cyrilzakka/clinical-trials huggingface dataset:
Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children

This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.

PRIMARY OBJECTIVES:

I. To test the feasibility of the study protocol in advanced cancer patients (recruitment/retention, dosage and fidelity of the intervention; program acceptability of program; and logistics).

II. To evaluate the short-term impact of the program on the diagnosed parents' and children's adjustment using a within group design (pre- and post-test design).

III. To compare outcomes from the Enhancing Connections Program with outcomes obtained from the completed Phase III trial (between group design).

OUTLINE:

Patients participate in Enhancing Connections Program comprising of anchoring patients to help their child, adding to listening skills, building on listening skills, being a detective of their child's coping, and celebrating success for 5 sessions. Patients also receive workbook which includes text from the sessions, handouts, and at-home assignments to be completed between sessions.

Eligibility Criteria:
Inclusion Criteria:

* Parents will be eligible if they have a diagnosis of incurable cancer of any type
* Read and write English among their languages of choice
* Have a child 5-17 years old living at home who has been told their parent's cancer diagnosis
* The child does not have learning challenges

Exclusion Criteria:

* Parents will be excluded if they are enrolled in hospice at time of enrollment; (however, they will be allowed to continue in the study if they enroll in hospice after beginning the study)
* Parents will be ineligible if their child lives in the home less than 50% of the time
Validation of an Oncology-specific Instrument to Measure Care Coordination

The overarching goal of the project is to use a mixed-methods research design to assess the validity of a new instrument developed to assess cancer patients' perceptions of care coordination across varied care settings.

This proposed cancer care delivery research project aims to validate a new instrument (CCI; cancer care coordination instrument) designed to assess cancer patients' perceptions of care coordination. Care coordination (CC) is important for all patients, and it is especially important for cancer patients as they have complex episodes of care, multi-disciplinary interventions, prolonged duration of care, and an overall high symptom burden. Further, CC is critical for cancer patients due to several transition points between stages of care (diagnosis, treatment, survivorship, and end of life), varied settings of care (inpatient, ambulatory), and multiple physicians (medical, surgical, radiation oncologists) and other healthcare providers (e.g., oncology nurses, primary care physicians, physicians/nurses' assistants) providing care.

A CCI validated in ethnically/racially diverse samples can be utilized to identify potential targets for intervention and improvement in CC for specific populations and to reduce or eliminate the disparities in cancer health outcomes. Validation of the CCI under this proposal will have widespread applicability to oncology care across varied practice environments and will form a foundation for the creation of similar tools for other chronic and complex conditions.

Eligibility Criteria:
Inclusion Criteria:

* Active therapy for cancer, defined as a minimum of three exams or therapy visits over a preceding three-month period.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

-
Skills to Enhance Positivity in Young Adults

The goal of this study is to test the feasibility and acceptability of a positive affect intervention for suicide in a population of young adults. Skills to Enhance Positivity (STEP) has been demonstrated to be feasible and acceptable among adolescents when delivered individually. The current study aims to test feasibility and acceptability in a group setting of young adults. The specific aims of STEP also seek to establish whether participants who received STEP report a significant increase in attention towards positive affect compared to those receiving Treatment As Usual (TAU). They also seek to explore whether participants who received STEP will report a significant decrease in suicidal ideation and depression compared to those receiving TAU. The final aim is to explore whether an increase in attention to positive affect regardless of condition is a potential mechanism of change for reductions in suicidal ideation and depression. Participants will be randomized into STEP or TAU groups, they will complete baseline and follow-up assessments after a period of 3-months. Participants enrolled in STEP will receive in-person group sessions focusing on psychoeducation of positive affect as well as skills in mindfulness, gratitude and savoring designed to promote positive affect. After completing the group sessions they will also receive text messages for one month, where they will receive prompts to practice skills they learned in the group setting.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a recent history of depression and are English-speaking
* Participants also must have a cell phone with text-messaging capabilities

Exclusion Criteria:

* Participants who have acute psychotic disorders or cognitive deficits that would preclude full understanding of the protocol, intervention and assessment materials
Body Surface Area Prediction Impacts on Ventricular Dilatation Prevalence

