cyrilzakka/clinical-trials huggingface dataset:
An Escape Room Intervention to Help Improve Breast Cancer Patients' Ability to Navigate Online Access to Nutrition Information

This clinical trial evaluates an educational escape room intervention for improving awareness of and concern about breast cancer misinformation and reducing vulnerability to believing cancer misinformation among patients with stage I-III breast cancer. Misinformation, or communication about health information that is inaccurate or false, can have serious health consequences for those that believe it. The rise of the access to and use of various sources of information on the internet such as websites and social media has caused the spread of misinformation and disinformation to grow rapidly, resulting in negative consequences on health outcomes. Cancer misinformation, in particular, has become an increasingly prevalent issue that poses a real threat to the many cancer patients in the United States. The educational escape room intervention is a game designed to teach participants how to discern whether cancer nutrition information is accurate or may potentially be misinformation. Participants are immersed in the narrative while solving puzzles to learn key themes such as the need to talk to their doctors, looking for scientific studies, as well as avoiding fads and trends, miracle cures, anecdotal evidence, and targeted and clickbait ads.

OUTLINE:

Patients complete a baseline before playing the virtual cancer nutrition information escape room game. Patients then play the virtual misinformation escape room game consisting of 5 puzzles and a final task over 30-45 minutes on study. Following the escape room game, patients complete a post-game survey and debrief interview (15 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* English speaking
* Able to provide informed consent
* Have access to a computer (desktop or laptop)
* Have been previously diagnosed with breast cancer (Stages I-III) and currently in active treatment for breast cancer
Safety and Efficacy of Nyxol With Pilocarpine Eye Drops in Subjects With Presbyopia

The objectives of this study are:

To evaluate the efficacy of Nyxol + Pilocarpine to improve DCNVA in subjects with presbyopia


Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥ 40 and ≤ 64years of age.
2. BCDVA of 0.0 LogMAR(20/20 Snellen equivalent) or better in each eye under photopic conditions.
3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse under photopic conditions in each eye and binocularly.
4. Subjects who depend on reading glasses or bifocals in which their binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better.

Exclusion Criteria:

Ophthalmic (in either eye):

1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening until study completion.
3. Current use of any topical ophthalmic therapy for dry eye.
4. Tear break-up time of \< 5 seconds or corneal fluorescein staining.
5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
6. Recent or current evidence of ocular infection or inflammation in either eye.
7. Any history of herpes simplex or herpes zoster keratitis.
8. History of diabetic retinopathy or diabetic macular edema.
9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations.
10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
11. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to Screening. Any subject with multifocal intraocular lenses are excluded.
12. History of any traumatic (surgical or nonsurgical) or non traumatic condition affecting the pupil or iris.
13. Unwilling or unable to discontinue use of contact lenses.
14. Conjunctival hyperemia ≥ grade 2 on the CCLRU 4-point scale.

    Systemic:
15. Known hypersensitivity or contraindication to alpha- and/or beta adrenoceptor antagonists.
16. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agents.
17. Clinically significant systemic disease that might interfere with the study as deemed by the Investigator.
18. Participation in any investigational study within 30 days prior to Screening.
19. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
20. Resting HR outside the specified range of 50 to 110 beats per minute.
21. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)

An open label 1:1 randomized phase II exploratory study investigating use of ctDNA-guided adjuvant chemotherapy compared to standard of care (SOC) after local treatment for metastatic colorectal cancer.

Patients are randomized 1:1 between SOC and ctDNA guided treatment and follow-up.

Escalation therapy comprises standard regimen of Fluorouracil (5-FU), Irinotecan and oxaliplatin (FOLFOXIRI), de-escalation therapy of monotherapy capecitabine or observation only. SOC is per institutional practice, based on national guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)
* No evidence of further disease based on pre-treatment work-up according to SOC
* Age at least 18 years
* Eastern Cooperative Oncology Group performance status 0-2
* Clinically eligible for adjuvant triple CT at investigators decision.
* Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)
* Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
* Written and verbally informed consent

Exclusion Criteria:

* Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis
* Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy
* Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade \> 1
* Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
* Pregnant (positive pregnancy test) or breast feeding women
* Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine
PET Evaluation of Response After 1 Course of Chemotherapy as Predictor of Treatment Outcome.

Study hypothesis : early decrease in fdg-pet measured SUV max after 1 cycle of chemotherapy can accurately predict response of chemotherapy as assessed by conventional radiology after 3 cycles of chemotherapy.

FDG-PET imaging will be done at J0 and J14 of a new line of chemotherapy treatment in metastatic colorectal cancer.

