cyrilzakka/clinical-trials huggingface dataset:
Nutrition Health Literacy of Cancer Patients and Their Support Networks.

An exploration of the impact of nutrition literacy on ability of cancer patients and their support networks to get, understand and use nutrition information during cancer treatment.

The study is composed of two component projects:

Project A: Validation of a NLit tool for UK population.

NLit tool is a measurement tool developed at Kansas University to measure nutrition health literacy. It assesses the following functional literacy skills: numeracy \& literacy and the following nutrition knowledge fields: macronutrients, food labels, portion sizes, food groups and consumer skills.

This project has two phases:

Phase A: Nominal consensus groups x 2 - consumer adaptation and tool review for UK use and pilot testing of electronic tool.

Phase B: Testing adapted tool in a group of cancer patients for statistical validation.

Project B: Planned survey of people with cancer and their families to explore experiences of access to nutrition information

This survey is a combination of validated and unvalidated questions built on models of nutrition health literacy. With validated fields being used to evaluate and understand responses to unvalidated questions.

It explores access to nutrition information, self-efficacy, confidence, health care infrastructure and support with nutrition information, population demographics, food security, sources of nutrition information, perceived practical skills and knowledge base.

Eligibility Criteria:
NLit-UK development

Inclusion Criteria:

* Members of the public (carers, health service users, lay persons)
* Cancer patients with confirmed diagnosis
* Friends or family members supporting a patient with a confirmed diagnosis of cancer
* \> 18 yrs old
* Received cancer treatment at Nottingham University Hospitals between Jan 15 and March 20

Exclusion Criteria:

* Paediatrics \< 18yrs at the time of diagnosis and treatment
* Unconfirmed diagnosis of cancer
* Patients on watch and wait
Maternal Vitamin D Status and Neonatal Bone Strength

Objectives:

1. To determine the incidence of vitamin D deficiency among Israeli pregnant women
2. To access whether maternal vitamin D status affects infant bone strength.

Methods:

1. Vitamin D levels -in cord blood and maternal blood
2. The mother will fill a demographic and nutritional questionnaire

   The Infants:
3. Growth assessment of the infants: weight length and head circumference
4. Bone strength measurement by Quantitative Ultrasound (Sunlight Omnisense 7000/8000TM)


Eligibility Criteria:
Inclusion Criteria:

* mother-baby pairs,
* birth week 35-42.
* Jewish and Arab women that read and understand Hebrew.

Exclusion Criteria:

* large neonatal congenital defects.
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).


Eligibility Criteria:
Inclusion Criteria:

* Is a male or female between the ages of 18 and 65 years, inclusive.
* Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
* Has been on a daily chronic treatment for ≥ 6 weeks.
* Is willing to use a smartphone study application to record study assessments and AEs.
* Has body weight more than 15 kilogram (kg).
* Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
* If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
* Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
* Is willing and able to provide written informed consent prior to participating in the study.
* Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
* At screening, has stable vital signs in the following ranges (after 5 minutes of rest):

  * Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
  * Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
  * Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)

Exclusion Criteria:

* Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
* Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
* Has had significant traumatic injury or major surgery within 30 days prior to study screening.
* Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
* Has participated in a clinical trial within 30 days prior to the first dose of study drug.
* Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
Patient-controlled Sedation in Port Implantation (PACSPI-1)

The purpose of this prospective, observational study is to assess the feasibility of patient-controlled sedation (PCS) for implantation of subcutaneous venous ports (SVP).

The main objective of this trial is to study the feasibility of (PCS) with propofol and alfentanil during SVP implantation.

Participants included in the study are able to administer a combination of propofol and alfentanil using a patient-controlled sedation pump. This allows the patient to self-control their sedation/analgesia during SVP implantation. The pump enables the patient via a hand-held button to trigger the release of a single bolus. A bolus of 0.5ml programmed into the pump contains a combination of 4.5mg propofol and 25µg alfentanil and is administered under a 7 second period resulting in a maximal amount of 8 bolus doses per minute.

Each SVP implantation procedure is separated into four time points at which sedation scores are recorded. Patients are monitored by anaesthesia staff and SVP implantation is performed by an anaesthesiologist according to hospital protocol.

Participants are asked to fill in a written questionnaire to indicate pain score and satisfaction with the procedure when ready for discharge.

Adverse events, time consumption and operators satisfaction with implantation conditions are recorded periprocedural.

The result of this trial will provide guidance for a larger randomized trial (PACSPI-2) comparing several clinically relevant aspects of the use of PCS and local anesthesia (LA) versus LA alone during SVP implantation.

Eligibility Criteria:
Inclusion Criteria:

• Adult patients (≥18 years) scheduled for SVP implantation at Ryhov County Hospital.

Exclusion Criteria:

* Inability to operate the PCS apparatus,
* Inability to communicate in Scandinavian languages.
* Patients who require general anaesthesia or patients eligible for local anaesthesia only (i.e. severe sleep apnea).
* Propofol or alfentanil allergy.
* Intake of food (or clear fluids) within six (or two) hours prior to the procedure.
* Failure to achieve peripheral vascular access.
* Pregnancy
Chemotherapy Plus Surgery in Treating Children at Risk of or With Stage I Wilms' Tumor

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for stage I Wilms' tumor.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and surgery in treating children who are at risk of or who have stage I Wilms' tumor.

