cyrilzakka/clinical-trials huggingface dataset:
Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）

The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed.

hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with nonunion of limbs by x-ray and bone scan;
* compliance to treatment and long term follow-up;
* be able and willing to participate in the study;
* written informed consent before study.

Exclusion Criteria:

* pregnant or breastfeeding;
* patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
* patients undergoing any other treatment that are not related to this study;
* others considered not appropriate selected patients.
Building Resilience and Attachment in Vulnerable Adolescents

Suicide is the second leading cause of mortality for Canadian adolescents. Mental health complaints are one of the leading reasons for an emergency department visit at the Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the present investigation is to test the efficacy of a brief group intervention for adolescents with passive suicidal ideation and their caregivers that will focus on coping, familial support, and emotional regulation. The investigators hypothesize that a brief group intervention, delivered in the weeks following presentation for crisis services, will reduce suicidal ideation and improve coping and familial support.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate suicidal ideation
* Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care)
* One or two caregiver(s) committed to attending the majority of sessions

Exclusion Criteria:

* Presence of a suicidal plan and/or recent gesture/attempt
* Psychosis
* Schizophrenia
* Dual diagnosis
* Developmental disability or delay
* "Behavioural problem" as primary concern
* Major substance abuse
* Currently receiving mental health services (once every two weeks or more frequently)
* Inability to commit to majority of sessions (minimum 4 of 6 sessions)
* Children's aid society involvement
* Inability of at least one caregiver to commit to attending the majority of sessions
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B

The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB) patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 to 65 years of age.
* Signed informed consent.
* Diagnosis of CHB and candidates for therapy
* Normal renal function
* Women of childbearing potential must have a serum negative pregnancy test at screening. Women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception.

Exclusion Criteria:

* Liver disease other than CHB
* Documented co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), or HIV
* Previous therapy with interferon alpha.
* Any other antiviral therapy for chronic hepatitis B within the previous 3 months prior to Screening Visit.
* Immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of Screening Visit.
* Evidence of cirrhosis
* Child-Turcotte-Pugh (CTP) score ≥ 7, either currently or at any occasion in the past
* Clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history.
* Malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix.
* Participation in any experimental protocol or therapy within 28 days prior to the Screening Visit.
* Current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.
Safety Awareness For Empowerment (SAFE): An RCT With Young People Experiencing Homelessness

The SAFE study examines the effects of brief mindfulness-based cognitive-behavioral intervention aimed at improving risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking) in order to reduce substance use and victimization among young people (ages 18-21) experiencing homelessness.

Youth (ages 18-21) living at a local youth shelter will be recruited and randomly assigned to receive the SAFE intervention (plus usual case management) or to receive usual case management only. Those assigned to SAFE will receive 12 mindfulness-based, cognitive-behavioral modules through a 3-day intensive group intervention provided by an agency intern and a hired project staff member. The intervention uses mindfulness-based cognitive-behavioral approaches to augment youth attention to risk-related processes, including risk detection, problem solving, assertiveness, and help seeking skills. It is hypothesized the intervention will result in reduced substance use and victimization and that these effects will be explained, at least in part, by improved risk-related attention skills (risk detection, problem solving, assertiveness, and help seeking skills). Post baseline interview, participants will be randomly assigned and will participate in a posttest interview (1 week post baseline) and follow up interviews at 6-weeks, 3-months, and 6-months post baseline interview.

Eligibility Criteria:
Inclusion Criteria:

* Reside at the partnering community based youth shelter

Exclusion Criteria:

As measured by the KSADS (a semi-structured diagnostic interview administered by trained interviewers at baseline):

* presence of psychotic symptoms;
* presence of a life-threatening medical/chronic neurological illness that would prevent participation in a 4-day intervention and/or assessments;
* suicide attempt in last 6 months without current enrollment in therapy or related services to address;
* chronic self-injurious behavior/cutting without current enrollment in therapy or related services to address
* hospitalization or residential treatment for psychiatric reasons in last 6 months without current enrollment in therapy or related services to address.
RSA Masterloc Study Australia

This is a prospective, multicentric study that aim to assess stability of a tapered porous coated stem and a cementless hemispherical acetabular component.

Main Translation and rotation around the x., y-, and z-axis of the femoral and cup component by radiostereometric analysis (RSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years

Aim of this study is to assess stem and cup migration over the time in patient subjected to a total hip arthroplasty. Medical Device Research Australia will perform image analysis services and reporting for model based radiostereometric analysis (RSA) of cementless fixation of the femoral and acetabular cup components. Migration of the components will be measured with model-based RSA (MBRSA) at immediate post op (within 5 days and before weight bearing), 6 months, 1year and 2 years A subgroup of 26 patients will be invited to be evaluated also by additional RSA analysis: the first 13 patients for each investigator who will accept.

