cyrilzakka/clinical-trials huggingface dataset:
Benefit of Surgical Hardware Removal Following Clavicle Fracture

Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.

Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.

Patients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ).

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* Radiologically consolidated clavicle fracture
* following ORIF using a superior anatomically preformed locking plate
* asking for elective implant removal
* written informed consent.

Exclusion Criteria:

* Pregnancy
* Under-aged
* Delinquent patients.
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth

The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be compared to a dog walking control group matched for educational content and dog contact time. The investigators expect that the AAI will result in improved empathy skills and that dog attachment will explain these findings. The investigators also explore the extent to which the AAI will improve internalizing and externalizing symptoms in these adolescents.

Adjudicated adolescents (i.e., teens who have committed criminal offenses and are incarcerated in juvenile detention centers) have deficits in emotion regulation, including empathy skills, and are at risk for a host of poor outcomes including repeat offenses, internalizing symptoms (e.g., depression, anxiety), externalizing symptoms (e.g., lying, truancy, fighting). Many of these problems stem from a lack of secure attachment to parents and peers. There is a need for novel and innovative programs to help these teens develop more secure attachments and better empathy skills to prevent poor outcomes. One type of intervention is animal-assisted interventions such as dog training programs. These programs appear to build empathy skills in at-risk youth, which may translate into better peer relations, less psychological distress, and less recidivism. The goal of this study is to test an existing animal-assisted intervention program that is already being used in juvenile detention centers to determine whether it is efficacious in improving adjudicated adolescents' empathy skills and psychological symptoms through building a secure attachment to the training dog.

Eligibility Criteria:
Inclusion Criteria:

* must be a resident of participating juvenile justice center in Michigan

Exclusion Criteria:

* none
Oxidative Status in Children With Autoimmune Thyroiditis

Oxidative status in autoimmune thyroiditis was not investigated previously in children and adolescents. We investigated oxidant and antioxidant systems in a cohort of Egyptian children and adolescents with AIT to explore their relation with biomarkers of autoimmunity and thyroid function.

Methods: A case control study included 32 children with autoimmune thyroiditis and 32 healthy subjects with matching age and sex were included as a control group. Thorough history, examination, thyroid ultrasound, measurement of thyroid-stimulating hormone (TSH) and free thyroxine (FT4), as well as anti-thyroid peroxidase antibodies (TPOAb) and anti-thyroglobulin antibody (TgAb) were done in addition to assessment of malondialdehyde (MDA) and total antioxidant capacity (TAC) levels as an oxidative stress markers. Results: Overt hypothyroidism was detected in 23/32 while subclinical hypothyroidism was detected in 9/32 of the studied patients. Malondialdehyde levels were significantly elevated while total antioxidant capacity levels were significantly decreased in autoimmune thyroiditis patients compared with healthy controls. The difference was more evident in patients with overt hypothyroidism than those with subclinical hypothyroidism. We also observed a significant positive correlation between anti-thyroid peroxidase antibodies levels and age, TSH, malondialdehyde, thyroid volume and a negative correlation with total antioxidant capacity and thyroxine .

Conclusions: The high serum malondialdehyde and lower total antioxidant capacity levels in patients with autoimmune thyroiditis and the correlation of thyroid antibodies with biomarkers of oxidative stress may reflect the role of autoimmunity in the development of oxidative stress. Future studies are needed for evaluation of the antioxidant therapy for autoimmune thyroiditis patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AIT.
* Age \>6 years \<18 years.
* Iodine sufficient region.

Exclusion Criteria:

* Children on antioxidants or antithyroid drugs
* Cardiac, renal and hepatic disease.
* Children with other autoimmune and collagen diseases
Prevention of Post Traumatic Stress Disorder by Early Treatment

To prospectively evaluate the effect of early treatment (cognitive therapy (CT), cognitive-behavioral therapy (CBT) and escitalopram (SSRI) in preventing the occurrence of post-traumatic stress disorder in recent survivors of traumatic events.

Consecutive civilian trauma survivors will be contacted, by phone, within five days of admission to Hadassah University Hospital in Jerusalem and asked about their early psychological responses to the event. A short telephone interview will be administered to consenting subjects, to evaluate the presence of acute stress disorder (ASD). Subjects with ASD (full or partial) and those who so desire will be invited to clinical assessment, which will take place within the next two weeks. Survivors with significant symptoms of post-traumatic stress disorder will be randomized to five arms of twelve-week long treatment: CBT, CT, SSRI/placebo and waiting list (WL) and start treatment immediately. Subjects will be allowed to decline one form of therapy. WL subjects will start therapy 12 weeks later. All subjects who had clinical interview will be interviewed again at four and seven months - and 14 months following trauma (phone interview).

