cyrilzakka/clinical-trials huggingface dataset:
Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma

RATIONALE: Cancer treatment may have risks that affect health outcomes later. It is not yet known what health outcomes may be related to previous treatment for rhabdomyosarcoma.

PURPOSE: Study to determine health outcomes in patients who have survived 5 years after receiving treatment for rhabdomyosarcoma on the Intergroup Rhabdomyosarcoma Study Group protocols.

OBJECTIVES: I. Determine the frequency of self reported health related outcomes in patients with rhabdomyosarcoma who survived 5 years from diagnosis after treatment on Intergroup Rhabdomyosarcoma Study Group (IRSG) protocols I, II, III, and IV pilot. II. Determine the mortality of these patients and compare this mortality to the general population, especially in the third and fourth decades of life. III. Determine treatment specific risks of developing a second malignancy following treatment of rhabdomyosarcoma and the potential genetic influences (family history of cancer). IV. Determine the association between decreased fertility/offspring and dose, schedule, and total dose of alkylating agents (especially cyclophosphamide) received during treatment and with selected genitourinary and paratesticular primaries. V. Determine the effect of the dose and location of therapeutic radiation for primary head and neck cancer on achieved final height. VI. Determine the association of therapy with doxorubicin (dose and age when received) with cardiac and vascular events.

OUTLINE: Patients (or parent or surviving family member) complete the baseline questionnaire plus other questionnaires (offspring, family history, other topic specific). Medical data is also collected from past records.

PROJECTED ACCRUAL: Approximately 1600 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Prior registration on Intergroup Rhabdomyosarcoma Study Group Study IRS-I, IRS-II, IRS-III, IRS-IV pilot, IRS-V, or IRS-V pilot, or one of the protocols of IRS-V (D9501, D9502, D9602) AND Survived for 5 years after diagnosis (may be deceased now)

PATIENT CHARACTERISTICS: Age: 5 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Downhill Walking Training in COPD

This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD.

Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of COPD according to internationally accepted guidelines
* Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)

Exclusion Criteria:

* Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities
* Absence of exacerbations in the previous month before entering the present study
* Patients included on the waiting list for lung transplantation
Suicide Prevention Among Recipients of Care

Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics.

Aim 1: Compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (SPI+), versus safety planning intervention plus caring contacts (CC)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (EDs) and primary care clinics.

Aim 2: Assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in EDs and primary care clinics.

Aim 3: Assess the acceptability of SPI+ and SP+CC among adult and adolescent patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient at St. Luke's Health System Emergency Department or Primary Care Clinic
* 12-17 years old (adolescents) or 18+ years old (adults)
* Screened positive for suicide risk on C-SSRS (any response of "yes") during current visit, or current visit is related to a suicide attempt
* Access to a phone for the duration of the study with the ability to receive calls
* The ability to send and receive email messages (required) and text messages (optional)
* English or Spanish speaking and reading

Exclusion Criteria:

* Unable or unwilling to provide informed consent to participate
* Inappropriate for study participation based on the clinical judgment of provider
Multi-Center Study of Iron Overload: Pilot Study

The purpose of this study is to initiate pilot studies to demonstrate that a sufficient number of iron-overloaded thalassemia, SCD and DBA populations with similar duration of chronic transfusion, and age at start of transfusions would be available for a confirmatory study and to validate that proposed multicenter MRI and biochemical studies can be completed. The study will examine the hypothesis that a chronic inflammatory state in Sickle Cell Disease (SCD) leads to hepcidin- and cytokine-mediated iron withholding within the RES (reticuloendothelial system), lower plasma NTBI (non transferrin bound iron) levels, less distribution of iron to the heart in SCD.

A detailed iron burden, transfusion and chelation history will be obtained from chart review or from participant recall.

Iron burden data will include: 1) documentation of liver iron, and 2) average annual ferritin values.

Transfusion data will include: (1) age at onset of regular transfusions, (2) years of chronic transfusion therapy, and (3) pre-transfusion Hb calculated as average of all assessments for each year.

MRI will be performed measuring pituitary, cardiac, and liver iron.

Laboratory samples should be obtained pre-transfusion and mid-cycle.

