cyrilzakka/clinical-trials huggingface dataset:
Testing Home-based Exercise Strategies in Underserved Minority Cancer Patients Undergoing Chemotherapy: the THRIVE Study

The purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in Black and Hispanic breast, colorectal, or prostate cancer patients.

The names of the study interventions involved in this study are:

* Supervised aerobic and resistance exercise (SUP) - virtually supervised 16- week aerobic and resistance exercise performed at home via Zoom.
* Unsupervised aerobic and resistance exercise (UNSUP) - home-based 16- week aerobic and resistance exercise.
* Attention control (AC) - 16-week home-based stretching.

This is a randomized control trial of Black and Hispanic patients who have been newly diagnosed with breast, colorectal, or prostate cancer and are being prescribed chemotherapy to determine the effects of home-based exercise on levels of physical activity. It will also evaluate the impact of home-based exercise on cardiovascular (heart health) risk factors.

The research study procedures include: screening for eligibility and study treatment including evaluations of body composition, blood tests, fitness and strength assessments, and surveys at study entry and follow-up visits.

Participants in this study will be randomly assigned to one of three groups: 1) Supervised aerobic and resistance exercise (SUP), 2) Unsupervised aerobic and resistance exercise (UNSUP), or 3) Attention control (AC).

Participation is expected to last for 8 months.

It is expected that about 135 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old; children under the age of 18 will be excluded due to rarity of disease
* Newly diagnosed with stage I-III breast, colorectal or prostate cancer
* Self-identify as Hispanic or Black
* Are within 4 weeks of initiating chemotherapy
* Overweight or obese (BMI \>25kg/m2 or body fat percent \>30)
* Physician's clearance to participate in moderate-vigorous intensity exercise
* Speak English or Spanish
* Engaging in less than 90 minutes of moderate-or-vigorous physical activity per week
* Willing to travel to Dana-Farber Cancer Institute for necessary data collection
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pre-existing musculoskeletal or cardiorespiratory conditions
* Patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease
* Patients with other active malignancies
* Patients with metastatic disease
* Participate in more than 90 minutes of structured exercise/week
* Unable to travel to Dana-Farber Cancer Institute for necessary data collection
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Peers Vs Professionals in Basic Life Support Training

An Evaluation of Peer-led basic life support training course compared with professional-led course in a limited resource environment; A randomized controlled trial

Peer training has been identified as a useful tool for delivering undergraduate training in basic life support (BLS) which is fundamental as an initial response in cases of emergency.

This study aimed to (1) Evaluate the efficacy of peer-led model in basic life support training among medical students in their first three years of study, compared to professional-led training and (2) To assess the efficacy of the course program and students' satisfaction of peer-led training.

A randomized controlled trial with blinded assessors will be conducted on 72 medical students from the pre-clinical years (1st to 3rd years in Syria) at Syrian Private University. Students will be randomly assigned to peer-led or to professional-led training group for one-day-course of basic life support skills.

Analysis will be done on students who underwent checklist based assessment using objective structured clinical examination design (OSCE) (practical assessment of BLS skills) and answered BLS knowledge checkpoint-questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Medical student from 1st, 2nd and third year at Syrian Private University.
* Sign the consent form.

Exclusion Criteria:

* presence of any health problems preventing students from doing physical exercise.
* any serious acute or chronic illness (infectious, psychological, physical).
* scheduling conflict between the date of the BLS course and other faculty's classes or exams.
* missing the course or the assessment for any reason.
* refusing to sign the consent and having any prior experience in BLS skills (previously trained on BLS).
Coping and Post Traumatic Distress in Children and Adolescents During Cancer Follow-up Care

To explore the presence of post traumatic disorder and its association with coping strategies in children and adolescents during cancer follow-up care.

Hypothesis: the investigators expect a reduction of post traumatic symptoms according to adequate coping strategies (eg. approach coping styles).

Oncological disease in childhood or adolescence can represent a highly traumatic experience, considering its physical, psychological and social consequences in the short and long term. The literature has investigated this population both in the acute phase of the disease and at the end of the therapies to explore the potentially traumatic effects of this experience. While some studies support the non-incidence of post-traumatic symptoms related to the disease and underline a post-traumatic growth, other studies confirm a high risk of developing post-traumatic symptoms. This risk increases according to specific demographic (eg. age of diagnosis) and clinical (eg. type of disease, of treatments, etc.) characteristics. The literature also points out that these consequences can be mediated by some factors, including coping strategies, that is the way patients manage stress.

The study aims: to investigate the presence of post-traumatic symptoms in patients out of therapy and in follow-up care; to explore the possible association between this post-traumatic symptomatology and the coping strategies used by the patients; to focus the possible correlation between post traumatic symptoms, coping and the demographic and clinical characteristics of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients in cancer follow-up care since less than 3 years
* Scheduled to follow-up appointement
* Italian speaking
* Patients' and parents' consent

Exclusion Criteria:

- Cognitive and/or developmental impairment
First-in-Human Study of EOS100850 (Inupadenant) in Patients with Cancer

Multicenter, open-label, dose-escalation Phase I/Ib clinical study to evaluate the safety and tolerability, the MTD/RP2D, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of EOS100850 (Inupadenant) as a Single Agent and in Combination with Pembrolizumab and/or Chemotherapy in Participants with Advanced Cancers.


