cyrilzakka/clinical-trials huggingface dataset:
Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors

This study will examine the efficacy of Men Moving Forward (MMF), a four-month community-based lifestyle intervention designed for AA PC survivors. MMF is rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with AA PC survivors. It will offer twice weekly sessions aimed at supporting adherence to the ACS nutrition and physical activity guidelines to promote improved body composition (i.e., decreased adiposity, increased lean mass).

Aim 1. To examine the efficacy of the Men Moving Forward guided intervention, as compared to a self-guided control intervention, in producing significant post-intervention changes in body composition in 200 AA PC survivors.

Hypothesis: Men randomized to the guided arm will exhibit significant post-intervention decreases in adiposity and increases in lean body mass compared to men randomized to the control arm.

Aim 2. To investigate the effects of participation in the Men Moving Forward guided intervention on health behaviors and quality of life outcomes.

Hypothesis: Men in the guided program will exhibit increased intake of fruits and vegetables and decreased intake of red meat/processed meat, greater levels of physical activity (minutes per week and #times/wk resistance training) and improved quality of life (targeting physical function, social isolation, sexual functioning) compared to men in the control arm.

Aim 3. To explore the effects of the intervention program on blood pressure, blood lipids, fasting glucose, and biomarkers associated with comorbidities and carcinogenesis (i.e adiponectin, leptin, C-peptide, IGF-1, IGFBP-3, C-Reactive Protein, estradiol, testosterone and sex hormone binding globulin)

Hypothesis: Men in the guided arm will exhibit greater improvements in biomarkers associated with chronic disease and carcionogenesis compared to men in the self-guided control arm.

Men Moving Forward supports PC survivors in adopting physical activity and eating patterns that will improve their body composition, bolster QOL and reduce risk for comorbidities and, potentially, PC recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Self-identify as Black or African American
* Diagnosed with non-metastatic Prostate Cancer (cancer that has NOT spread elsewhere in the body)
* Completed all treatments (including Androgen Deprivation Therapy) at least six months prior to enrollment
* BMI \> 25 kg/m2
* Able to participate in moderate physical activity as assessed by healthcare provider
* Exercise less than the ACS recommended guideline of 150 min/week or 30 min/day.
* Fruit and vegetable consumption is less than 5 servings each day.
* Lift Weights or engage in strength training less than twice a week.
* Can walk continuously for 5 minutes without stopping because of pain or shortness of breath.
* Have access to a mobile phone
* Approval from Primary Care Provider/Medical Oncologist
* Available to attend intervention

Exclusion Criteria:

* • Does not meet the Inclusion Criteria
Anti-PD-1 Antibody Plus DEB-TACE for BCLC Stage A/B HCC

This study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection in combination with transarterial chemoembolization with drug-eluting beads(TACE-DEB) in patients with BCLC Stage A/B Hepatocellular Carcinoma Beyond the Milan Criteria.

Patients with hepatocellular carcinoma (HCC) of BCLC stage A/B exceeding the Milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. This study aimed to investigate the efficacy and safety of preoperative DEB-TACE plus sintilimab for the treatment of patients with BCLC stage A/B HCC exceeding the Milan criteria.

Eligibility Criteria:
Inclusion Criteria

1. Age between 18 years and 75 years;
2. ECOG PS 0/1;
3. Patients with histologically- or clinically-confirmed HCC (based on the American Association for the Study of Liver Diseases criteria) that was either BCLC stage A and exceeded the Milan criteria, or BCLC stage B
4. Have not received any anti-tumor systemic treatment in the past
5. No contraindications for the treatment of DEB-TACE and PD-1 inhibitors;
6. Liver function: Child-Pugh score Class A
7. The expected survival of the patient is more than 3 months
8. The following conditions must be met:

   Platelets ≥ 75 × 10\^9/L White blood cell count (WBC) ≥ 3.0 × 10\^9/L Hemoglobin ≥ 90 g/L Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN Blood creatinine ≤ 1.5 × ULN PT prolonged ≤ 3 s
9. Adequate bone marrow, cardiac, and renal function
10. Patients must agree to accept postoperative follow-up required by the design of this study;
11. Patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study.