All interviews, exams, laboratory tests, study procedures and MRI assessments should be completed within a 0 to 12 weeks time span.

In addition, a healthy control group will also be recruited with similar age, gender, and ethnicity as the disease groups.

Eligibility Criteria:
Inclusion Criteria:

* 10-20 years of transfusion (defined as 0.2-0.6mg Fe/kg/day exposure with annual ferritin levels greater than 2500 in at least 60% of years of chronic transfusion);
* 0 to 9 years old at the initiation of chronic transfusions; no exchange transfusions in the previous 6 months
* iron overload documented by either liver biopsy, MRI or SQUID with estimated LIC of greater than 7 mg/g dry wt in the previous 6 months or ferritin level greater than 1500mg/dl.

Exclusion Criteria:

* Patients with HbSC, HbS/β thalassemia
* Pacemaker (active or inactive) or other implanted magnetic devices, severe claustrophobia, or other contraindications to MRI; Unable to remove ferro-magnetic objects from the body in regions to be imaged (e.g., jewelry or piercing)
* Presence of any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment;
* Any chronic inflammatory illness other than the SCD, TM or DBA;
* Any acute illness within a 14 day period prior to blood sampling;
* Patients receiving intensive chelation in the 6 months prior to enrollment including deferoxamine 24 hours per day, 7 days per week or combination treatment with 2 chelators
* Pregnancy
Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

If tigecycline clearance increases with body size then serum exposure values will be lower in obese class III compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.

Not required

Eligibility Criteria:
Inclusion Criteria:

Subjects fulfilling the following criteria will be eligible:

1. males and females, 18 to 50 years of age;
2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers;
3. Body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class III);
4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period

Exclusion Criteria:

1. history of significant hypersensitivity reaction to any components of Tygacil®;
2. history of significant clinical illness requiring pharmacological management;
3. history of blood donation in the past eight week period;
4. abnormal serum electrolyte or complete blood count requiring further clinical work-up;
5. transaminases (AST or ALT) \> 2.5 x upper limit of normal;
6. subjects with stage 4 or 5 chronic kidney disease;
7. positive serum pregnancy test (if female);
8. abnormal electrocardiogram (ECG) as judged by study physician;
9. unable to tolerate venipuncture and multiple blood draws;
10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up;
11. unable to independently provide a written informed consent.
CeraShield™ Endotracheal Tube Feasibility Study

Single-arm, feasibility study to evaluate the Ceragenin Coated Endotracheal Tube (the CeraShield ETT) in adults who require intubation and are expected to be mechanically ventilated for ≥ 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older;
* Patients requiring a 7.0mm, 7.5mm, 8.0mm or 8.5mm endotracheal tube;
* Expected to be mechanically ventilated for ≥24 hours.

Exclusion Criteria:

* Currently participating in another clinical trial which conflicts with this trial's design.
* Patients with a pre-existing respiratory infection, i.e., pneumonia.
* Patients with pulmonary contusions.
* Patients with cystic fibrosis.
* Patients demonstrating symptoms of bronchiectasis.
* Patients demonstrating symptoms of severe or massive hemoptysis. Severe or massive hemoptysis defined as greater than 500 ml of blood per day, or greater than 200 ml in six hours.
* Patients who have been intubated within the last 30 days requiring reintubation.
* Women of child-bearing potential who have not undergone a pregnancy test will be excluded from the study.
* Patient is pregnant.
Personality Change During Medical Residency

The Ethics Committee of Hospital and University Center of Coimbra (Portugal) complies, reports and is supervisioned by the Portuguese Ethics Committee.

The Ethics Committee of Hospital and University Center of Coimbra is an multidisciplinary organ of Ethics experts that give support to the board of hospital directors, the health personnel and patients, regarding bioethical issues emerging from clinical assistance activities (addressed to patient's health being, education and clinical research).


Eligibility Criteria:
Inclusion Criteria:

* Medical residents with ages between 23 and 45 years old, attending the first year of medical specialty in Portugal in the following specialties\*: General Surgery, Neurosurgery; Orthopedics; Intern Medicine, Gastroenterology; Cardiology; Rheumatology; Endocrinology; Oncology; Intensive Medicine; Pediatric; Radiology; Clinical Pathology; Neurology and Psychiatry.
* Acceptance and commitment to participate in the study.
* Signature of study' informed consent.