The goals of this observational study are to investigate the accuracy of different predictive equations for body surface area (BSA) estimation and to evaluate the impact of different BSA normalizations on ventricular dilatation prevalence in youth soccer players. Two convenience samples of young soccer players of both genders will be recruited. Acquisition of optical images (for the players of the first sample), two-dimensional echocardiographic assessment (for the players of the second sample), and weight and height measurements (for the players of both samples) will be performed. BSA estimates will be derived from optical images (for the players of the first sample) and from ten different predictive equations obtained from the literature (for the players of both samples). Comparisons between optical imaging - derived BSA and BSA estimates obtained with the ten predictive equations will be performed for the players of the first sample. Absolute and relative values of different echocardiographic variables will be considered for the players of the second sample to assess the ventricular dilatation prevalence.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* regular sports participation

Exclusion Criteria:

- athletic heart syndrome
Lumbar Spinal Fusion - Web-based Platform Targeting Anxiety and Depression

The purpose of the present study is to investigate the effect of a Web- based Platform (WP) on anxiety and depression and health economics among patients undergoing lumbar spine fusion (LSF).

This study will seek to reduce pre- and postoperative anxiety, depression and functional impairments using alternative cognitive and educative methods, targeting the underlying factors for development of anxiety and depression.

It is known that there is a rationale behind using Cognitive Behavioural Therapy (CBT) in order to reduce pre- and postoperatively anxiety and depression. The main assumption within CBT is that patients´ perceptions create their thoughts and beliefs, which influence their feelings and subsequently their behaviour. The features of WP in this study will seek in several ways to exceed this expected behaviour modification. The preliminary choices of features on the WP are made in order to prevent catastrophic images and thereby reduce anxiety and depression. The WP will offer patients non-catastrophic images through animated information mirroring the course of treatment, which will aim to influence their beliefs, feelings and their behaviour.

To examine the effect of the WP versus conventional information and course of rehabilitation, on patients' degree of anxiety and depression, a randomized controlled trial will be preformed. A total of 114 patients scheduled for elective instrumented LSF will be included and randomly assigned to the control group or to the intervention group receiving access to the WP.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to have a one-three level instrumented Lumbar Spinal Fusion

Exclusion Criteria:

* Age below 18, known psychiatric disorder, prior LSF, as the success rates of re-operations are found as low as 35%, inability to communicate in Danish and finally patients with no internet connection.
The COOKER-BLADDER Trial

The goal of this interventional study is to test the influence of food intake with characteristics of the urinary bladder. The main questions it aims to answer are:

* How does food intake modify the characteristics of urothelial cells?
* Does change of specific diet regimes influence biomarker characteristics in urine? Participants will follow specific diet regime for a given time period. After completion of this period biomarker assessment is performed. Thereafter the participants follow an opposite diet regime for the same time period with identical biomarker assessment at the end.

Biomarkers within the participants and between the diet regimes will be compared to investigate the influence of food intake on the urinary bladder.


Eligibility Criteria:
Inclusion Criteria:

* no daily medication
* no ongoing medical treatment

Exclusion Criteria:

* Chronic disease
* Regular medication
* Not willing to follow diet instructions
Verapamil in Supraclavicular Brachial Plexus Block

Supraclavicular brachial plexus block (SCBPB) is the common approach to provide surgical anesthesia of upper limb. The effects of single-injection brachial plexus nerve blocks recede after several hours unmasking the moderate to- severe pain of the surgical insult.

Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, a2 agonists (i.e. clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone.

The investigators will use calcium channel blocker as adjuvant to bupivacaine in supraclavicular block. Calcium plays an important role in analgesia produced by local anesthetics. The activation of N-methyl-D-aspartate receptors may lead to calcium entry into cells and potentiation of spinal cord and plays a role in pain formation. Hence, calcium channel blockers may prevent central sensitization and provide better sensory motor block characteristics. Verapamil, a calcium channel blocker can potentiate analgesic action of local anesthetics and reduce postoperative pain and analgesic consumption. Few studies were there using 2.5 mg of verapamil, showing no effect on onset and duration of sensory motor block. Hence, the investigators have used 5 mg of verapamil as adjuvant to bupivacaine. The primary aim of the study was to know whether verapamil (5 mg) as adjuvant to bupivacaine in supraclavicular brachial plexus block would delay the need of rescue analgesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients older than 18years and scheduled for forearm and hand surgeries like :

  1. fracture radius and ulna.
  2. cut wrists.