Exclusion Criteria

1. History of other malignancies；
2. In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 5.0 adverse events of grade 2)；
3. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).
4. Spontaneous rupture and bleeding of HCC
5. Hepatic tumor burden \>50% total liver volume
6. Complete occlusion of the portal vein
7. Evidence of a bleeding diathesis or coagulopathy, active infections, and autoimmune disease
8. Recurrent disease after surgery within the last 5 years
9. History of organ transplantation or plan to have liver transplantation;
10. Pregnant women, nursing mothers.
11. Patients have other factors that may interfere with patient enrollment and assessment results.
12. Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Service Development of POCUS in the IBD Clinic

Study to determine whether the use of an ultrasound completed during an inflammatory bowel disease (IBD) clinic will speed up diagnosis, treatment initiation, reduce complications, save money and reduce investigations compared with our current standard of care.

After being provided with study information and providing written informed consent, participants attending the inflammatory bowel disease clinic will be randomised to standard of care or to receiving an ultrasound during the clinic appointment. This ultrasound result will be used to determine treatment decisions. Participants will have a 6 month follow-up to capture outcome data and further medical record review will be conducted at one year.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 years or above
* Attending IBD clinic face-to-face
* Able to give informed consent.
* Belonging to one of the following groups:

  1. New patients with high clinical suspicion of IBD
  2. Known UC/IBD-U and possible flare
  3. Known Crohn's and possible flare
  4. Known IBD and assessing response to a new medication or following surgery
  5. Known IBD and clinician planning endoscopic or radiological investigations

Exclusion Criteria:

* Inflammatory bowel disease limited to proctitis with no clinical suspicion of extension
GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis as defined by the 1987 ACR classification
* Severe active seropositive disease
* Inadequate response or intolerance to other DMARDs and anti-TNFs
* Treatment with Methotrexate

Exclusion Criteria:

* Patients with systemic manifestations of rheumatoid arthritis
* Female patients nursing
* Women of childbearing potential unless using birth control
* Active infection
* Known immunodeficiency syndrome
* Positive Hepatitis B surface antigen or antibodies to Hepatitis C
* History of cancer

Other protocol-defined inclusion/exclusion criteria may apply
Eating in the Absence of Hunger and Caloric Compensation in Preschool Children, Link With Parental Feeding Practices

Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link these measurements with individual characteristics (adiposity, age, gender) and parental feeding practices.

Design: Three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Parental eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.


Eligibility Criteria:
Inclusion Criteria:

* To be registered to the school canteen, to provide parental approval

Exclusion Criteria:

* Chronic disease or food allergies.
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer

A Study to evaluate the utility of the ProLung Test as an adjunct to CT scan in the diagnosis of lung cancer.

This Study will assess the stability of the ProLung Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung Test when used to evaluate patients with a positive CT scan for lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, age 18 or above.
* If female, subject

  * is of non-childbearing potential meaning permanently sterile, or
  * is one year post-menopausal; or
  * is not pregnant as confirmed by negative urine pregnancy test and using adequate birth control at time of screening.
* Subject presents with one or more of the following clinical symptoms or suspicious radiological finding(s):

  * Persistent cough
  * Hoarseness
  * Shortness of breath
  * Sputum streaked with blood
  * Fatigue
  * Unexplained recent weight loss
  * Recurrent pneumonia or bronchitis
  * Chest pain
  * Abnormal chest radiograph
* Subject has undergone a CT scan of the lungs within 44 days of measurement that indicates one or more non-calcified nodules (NCN) or lung masses suspicious for lung cancer.
* Subject is capable of understanding and agreeing to fulfill the requirements of this protocol.
* Subject has signed the IRB/IEC approved informed consent form.

