cyrilzakka/clinical-trials huggingface dataset:
Effects of Sleep Hygiene Education on Sleep Health in Adults Ages 50-80

This will be a study looking at trying to change older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.

Older adults ages 50-80 will be recruited and placed into one of three groups. Group One will watch a one-time educational video on sleep hygiene, Group Two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video, and Group Three will be a control group with no intervention. The participants in Groups One and Two will receive the education after two weeks of data tracking on a Fitbit device. They then will have four additional weeks of tracking. At the end of the study time of six weeks, all participants will return for follow-up testing. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep.

Eligibility Criteria:
Inclusion Criteria:

* own a smartphone with the capability of receiving text messages.

Exclusion Criteria:

* an untreated diagnosed sleep disorder such as insomnia or obstructive sleep apnea
* inability to wear the device on their wrist
Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic.

This Phase II project is a collaboration among: 1) APDM, an innovative small business that has successfully commercialized several innovative products to quantify human movement; 2) the Balance Disorders Laboratory in the department of Neurology at Oregon Health \& Science University (OHSU); and 3) NorthWest Rehabilitation Associates (NWRA), a nationally-recognized outpatient rehabilitation center that will test the effectiveness of Mobility Rehab for adults with mobility disturbances.

The objective of this Phase II application is to prepare the Mobility Rehab system for commercialization and demonstrate its efficacy for mobility training. Our hypothesis is that feedback-based rehabilitation will be more effective than standard rehabilitation for gait in older adults with gait disturbances. In this Phase II, we will use a pragmatic clinical trial to evaluate the effectiveness of Mobility Rehab on 300 patients with various types of gait disturbances in a physical therapy clinic. In addition to visual feedback, the system will be optimized in Phase II to also provide verbal feedback commands for patients during training.

Eligibility Criteria:
Inclusion Criteria:

* 60-89 years old
* gait disturbances requiring physical therapy

Exclusion Criteria:

* unable to follow instructions (up to the practitioner's judgement)
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer

This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without docetaxel) or atezolizumab and trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC), and atezolizumab with doxorubicin and cyclophosphamide in HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented HER2-positive and HER2-negative (cohort E only) breast cancer
* Metastatic breast cancer that is measurable (Stage 1) or early breast cancer with a primary tumor size greater than (\>) 2 centimeter (cm) (Stage 2)
* Eastern cooperative oncology group (ECOG) performed status of 0, 1 or 2; 0 or 1 (cohort E only)
* Life expectancy of 12 or more weeks
* Adequate hematologic and end-organ function
* Left ventricular ejection fraction greater than or equal to (\>=) 50 percentage (%); \>=55% (cohort E only)

Exclusion Criteria:

* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
* Leptomeningeal disease
* Pregnancy or lactation
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction

This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 55 years with partial or complete anterior cruciate ligament (ACL) rupture, diagnosed clinically and by Magnetic Resonance Imaging (MRI), requiring reconstructive surgery.
* Patients with symptoms of acute or subacute ACL rupture (such as inflammation of the knee and pain with leg movement) or chronic ACL tear, including instability of the knee.
* Patients with ACL ruptures without osteochondral lesions requiring additional surgery.
* Patients with a medical history of therapeutic benefit using analgesic agents.

Exclusion Criteria:

* Patients with concomitant osteochondral pathology.
* Patients treated with intra-articular injections of corticosteroids and/or platelet-rich plasma, or with oral glucosamine, CS, HA or CH in the two months prior to surgery.
* Patients with systemic diseases, those treated with antibiotics or other drugs that might alter the healing process, and those who had undergone arthroscopic lavage in the 90 days prior to surgery.
Early Surgical Effects and Influencing Factors of High Tibial Osteotomy in the Treatment of Knee Osteoarthritis

Exploring the factors influencing postoperative functional recovery after high tibial osteotomy

A retrospective study was conducted on patients who underwent HTO at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, and the preoperative and postoperative imaging indicators \[medial proximal tibial angle (MPTA), joint line intersection angle (JLCA), hip-knee-ankle angle (HKA angle), knee weight-bearing line percentage (WBL%), postoperative distraction distance, postoperative distraction angle\] and knee joint function score \[including the American Hospital for Special Surgery (HSS) knee score, American Knee Society score (KSS), Lysholm score, Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC), and all were included in logistic regression analysis to study the surgical effect and impact of HTO factor

Eligibility Criteria:
Inclusion Criteria:

* Medial knee OA, varus deformity is mainly in the tibia
* Aged ≤70 years old, with higher requirements for future activities
* Knee joint extension is limited to ≤10°, and flexion is \>90°
* Body Mass Index (BMI) ≤ 40
* No subchondral bone wear

Exclusion Criteria:

* There is a history of fracture or surgery of the lower limb on the operated side
* Traumatic KOA
* Combined with nerve, muscle or connective tissue diseases
* Incomplete imaging data and loss of follow-up
The Effect of Simulation on Cardiac Auscultation Competence

This randomized controlled study aims to determine the effect of simulation on the cardiac auscultation competence of nursing students. The main questions it aims to answer are:

* Simulation is effective in developing the cardiac auscultation competence of nursing students.
* The psychoacoustic approach is effective in developing the cardiac auscultation competence of nursing students.

