cyrilzakka/clinical-trials huggingface dataset:
Nourish Pilot & CoDesign Study

The purpose of the research study is to learn more about the best ways to teach cooking and food skills to adults, and how cooking classes may help reduce one's stress and food waste, as well as improve their diet.

Currently, 12.8% of Americans experience food insecurity, and food insecurity is associated with elevated perceived stress. Food literacy is proficiency in food-related skills and knowledge, including food preparation and cooking skills, basic nutrition knowledge, and the ability to prevent food waste. Recent research conducted in Australia suggests that food literacy interventions are associated with improved food security. Traditionally food literacy interventions take a recipe-based approach to culinary nutrition and lack information about key components of food literacy, such as food storage and food waste reduction techniques. However, recent research by the PI contends that recipes may be difficult for food insecure individuals to implement at home, given the challenge of procuring ingredients, suggesting the need for a new approach. In addition, food insecure households face additional environmental challenges, such as owning fewer cooking utensils, compared to food secure households. Based on the Social Cognitive Theory, the Nourish intervention addresses these limitations by incorporating food waste reduction, food storage knowledge, and improvisational cooking skills (cooking with what you have on hand) into food literacy and culinary nutrition education, as well as providing key cooking utensils. Eventually, the study team plans to test the impact of the Nourish intervention on food literacy, perceived stress, diet quality and food security to determine if food literacy interventions can positively impact perceived stress, diet, and food security. The present pilot study will test the feasibility and acceptability of the Nourish intervention and corresponding evaluation, as well as provide participant feedback on the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Ability to attend classes in person

Exclusion Criteria:

* Non-English speaking
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C

This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history of chronic hepatitis C and compensated liver disease
* No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with HBV or HIV

Other protocol-defined exclusion criteria may apply.
The Effectiveness of Patient Navigation in Cancer Care

Rationale: Supportive care such as physical therapy, psycho-social education, and dietary advice is likely to have a positive effect on the recovery and quality of life of cancer patients. Currently, not all patients know how to access supportive care, which results in unmet supportive care needs. This study determines whether these unmet needs can be reduced or prevented by a patient navigation intervention that focuses on timely screening and systematic monitoring of patient's supportive care needs.

Objective: The primary objective is to determine the effect of patient navigation on health related quality of life. Secondary objectives are: 1) to determine the effect of patient navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to determine the effect of patient navigation on patients' self-management; 3) to explore how patient navigation affects the cost-effectiveness of cancer care.

Study design: Longitudinal randomised controlled trial with two study arms: a patient navigation intervention and care as usual.

Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the Netherlands Cancer Institute.

Intervention : Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.

Main study endpoints: The main endpoint of this study is health related quality of life, which is defined as an individual's perceived emotional, social, physical, and functional wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to strongly benefit from consulting the patient navigator without being subjected to any severe risks. Consultations will be provided by highly qualified professionals, and result in benefits such as decreased severity of cancer-related psychosocial and physical distress. To minimise burden, face-to-face consultations will always be scheduled alongside other appointments of at the NKI-AVL. Furthermore, questionnaire completion takes no more than 30 minutes per data collection round, of which three are scheduled in this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with lung, melanoma, urology or gynecology related cancer
* Male or female
* Treated at the Dutch Cancer Institute
* Has not started treatment at the Dutch Cancer Institute
* 18 years of age and over
* Curative or palliative treatment
* Able to understands and speak Dutch

Exclusion Criteria:

* Not willing to sign the consent form
* Not willing to meet with the patient navigator
* Not willing to complete questionnaires at any point in time
Virtual Autopsy for Quality Control on Intensive Care Medicine

The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine.

The study aimed to compare CT-based virtual autopsy with classic autopsy as a tool for quality control in intensive care medicine. Especially with respect to complications during intervention like catheter pacement.

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* all patients dying in the icu during the study period

Exclusion Criteria:

* relatives refuse participation in the study
Behavioural Activation for Bipolar Depression

Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. Psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with BD. Behavioral activation therapy (BA) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. It helps people re-establish healthier activity patterns and sleep regulation, especially in BD for mood stabilization. BA is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering BA to people with BD.

The first aim of the current research is to implement BA for people with depression in Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do a pilot study on the effectiveness of the treatment for this patient group. The research will be implemented with people seeking treatment at the specialized service for bipolar disorder at Landspítali University Hospital in Iceland. The participants will receive treatment as usual and the BA will be adjunctive.

At least ten people, that are currently experiencing Bipolar Depression and are willing to take part, will receive up to 20 individual therapy sessions of BA that have been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews.

The study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.


Eligibility Criteria:
Inclusion Criteria:

* scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

meeting diagnostic criteria for Bipolar I or II Disorder DIAMOND) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator.

Exclusion Criteria:

* current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy
* current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali.
* currently lacking the capacity to give informed consent
* currently receiving other psychosocial therapy for depression or bipolar disorder
* presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)
Dynamic Infrared Thermography as an Alternative to CT Angiography

Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing radiation or contrast injection. The study evaluates if DIRT can be an alternative to computed tomographic angiography (CTA) in perforator mapping. DIRT findings are compared with hand-held Doppler, CTA and intraoperative findings.