Eligibility Criteria:
Inclusion Criteria:

* Adults survivors of traumatic events

Exclusion Criteria:

* Traumatic brain injury
* Lifetime psychosis
* Life time (prior) PTSD
* Medical conditions forbidding SSRIs
PillSense System for Detecting UGI Bleed

This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Patient eligibility as set out in the inclusion/exclusion criteria for the clinical investigation will be reviewed prior to study enrollment. Prior to administering the PillSense Capsule, the PillSense Receiver will be paired with the PillSense Capsule. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No Blood detected". The overall investigation from the PillSense Capsule activation and ingestion until the result message is displayed takes less than 10 minutes. Esophagogastroduodenoscopy (EGD) should be completed immediately or up to 4 hours after PillSense Capsule administration in each patient that receives a "Blood detected" or "No blood detected" result to confirm the result achieved with the PillSense System. The endoscopy will be conducted according to the site's standard of care. Prior to discharge each patient will undergo an X-Ray examination to evaluate for PillSense Capsule presence. Following discharge, if there is no verifiable evidence that the PillSense Capsule passed through the gastrointestinal tract (GIT) (such as a photograph of stool with capsule in it or photograph of the capsule alone), the patient may undergo an X-Ray examination at Day 7 ± 5 days and, if necessary, at Day 14± 7 days to ascertain the passage status of the PillSense Capsule. If the PillSense Capsule did not pass through the GIT, it should be removed by an endoscopic method.

Eligibility Criteria:
Inclusion Criteria

* Age \>=18 years
* Ability to provide informed consent
* Clinical suspicion of UGIB

Exclusion Criteria:

* Circulatory or hemodynamic instability
* Known GI tract stricture
* Using an implantable electrical device
* Difficulties in swallowing pills the size of the capsule
* History of: achalasia or known esophageal dysmotility; gastroparesis; severe constipation; Crohn's disease; bowel obstruction
* Currently taking medications intended for stimulation of GI motility
* Currently pregnant or breastfeeding, or intend to become pregnant during the investigation
* Suspected or previously diagnosed obstructing gastrointestinal tumor
Biomarkers in Perioperative Management

Rationale: The rate of postoperative complications after high-risk surgery remains high despite recent advances in perioperative management. There is a lack of objective and reliable information that can be used for risk stratification and to guide treatment decisions.

Objective: To describe the perioperative biomarker response in surgical patients with and without a postoperative complication and construct a preoperative and postoperative prediction model for postoperative complications. To systematically collect perioperative blood samples and clinical data in high-risk surgical patients for the development en analysis of biomarkers.

Study design: Multicenter, prospective, observational study. Study population: 4819 patients undergoing elective cardiac, colorectal, vascular and lung surgery.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: Main study parameters are levels of PCT, CRPhs, IL-6, GDF-15, sFLT, NT-proBNP, cTNThs, CysC and NGAL. Main study endpoint is the occurrence of a major postoperative complication which is defined as a surgical site infection, pneumonia, sepsis, acute kidney injury, major adverse cardiovascular events or death within 30 days of surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In each patient five blood samples will be drawn for analysis. Most of the blood samples are drawn simultaneously with routine perioperative laboratory testing, which is common in this study population. In case a patient is admitted to the Intensive Care Unit blood samples will be collected using an arterial line. There are no direct risks or benefits for patients included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac surgery (isolated coronary artery bypass grafting or combined with single valve surgery, isolated single valve surgery)
* Gastrointestinal surgery (colorectal, pancreatic, gastric surgery).
* Vascular surgery (open and endovascular aortic surgery, peripheral vascular surgery)
* Lung surgery (pneumonectomy,(bi)(sleeve)lobectomy or segmentectomy)

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Emergent surgery
* No informed consent
Impact of Rapid ART Initiation on Retention in Care in the Southern US

Impact of Rapid ART Initiation on Retention in Care in the Southern US

Specific Goals and Aims:

The major goal for this study is to determine if rapid start of antiretroviral (ART) therapy increases retention in HIV medical care. The investigators hypothesize that there will be an increase in retention in care with rapid start, by removing barriers that would normally delay enrollment in a treatment program and enforce the importance of linkage to care and ART initiation from diagnosis.

