cyrilzakka/clinical-trials huggingface dataset:
Study of PRoliferation and Apoptosis in Rectal Cancer, Predictive & Prognostic biOmarkers: Histopathology and Imaging

This study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the Royal Marsden Hospital between 2011 and 2013, who have an mrTRG score at post-chemoradiotherapy MRI. It is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.

The investigators hope to validate the apoptotic and proliferative index as a predictive response marker and lend support to mrTRG as a putative prognostic tool in the treatment pathway for rectal cancer patients. Even though this is a retrospective study, the investigators hope that pre-treatment apoptotic and proliferative scores will correlate to post treatment response and mrTRG scores. In doing so, the investigators can predict how patients will respond to treatment from initial diagnostic biopsies and foresee a patients individual treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on CT and MRI).
* Tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery.
* Patients must have had a pre- and post-treatment MRI scan of the rectum and pelvis.
* We must have access to stored tissue for each patient

Exclusion Criteria:

* No pre-operative radiotherapy
* Patients with synchronous tumours
* Patients under the age of 18 years
Picosure Alexandrite Laser for the Treatment of Unwanted Tattoos

The purpose of this study is to evaluate the Picosure Laser System for the treatment of unwanted tattoos.


Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old.
2. Is willing to consent to participate in the study.
3. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
4. The tattoo must include red pigment.

Exclusion Criteria:

1. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. Is hypersensitive to light exposure OR takes photo sensitized medication.
3. Has active or localized systemic infections.
4. Has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to the heavy use of aspirin {greater than 81 mg per day}).
5. Has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
6. Is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
7. Has used Accutane within 6 months prior to enrollment.
8. Has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
9. Has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
10. Has a history of keloids.
11. Has evidence of compromised wound healing.
12. Has a history of basal cell carcinoma, squamous cell carcinoma or melanoma.
13. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications or has an autoimmune disorder.
14. Is allergic to topical lidocaine or topical steroids.
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)

A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.

This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
* Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.

Exclusion Criteria:

- Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
Assessment of the Clinical Efficacy and Acceptability of Think Positive (T+) in Diabetes Management

New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. More recently the focus has been moving to portable systems equipped with Bluetooth. This study consists of evaluating an application called the Think Positive (T+) diabetes management software. It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system. The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 and type 2 diabetes patients
* Insulin requiring patients
* Sufficiently fluent in english
* HbA1c \> 7.5
* Last visit with Diabetes Specialist Nurse (DSN) \< 12 months

Exclusion Criteria:

* Psychiatric disorders
* Poor vision or/and lack of manual dexterity
* Prior use of T+
* Participation in another ongoing trial
* Patients with antenatal/gestational
* Patients who are in transition between the children services and adult services Insulin pump users
Methotrexate and Temozolomide Versus Methotrexate, Procarbazine, Vincristine and Cytarabine

The purpose of this study is to evaluate two types of chemotherapy for primary central nervous system lymphoma in the elderly (age older than 60) :

* Methotrexate, procarbazine, vincristine and cytarabine
* Methotrexate and temozolomide

The aim of the study is to evaluate efficacy and toxicity associated with both protocols in this population, without radiotherapy.

Patients will be randomized to receive one of the two regimens in one of the participating centers. Neuropsychological evaluation will be performed in all patients. Patients will be followed with serial MRIs.

Eligibility Criteria:
Inclusion Criteria:

* primary central nervous system lymphoma histologically confirmed by brain biopsy, CSF cytology or vitrectomy
* KPS 40 or higher
* Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
* Leucocytes\>3.500/mm3, platelets\>130.000/mm3, Bilirubin \< 2 mg, transaminases \< 2.5 N), creatinine \< 150 μM/l, creatinine clearance \> 40 ml/min
* Age ≥ 60 years
* Negative HIV test
* Signature of informed consent

Exclusion Criteria:

* previous cranial radiotherapy
* prior chemotherapy for primary central nervous system lymphoma
* presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
* systemic lymphoma (outside the CNS)
* Isolated ocular lymphoma
* Immunosuppressed patients (HIV , use of immunosuppressors)
* Other uncontrolled or progressive disease compromising shot-term survival
* Severe renal or hepatic disease
* Patients not legally covered by the French Social Security
* Inability to swallow the medication
Fall Risk Assessment Using Hybrid Machine Learning and Deep Learning Approaches and a Novel Posturography