Exclusion Criteria:

• Subjects who meet one or more of the following criteria may not be enrolled in this Study:

* Subject has a pacemaker or other implanted electronic device.
* Subject with diagnosed malignancy within the past 5 (five) years except for non-melanoma skin cancer.
* Subject with significant systemic diseases including uncontrolled diabetes, severe heart failure, uncontrolled hypertension, myocardial infarction and/or auto-immune conditions within the prior 3 (three) months.
* Subject taking systemic corticosteroid medication (except for inhaled) within 14 days prior to measurement session.
* Subject has had an invasive medical procedure that involves the thoracic cavity within 30 days prior to the measurement session.
* Subject who currently abuses alcohol or drugs.
* Subject presents with an anomalous physical or anatomical condition that precludes measurement.
* Subject will have undergone unusually strenuous exercise within 24 hours prior to measurement session.
* Subject who has, in the Principal Investigator's opinion, any medical condition or other circumstance that would prevent completion of this Study or interfere with analysis of the Study results.
* Subjects who have undergone radiation and chemotherapy treatment within the past 30 days.
* Subject receiving therapy for documented or suspected chest infection.
* Pregnant or lactating females.
Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury

To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI.


Eligibility Criteria:
Inclusion Criteria:

* patients with SCI

Exclusion Criteria:

* had neurologic impairments unrelated to SCI, such as peripheral nerve injury, brain injury and cognitive deficits, or if they were unable to complete the questionnaire.
Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma

The coronavirus disease 2019 (COVID-19) was classified as a pandemic by the World Health Organization (WHO) in March 2020. The SARS-COV-2 virus is easily transmissible and there is currently no approved treatment with effective results. Although the main epidemiological parameters are currently being studied, apparently the speed of contagion, the incidence and the mortality rate in severe cases appear to be high. Therefore, there is an urgent need to find a viable therapeutic option. The present trial is a pilot study with an objective to determine the efficacy of standard treatment reinforced with two repeated doses in two consecutive days of plasma from former convalescent people of the COVID-19 disease already discharged and / or with results in negative COVID-19 screenings, transfused to hospitalized COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the HIP and sign the study IC
* male or female =/\> 18 years
* Patient hospitalized with a COVID-19 diagnosis by PCR on nasopharyngeal swabs or any other biological sample.
* Presence of respiratory symptoms and / or fever associated with COVID-19, with clinical evolution time for COVID-19 equal to or less than 7 days.
* Presence of pneumonia on chest X-ray and / or SatO2 \<94% aa.
* Sequential Organ Failure Assessment (SOFA) score ≤ 6.
* Accept the condition of complying with the procedures established in the protocol.

Exclusion Criteria:

* Patients with a previous history of allergic transfusion reaction.
* Lactating or pregnant women and a positive pregnancy test.
* Patients who have been treated with plasma in the 21 days prior to the screening / baseline visit.
* Patients who are at the time of study, participating in another clinical trial.
* Patients who haven't completed all study procedures.
An Intermediate Expanded Use Trial of DFMO

To provide DFMO in an expanded use setting to subjects with relapsed rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase.


Eligibility Criteria:
Inclusion Criteria:

* Age: 0-30 years at the time of initial diagnosis.
* Diagnosis: Histologic verification at either the time of original diagnosis or a previous relapse of High Risk neuroblastoma, medulloblastoma, atypical teratoid rhabdoid tumor, embryonal tumor with abundant neuropil and true rosettes, ependymoblastoma, medulloepithelioma and other rare pediatric MYC, ODC or LIN28/Let7 driven tumors (each type will form a new subset).
* Disease Status: Subjects must be in one of the following disease categories:

  1. High risk neuroblastoma patients that have completed standard of care upfront therapy and are not eligible for NMTRC014.
  2. Medulloblastoma patients who have completed standard of care therapies.
  3. Relapsed/refractory neuroblastoma patients who have completed standard of care therapies.
  4. Rare tumors with increased LIN28 expression or MYCN amplification or up regulation of ornithine decarboxylase who have completed standard of care therapies.
* Subjects are not eligible to enroll on DFMO studies NMTRC002, NMTRC003, NMTRC010, or NMTRC014.
* A negative serum or urine pregnancy test is required for female subjects of child bearing potential (onset of menses or ≥13 years of age).
* Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.
* Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

* BSA (m2) of \<0.25
* Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.
Testing Counseling Styles to Motivate Smokers to Quit

The purpose of this study is to determine, among a sample of general adult smokers, the effectiveness of three different counseling interventions for motivating quit attempts among smokers not yet ready to quit.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Smoke at least once a day for the past 30 days
* Are willing to participate in all study components
* Sufficient language skills in English for counseling and assessments
* Has a home address
* Has a working phone number

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 6 months
* Currently using a smoking cessation medication
* Currently participating in smoking cessation program
* Motivated to quit smoking
* Planning to quit smoking in the next 2 weeks
* Lives in a home with someone currently enrolled in the study
* Minor
Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan

This study aims at investigation of the caregiver burden of Wet Age-related Macular Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural settings where public transportations are not readily available.


Eligibility Criteria:
Inclusion Criteria:

* \[Patients\]

  * Female and male out-patients diagnosed with wAMD.
  * Patients who are accompanied by his/her caregiver(s).
  * Patients who have been receiving anti-VEGF therapy with proactive regimen for 12 months or more at the participating site.
  * Providing informed consent for the participation in this study.
* \[Caregivers\]

  * Providing informed consent for the participation in this study.
  * Capable of understanding and completing the questionnaires without any help from others

Exclusion Criteria:

* \[Patients\]

  * Presence of a disease or a condition more disabling than wAMD in term of caregiving.
  * Presence of intractable neurologic disease, physical handicap, mental handicap, or any condition that rendered them unable to walk independently.
  * Intraocular surgery for other eye diseases after the start of wAMD therapy.
* \[Caregivers\]

  * Professional carers
Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome

This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* early infantile epileptic encephalopathy with HCN1 channel mutation
* control patients with no neurologic pathology (age, gender and body temperature matched)
* epileptic patients (age, gender and body temperature matched)

Exclusion Criteria:

* pregnant or breast feeding patient
Mister Parkinson: Educational Therapy in Parkinson's Disease (PD)

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. These can contribute to the burden of the disease on patients and their caregivers, and often remain unrecognized and untreated.

This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

Parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. A multidisciplinary and comprehensive approach, based on the chronic care model, is considered the best way to manage motor and non-motor symptoms of the disease, although this model of care is still not standardized and previous trials showed conflicting results.

The study planned to enrol 40 advanced PD patients and related caregivers for each investigational site. This was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic Parkinson's disease (according to UK Brain Bank criteria)
* being aged 20-80 years
* being able to complete questionnaires
* having no severe cognitive impairment (mini-mental state examination ≥24)
* having a stable caregiver

Exclusion Criteria:

* atypical parkinsonian
* severe comorbidity significantly interfering with quality of life
A Study of LY3002815 in Healthy Participants

The purposes of this study are to determine:

* The safety of the study drug and any side effects that might be associated with it.
* How much of the study drug gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the Clinical Research Unit (CRU) for 3 overnight stays.

This study involves a single dose of LY3002815 or placebo given as an injection into the vein. This study will last approximately 16 weeks including screening. Additional follow-up may be required.

This study is for research purposes only, and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination. Males will be required to use reliable method of birth control. Females have to be of non-child-bearing potential
* Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²) inclusive, at screening

Exclusion Criteria:

* Have family history of early onset Alzheimer's Disease (AD)
* Have impaired cognitive function
* Have significant abnormalities in brain magnetic resonance imaging (MRI); or have contraindications for MRI
* Have significant allergic reactions to LY3002815, or related compounds, or have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Women who are lactating
* Have clinically significant neurological or psychological illness, or other illnesses that could affect the study results