Exclusion Criteria:

* Attendance, during the study, in an international formative stage with a duration superior to 12 months.
* Previous attendance of other medical specialty for more than one year.
* Present or past history of major psychiatry disorders (illicit drug abuse with dependence, schizophrenia, bipolar disorder or schizoaffective disorder)
Prediction of Coronary Artery Disease Based on Multimodal, Non-contact Information With Artificial Intelligence

The goal of this observational study are 1) to assess the effectiveness of modalities and/or their combination of multimodal non-contact information in predicting coronary artery disease; 2) to prospectively validate the performance of the developed artificial Intelligence models in predicting coronary artery disease.

This observational study aims to assess the effectiveness and potential mechanism of modalities of non-contact captured bio-physiological information, including facial RGB information, infrared thermography temperature information, gait information, and wearable device information, individually and/or in combination, in predicting coronary artery disease (CAD) with artificial intelligence technology.

Individuals suspected of CAD and referred for evaluation will be invited to participate in the current study for analyzing the non-contact information and association with underlying CAD status, in order to establish the most efficient artificial Intelligence modeling strategy, and prospectively validate the predictive performance of the developed artificial Intelligence models for CAD prediction.

Eligibility Criteria:
Inclusion Criteria:

* Suspected individuals referred to for coronary angiography or coronary computer tomography angiography.

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft (CABG)
* Undergoing confirmatory coronary evaluation as pre-operation routines for other cardiac diseases
* With artificial body alteration (e.g. cosmetic surgery, facial trauma, or make-up) that may affect the non-contact information of study interest
* Age less than 18 years old
* Other circumstances that prevent participants from cooperating with the study process
* Decline to consent for study participation
Hippocampal Plasticity of Young Adults With Childhood Adversity

This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.


Eligibility Criteria:
Inclusion Criteria:

* having childhood adversity
* no history of psychiatric disorders of psychotic features or neurological disorders
* verified age between 21-35 years old;
* no suicidal attempts during the past six months;
* being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
* passing MRI eligibility criteria.
* provided written informed consent to participate in this study;
* committed to meeting the requirement of refraining from using marijuana or illicit drugs.

Exclusion Criteria:

* psychosis
* active suicidal attempts during the past 6 months
* psychoactive substance abuse
* MRI exclusion criteria
Pro APP Prosthetic Outcome Registry

A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.

This US national patient and outcome registry will provide demographic information on lower-limb prosthesis users and their real-world clinical outcomes. The intent is to collect data from multiple certified O\&P clinics that have access to use the digital data collection tool PRO App (https://www.ossur.com/en-us/professionals/PRO App). Any patient undergoing prosthetic treatment with their prescribed devices (such as a new fitting, alignment, or replacement of a previous prosthesis) at the investigational sites will be offered to provide data to the registry. Data collection will be a part of the standard of care and is entered by the participating prosthetists, physicians, physical therapists, or other designated staff during clinic/service visits. Data already entered into the PRO App system may also be collected into the registry if the participant consents. This registry will recruit patients who meet the inclusion criteria. Participation is fully voluntary. After the enrollment, all participants would be evaluated during follow-up visits as demanded by their standard of care.

Exploratory analyses may be implemented, utilizing the already collected data, to investigate specific populations and their outcomes depending on the enrollment of said population groups. As an example; data will be collected from the registry to stratify two demographically matching groups of prosthetic users using a powered knee and a non-powered knee.

Eligibility Criteria:
Inclusion Criteria:

Cognitive ability to understand all instructions and questionnaires in the study Willing and able to participate in the study and follow the protocol Individuals with lower limb loss, amputation or deficiency

Exclusion Criteria:

None
Evaluation of the Strong Hearts Urban Program

The aim of this study is to assess the feasibility and preliminary effectiveness of the adapted Strong Hearts (SH) intervention to improve weight status, American Heart Association's Life's Essential 8 (AHA Essential 8), and health behaviors among Black/African American and/or Hispanic/Latinx urban residents with overweight or obesity.