The purpose of this project is to combine a novel posturogrpahy based on HTC VIVE trackers and hybrid machine learning and deep learning algorithms to establish a set of simple, convenient and valid fall risk assessment tool. This observational and follow up study will community elderly aged over 60 years old. The investigators will collect demographic data, questionnaire surveys, traditional balance tests and the tracker-based posturography to obtain the trunk stability parameters in different standing task. The fall risk will be classified according to self-reported falls n the past one year and verified in a 6-month follow up. The investigators will evaluate the performance of different hybrid machine learning and deep learning algorithm to extract the important features of multiple posturographic parameters and select an optimal model. The investigators will use the receiver operating characteristic curve analysis to compute the sensitivity, specificity and accuracy of different algorithms for risk classification and also compare the performance with traditional balance assessment tools.

The purpose of this project is to combine a novel posturogrpahy based on HTC VIVE trackers and hybrid machine learning and deep learning algorithms to establish a set of simple, convenient and valid fall risk assessment tool. This observational and follow up study will community elderly aged over 60 years old. The investigators will collect demographic data, questionnaire surveys, traditional balance tests (Berg Balance scale, Timed-up-and-go, 30s-sit-to-stand, four-stage balance tests) and a tracker-based posturography to obtain the trunk stability parameters in different standing task. The fall risk will be classified according to self-reported falls in the past one year and verified in a 6-month follow up.

The investigators will evaluate the performance of different hybrid machine learning and deep learning algorithm to extract the important features of multiple posturographic parameters and select an optimal model. The investigators will use the receiver operating characteristic curve analysis to compute the sensitivity, specificity and accuracy of different algorithms for risk classification and also compare the performance with traditional balance assessment tools. The investigators will evaluate the correlation of these posturographic features and data obtained by other methods. Risk factors of previous falls and future falls will also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* can walk in the household without device independently

Exclusion Criteria:

* with terminal disease
* with cognitive impairment to follow verbal instruction
* with neurological conditions that are associated with leg weakness
* with significant visual impairment that interferes with daily living and walking
Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated With Immuno-Oncotherapeutics

The researchers doing this study are interested in doing the following:

* Biomarker research using fresh tumour tissue and normal blood cells, and if required, tumour tissue already collected.
* Bio-banking for use in future research using the collected tumour tissue / blood .

This study is being done to enable the collection and study of these samples. The results will also look at information on how participants with this type of cancer who received immunotherapy responded to treatment.

Bio-banking is the collection, storage, and use of human body samples and related health information for future research. It provides an important resource for health research locally, across Canada, and around the world. The researchers doing the main study also are interested in storing any left-over tissue and/or blood samples that have not been used up for future research. The research that may be done on these samples in the future is unknown at this time.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to submit a blood sample for buffy-coat and at least one tumour biospecimen.
* CAN-PREDICT-IO subgroup:

Provision of pre-treatment fresh tumour biopsy/resection tumour tissue for patients who will receive IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.

OR

* CAN-PIVOT subgroup:

Provision of on-treatment or at-progression fresh tumour biopsy/resection tumour tissue for patients who have received IO treatment, in a specified list of IO therapeutic trials currently active in CCTG.

There are 2 CAN-PIVOT subgroups: Primary resistance is defined as disease progression evident in initial on-treatment imaging or disease stability lasting less than six months. Acquired resistance, on the other hand, manifests as disease progression subsequent to an initial partial or complete response or after a period of disease stability lasting six months or more. Patients on adjuvant treatment, wit no evidence of disease (NED) by radiological assessment who develop disease (local recurrence or metastases) after or while on immunotherapy are included.

* Archived formalin fixed paraffin embedded (FFPE) blocks or slides would only be collected from patients who met CAN-IMPACT-IO study criteria and underwent fresh tumour biopsy/resection following consent but had a tumour specimen deemed insufficient for WGTS. The FFPE sample may be used to provide an alternate source of tumour tissue for WGTS in such cases. Where local centre regulations prohibit submission of blocks of tumour tissue, a predetermined number of unstained slides of representative tumour tissue may substitute the tumour block.
* Participant consent for the CAN-IMPACT-IO study must be appropriately obtained in accordance with applicable local and regulatory requirements.
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device

This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up.