One week after the 2-hour theoretical lecture, all three groups will be taken simultaneously to a 3-hour laboratory practice for cardiac auscultation. An instructor will lead each group to ensure coordination. The psychoacoustic approach group will listen to normal heart sounds (S1, S2), abnormal heart sounds (S3, S4) and murmur sounds from the audio file uploaded to their mobile phones in the laboratory environment through headphones for 500 repetitions each. The simulation group will practice auscultation of heart sounds in a one-to-one and repetitive manner, working with a high reality simulator. Trainers will act as facilitators during the cardiac auscultation practice of the students in the intervention groups. The control group will continue with the standard education.


Eligibility Criteria:
Inclusion Criteria:

- First-time registration in the course.

Exclusion Criteria:

* Non-native speakers of the country's native language.
* Previous graduation from any health-related university.
Liposomal Bupivacaine (Exparel) in Sarcomas

The purpose of this research is to study a medication called liposomal bupivacaine (EXPAREL®). Study doctors want to see if it is safe, if it can reduce pain after surgery, and the study doctor want to study its use after the removal a soft tissue tumor called a sarcoma

The hypothesis for this project is that using liposomal bupivacaine will reduce patients' morphine equivalent usage postoperatively while maintaining similar pain scores and lengths of stay when compared to patients that did not receive intraoperative liposomal bupivacaine. Thus, if the use of liposomal bupivacaine proves to aid in pain control and the reduction of initial opiate use following soft tissue sarcoma resection, it could be reasonably suggested that liposomal bupivacaine become incorporated into a multimodal form of pain management following soft tissue sarcoma resection. These results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects while decreasing health care expenditures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a soft tissue sarcoma of the thigh
* Must have sufficient health to withstand the physical demands of surgery
* ≥ 18 years old
* ECOG performance status of ≤ 2
* Ability to understand and the willingness to sign an IRB-approved informed consent document

Exclusion Criteria:

* History of clinically significant medical conditions including: Cardiovascular: Atrial Fibrillation, Ventricular Fibrillation, Significant Coronary Artery Disease. Hepatic: Viral or Autoimmune Hepatitis, Cirrhosis of the Liver, Liver Metabolism Disorders. Renal: Any form of renal impairment. EXPAREL® is cleared by the kidneys, thus any form of renal impairment could lead to an adverse reaction.
* Medical condition(s) or concurrent surgery that may have required analgesic treatment in the postoperative period for pain that was not strictly related to the study surgery.
* Any clinically significant event or condition discovered during surgery that may have complicated the patient's post surgical course such as vascular or nerve involvement that was unknown before surgery.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal bupivacaine.
* Pregnant women are excluded from this study because EXPAREL has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EXPAREL, breastfeeding should be discontinued if the mother is treated with EXPAREL.
A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo

Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in healthy female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult female subjects
* 18-55 years of age (inclusive)
* BMI must be between 18.5 and 27 kg/m2 (inclusive)

Exclusion Criteria:
Buteyko Method for Children With Asthma

This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.

Children from 7 to 12 years old with asthma diagnose will be included. Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. The investigators will assess quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen peripheral saturation will also be assessed during the tests. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage .

Eligibility Criteria:
Inclusion Criteria:

* Children from 7 up to 12 years old with asthma diagnose;
* Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
* Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.

Exclusion Criteria:

* Children that are not able to perform some of the necessary procedures;
* Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.

To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes.

A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without isthmocele will be included in the control group and 30 patients affected with isthmocele in the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be obtained simultaneously the day of egg retrieval. Patients will follow a protocol for all-freezing embryos or oocytes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with isthmocele:

   * Patients performing IVF treatment with a planned cycle segmentation and consecutive frozen embryo transfer on a hormone replacement therapy (HRT) cycle or natural cycle.
   * Age between 18 - 45 years all (both inclusive).
   * One or multiple C-sections.
   * Isthmocele present during TV scan.
   * BMI: 18,5 - 35 kg / m2 (both inclusive).
2. Patients without isthmocele:

   * Patients performing IVF treatment with planned cycle segmentation and who would have embryo transfer with frozen embryos under hormone replacement therapy.
   * NO Isthmocele present during transvaginal ultrasound.
   * BMI: 18,5 - 30 kg / m2 (both inclusive).

Exclusion Criteria:

* Age \< 18 and \> 45 years old.
* Previous or active endometritis.
* Patients who are IUD carriers for the last 3 months.
* Patients who have taken prescribed antibiotics in the last 3 months previous to sample collection.
Social Activity, Loneliness and Stigma During COVID-19 Outbreak

The overall goal of this study is to evaluate the association of quarantine measures for COVID-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak.

Specific Aims:

In the proposed study, participants will include members of the United States general population who will be randomly assigned to either (a) a vignette to learn about the COVID-19 outbreak, (b) a vignette to learn about the COVID-19 outbreak AND a video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends, (c) a vignette to learn about the COVID-19 outbreak AND a video aimed at sensitizing participants to COVID-19 related stigma, (d) Control arm. Web-based self-report questionnaires will be conducted to compare interventions and control groups. The short and low-cost online module will allow recruitment of a large sample of people.