The results of this work will establish the mechanical stability of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), provide a general estimate of survivorship, and establish clinical safety and efficacy as measured by RSA and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the hip necessitating primary hip replacement,
* Suitability for straight cementless stem,
* Adult male and female under 70years old,
* Ability to give informed consent,
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

* Post-traumatic deformity in the affected hip,
* Patient suffering by rheumatoid arthritis,
* Patient suffering by congenital or developmental deformity,
* Severe osteoporosis,
* Earlier surgery in the hip to be operated on,
* Perioperative fracture,
* Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
* Patients with a history of active infection
* Pregnant women or those seeking to become pregnant
Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia

This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent reflux symptoms (GERDQ \>8) despite proton-pump inhibitor (PPI) therapy.
* Patients screened positive for chronic insomnia (insomnia severity index \[ISI\] ≥15).

Exclusion Criteria:

* Patients with major esophageal motility disorder, prior foregut surgeries, severe cardiopulmonary diseases, or major psychological comorbidities.
* Patients who report being in "poor" or "very poor" physical or mental health.
* Patients with sleep apnea (based on STOP-BANG questionnaire \>4)
* Patients with AUDIT score \>15, indicating alcohol dependence
* Patients regularly taking medications for sleep \>2 times per week who cannot stop the sleep aid at least 4 weeks prior to and during the study trial.
* Patients who have previously undergone CBT for insomnia (in person or online).
Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo elective LC

Exclusion Criteria:

* Patients undergoing chronic pain treatment
* Previous allergic response to local anesthetics or 5-HT3 receptor antagonists
* Patients who received analgesics or sedatives 24 h before scheduled surgery
Tucidinostat and Nab-paclitaxel in Advanced HR+/HER2- Breast Cancer

This study is looking to see whether the combination of Tucidinostat and nab-paclitaxel is safe and effective in participants with advanced HR+/HER2- breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years, ≤75, female;
2. Histologically confirmed HR positive and HER2 negative postmenopausal metastatic breast cancer patients \[HER2 negative is defined as immunohistochemistry(IHC) 0 or IHC 1+, and if the score of IHC is 2+, fluorescence in situ hybridization technology (FISH) test must be negative, HR positve is defined as ER or PR ≥1%\];
3. Primary endocrine resistance or at least experienced one line of endocrine therapy for recurrent or metastatic disease;
4. No more than 1 prior line of chemothrapy for recurrent or metastatic disease;
5. Patients who have been exposed to taxanes in neoadjuvant or adjuvant setting will be allowed to enroll, if they have obtained benifits from neoadjuvant treatment or have progressed ≥ 12 months from completion of adjuvant treatment;
6. ECOG performance status ≤ 1;
7. At least one measurable disease based on RECIST v1.1
8. Adequate organ function;
9. Life expectancy is more than 3 months;
10. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Prior exposed to histone deacetylase inhibitors, or received taxanes for metastatic disease;
2. Known hypersensitivity to any formulation component of the study drug;
3. Received chemotherapy, targeted therapy, Chinese herbal medicine with anti-tumor indications, or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 4 weeks before enrollment, or still within 5 half-lives of such drugs;
4. Toxicities that did not recover to National Cancer Institute Common Adverse Event Terminology Version 5.0 (NCICTCAEv5.0) grade 0 or 1 toxicity from prior antineoplastic therapy prior to the first dose of study treatment(alopecia, grade 2 fatigue, grade 2 anemia, non-clinically critical and asymptomatic laboratory abnormalities can be enrolled);
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. Pregnant or lactating female.
7. Any other conditions deemed inappropriate by the investigator to participate in this study.
The Role of Periodic Health Examination in Determining Indirect Muscle Injury Risk in Elite Football (Soccer)

Preseason periodic health examination (PHE) is used routinely in elite football (soccer) and can be used to inform injury prevention strategies. Indirect muscle injuries (IMI) are a considerable burden to elite teams. This investigation aims to evaluate whether measurements from PHE can be used in a multivariable model to predict IMI risk in elite players, or to establish prognostic factors that are associated with IMIs.