Exclusion Criteria:

1. allergy to the study drugs,
2. skin infection at site of needle puncture,
3. significant organ dysfunction, coagulopathy, drug or alcohol abuse, epilepsy, and psychiatric illness that would interfere with perception and assessment of pain.
Vision Response to Dopamine Replacement

The purpose of the study is to evaluate and document physiologic and functional changes in visual performance and retinal function of patients diagnosed with albinism (a dopamine deficiency state) following a trial of oral Levodopa/carbidopa treatment.

In this study the investigators propose that the retina itself in albinism is deficient in dopamine, and vision improvement will occur as a result of improved retinal function in response to the deficient neurotransmitter dopamine. This study has a pretest-posttest design in order to determine if improvement in vision is in response to replacement of deficiency (dopamine). The electroretinography (ERG) testing and optical coherence tomography (OCT) will be critical determinants to confirm vision improvement as a result of improved retinal function, but are not primary outcome data. Main outcome measures will be collected at pre-treatment, 1 month, 3 months, and 4 months. Change in visual acuity as measured in logMAR by Snellen or sweep visual evoked potential (SVEP) after 3 months of treatment is the primary outcome. Patients include OCA1a patients, OCA1b, OCA2, and unclassified Oculocutaneous albinism (OCA). OCA1a patients clinically are known to have the worst vision, and physiologically have the lowest (or absent) levels of tyrosinase function (Dopamine Production). All patients will be treated with Levodopa/carbidopa 4mg/kg/day in three divided doses.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of oculocutaneous albinism
* age over 3 and weight over 25 lbs.

Exclusion Criteria:

* ocular only albinism
* ocular pathology other than albinism
* neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy
Exercise in Patients With Advanced Non-small Cell Lung Cancer

Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.

The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.

The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.


Eligibility Criteria:
Inclusion Criteria

* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria

* Severe cardiopulmonary disease (EF\<30%)
* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases
* Expected life expectancy \< 3 months
* Bone metastases with acute risk of fracture
* ECOG (Eastern Cooperative Oncology Group) performance status \> 2
* Acute pulmonary embolism
* Acute myocardial infarction
* Requiring surgery for aortic aneurysm
* Tension pneumothorax
* Lack of proficiency in the German language
* Active infection
Acceptability and Tolerance Study of New Oral Nutritional Supplement

* To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).

To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES ROME (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
* Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
* Patients expected to require oral nutritional supplementation for at least 2 further weeks.
* Informed consent obtained.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Patients requiring a milk free diet
* Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
* Patients with significant renal or hepatic impairment
* Patients with swallowing impairment requiring thickened fluids
* Patients with inflammatory bowel disease or previous bowel resection.
Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance

Dietary protein is a key element of most effective weight loss regimens. This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.

This is a randomized study comparing the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly State of Slim group classes. Subjects will be followed in the study for one year. The Colorado Diet consists of 3 phases: phase 1 (week 1-2), phase 2 (weeks 3 - 8), and phase 3 (weeks 9 - 16). The maintenance phase lasts from months 5 - 12. Body weight will be monitored at each study visit and body composition will be determined using DXA. Blood lipid and lipoprotein concentrations, health \& wellness questionnaires, and fitness measures will also be assessed throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 27-40
* Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
* Generally healthy
* Able to exercise 70 minutes per day at moderate intensity
* Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.

Exclusion Criteria:

* Pregnant or trying to become pregnant.
* Diagnosis of type 1 or type 2 diabetes
* Individuals following a vegetarian only diet
* Food allergies (to soy, dairy, wheat/gluten, or peanut)
* Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or OTC weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study.
* Known renal disease
* Clinical hypothyroidism
* Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
* Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
* LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.
Visual Outcomes for Toric Efficacy Study

This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 39 years of age (inclusive)
* Able to read and understand the study informed consent
* Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye
* 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye
* Best corrected acuity of 20/25 or better in each eye
* No history of ocular pathology or surgery
* No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia)
* No gas permeable lens wear for at least 1 month
* No systemic or ocular contraindications for contact lens wear
* Not pregnant/lactating (by self-report)

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.
* Pregnant/lactating women (by self-report)
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
* Patients with a measurable lesion by contrast CT
* Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
* Patients who have not previously received intra-arterial hepatic chemotherapy

Exclusion Criteria:

* Patients receiving the herbal medicine shosaikoto
* Patients with autoimmune hepatitis
* Patients with a history of hypersensitivity to OPC-18 or other interferon preparations