The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture
* Subject who received an information form and is willing to participate in the study

Exclusion Criteria:

* Contraindications described in the instructions for use
* Usual surgical contraindications
* Subject who is not able to express his/her non-opposition
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).


Eligibility Criteria:
Inclusion criteria:

1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
2. Patients who have completed Phase II double-blind study (E2020-J081-431).
3. Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Exclusion criteria:

1. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or who underwent brain surgery causing unsolved deficiency.
2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.
Prophylactic Effect of a CANDIDA Mouthwash, Containing the Curolox™ Peptide

In vitro results showed a protective effect against acids for the mouthwash containing Curolox™ peptide. The goal of this in situ study is to detect the Curolox™ peptide under natural oral conditions on the tooth surface and to proof the in vitro results obtained. So far there are no effect and safety data of the Curolox™ mouthwash under natural oral conditions available.

The primary objective of the study is the detection of the Curolox™ peptide on the bovine enamel sample (proof-of-concept) under in vivo conditions after rinsing with the peptide-containing mouth wash.

Secondary Objectives

The secondary objectives of the study are:

1. safety and tolerance of the mouthwash in participants
2. identification of the duration the Curolox™ peptide is present on the bovine tooth surface under in vivo conditions
3. identification of the most effective mouthwash rinsing volume (2.5 mL or 5 mL)
4. prophylactic effect of multiple applications of the mouthwash confirmation of the prophylactic effect of the Curolox™ peptide obtained in in vitro study

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and to follow the study procedures and instructions
* Willing to wear a dental appliance for 7 days
* Willing and able to attend the on-study visits
* Good oral hygiene throughout the study
* Written informed consent before participation in the study

Exclusion Criteria:

* Volunteer with an active periodontal disease or periodontal surgery \< 1 year prior to study participation
* Volunteer with hypersensitive teeth or with any other (painful) oral pathology or defect
* Volunteer with an orthodontic appliance
* Volunteer undergoing a medical treatment
* Volunteer who is allergic to dental products
* Pregnant and lactating woman
* Concurrent participation in another clinical trial
Stress Management and Biological Age in Breast Cancer Patients.RCT

Intense stress has harmful effects on the body, contributing to various disorders. Breast cancer patients experience a build-up of stress due to their diagnosis and treatments. Stress can cause epigenetic changes in a cellular level (such as accelerated increase in biological age) that may negatively affect oncological treatments.

This study aims to investigate the effect of stress management, specifically the Pythagorean Self-Awareness Intervention, on telomere length in T-leukocytes of breast cancer patients after completing all treatments except hormonal therapy. The study involves self-referred questionnaires, hair cortisol collection, and blood material extraction.

Understanding the role of stress management in breast cancer may lead to improved patient outcomes and survival rates.

Distress can have serious effects on the human body and is known to contribute to various disorders, including cardiovascular diseases. In the case of breast cancer, patients often experience a build-up of stressful events throughout their journey with the disease, such as diagnosis, surgery, chemotherapy, radiotherapy, survival, and dealing with side effects of anticancer therapy.

Many studies have shown that psychological stress is closely related to increased cortisol levels in the body. This stress may lead to epigenetic changes in telomere length, the action of telomerase, the function of T-leukocytes, and the response of pro-inflammatory cytokines, all of which play significant roles in the treatment of oncological patients.

Considering these factors, managing stress becomes crucial, as it can not only indirectly affect the disease's outcome but also impact survival. This scientific protocol aims to investigate the impact of a holistic stress management program on the telomere length of T-leukocytes in the peripheral blood of women diagnosed with breast cancer.

The stress management technique to be employed is the Pythagorean Self-Awareness Intervention, which will be administered only after completing all cancer treatments, except for hormonal therapy. The methods that will be followed include distributing self-referred questionnaires to assess stress and lifestyle, collecting hair cortisol samples, and extracting genetic (DNA) material to study the telomere length of T-cells from peripheral blood.

By studying the impact of stress and its management on telomere length in breast cancer patients, this study aims to contribute to a better understanding of how stress affects health outcomes and potentially provide insights into improving patient care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary breast cancer
* Completion of anticancer therapy (except for hormonal therapy)

Exclusion Criteria:

* Psychiatric diagnosis and treatment
* Metastasis
* Previous participation in any stress management and health promotion study
* Inability to read or write in Greek