SUV max will be recorded and delta SUVmax will be compared to the results of conventional radiological evaluation after 3 courses of chemotherapy. Results will also be compared to the time to disease progression.

statistical hypothesis : Sample size calculation for FDG-PET in metastatic patients.

In the paper of Cascini et al. \[1\], they have 18 patients with a TRG response (TRG = Tumor Regression Grade) and 15 patients with no response.

SUV mean was measured at baseline and at day 12 in all 33 patients. All 33 patients showed a reduction in SUV-mean from baseline to day 12. The median reduction in SUV-mean was 63% (mean 66%) in responding tumors and 22% (mean 22%) for non responding tumors. Using a cutoff level of 52% a perfect accuracy could be obtained, i.e. all responding tumors had a SUV-mean reduction higher than 52% and all non responding tumors had a SUV-mean reduction lower than 52%.

(Standard deviation of the SUV-mean reduction was 25.) All 33 patients showed also a reduction in SUV-max from baseline to day 12. The median reduction in SUV-max was 62% in responding tumors and 28% in non responding tumors. (No information about mean or standard deviation of SUV-max available in \[1\].) Based on the data of SUV-mean we can do a power calculation based on the Wilcoxon test: In order to demonstrate an absolute difference in the mean of ΔSUV-mean of 44% between responding and non responding patients, with an estimated standard deviation of 25, using 35 patients (50% response, 50% no response), at a significance level of 5%, we obtain a power of 0.98.

For SUV-max, if we assume that the difference in the means is similar to the difference in the medians, i.e. 34% and the standard deviation is similar to the one of SUV-mean, i.e. 25, we obtain a power of 0.93 If we, to be safe, are a little bit less optimistic and estimate that the difference in the mean of ΔSUV-max between responding and non responding tumors would be a little lower than in \[1\]: 35%, and the standard deviation a little bit higher: 30, then we need 40 patients at a power of 0.90

Référence 1 : Cascini GL, Avallone A, Delrio P, Guida C, Tatangelo F, Marone P et al.: F-18-FDG PET is an early predictor of pathologic tumor response to preoperative radiochemotherapy in locally advanced rectal cancer. Journal of Nuclear Medicine 2006, 47: 1241-1248.

Eligibility Criteria:
Inclusion Criteria:

* advanced colorectal cancer
* evaluable disease
* signed informed consent

Exclusion Criteria:

* no other cancer
* no other life-threatening condition
* unwillingness or inability to sign informed consent
* active cerebral metastasis
Zeit Alert for Stroke at Home (ZASH) Protocol

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use.

Eligibility Criteria:
Inclusion Criteria:

1. New ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the reason for current hospital admission or stroke clinics visit. Time from ictus to enrollment should be ≤ 2 weeks;
2. RRE-90 \> 2;
3. Age ≥ 18 years old;
4. Patient is discharged to home;
5. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population;
2. Treatment with another investigational drug or intervention within the last two (2) weeks prior to start of this study, if said drug/intervention is expected to interfere with the normal function of the Halo Alert System;
3. Does not have WIFI internet access in their home;
4. Does not have access to a smartphone;
5. Open traumatic injury on the head;
6. Allergy to any of the components of the headband, such as the fabric of the band (88% Rayon, 9% Nylon, 3% Spandex), the electrode surfaces (conductive silver ink.)
Rehabilitation of Cancer Survivors in Denmark: The Effect of a Psychosocial Rehabilitation Course

This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at a Danish rehabilitation centre for cancer survivors. The investigators hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Worldwide, the number of cancer survivors is increasing. In the Danish population of 5.4 million people, more than 300 000 are cancer survivors. Given the range of physical, psychological and social late effects of cancer and its primary treatment many survivors need tailored rehabilitation interventions. This randomized study evaluates the effect of a multi-focused, psychosocial 6-day residential rehabilitation course at the Dallund Rehabilitation Centre in Denmark. We hypothesize that individuals in the intervention group will experience better psychosocial well-being and more adaptive health behaviour changes as compared to individuals in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast, colorectal or prostate cancer
* Completion of primary treatment
* Ability to participate physically in the activities offered in the intervention

Exclusion Criteria:

* Acute need for treatment
* Terminal cancer phase
Evaluation of the Parent Centre's Positive Parenting Skills Training.

The purpose of this study is to determine whether the Parent Centre's Positive Parenting Skills Training (PPST), a parenting programme being delivered in South Africa, is effective in improving parenting, and child behaviour related outcomes.

The evaluation of the PPST will assess both the fidelity of the intervention's implementation, as well as the outcomes of the programme in a randomised controlled trial. Programme facilitators and intervention group participants will provide data for the former. For the outcome evaluation, two types of participants will be recruited who will provide self-report data: primary caregivers (n = 80) and where possible another adult living in the home with this primary caregiver and their selected child (n = 60). This "other adult" data will serve to verify the primary caregivers' self-report data. Both participants will provide demographic information, and report on parenting behaviour and child behaviour. Their data will be analysed separately in intention to treat analyses and secondary analyses which consider moderators of programme effectiveness.