Hypotheses:

(1) the video-based intervention groups will demonstrate lower rates of anxiety and loneliness than vignette and control groups, (2) the video-based group that presents an individual with COVID-19 will demonstrate lower rate of stigma than other groups.

Currently, the world is experiencing a Coronavirus outbreak, COVID-19, which originated in mainland China in December 2019, spread rapidly to South Korea and Europe, Italy in particular, between January and March of 2020 and is currently spreading in all continents and has been recognized as a pandemic. It is of high importance to monitor how the trends in COVID-19 outbreak are shaping the social contexts and norms across communities and families. In a time in which individuals all over the world are experiencing quarantine, it is important to evaluate the potential surge of the phenomena of social anxiety, stigma, and of perceived fear and loneliness. Furthermore, it is critical to study interventions that aim to reduce each of these. The overall goal of this study is to evaluate the association of quarantine measures for COVID-19 and perceived anxiety, stigma and loneliness and to evaluate the efficacy of interventions in reducing anxiety, loneliness and perception of stigma induced by self-isolation during the outbreak. The hypotheses will be tested using ANOVA and multinomial logistic regressions. An alpha level of 0.01 will be used to account for multiple testing.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Younger than 70 years old
* United States resident

Exclusion Criteria:

* Less than 18 years old
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Male \& female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
* PANSS score \>= 80, inclusive, at screening and baseline

Exclusion Criteria:

* Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
* Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders
* Subjects who have been hospitalized \> 21 days for a current exacerbation of schizophrenia at the time of baseline.
* Any neurological disorder other than Tourette's Syndrome
* Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
* Subjects with epilepsy, a history of seizures, severe head trauma or stroke
* Subjects who test positive for drugs of abuse at screening
Microsurgical Breast Reconstruction & VTE

Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common cause of preventable in-hospital death as evidenced by over 100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial, with annual costs to the U.S. healthcare system in excess of $7 billion.

Cancer patients have been identified as a particularly vulnerable patient population. Of these, breast cancer patients represent the largest group treated by plastic surgeons. An increasing number of breast reconstructions are performed in the U.S. with a documented 35% increase in the annual number of breast reconstructions since 2000. Over 106,000 breast reconstructions were performed in 2015 alone.

Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is associated with the highest risk for VTE. We believe that a key element rendering these patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is supported by the observation that VTE risk remains elevated for up to 12 weeks postoperatively. We hypothesize that lower extremity deep venous system stasis is a procedure-specific key contributing factor to postoperative VTE risk.

This study examines the duration of postoperative lower extremity venous stasis to identify patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging technology to examine the lower extremity deep venous system preoperatively, on postoperative day 1, and on the day of discharge to determine if patients display radiographic evidence of lower extremity venous stasis at the time of hospital discharge.

A better understanding of pathophysiologic mechanisms that contribute to the development of VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE prophylaxis, thus, favorably impacting clinical outcome in a large patient population.


Eligibility Criteria:
Inclusion Criteria:

* see study population description

Exclusion Criteria:

* Superficial inferior epigastric artery flaps
* Donor-sites other than the abdomen
* Chronic obstructive pulmonary disease (COPD)
* Liver disease.
Clinical Study of Glycosylated Extracellular Vesicles for Early Diagnosis of Breast Cancer

This is a prospective, single-center, non-randomized, cohort study designed to evaluate the clinical diagnostic performance of glycosylated extracellular vesicles and their contents for early detection of breast cancer.

Early screening technology can improve the survival rate of breast cancer patients. Traditional mammography and ultrasonography have limitations on performance in clinical practice. Extracellular vesicles, one of the three major resources of liquid biopsy, contain multi-omics information that can be used to discover effective biomarkers for early diagnosis and screening of cancers.

In this study, we are going to isolate glycosylated extracellular vesicles from serum of cancer patients and non-cancer people with the novel GlyExo-Capture technology, and perform miRNA sequencing to selected out breast cancer-related markers. Then an early diagnosis model of breast cancer based on the GlyExo-Capture platform is able to be established using machine learning techniques and validated by qPCR experiments.

Eligibility Criteria:
Inclusion Criteria:

1. Patients≥18 years old；
2. Histologically confirmed breast cancer patients，Benign breast disease （ig. breast fibroma, intraductal papilloma,mammary hyperplasia, breast cyst）or No breast lesions detected by clinical examination/mammography/ultrasound/breast magnetic resonance imaging (MRI)
3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments.
4. Subjects signed informed consent；

Exclusion Criteria:

1. A history of prior or concomitant malignancies;
2. advanced stage breast cancer (stage IV)；
3. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
4. Pregnant or lactating women ；
5. Suspected or confirmed lesion was surgically removed；
6. Patients with incomplete clinical data；
7. Patients with poor compliance；
8. Patients with severe mental illness；
9. Patients had received blood transfusions during one month一；