Eligibility Criteria:
For more information regarding participation in the Trial, please refer to your physician

Inclusion Criteria:

* Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Subject with histologically or cytologically confirmed advanced solid tumor for whom no standard treatment is further available.
* At least 4 weeks since any previous treatment for cancer
* Subject must consent to pretreatment and on treatment tumor biopsies
* Adequate organ and marrow function

Exclusion Criteria:

* Patients with primary brain tumors or primary tumors with central nervous system metastases as only location of disease. Controlled brain metastases are permitted
* Participants with second/other active cancers requiring current treatment
* Uncontrolled/significant heart disease
* Known History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)
* Active/uncontrolled autoimmune disease
* Active infection

Other protocol defined inclusion/exclusion criteria could apply
Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia

The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
* Blood culture drawn in the Emergency Department (ED)

Exclusion Criteria:

* Patients not admitted to hospital
* Patients discharged from hospital prior to blood culture positivity
* Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
* GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
* Deceased or palliative care at the time of randomization
* Patient who is moribund (does not survive the initial 72 hours after enrollment)
Home-Based Exergaming Intervention

This study will employ a 3-arm randomized clinical trial to determine the effects of a 6-month home-based exergaming intervention on preschoolers' physical activity, health-related fitness, cognition, and screen time, across time, at 3, 6 and 12 months, and as an exploratory outcome, will explore the moderating effects of parent involvement and physical home environment on the intervention role of exergaming across time. Briefly, a total of 330 child-parent dyads from the Twin Cities area in Minnesota will be individually randomly assigned to: 1) an exergaming intervention group (30 min. per session, 5 sessions exergaming play per week for a 6-month period); 2) a traditional PA group (phone consultations and workshops for parents to offer 5 times 30 min. PA at home for 6 months); and 3) an attention control group (continue with usual activities at home with emailed PA tips).


Eligibility Criteria:
Inclusion Criteria:

* response to an advertisement for the study;
* has only one child aged 4-5 years old in the family;
* speaks English;
* family with income within 185% of the Federal Poverty Guideline Levels determined by parents' self-report;
* has a TV with HDMI port or VGA port or video port at home
* the child has no medical conditions or physical disabilities that prohibit engagement in PA;
* physically inactive child who does not meet 120 min. PA per day;
* parental agreement to participating in the home visits and evaluations;
* lives within 20 miles of the UMN;
* family willingness to commit to 6 months of intervention and 6 months of follow-up;
* not moving out of area for the next 12 months.

Exclusion Criteria:

* children/parents from families that already own exergame(s) as these children tend to possess high experience levels with exergaming play;
* child who are physically active for more than recommended 180 min. PA per day as reported by parents.
Prevalence of Temporomandibular Joint Disorders in Wind Musicians

This study aims to analyze the prevalence of temporomandibular joint disorders (TMD) in wind musicians, differentiating the impact by instrument type (woodwind vs. brass) and identifying potential risk factors (embouchure, posture, practice time). A cross-sectional observational design will be used, including professional and student musicians from orchestras and conservatories.

This observational cross-sectional study aims to assess the prevalence of temporomandibular joint disorders (TMD) in wind musicians and analyze the impact of instrument type (woodwind vs. brass) on TMD prevalence. Additionally, the study will explore potential risk factors such as embouchure, posture, and practice time.

The study will recruit professional and student wind musicians from orchestras and conservatories. Participants will complete a validated questionnaire (DC/TMD) and undergo a clinical assessment to evaluate mandibular mobility, the presence of joint sounds (clicking, crepitus), and symptoms related to TMD.

The data collection will take place in a single session per participant, estimated between March 1, 2025, and April 15, 2025. The collected data will be analyzed to compare TMD prevalence between different instrument groups and assess correlations with practice habits and postural factors.

All data will be anonymized and stored securely according to applicable data protection regulations (LOPD 3/2018, GDPR 2016/679). Participation in the study is voluntary, and written informed consent will be obtained from all participants, or from their legal guardians in the case of minors.

Eligibility Criteria:
Inclusion Criteria:

* Wind musicians (professional or student).
* Any age (if under 18, parental/legal guardian consent is required).
* Signed informed consent.

Exclusion Criteria:

* History of maxillofacial surgery.
* Presence of neurological disorders affecting mandibular function.
* Recent treatment for TMD.
* Severe bruxism diagnosis.
Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999

Idiopathic Parkinson's disease (IPD) is a degenerative disease affecting the dopaminergic system. Clinical symptoms of IPD commonly begin after the loss of at least 40 to 50% of striatal dopaminergic terminals (specially putaminal terminals).