OBJECTIVES: I. Determine the initial extension of disease, surgical procedures, gross and histological morphology, treatments, clinical outcome, and late consequences of therapy after treatment with neoadjuvant chemotherapy, surgery, and adjuvant chemotherapy with or without maintenance chemotherapy in patients with intermediate risk or anaplastic stage I Wilms' tumor. II. Determine the safety and effectiveness of reduced chemotherapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients receive dactinomycin IV on days 1-3 and 15-17 and vincristine IV on days 1, 8, 15, and 22. Patients then undergo surgery about a week after completion of chemotherapy. After surgery, patients receive vincristine IV on days 1, 8, 15, and 22 and dactinomycin IV on days 8-12. Patients are then randomized to one of two treatment arms after week 9. Arm I: Patients receive dactinomycin IV on days 1-5 of week 10 and vincristine IV on day 1 of both weeks 10 and 11. This course is repeated during weeks 17 and 18. Arm II: Patients receive no further treatment. Patients are followed every 3 months for 3 years, then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 350 patients (175 per treatment arm) will be accrued for this study within 7-8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Initial diagnosis of a unilateral tumor with clinical and radiological characteristics of a nephroblastoma Histologically proven stage I Wilms' tumor after neoadjuvant treatment and surgery Intermediate risk or anaplastic No detectable distant metastases 4 weeks after adjuvant chemotherapy

PATIENT CHARACTERISTICS: Age: 0.5 to 17 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent.
* Patients must already be receiving DYNEPO treatment at time of study entry.
* Patients who are likely to receive DYNEPO for at least 1 year.

Exclusion Criteria:

* Known intolerance to EPO of any of its excipients
* Known of suspected Pure Red Cell Aplasia (PRCA)
Effect of an Anti-ageing Supplement on Oxidative Stress

This pilot study serves to investigate whether ProManna intake leads to any changes in baseline levels for oxidative stress markers. In addition, biomarker responses following oxidative stress challenge tests will be assessed in subjects taking ProManna versus placebo supplements.

Ageing is characterized by a progressive decline in the efficiency of physiological function and by the increased susceptibility to disease and death. Most ageing-associated diseases develop silently for many years before symptoms appear, leading to irreversible pathological conditions. Examples of these diseases are Alzheimer's, Parkinson's, osteoporosis, diabetes, cardiovascular disease and also cancer. Typically, patients are treated when most of the damage has already occurred, and existing drugs can rarely cure these diseases, but merely slow down further progression of the disease. Therefore, preventive measures that may delay the onset of these diseases can hold the best promise for healthy ageing. of the most plausible and acceptable explanations for the mechanistic basis of aging is the "free radical theory of aging". This theory postulates that aging and its related diseases are the consequence of free radical-induced damage to cellular macromolecules and the inability to counterbalance these changes by endogenous anti-oxidant defences. ProManna is a novel and safe food supplement that aims to decrease free radical-induced damage, thereby contributing to healthy ageing.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteer aged ≥ 60 to ≤ 70
2. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, cycling-racing, swimming)
3. Stable weight and no intention to lose weight until completion of the study (three times a day: a normal eating pattern).
4. Two weeks before the start and during the study no use of over the counter medication, prescribed medication, herbal medication or dietary supplements which in the investigator's opinion could affect study results, or which could be affected by the study product (i.e. absorption of oral medication will be influenced by D-Mannitol). Exception for sporadic use of paracetamol and/or treating an AE.
5. Able and motivated to comply with protocol requirements like for instance take the investigational product the way it is prescribed and to do the tests.
6. Voluntary signed written informed consent form (ICF) before the start of the pilot.

Exclusion Criteria:

1. BMI \< 25 or \> 30 kg/m2
2. Not being able to fast overnight (12 hours)
3. Diabetes mellitus
4. Gastrointestinal disorders
5. Undergone digestive tract surgery (except appendectomy)
6. Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study)
7. Weed smoking
8. Donation of blood within the last 3 months prior to admission to the clinic
9. Participation to another clinical study within 90 days before enrolment
10. Clinically relevant abnormalities in clinical chemistry or positive HIV, HbsAg and/or HepC at screening
11. Positive drug screen or alcohol breath test at D-1
The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors

The Effects of Labor Stages and Interventions on Hemodynamic Measures During and After Childbirth ( Epidural, Rupture Membranses Cesarean Sections and Preeclampsia) With Noninvasive Sensors.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman between 18-45 years old
* with non cardiovascular disease

Exclusion Criteria:

* woman with a cardiovascular disease
* woman who don't agree to participate in the trial
Voice Activated Personal Assistant for Depression Among Older Adults

Participants will use Amazon Alexa to test a new voice-assisted program for mental health management. The participant will use this program to help with goal setting, reminders, and various other services. The participant may be supported by a caregiver, if available, or by research team member who will serve as a coach for the duration of the study to guide them with using the program. Participants will be asked to complete surveys and assessments about their experiences during the 12-week study period. Participants will be randomized into two groups: those who receive a guide to help them with utilization of the program to its fullest potential and those who do not receive that guide.