Cultural adaptation of effective health behavior interventions holds the potential to improve health behaviors and ultimately health outcomes among underserved populations. The Strong Hearts (SH) Urban Intervention will adapt the existing SH curriculum for delivery in urban Dallas communities to improve weight status and Life's Essential 8 score for ideal cardiovascular health. Despite declines in heart disease mortality in the United States since 2000, it remains the leading cause of mortality in both men and women-accounting for about one-third of all deaths in the U.S. Costs related to cardiovascular disease (CVD) place a substantial financial burden on the health care system, accounting for an estimated $320 billion in 2016. Although most obesity or CVD prevention programs target only the individual level, the US Centers for Disease Control and Prevention recognizes that health is affected by factors at multiple levels: individual (e.g., behaviors, knowledge, attitudes, skills, psychological factors), social (e.g., influences from one's social network on health-related behaviors), and environmental (e.g., safe places to walk, food choices at workplaces, availability of affordable fruits and vegetables), and recommends integrating approaches to make changes beyond the individual level to support long-term, sustainable behavior change. Providing individuals with the motivation, skills, and opportunity to change behaviors may be less effective if their social or community environment makes it difficult to adopt or maintain these behaviors

SH is a multilevel, multicomponent community-based program, in which an experiential learning focus is combined with social and environmental components, including civic engagement activities related to local resource awareness and enhancement. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches, which have limitations in terms of cost, impact, reach, and sustainability, to effectively reduce CVD health disparities using an integrated, multi-level, community-engaged approach. This pilot study will provide needed data on the feasibility and preliminary effectiveness of such approaches in urban and underserved communities.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 or older
2. Overweight or obese (BMI≥25)
3. Less than 150 minutes of moderate physical activity per week
4. Black/African American race and/or Hispanic/Latinx ethnicity

Exclusion Criteria:

1. Pregnancy, or intent to become pregnant during the study duration
2. Unable to read and communicate in English
3. Planning to participate in another health behavior change program in the next three months
4. Unable/unwilling to provide informed consent
Trichomonas Vaginalis Recurrence Among HIV+ Women

The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.

This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years or older
* HIV-positive
* TV positive by either wet preparation or culture
* ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
* willing to take metronidazole treatment

Exclusion Criteria:

* pregnant
* incarcerated
* previously enrolled
* currently taking disulfiram
* alcoholism or known liver damage
* medical contraindications to metronidazole
* treated with metronidazole within the previous 14 days
* requires treatment for B.V. per Amsel's criteria
Comparison of Clinical Outcomes of Distal Radius Fractures Treated Surgically With WALANT and Peripheral Nerve Block

WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high patient satisfaction. There are studies with a high level of evidence showing that the WALANT technique has such advantages in soft tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.), surgical treatment is performed with the WALANT technique and positive results have been reported. Although there is a study comparing WALANT and general anesthesia in the surgical treatment of distal radius fractures, there is no study comparing the peripheral nerve block technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Patients who had acute distal radius fracture which underwent surgery

Exclusion Criteria:

* Patients with open fractures
* Additional injuries in the same extremity, peripheral vascular disease, and local anesthetic allergy at the time of first admission
* Patients who are switched to general anesthesia after both techniques
* Patients who underwent a second surgery on the same extremity due to any complication
* Patients who had lacked follow-up examination information
Monitoring of Arrhythmias and HRV in Patients With Heart Failure Treated With the CRT Pacemaker Renewal TR2

The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe chronic heart failure, defined by the presence of NYHA class III or IV symptoms, Intra/interventricular synchronization disorder evaluated by echocardiography and/or Doppler Tissue Imaging (DTI, Yu's method22), Ejection fraction (EF) ≤ 40 %, If previous history of myocardial infarction, MI must be \> 60 days from the date of inclusion, Estimated life expectancy \> 6 months in the case of concomitant disease, Age ≥ 18 years, Optimal drug treatment of chronic heart failure (according to SFC\* recommendations).

Exclusion Criteria:

* Conventional indication for treatment by implantable defibrillator upon inclusion, Cardiac transplant envisaged within 6 months, Unexplained syncope, MI \< 60 days before inclusion, Non compliance to drug treatment for chronic heart failure, Any coronary pathology which may be treated by revascularisation.