Eligibility Criteria:
This study will include two types of participants: (1) primary caregivers and (2) another adult. Both have separate eligibility criteria.

Inclusion Criteria:

1. Primary caregivers (the person most responsible for the well-being of a child)

   * Has a child between the ages of 5-12 years
   * Looks after this child for a minimum of four nights a week
   * Indicated interest in the programme and expressed willingness to enrol in the study
2. Another adult in the household (if available)

   * Lives with the index child (selected by the formerly mentioned caregiver) for at least four nights a week

Exclusion Criteria:

(1) Primary Caregiver

- Has already participated in the Parent Centre's Positive Parenting Skills Training or the Parenting and Leadership Training
Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial

Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.

In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:

Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.

Patients referred for hemithyroidectomy will be randomized to either:

(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for thyroid lobectomy
* Age \> 18
* Able to understand patient information
* Able to give informed consent

Exclusion Criteria:

* Completion lobectomy
* Need for accelerated surgery
* Age \< 18
* Unable to understand patient information
* Unable to give informed consent
Intern Health Study 2021

The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.

Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and compete with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.

The primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score.

Eligibility Criteria:
Inclusion Criteria:

* Medical intern during the 2021-2022 internship year
* Enrolled in study by the start of internship (7/1/22)

Exclusion Criteria:

* None
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in Taiwan

The study is designed as a prospective, observational study to assess the effect of adalimumab on health-related quality of life (QoL) and work productivity in patients with rheumatoid arthritis (RA) in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR/the European League against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
* Male or female subjects \>= 18 years of age (local definition according to adalimumab label) who is in compliance with eligibility for adalimumab based on the local label.
* Patients with moderate to severe RA defined as Disease Activity Score in 28 Joints (DAS28) Erythrocyte Sedimentation Rate (ESR) or DAS28 C- Reactive Protein (CRP) \>3.2
* Biologically treatment naïve and initiated adalimumab at baseline visit
* Availability of clinical data of the previous 12 weeks prior to baseline
* Ability to self-complete patient questionnaires
* Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

* Patients who are pregnant or breast feeding at enrolment or wish to become pregnant in the next 24 weeks.
* Participation in any RA-related clinical trial at the time of enrolment, at baseline or at any point during the past 24 weeks prior to baseline
* Patients, who in the clinician's view, may not be able to accurately report their QoL or prior resource utilization
* Patients, who in the clinician's view, may not be able to adhere to adalimumab therapy over 24 weeks.
Lifestyle On-line Intervention in Patients With Obesity and Hypertension

This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Design: Randomized Controlled Trial.

Healthy eating and regular exercise play an important role to maintain health while ageing. Nutritional education and exercise practice could be monitored by different means, such as Internet, face to face and/or through exercise diaries. Information and Communication Technologies (ICTs) could be a useful tool to promote health, and could be used to work on barriers, such as low motivation and difficulties to maintain exercise or diet. ICTs also have other important advantages, especially their good cost-benefit relationship and the possibility of increasing the efficiency of interventions, allowing them to reach a wider audience at a lower cost. This study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. Participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. Assessment will include: body composition (BMI), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity (BMI= 25-35 kg/m2)
* Hypertension

Exclusion Criteria:

* Not having access to the Internet or lack of information about it.
* Treatment with more than 3 antihypertensive drugs.
* Diabetes Mellitus Diagnosis.
* Meet the criteria of the DSM-IV-TR of a Food Disorder.
* Presenting some type of severe psychiatric disorder.
* Disability that prevents or hinders physical exercise.
* Be receiving some treatment for weight loss in another center.
Clinical Trial to Evaluate the Efficacy and Safety of DA-8031 in Male Patients With Premature Ejaculation

This study is designed to evaluate the efficacy and safety of DA-8031 and to decide the optimal dose of DA-8031 in male patients with premature ejaculation after oral administration on-demand.

The investigators hypothesized that newly-developed DA-8031 would effect in delaying ejaculation in patients with premature ejaculation (PE).

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged with premature ejaculation for more than 6 months.
* PEDT score ≥ 11

Exclusion Criteria:

* IIEF-EF domain ≤ 21
* Serum Creatinine ≥ 2.5 mg/dl
* AST, ALT \> 3\*Upper limit of normal
* Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>180/100mmHg)
* Subjects with chronic depression, psychiatric or schizophrenia,
* Subjects with alcohol, drug or substance abuse