In deep inferior epigastric perforator flap (DIEP) breast reconstruction the blood supply to the DIEP flap is reestablished by anastomosing the perforator to the internal mammary vessels. The selected perforator is crucial for flap survival as it is the only source of blood supply to the flap. CTA allows for precise anatomical description of the origin of perforators, their intramuscular course and point of fascia penetration but expose the patient to ionizing radiation and an intravenous contrast medium.

DIRT is an imaging method that does not require ionizing radiation or contrast injection. The study evaluates if DIRT can be an alternative to CTA in perforator mapping. The study is performed in a hospital where DIRT and CTA have been established preoperative imaging methods that have been used for several years as routine examinations for all DIEP breast reconstruction patients.

25 patients scheduled for secondary breast reconstruction with a DIEP flap are included. Preoperatively, the lower abdomen is examined with hand-held Doppler, DIRT and CTA. Arterial Doppler sound locations are marked on the skin.

DIRT examination involves rewarming of the abdominal skin after a mild cold challenge. The locations of hot spots on DIRT are compared with the arterial Doppler sound locations. The rate and pattern of rewarming of the hot spots are analyzed. Multiplanar CT reconstructions are used to see if hot spots are related to perforators on CTA and intraoperative findings.

When intraoperative findings confirm that a useful perforator is located at the same localization as indicated with DIRT, this perforator is used for DIEP breast reconstruction. Postoperatively the surgical outcome and possible complications related to the selected perforator are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for breast reconstruction with DIEP flap

Exclusion Criteria:

* Prior breast reconstruction / abdominal flap surgery
A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Type of Participant and Target Disease Characteristics

1. Advanced or metastatic RCC
2. Histologically confirmed, previously untreated (treatment-naive) RCC
3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
6. Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

Exclusion Criteria:

1. Medical Conditions

   1. Subjects with any active autoimmune disease or a history of known autoimmune disease
   2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
   3. Known HIV or AIDS-related illness
   4. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
2. Prior/Concomitant Therapy

   1. Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
   2. Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
   3. Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.

Other protocol defined inclusion/exclusion criteria apply
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

This study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (CTEPH) patients following surgical or percutaneous intervention. Eligible participants will be enrolled and have a 12 week home based exercise training program.

The study team hypothesizes that:

The following percentage of participants successfully complete the ramp-up phase of the exercise program:

* Greater or equal to 70% at end of week 7
* Greater or equal to 80% at end of week 10
* Greater or equal to 90% at end of week 12
* Greater or equal to 80% of participants will both complete ≥1 week of maintenance phase exercise and complete 12 weeks of the exercise intervention.
* Patients will have no adverse events, defined as syncope, worsening World Health Organization (WHO) functional class, pulmonary hypertension (PH) related hospitalization, or death, caused by the exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients post-Pulmonary Thromboendarterectomy (PTE) or Balloon Pulmonary Angioplasty (BPA)
* Planned follow-up at Michigan Medicine for at least one year
* Has access to an Android or iPhone with study supported operating software, is willing to install MyDataHelps application, and is willing to wear a smart watch while awake

Exclusion Criteria:

* Life expectancy under 1 year
* Orthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training session
* Currently receiving palliative care and/or in hospice care
* Persistent severe Right Ventricular (RV) dysfunction on echocardiography post BPA or PTE
* Recently completed, current enrollment, or planned enrollment in pulmonary rehabilitation
* Moderate or severe obstructive lung disease or restrictive lung disease
* Arterial oxygen saturation (SpO2) \<88% during 6 minute walk test(6MWT) on baseline home oxygen prescription
* Wrist too large to wear a smart watch comfortably.
* Participant noted to wear smart watch for less than 8 hours per day prior to intervention.
* Determined to be unsafe for participation in exercise therapy as assessed by the clinical team.
* Those with mobility issues that are unable to complete 6MWT.
* Participant has sex minute walk distance (6MWD) greater or equal to 90% predicted at visit 1.
* Pregnancy or lactation
* Non-English speaking
Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair

Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Eligibility Criteria:
Inclusion Criteria:

* children age 1 month- 20 years old with recurrent TEF.
* Failure of surgical repair.
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors

The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (N=36) A subset (n=10) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
2. At least one domain of neurocognitive function \>1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
3. \>1 month post brain surgery and/or radiation therapy, if applicable
4. Estimated premorbid intelligence \>75.
5. Patients must be age 18+ and primarily English speaking

Exclusion Criteria:

1. Presence of major neurocognitive impairment that would prevent participation in the intervention, and/or severe aphasia, and/or inability to understand and provide informed consent
2. Inability to attend weekly telehealth appointments; based on EAB results
3. Clinically significant insomnia symptoms
4. \< 1 month post brain surgery and/or radiation therapy
5. Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
6. To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.
Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.

Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total Body Surface Area (BSA), and affected area on the limb and/or trunk ≥ 1% BSA. The long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively.
* In good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs.
* Men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. Female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study.
* Have signed a written informed consent before entering the study.

Exclusion Criteria:

* Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis.
* Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Drug-induced psoriasis.
* Present with or had historical interstitial lung disease.
* In the opinion of the investigator, the subjects were not considered appropriate candidates.