimed at improving family and community eating environments of participants and social cohesion of these communities. Attendance at each lesson will be limited to 30 individuals. Attendees will register via REDCap using their names and email addresses. There is no limit to how many lessons an individual can attend, but after the first lesson the investigators reserve 15 of the 30 spots for people who have not attended previously, as identified by their registration information. At each quarterly event, the investigators survey participants to assess their reaction to the lesson, their vegetable and fruit intake, self-efficacy for healthy diet, and perceptions of community cohesion. Surveys will take \~5-10 minutes to complete. Additionally, the investigators will survey random samples of homestead households (n = 20 per homestead, total n = 140 per year) in Projects Years 1 - 5. Total sample for this activity is 700. Each sample will be selected independent of previous samples, and it is possible the same households will be sampled multiple times.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+ (looking for older adults)
* Native Hawaiian resident in a participating homestead
* Overweight or obese (BMI ≥ 25 kg/m\^2)
* Prior diagnosis of type 2 diabetes or pre-diabetes, hypertension, and/or dyslipidemia (LDL cholesterol ≥ 130 mg/dL)
* Capable of 150 minutes of moderate physical activity (e.g., brisk walking) per week
* Willing and able to participate in all aspects of the individual and household-level intervention
* Fluent in written and spoken English

Exclusion Criteria:

* No children
* Pregnancy
* Serious illness such as cancer or chronic pain that may contraindicate full participation
Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control

The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.

The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI\>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.

Eligibility Criteria:
Inclusion Criteria:

* Healthy obese subject (BMI \>27)
* Aged between 20 to 80 of both genders with a desire to lose weight.

Exclusion Criteria:

* Subjects with cancer
* Hyperglycemic (diabetic)
* Hypertension,
* Stroke
* Renal dysfunction
* Cardiac or hepatic dysfunctio
* allergic to the dairy product and eating disorders
* Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects
Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture

The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.

The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.

This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 60 years inclusive
* Open diaphyseal fracture
* Gustilo-Anderson Type I, II, IIIA

Exclusion Criteria:

* Closed, periarticular or pathological fracture
* Gustilo-Anderson Type IIIB,IIIC
* Patients with concomitant fractures in the ipsilateral limb
* The patient is unable to medically tolerate general anesthesia
* The patient is unable to provide informed consent or comply with completing questionnaires
* Tibia already infected as diagnosed by a surgeon
* The patient has been diagnosed with a severe psychiatric condition
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.


Eligibility Criteria:
Inclusion criteria

* Men aged 20 to 45 years, inclusive, at screening.
* Elderly men or women aged 65 years and above as of screening.
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
* Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.
Neuralgic Amyotrophy: Central Reorganization and Rehabilitation After Peripheral Dysfunction

This study evaluates the effect of a specific, multidisciplinary and personalized rehabilitation program compared to usual care, on motor control and functional disability in patients with neuralgic amyotrophy.

Half of the participants will start with the 17-week specific rehabilitation program while the other half will first continue their usual care for 17 weeks, after which they will also receive the 17-week specific rehabilitation program.

Neuralgic amyotrophy (NA) is a common (incidence 1:1000) peripheral nervous system disorder caused by acute autoimmune inflammation of the brachial plexus, the nerve bundle going to the shoulder and arm. Many NA patients develop abnormal motor control of the shoulder region (i.e. scapular dyskinesia), which persists even after the peripheral nerve damage has recovered. This suggests that persistent scapular dyskinesia in NA may result from (mal)adaptive changes in the central motor system.

Clinical experience shows that the specific, multidisciplinary and personalized rehabilitation program, focused on cognitive motor control can restore scapular dyskinesia in NA patients. This indicates that impairments in the central motor system likely play a role in persistent scapular dyskinesia and that specific rehabilitation may restore any alterations in central motor control.

We hypothesize that the specific rehabilitation program, focused on cognitive motor control is more effective in improving functional disability than usual care and that it can reverse maladaptive changes in central motor control.