In order to test this hypothesis, the investigators have the following specific aims for their proposed study:

1. Study retention in care after rapid ART start in comparison to standard of care.
2. Analyze risk factors for decreased retention in care, with focus on high-risk populations.
3. Analyze potential demographic and geographic determinants of retention in care.
4. Generate retention in care data in a Southern US state.

The investigators hypothesize the introduction of rapid start ART, as well as the introduction of care navigators, will lead to improved clinical outcomes, including retention in care at one year, viral suppression at one year, time to viral suppression, and time to first missed appointment. In the event rapid start ART fails to have a positive impact on clinical outcomes, the results of this study will still positively contribute to the knowledge gap, since there is a scarcity of data in the Southern United States, specifically in high-risk populations, such as racial and ethnic minorities, youth, and patients co-infected with hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

* Prospective arms: Human subjects ≥18 years old, newly diagnosed with HIV who are establishing care at the 550 Clinic.
* Retrospective arm: Human subjects ≥18 years old, newly diagnosed with HIV who established care at the 550 Clinic and were treated with ART between 2012-2019.

Exclusion Criteria:

* Pregnancy
* Prior HIV diagnosis or exposure to ART
* Medical necessity for therapy with ART agent other than bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), such as drug allergy, drug-drug interactions, creatinine clearance \<30.
MultIceNtre Non-intERVentional Study for Efficacy,Safety Evaluation of BREZTRI in Pts With COPD in RussiA

This is a retrospective-prospective, non-interventional, multi-centre study that will be conducted in routine clinical settings in Russia. Eligible patients with moderate to severe COPD routinely treated with BREZTRI will be observed according to routine clinical practice for up to 24 weeks.

Chronic obstructive pulmonary disease (COPD) is a disease characterized by persistent airflow limitation that is usually progresses and is a consequence of a chronic inflammatory response of the respiratory pathways and lung tissue to the effects of inhaled harmful particles or gases. Exacerbations and comorbid conditions are an integral part of the disease and contribute significantly to the clinical picture and prognosis \[1\].

Patient-reported outcomes (both symptom-based and health-related quality of life-specific) are essential to evaluate symptoms, impact of symptoms on activities of daily living, and treatment response in COPD patients \[12\].

There is a need to evaluate the patient-reported outcomes during a triple therapy with budesonide + glycopyrronium bromide + formoterol (Breztri) in a real-life clinical practice. The aim of the study is to evaluate clinical and patient-reported outcomes of treatment with BREZTRI through effectiveness measures assessed pre- and post-treatment initiation and safety monitoring. The study results will be interpreted in the context of an open label, single arm study design where multiple factors, in addition to the new treatment, may contribute to the treatment effect.

Eligibility Criteria:
Inclusion Criteria:

1. Physician-diagnosed COPD no less than 12 months before BREZTRI treatment start;
2. Patients who have not achieved adequate disease control when treated with a combination of ICS and LABA or a combination of LABA and LAMA
3. Initiated treatment with BREZTRI ≤12 weeks before inclusion as prescribed according to the label;
4. CAT score not more than 1 week before BREZTRI start is available;
5. Patients must be able and willing to read, comprehend and follow written instructions, and to comprehend and complete the questionnaires required by the protocol
6. Have signed a written Informed Consent Form (ICF).

Exclusion Criteria:

1. Documented COPD due to α-1 antitrypsin deficiency;
2. Previous treatment with triple fixed-dose combination in 12 months prior to inclusion;
3. Pregnancy or lactation period;
4. Concomitant uncontrolled disease;
5. A diagnosis of bronchiectasis, sarcoidosis, interstitial lung disease, or idiopathic pulmonary fibrosis;
6. Participation in other non-interventional observational trials that might, in the investigator's opinion, influence the assessment for the current study, or participation in any observational or clinical trial in the last 30 days prior to inclusion.
A Longitudinal Study to Investigate and Develop a Patient-centered and Effective Fatigue Screening

MERLIN will include 300 cancer patients at the beginning of their systemic cancer therapy. Patients' fatigue-levels will be surveyed at short time intervals during their cancer therapy and at longer intervals during the subsequent post-treatment phase.