BACKGROUND Indirect muscle injuries (IMIs) are a considerable burden to elite football (soccer) teams and prevention of these injuries offers many benefits. Preseason medical, musculoskeletal and performance screening (termed periodic health examination (PHE)) is used to help determine players at risk of injuries such as IMIs, where identification of PHE-derived prognostic factors (PF) may inform IMI prevention strategies. Furthermore, using several PFs in combination within a multivariable prognostic model may allow individualised IMI risk estimation and specific targeting of prevention strategies, based upon an individual's PF profile. No such models have been developed in elite football and the current IMI prognostic factor evidence is limited. This study aims to: 1) to develop and internally validate a prognostic model for individualised IMI risk prediction during a season in elite footballers, using the extent of the prognostic evidence and clinical reasoning; 2) explore potential PHE-derived PFs associated with IMI outcomes in elite footballers, using available PHE data from a professional team.

METHODS A retrospective review has been completed of PHE and injury data, routinely collected over 5 years (from 1st July 2013 to 19th May 2018) from a population of elite male players at an English Premier League football club. Of 60 candidate PFs, 15 were excluded. Ten factors will be included in model development, identified from a systematic review, missing data assessment, measurement reliability evaluation and clinical reasoning. A full multivariable logistic regression model will be fitted, to ensure adjustment before backward elimination. The performance and internal validation of the model will be assessed. The remaining 35 candidate PFs are eligible for further exploration, using univariable logistic regression to obtain unadjusted risk estimates. Exploratory PFs will be grouped according to type and incorporated into multivariable logistic regression models to determine risk estimates.

DISCUSSION This study will offer insights into clinical usefulness of a model to predict IMI risk in elite football and highlight the practicalities of model development in this setting. Exploration may identify other relevant PFs for future confirmatory studies, model updating, or influence future injury prevention research.

Eligibility Criteria:
Inclusion Criteria:

* had an outfield position (i.e. not a goalkeeper);
* participated in PHE testing for the relevant season.

Exclusion Criteria:

- if players were on trial or not contracted to the club at the time of PHE.
Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
* Intact uterus

Exclusion Criteria:

* Known or suspected breast carcinoma or estrogen-dependent neoplasm
* Undiagnosed abnormal genital bleeding
Different Levels of Patient Education for Care of Ostomy Site

This is a randomized study of standard versus extra ostomy education.

The purpose of this study is to evaluate the effectiveness of pre-operative and post-operative ostomy education compared to standard of care ostomy education.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years of age at the time of consent.
* Scheduled to undergo surgery at IU Health North Hospital that will results in a temporary or permanent colostomy or ileostomy for a benign or malignant disease process.
* Are willing and able to provide written informed consent for participation in the study and authorization for release of health information.
* Are willing and able to attend up to two additional clinic visits at IU Health North Hospital for the purpose of ostomy teaching and care.
* Subjects who currently do NOT have a urostomy or any other type of urinary diversion and/or are NOT planning to have a urostomy or any other type of urinary diversion as part of the surgery procedures at the time of their surgery for placement of colostomy or ileostomy.
* Subjects who do NOT have any history of prior colostomy or ileostomy.

Exclusion Criteria:

* Subjects not meeting any of the above eligibility criteria.
REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy

The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.
Development of Low Cost Devices to Increase Access to Treadmill Training

The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.

The investigators will develop and assess the use of spring-loaded devices to assist limb swing and forward propulsion during body weight supported treadmill training (BWSTT) (Aim 1). Prototype models of both devices have been developed.

These devices will be:

1. simple to use in the clinical setting;
2. will be easily adjustable to alter the assistance provided; and,
3. will be able to quantify the amount of assistance necessary to facilitate normal stepping patterns.

The investigators will also evaluate short- and long-term adaptations in locomotor performance following BWSTT in individuals with incomplete SCI with the use of these devices. This information will identify the effects of variable assistance at the limbs or trunk to modulate muscle activity and/or motor performance (kinematics) during stepping to maximize walking recovery.

Eligibility Criteria:
Inclusion Criteria:

* non-progressive lesion between spinal levels C1-T10 of \> 3 months duration. Subjects with below T10 will be excluded due to potential lower motor neuron (LMN) injury
* score \> 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in SCI. For the LEMS criteria, preliminary data indicate that subjects with LEMS \< 10 in the chronic stages do not recover walking
* All subjects must require physical assistance to ambulate on the treadmill at a speed of 4.0 kmph at 0% body weight support (BWS)
* All subjects will have an overground gait speed \<.8m/s
* range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait
* medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury)
* able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population)
* women of childbearing potential

Exclusion Criteria:

* women who are pregnant will be excluded due to potential forces at trunk from BWS or pelvic assistance
* those in concurrent physical therapy to eliminate effects of additional interventions