Eligibility Criteria:
Inclusion Criteria:

* (Suspected) diagnosis of neuralgic amyotrophy
* In subacute or chronic phase of neuralgic amyotrophy (\>2 months after attack onset)
* Right-handed
* Neuralgic amyotrophy predominantly present in right upper extremity
* Presence of scapular dyskinesia

Exclusion Criteria:

* Patients in the acute phase of NA (characterized by severe pain and inflammation of the brachial plexus)
* (Prior) NA attacks of the lumbosacral plexus or the left upper extremity
* Sever comorbidity
* Any (bio)mechanical constraints of the shoulder girdle
* Any other central nervous system, neurological, or neuromuscular disorder
Preserving Function in Breast Cancer Patients

Breast cancer patients experience functional limitations related to the cancer and treatment side effects. Early functional limitations affect short- and long-term quality of life, and may lead to long-term complications. Patients living in rural areas are at particular risk because they do not have easy access to services. Therefore, early intervention is indicated to have an impact on the overall public health. Problem solving training (PST) is a standardized manual driven intervention that may be ideally suited to assist breast cancer patients to preserve their valued activities and to comply with recommended symptom management regimens (e.g., physical therapy, aerobic exercise and relaxation/guided imagery) that improve function. Telephone-based PST provided from a centralized location (such as the comprehensive cancer center) may improve access and outcomes in a cost-effective manner. We propose to conduct a feasibility study of a PST intervention with 30 rural breast cancer patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The intervention group will receive weekly phone-based PST sessions for six consecutive weeks. The specific aims of this R03 small grant application are to:1) Test the feasibility of enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine effect size estimates that will inform power analyses for a full scale randomized controlled study. Primary outcome measures will be acceptance rates for enrollment in the study, retention rates across both intervention arms, and satisfaction levels with the PST intervention. Assessments will be conducted at baseline, and at six weeks (end of PST intervention) and 3 months following baseline. The long-term goal of this line of investigation is to develop practical, widely applicable rehabilitation models of care to preserve function and decrease distress in cancer patients undergoing treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Females, age \> 18 years.
2. First breast cancer diagnosis, Stages 1-3.
3. Beginning the second chemotherapy cycle.
4. English speaking and literate.

Exclusion Criteria:

1. Previous or concurrent malignancy, except for non-melanotic skin cancers.
2. Lifetime diagnosis of schizophrenia or bipolar disorder.
3. Moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener.
Octaplas Pediatric Plasma Exchange Trial

To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.


Eligibility Criteria:
Inclusion Criteria:

1. Patients in whom therapeutic plasma exchange (TPE) is required.
2. Patient is male or female ≥ 2 years to ≤ 20 years of age.
3. Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily written and signed informed consent before any study-related procedure is to be performed. If children are old enough (age usually deemed by each institution) to understand the risks and benefits of the study, they should also be informed and provide their written assent.

Exclusion Criteria:

1. Patient with known homozygous congenital deficiency of Protein S.

   Exclusion Criteria:
2. Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
3. Patient has an already known IgA deficiency with documented antibodies against IgA.
4. Patient is currently participating in another interventional clinical study or has participated during the past 1 month prior to study inclusion. This is not applicable to non-interventional trials and does not exclude patients who have been exposed to Investigational Medicinal Product with a washout of at least 30 days from enrollment in LAS-213. Concurrent participation in a device study will be considered on a case by case basis.
5. Patient is pregnant.
6. Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the first infusion episode or planned used of these medications while on study.
Detection and Classification of Cardiac Rhythm and Atrial Fibrillation Using a Finger-worn Ring

Everbeat is a finger-worn ring that has a built-in electrocardiogram (ECG). In this study the investigators ensure that the ECG as read by the everbeat correctly classifies heart rhythms and detects atrial fibrillation. Investigators will also correlate the everbeat ECG waveform with a clinical-grade FDA approved electrocardiogram to ensure it may be reliably interpreted by clinicians or other algorithms.

In this study the participant will obtain a simultaneous electrocardiogram from both the everbeat ring system and a clinical-grade diagnostic ECG machine for correlation and analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* Presence of pacemaker or defibrillator
* Inability to wear a ring in size range available
To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia

The goal of this interventional study is to evaluate the effects of bundle combination of Amway All-plant protein booster with Nutrilite Lifestyle guideline and/or EMS (Electric Muscle Stimulation) device on Osteoarthritis \& Sarcopenia in the middle-aged and elderly (50-70 years old) people.

240 eligible participants will be randomly assigned to 4 equal size study groups (ideally 52 for each group will complete the study) in the two study centers in Shanghai, three site visits will be made during the 6 months of study after screening test. All clinical data will be measured /captured on paper CRF(Case Report Form) and then recorded into CTMS(Clinical Trial Data Management System) for analysis and reporting. It's essential that participants should practice with the assigned guideline and device besides taking the products per day.

Researchers will compare the four groups to see if there is significant improvement of Amway study products with bundle combination of Nutrilite Lifestyle guideline and/or EMS on Osteoarthritis \& Sarcopenia in the participants.


Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females, age between 50-70;
* SPPB scale 4 - 9, but walking 400 meters within 15 minutes;
* Reporting \<20 min/week in the past month performing regular physical activity and \<125 min/week of moderate physical activity;
* Willing to comply with all research requirements and procedures;
* Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Exclusion Criteria:

* Have used any medication for OA \& SA at least one month before this study.
* Subject having done plastic surgery for OA \& SA.
* Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
* Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
* Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
* Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
* Be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
* Have any of the following conditions or factors that the investigator believes may affect the study objectives caused by medication by protein, glucosamine, calcium and magnesium or supplements to improve capability of the sports.
* Have any allergy caused by all-plant protein and sea-food.
* The regular exercises more than 125 minutes per week.
Rapid Sequence Intubation With Rocuronium in Elderly Patients

With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. The use of rocuronium at a dose of 1 mg/kg in RSI also causes prolongation of the recovery of neuromuscular block. This study aimed to compare the intubation conditions and train-of-four count(TOFC) 1-2 times of the rocuronium doses with priming according to ideal body weight(IBW), corrected body weight(CBW), and total body weight(TBW) in RSI of patients aged \>65 years.

The number of elderly patients (\>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. Changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. One of the reasons for rapid sequence intubation(RSI) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. Guidelines regarding this subject recommend securing the airway quickly with RSI, and it is reported that aerosol production would decrease with this method. This study aimed to compare the intubation conditions and the train-of-four count (TOFC) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(IBW), corrected body weight(CBW), and total body weight (TBW) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.

Eligibility Criteria:
Inclusion Criteria:

* Elective abdominal surgery
* Age \> 65 years
* ASA I-II -III

Exclusion Criteria:

* Patient with history of allergy to rocuronium
* Body Mass Index \> 35 kg/m2
* Patient who had history of difficult intubation or high possibility of difficult intubation
* Neuromuscular disease
* Kidney failure (GFR \< 30 ml/dk/m2)
Self-Efficacy in Weight Loss Treatment

This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.

Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:

* every week during the first month of the study,
* every other week for the second month
* once a month for months 3-12
* every 6 weeks for months 13-18

Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.

Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* BMI \> 27 and \< 43
* willing to be randomized to one of the two treatment conditions
* successful completion of screening requiring 5-day recording of food intake in a paper diary
* have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)

NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)

Exclusion Criteria:

* presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
* physical limitations precluding ability to engage in physical activity at moderate intensity
* pregnancy or intention to become pregnant in the next 18 months
* current treatment for a psychological disorder
* reported alcohol intake \> 4 drinks/day
* previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
* planned extended vacations, absences, or relocation within the next 18 months