The Dopamine neuronal transporter (DAT) is a highly expressed protein in the membrane of presynaptic nigrostriatal dopaminergic terminals. The use of a DAT's radioligand in the initial stages of the disease would lead to an early detection of nigral cell loss.

Currently, only one DAT's radioligand has obtained marketing authorization in France, the 123I-FPCIT, for use in Single Photon Emission Computed Tomography (SPECT).

Otherwise, the Positron Emission Tomography (PET), a more sensitive technology than SPECT with higher resolution has become for a few years the new gold standard for visual analysis and quantification of neurotransmission systems (including the dopaminergic system).

A DAT tracer labelled with Carbon 11 (\[11C\] PE2l) have been developed and is currently used as a reference in various research centers.

However, in order to enable a clinical use of this tracer (which currently can't be because of the too short period of Carbon 11), the unit INSERM U930 "Imaging and Brain" in collaboration with the CERRP (Center for Studies and Research on Radiopharmaceuticals) developed a new version of this tracer, labelled with 18-fluor: the \[18F\] LBT-999.

The main goal of this study is to compare the \[18F\] LBT-999 uptake between a group of patients suffering from a Parkinsonien syndrome to a group healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

Criteria common to all participants:

* Age between 45 and 75 years old
* Signed informed consent
* Affiliated to a social security system

Criteria for patients:

* idiopathic Parkinson's disease according to the UKPDSBB criteria
* stage 1-3 Hoen and Yahr (unilateral disease to moderate or mild bilateral disease in a self patient )

Criteria for healthy volunteers:

* matching according to age (± 5 years)

Exclusion Criteria:

Criteria common to all participants:

* history of taking an antipsychotic or any other drug with a dopaminergic effect in the previous 6 months
* contraindications to MRI
* person with severe claustrophobia
* patient with a legal protection measure
* alcohol or drug abuse history (in the past 10 years)
* history of progressive disease that can affect the central nervous system (blood pressure greater than or equal to 180/100 mmHg, chronic lung disease with hypoxia, heart failure stage 4)
* all medical and surgical affection older than 3 months
* history of stroke
* history of head trauma (coma\> 24h)
* MMS\<24
* pregnancy or lactating woman without reliable contraception
Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists

The study is aimed at verifying if a pulmonologist in training can reliably assess the adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training provided by an experienced pathologist.


Eligibility Criteria:
Inclusion Criteria:

* Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings
* Signed informed consent

Exclusion Criteria:

* High risk conditions for the performance of bronchoscopy and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)
* High risk condition for deep sedation (ASA 4)
* Pregnancy
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe acne
* 25-70 non-inflammatory lesions at Baseline
* 20-40 inflammatory lesions at Baseline

Exclusion Criteria:

* Subjects with known allergy to any component of the test material or vehicle
* Women who are pregnant or nursing
Skeletal Metastasis Registry

This is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at Sibley Memorial Hospital and Johns Hopkins Medicine to an international registry hosted by the Swedish Regional Cancer Centrum in Stockholm, Sweden. This protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the International Skeletal Metastasis Registry (ISMR)

The registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. The models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 22 or older
* Biopsy-proven or clinically-obvious metastatic bone disease
* Symptomatic bone lesion requiring intervention o Including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy

The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Renal biopsy confirmed primary IgA nephropathy
3. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
4. eGFR≥30 mL/min/ 1.73m2
5. 40kg≤ Weight ≤100kg
6. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

Exclusion Criteria:

1. systemic disease which may cause secondary IgA deposition in the mesangial region
2. Specific type of IgA nephropathy
3. History of severe opportunistic infection
4. A history of chronic or recurrent infection within 1 year prior to screening
5. History of active digestive system within one year
6. Have a malignant tumor or a history of malignant tumor
7. Subjects who have received organ transplants
8. Associated with other serious or poorly controlled systemic diseases
9. Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
10. Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
11. Received any systemic glucocorticoid 8 weeks before screening or during run-in period
Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Seasonal affective disorder(SAD) is a type of depression in which a patient's depressive symptoms worsen in the winter. These patients' depressive symptoms often lessen in the spring and summer months. Much of the focus of the treatment of SAD (light therapy and melatonin) has involved the brain's suprachiasmatic nucleus(SCN), as it is hypothesized that one potential reason for SAD is a desynchronized SCN. Ramelteon offers a new and more pharmacologically exact mechanism to re-synchronize the SCN. The administration of ramelteon for this patient population may improve sleep, and in addition, do so in a manner that may also reduce their seasonal affective depressive symptoms. Patients eligible for enrollment will be administered either ramelteon or placebo and return to the study office for 4 monthly visits over the winter months, to evaluate the effects of ramelteon versus placebo on sleep and mood.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18-65 yrs.
* A diagnosis of seasonal affective disorder
* A Pittsburgh Sleep Quality Index \>5
* English speaking
* Be able to sign informed consent

Exclusion Criteria:

* Active substance abuse
* Current psychotic symptoms
* Severe personality disorders
* Primary sleep disorders
* Severe chronic obstructive pulmonary disease (COPD)
* Prescription fluvoxamine(Luvox) use