Older adults have often been on the fringe of benefiting from technology. However, voice-controlled intelligent personal assistants (VIPAs; e.g. Google Home, Amazon Echo), with their natural interaction style and ease of use, are a simple interface technology that may be useful to older adults with depression in the home setting. The caregiver or coach will be able to schedule and follow the interactions between the older adult and the VIPA. The VIPAs would potentially be able to provide functional, cognitive, and social stimulation as well as improve anti-depressant medication adherence through reminders to older adults.

The aim is to evaluate a VIPA that was designed to deliver behavioral activation prompts to older adults with depression. Through user centered design (UCD), the investigators have adapted the model for remote support with the aid of VIPAs that provide psychoeducation, as well as features that support social, cognitive, and functional stimulation and reminders.

The intervention will be 8 weeks, with a 4-week follow-up. During 8-week intervention, participants will be able to use Amazon Echo Show 8 and the study's VIPA program to set goals, reminders, and the like to help with their mood. Participants will also be asked to completed associated assessments. If caregivers are involved, they will also be asked to complete assessments.

Eligibility Criteria:
Inclusion criteria:

* Adults 65 years or older
* English-speaking
* Elevated depressive symptoms (PHQ-9 ≥ 10)
* Have Wi-Fi access
* Cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥17)

or

Inclusion criteria:

* Adults 18 years or older
* English-speaking
* Provide support to an older adult (65 or older)
* Have access to Wi-Fi
* Demonstrating capacity to consent
* Cognitively intact (Montreal Cognitive Assessment (MOCA) score ≥17 if 65 years or older)
High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. There are different tools to correct them, like spectacles, contact lenses, and refractive surgery. Many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. In the present study we want to investigate the variability and reproducibility of prelens and postlens tear film thickness measurements.


Eligibility Criteria:
Inclusion criteria

* Men and women aged over 18 years
* Soft or rigid contact lenses wearers
* Schirmer Test ≥ 10 mm/5 min
* Tear Breakup Time (TBUT) ≥10 seconds

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating
Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Eligibility Criteria:
Inclusion Criteria:

1. They are aged between 18-39 years.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They can attain at least 6/9 in each eye with their spectacle refraction.
5. They have successfully worn contact lenses within six months of starting the study.
6. They can be fitted with toric soft contact lenses to match the available power range.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Cognitive Effects of Immediate Release Topiramate vs Extended Release Topiramate in Patients With Migraine

Crossover, randomized, double blind: Q12h dosing in both periods; matching placebo for evening dosing during XR treatment; target dose: 100mg

The primary objective is to compare the effect of treatment with an immediate-release topiramate (IR-TPM), namely Topamax®, to an extended-release topiramate (XR-TPM), namely Trokendi XR®, regimen on cognition in adults with migraine.

The secondary objective is to determine the factors that explain inter-individual variability in cognitive response. Pharmacokinetic and demographic factors will be explored. Variability in cognitive response between individuals can be large. A population approach (nonlinear, mixed effects) will be used to determine drug exposure response relationships.

Eligibility Criteria:
Inclusion Criteria:

1. Established history of episodic migraine with or without aura, as assessed by International Headache Society criteria, for at least 6 months before screening and frequency of 3 or more headache attacks per month during the past 3 months
2. Male or female, ages 18-65
3. Women are required to be postmenopausal, surgically incapable of bearing children, or practicing a medically acceptable method of birth control (i.e., double barrier method, IUD, Mirena, etc) for at least 1 month before study entry through 30 days following last dose.
4. If postmenopausal and on hormone replacement therapy (HRT) then must to be on a stable regimen for at least 2 months (continuous stable regimen of cyclic or non-cyclic HRT); negative pregnancy test.
5. Native English speakers (due to speech and language analysis)
6. Montreal Cognitive Assessment (MoCA) score equal to or greater than 26.

Exclusion Criteria:

1. Onset of migraine occurred after age 50 years, or overuse of analgesics or migraine specific agents for the acute treatment of migraine episodes; examples of analgesic overuse included the following: more than 8 treatment episodes (episode defined as any calendar day of usage) of ergot containing medications a month; more than 8 treatment episodes of triptans a month; or more than 6 treatment episodes of potent opioids a month.
2. Required, continued use of the following medications for any medical reason during the study: beta-blockers, benzodiazepines, tricyclic antidepressants, antiepileptics, calcium channel blockers, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs) daily, opioids, agents for insomnia (e.g., Ambien, diphenhydramine-containing OTC products); corticosteroids, local anesthetics, botulinum toxin within last three months, or herbal preparations such as feverfew or St John's wort. However, subjects will be permitted to be on a stable regimen of a selective serotonin reuptake inhibitor or SNRI for 3 months or more for depression and/or anxiety.
3. A history of nephrolithiasis
4. Have previously taken topiramate
5. Received an experimental drug or used an experimental or approved device for migraine prevention (e.g., TENIS unit) within 30 days of screening