MERLIN aims to answer the question, how a fatigue screening tool should be designed for use in clinical practice to reliably and efficiently detect fatigue in cancer patients.

Patients will be surveyed at short time intervals during their cancer therapy (every 1-2 weeks) and at longer intervals during the subsequent post-treatment phase (every 4-6 weeks).

In addition, important psychological factors, which may exacerbate fatigue or contribute to its maintenance will be assessed at baseline, after 3, 6, 12 and 18 months (e.g. depressive symptoms, anxiety, sleep disturbances, coping). These data will be collected by online questionnaires.

Additional data, e.g. medical history, cancer characteristics and treatment as well as concomitant medication and complementary therapies will be extracted from the clinical documentation systems.

In total, the study will provide important information for the establishment of a patient-oriented fatigue screening. Thus, MERLIN will contribute to the early detection and alleviation of this frequent and distressing side effect of cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* having received a cancer diagnosis (any entity, any stage)
* before or within the first month of systemic therapy or radiotherapy against this cancer
* age ≥ 18 years
* having the ability to consent to the study

Exclusion Criteria:

* previous systemic cancer therapies or radiotherapy within the last 6 months
* diagnosis of chronic fatigue syndrome / myeloid encephalitis
* unable to understand the study protocol and complete scheduled assessments during the study period (e.g., for language, cognitive, medical, or organizational reasons)
* not able to complete the survey online via smartphone, PC, or tablet
Ocular Availability in Human Tears After Topical Administration of 1.5% Levofloxacin Compared to Active Comparators

The primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent and HIPAA indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Be willing and able to follow all instructions and attend all study visits
* If female and of childbearing potential, not be pregnant, nursing or planning a pregnancy and agree to submit to a pregnancy test. The result of the test must be negative and female subjects of childbearing potential must also agree to use an acceptable method of contraception for the duration of the study (acceptable method of contraception includes oral, implantable, transdermal, or injectible contraceptives, spermicide with barrier, IUD, or surgical sterilization of partner)

Exclusion Criteria:

* Have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the study
* Have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders)
* Have a history of dry eye syndrome
* Use disallowed medications (systemic or topical) (i.e. any fluoroquinolone anti-infective agents or any topical ophthalmic products) during the appropriate pre-study washout period and during the study.
* Be a contact lens wearer who is unwilling to forego contact lens wear within 3 days prior to the start of the study and for the duration of the study
* Have had any ocular surgical intervention 12 months prior to the study or anticipate having ocular surgery during the study
* Be pregnant or nursing women; or women who have a positive urine pregnancy test at screening or women of childbearing potential who refuse to use an adequate hormonal or mechanical means of birth control
* Be concurrently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of entry into this study
* Employees of the investigator or study center, with direct involvement in th proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Superset Strength Training for Time-efficiency

Physical inactivity is a global challenge and there is an urgent need to find strategies to increases people's activity levels. Strength training is one of the activities that is recommended to engage in regularly by both the American College of Sports Medicine and the World Health Organization. Understanding how strength training can be done effectively without spending much time could potentially increase people's involvement in strength training, as lack of time often is reported as barrier to training. Superset strength training can potentially be a time-efficient way of strength training, as this training method has been found to take half the time of the traditional ways of training.

The aim of the present study is therefore to compare the effects of superset strength training and traditional strength training on muscular strength, body composition and fatigue.


Eligibility Criteria:
Inclusion Criteria:

* living in Trøndelag
* did not perform weekly strength training during the past 6 months.

Exclusion Criteria:

* any known severe somatic condition (e.g., autoimmune and systemic inflammatory diseases, cancer, severe osteoporosis)
* any known severe psychiatric condition
* other contraindications for heavy resistance training (e.g. shoulder pain).
DNA Tests in Detecting Disseminated Disease in Tumor, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma

RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated.

PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.

OBJECTIVES:

* To establish a panel of hypermethylation assays for minimal disseminated disease analysis in rhabdomyosarcoma (RMS).
* To apply the hypermethylation assays to a series of bone marrow specimens from RMS patients.

OUTLINE: Archived tumor, bone marrow, and peripheral blood samples are analyzed for DNA hypermethylation by PCR-based assays and microarray assays. Results are then compared with each patient's clinical and pathological characteristics, and outcomes. Patterns of locus hypermethylation in tumor and paired bone marrow samples are also compared.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with rhabdomyosarcoma (RMS)
* Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified