cyrilzakka/clinical-trials huggingface dataset:
Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis

The study aims to evaluate the effects of a single intra-articular injection of micro-fragmented adipose tissue obtained with the Lipogems® system in patients affected by knee chondropathy. End-points were determined by evaluating the patients in terms of improvement in symptoms, functional recovery and radiographic appearance compared to baseline.

Background: The social impact of degenerative diseases is steadily increasing, because of the continued rise in the mean age of the active population. Articular cartilage lesions are generally associated with disability and symptoms such as joint pain and reduced function, and remain a challenge for the orthopaedic surgeon. Several non-invasive solution have been proposed, but the results achieved to date are far from being completely satisfactory. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have been developed. Among the many sources, the adipose tissue is nowadays considered one of the smartest, due to its abundance and easy access.

The aim of this retrospective study is to explore whether patients affected by symptomatic knee osteoarthritis treated with micro-fragmented adipose tissue associated with a chondral shaving procedure experience an improvement in symptoms and function.

Methods: Thirty-eight consecutive patients affected by symptomatic knee osteoarthritis were treated in 2015 with an arthroscopic procedure associated with an injection of autologous and micro-fragmented adipose tissue. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical examination. Safety of the procedure, recording type and incidence of any adverse event, was also assessed.

Eligibility Criteria:
Inclusion Criteria:

* knee chondropathy grade \> II (ICRS classification),
* constant pain and failure of conservative treatments (physiokinesitherapy, corticosteroids, HA and/or PRP) for at least 12 months.

Exclusion Criteria:

* immune-mediated (non-infectious) synovitis
* OA Kellgren-Lawrence grade \>3
* axial defects \>10°
* metabolic disorders
* BMI \> 40
Carotid Ultrasounds Measurements in Septic Shock

The aim of the study is to assess carotid ultrasounds measurements, namely corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak), as a predictor of fluid responsiveness in septic shock patients.

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection . Early identification and appropriate management in the initial hours after the development of sepsis improve outcomes.

For patients with sepsis-induced hypoperfusion or septic shock it is recommended to give IV crystalloid fluid within the first 3 hr of resuscitation . However, fluid responsiveness varies widely between cases. Determining the optimal amount of fluid to be administered remains a critical issue in clinical practice and research. Recent studies have shown that not every patient advantages from intravenous hydration, only 40% of hypotensive patients with sepsis benefit, and the others who do not respond are liable to develop pulmonary edema with high associated mortality . Studies have shown that aortic blood peak velocity had high sensitivity and specificity to predict fluid responsiveness, however, measurements of aortic blood flow velocity need a transesophageal ultrasound which is an invasive procedure . Measurement of left ventricular outflow tract velocity time integral (LVOTVTI), derived stroke volume (SV), and cardiac output reliably predicts fluid responsiveness in critically ill patients but it is difficult and dependent on operator and echo windows . There is a need to find a non-invasive accurate and easy method to assess fluid responsiveness in septic shock patients. Different Measurements of carotid artery flow have been suggested recently to predict fluid responsiveness. A promising measurements are corrected flow time (FTc), velocity time integral (VTI) and respirophasic variation in carotid artery blood flow peak velocity (ΔVpeak).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-75 year old) diagnosed with septic shock (MAP \>65mmHg), within 6 hours of admission or development of septic shock if previously admitted with other diagnoses.

Exclusion Criteria:

* patients have any of these conditions: Carotid artery stenosis ≥50%, known heart failure (Ejection fraction ≤45%) or End Stage Kidney Disease requiring haemodialysis.
Commuter Air Pollution Intervention Study

Traffic related air pollution is a well-recognised and much studied contributor to smog and is linked to a number of adverse health outcomes. Although traffic pollutants can travel long distances, exposure to the highest levels of the raw emissions can occur closest to the source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to half of commuters' daily exposure to certain air pollutants. Most new cars now have or allow for a cabin air filter, but it is not known how well cabin air filtration can reduce exposure to traffic-related air pollution.

This intervention study will measure commuters' exposure to air pollutants in rush hour traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and short term cardiopulmonary health indicators such as blood pressure, heart rate variability and respiratory inflammation. It will also look at effects on cognition (mental processing and judgement) in this real world environment where any deficit could be important to safety. In addition, the study will examine whether cabin air filtration can reduce the exposure to traffic related air pollutants and result in improvements in short term cardiopulmonary and cognitive function. This research will contribute to our understanding of how this environment contributes to Canadians' overall air pollution exposure as well as the potential health impacts. It will also test a potentially valuable and economical means of reducing exposure to traffic related air pollution in a commuting environment. The study may also guide the future implementation of the use of cabin filters as an exposure reduction intervention.

Overall Project Objectives:

Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does commuter exposure to air pollution affect short term stress, and cardiopulmonary and cognitive function? Can cabin air filtration mitigate the health effects of commuters' exposure to air pollution?


Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals;
* non-smoking.

Exclusion Criteria:

* Smokers;
* living in a smoking household;
* currently experiencing seasonal allergies;
* suffering from heart rhythm problems or heart conditions;
* regularly taking corticosteroid medication;
* pregnant or breastfeeding;
* allergic to latex;
* sensitivity to adhesives
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis

To test the hypothesis that an exercise session combined with adequate nutritional supplementation improves skeletal muscle protein accretion during a hemodialysis session.


Eligibility Criteria:
Inclusion Criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
* Adequately dialyzed (Kt/V \> 1.2).
* Age 18-75

Exclusion Criteria:

* Pregnant women.
* Patients unable to perform exercise
* Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients with malfunctioning arterial-venous access (recirculation and/or blood flow \< 750 ml/min)
* Patients receiving steroids and/or other immunosuppressive agents.
Behavioral Therapy for Children and Adolescents With Tourette Syndrome

Tourette Syndrome (TS) is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan.

TS is a common neuropsychiatric disorder in childhood and adolescence, and often comorbid with psychiatric comorbidity. Antipsychotic medications are usually the first choices, but may associate with adverse effects. Behavioral intervention for TS has been shown to be an effective treatment for children and adolescents, yet have not been performed and evaluated using control trails in Taiwan. This study therefore was to evaluate the efficacy of a comprehensive behavioral intervention therapy on improving tics and tic-related impairment for children and adolescents with Tourette syndrome.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 Diagnostic Criteria For Tourette Syndrome
* Patients aged from 6-15 years who were diagnosed with TS or CTD,
* Never received any pharmacological treatment
* Ability to understand the study purpose and/or provide consent for participation independently and via a caregiver serving as a proxy

Exclusion Criteria:

* Have been diagnosed with another mental illness,
* Had no physical or medical condition,
* Had been received CBIT or cognitive behavior therapy before.
Arch Support Effects on Balance and Gait in Older Adults With Mild Cognitive Impairment

This study aims to explore the effects of arch support insoles on balance and gait performance in older adults with mild cognitive impairment (MCI). We will recruit 40 female older adults with MCI. A randomized crossover trial will be used to determine the immediate effect of arch support insoles. All participants received one assessment session wearing and one session not wearing insole in a random order within 1-day. Then participants will be randomly allocated to experimental group (arch support insoles, n=20) or control group (no insoles, n=20) for at least 4-h every day for 1-month. Our primary outcomes include static standing balance, timed-up-and-go test, 10-m obstacle crossing, functional reach test, Short Physical Performance Battery (SPPB), and gait assessment during single- and dual-task walking for 20 m at self-selected comfortable pace while performing serial subtractions (cognitive interference) or carrying a tray (motor interference). Assessments will be conducted at baseline and after 2-wk and 4-wk of insole wear. Statistical analyses will be performed using SPSS 21.0 software. Two-way mixed ANOVA will be used to determine the immediate and short- and long-term effect of arch support insoles. The results of the current study are expected to provide evidences in supporting the use of arch support insoles for improving gait performance and postural stability for older adults with MCI which will contribute to balance and gait training as well as fall prevention.


Eligibility Criteria:
Inclusion Criteria:

* (1) female aged 65 years and over; (2) able to walk more than 20 m without walking aids; (3) had a Montreal Cognitive Assessment (MoCA) score lower than 26 ; (4) had self-reported memory complaints; and (5) had the ability to perform ADLs.

Exclusion Criteria:

* (1) dementia; (2) a history of malignant tumors ; (3) the presence of an unstable neurological or orthopedic disease, or visual problems interfering with participation in the study; and (4) an education level less than 6 years (elementary school).
Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes

Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c \>9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-17 years
* Diagnosis of type 1 diabetes for at least 12 months
* Uncontrolled diabetes with A1c at least 9.0%
* Parent or guardian agrees for adolescent to participate

Exclusion Criteria:

* Diagnosed cognitive disabilities
* Other uncontrolled chronic diseases as assessed by PI
* Inability to attend visits due to individual schedules
Assessing Functional Status Needs Via PRO Measures for Pts With Metastatic Breast Cancer

The purpose of this single-site non-randomized study is to identify areas of need related to functional status and overall health, including nutrition and mental health in subjects with metastatic breast cancer (MBC). A decline in functional status is observed after breast cancer diagnosis and exacerbated by treatment. Declining functional status impacts the quality of life and can lead to increased comorbidity burden, hospitalization, and increased mortality. Functional status is assessed by specific provider-graded scales. Patient Reported Outcome (PRO) measures may better assess certain aspects of patient health and symptom domains. Thus, potentially supporting the future implementation of effective prehabilitation strategies. This study explores whether a PRO-based survey will identify the physical and emotional health and the social and financial status of patients newly diagnosed with MBC.


Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent was obtained from participants in the study and HIPAA authorization for release of personal health information.
2. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
3. Age ≥ 18 years at the time of consent.
4. Recent diagnosis of new metastatic breast cancer at time of screening.

Exclusion Criteria:

1. Exclusion Criteria
2. Inability to read or speak English.
3. Dementia, altered mental status, or any psychiatric condition as determined by clinical or study team that would prohibit the understanding or rendering of informed consent.
4. Current incarceration.
5. Subject has already received treatment for metastatic breast cancer prior to screening.
Empagliflozin and Renal Oxygenation in Healthy Volunteers

SGLT-2 inhibitors belong to a new class of hypoglycemic drugs with the unique property of decreasing blood glucose through an increase in glucosuria. These drugs inhibit the sodium glucose transporter 2 (SGLT2) expressed at the luminal membrane of the proximal tubule.

SGLT-2 inhibition in type 2 diabetic subjects and in healthy volunteers shifts the threshold for renal glucose excretion to lower levels. This effect is independent from insulin. The inhibition of SGLT2 decreases HbA1C, systolic blood pressure and weight in diabetic subjects. Recently, the EMPA-REG trial demonstrated a decrease in cardiovascular mortality and renal endpoints in empagliflozin treated type 2 diabetic patients with established cardio-vascular disease.

Because this novel hypoglycemic drug has unique and direct effects on renal tissue metabolism, it is important to better examine its effects on the kidney. With this study, we propose to explore the effects of empagliflozin on renal tissue oxygenation. Our hypothesis is that SGLT-2 inhibition decreases renal cortical energy requirements with consequently an increase in renal tissue oxygenation.

This study is a double-blind, randomized, placebo-controlled study that will examine the acute and chronic renal effects of empagliflozin in healthy volunteers.

A total of 45 healthy volunteers will be included in the study: 15 normal weight, 15 overweight (BMI: 25-30kg/m2) and 15 obese (BMI\>30kg/m2) non diabetic subjects (as determined after an oral glucose tolerance test).

Empagliflozin 10mg vs placebo will be administered in a blinded fashion qd. The acute and chronic renal response to empagliflozin will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Normal weight (BMI: 19-24.9kg/m2), overweight (BMI:25-30kg/m2) or obesity (BMI\>30kg/m2)
* Men and women (with a negative pregnancy test) during the follicular phase of the menstrual cycle. All groups will have a balanced number of men and women.
* OGTT/HbA1C: normal or pre-diabetes
* eGFR\>60ml/min, albumin/creatinine ratio \<3.3mg/mmol (\<30 mg/g)
* Signed consent form
* Normal renal ultrasound
* Normal urine dipstick

Exclusion Criteria:

* Antihypertensive therapy
* NSAID treatment
* Former bariatric surgery
* Age\<18y or \>50y
* At risk of dehydration or hypotension
* Past history of recurrent genital or urinary tract infections
* Contra-indication for MR imaging (pacemaker or other implanted metallic device, claustrophobia)
* Pregnancy
* Sustained systolic blood pressure \>150mmHg or diastolic blood pressure \>95mmHg
Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents

The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of MDS by bone marrow biopsy based on the World Health Organization (WHO) classification - Low, Intermediate-1 or Intermediate-2 risk category MDS using the IPSS (International Prognostic Scoring System) - Planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles Exclusion Criteria:

* Prior exposure to \>3 cycles hypomethylating agents
* Prior history of leukemia or aplastic anemia
* Prior history of bone marrow transplantation
* Prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization
* Active or uncontrolled infections
* Unstable angina, congestive heart failure \[NYHA (New York Heart Association) \> class II\], uncontrolled hypertension \[diastolic \> 100 mmHg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
* History of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year
* History of venous thrombosis that currently requires anti-coagulation therapy
* Received IL-11 within 4 weeks of screening
* Less than 4 weeks since receipt of any therapeutic drug or device that is not FDA approved for any indication
* Have previously received any other thrombopoietic growth factor
Abdominal Wall Local Anesthesia to Maximize Postoperative Pain Control After Cesarean Delivery

This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Non-emergent CD with planned spinal anesthesia
* American Society of Anesthesia physical status class I \& II
* Age ≥ 18 years
* Term gestational age (≥ 37 weeks)
* English-speaking

Exclusion Criteria:

* Morbid Obesity (BMI³ 45 kg/m2)
* Laboring women
* Emergency CD
* Severe maternal cardiac disease
* Subjects with significant obstetric co-morbidities
* Failed spinal anesthesia
* Patient enrollment in another study involving medication within 30 days of CD
* Any other condition which may impair ability to cooperate with data collection
* Height less than 152 cm (5'0")
* Fetal anomalies or intrauterine fetal death