cyrilzakka/clinical-trials huggingface dataset:
Responding to Late Effects in Survivors of Childhood Cancer

Survivors of childhood cancer need ongoing support to navigate their needs after cancer treatment. Using technology may offer us new ways to collect and share information about cancer survivorship follow-up with young survivors, their carers, and primary care providers.

Through the support of the Kids Cancer Project, in Phase 1 of this study, will co-design an electronic survivorship 'portal' that links young survivors with their cancer treatment information, and health care teams. In later Phases we will implement and evaluate the survivorship portal.

The RECOVER study aims to develop and implement a comprehensive Model of Care for childhood cancer survivors, integrating technology and a human-centered co-design approach to provide continuous, holistic care. Our primary objectives are to assess the feasibility and acceptability of the RECOVER Model of Care in routine pediatric oncology practice. Secondary objectives include evaluating preliminary efficacy results and identifying factors that influence the successful adoption and integration of the model.

Data Sources: This project will be conducted in three settings in Australia. The study will use a mixed methods approach, starting with a feasibility study (Phase 1), following implementation science methods to assess the integration of the new Model of Care (Phase 2), and culminating in a Type 2 Hybrid Implementation/Effectiveness non-randomized controlled trial (Phase 3) to compare historical and prospective data. The quantitative component of RECOVER (non-randomized controlled study) will involve the use of digital technologies to (1) enable multimodal, real-world data collection, (2) provide patients and caregivers with an interactive, supportive digital interface, and (3) equip healthcare professionals with a comprehensive patient-monitoring system. The qualitative component will determine end-user feasibility and acceptability through focus group workshops, surveys, and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 15-39 years who have completed cancer treatment.
* Ability to read and understand English.
* Willingness to comply with study procedures and provide informed consent.
* Clinicians (doctors, nurses, allied health professionals) providing care through \*Queensland Health public hospitals

Exclusion Criteria:

* Patients deemed unsuitable by their clinical treatment team due to potential distress or lack of cognitive or communicative capacity.
* None specified, as long as they meet the inclusion criteria.
Radiochemotherapy and Interventional Radiotherapy in Vaginal Cancer

Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer

Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer

Eligibility Criteria:
Inclusion Criteria:

* Age more than18 years old
* Performance status 0,1
* Hystological diagnosis of squamous vaginal cancer
* HPV, p16, p53 status
* Stage I, II, III and IV (AJCC 2018th version)
* Stadiation with magnetic resonance and positron emission tomography
* Informed consensus

Exclusion Criteria:

* Age inferior 18 years old
* Performance status more than 2
* Previous cancer in the last ten years
* Previous radiation treatment in the region of interest
* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
* Presence of internal pathologies that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
* Presence of distant metastases in sites other than the pelvic lymph nodes
* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
Feasibility of Tight Blood Glucose Control With the Space TGC System in Surgical ICU Patients

Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an tight glucose control range (4.4 to 6.1 mmol/L) in surgical intensive care patients.


Eligibility Criteria:
Inclusion:

* age: \> 18 years of age
* stay in the ICU expected to be \> 20 h
* blood glucose \> 110 mg/dl or patient on insulin treatment

Exclusion:

* patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
* known or suspected allergy to insulin
* any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
* moribund patients likely to die within 24 hours
Acceptance and Commitment Therapy for Neuro-Oncology Wellbeing

Background. Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered Acceptance and Commitment Therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours.

Aims. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among young brain tumour survivors.

Method. This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control. Participants will be aged 11-24 years and survivors of brain tumours who have completed cancer treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The durability of treatment effects will be assessed by further follow-up assessments at 24-, 36- and 48- weeks. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically.

Discussion. This study will provide an initial assessment of the value of remotely delivered ACT in supporting recovery and coping for young people after brain tumour treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 11-to-24 years at the time of randomisation
* Received treatment for a brain tumour at a participating Principle Treatment Centre
* Active brain tumour treatment is complete and their condition stable for at least six-months
* Have sufficient cognitive ability to engage with ACT sessions as judged by the clinician at baseline assessment
* competent to provide informed consent (participants aged 16 or over) or assent (participants aged 11-15)
* Parent/carer competent to provide informed consent (for participants aged 11-15)

Exclusion Criteria:

* Received a structured behavioural intervention within six-months prior to study recruitment
* Previous or current alcohol/substance dependence, psychosis, suicidality, or eating disorder
* Moderate or severe intellectual disability, confirmed through researcher judgement at screening through questions relating to school type and previous diagnoses
* Immediate risk to self or others
* The patient or their parent/carer is not able to speak, read or write English
Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.

In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.

According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.

But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).

The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.

The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
* Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.

Exclusion Criteria:

* Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels\> 15 IU / ml, major surgery in the ovaries (removal), and age \<22 years and \> 40 years old.
* Active pelvic inflammatory disease
* IVF/ICSI with donor eggs
* Previous participation in this trial
Hypnoanalgesia for Dermatological Surgery in Children

This randomized clinical trial will evaluate the effect of hypnosedation on the need of sedation and analgesia in a pediatric population undergoing dermatological surgery, both during the procedure, and 24 hours after surgery. In addition, a secondary objetive is to evaluate the effect by specific age groups.

In this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a single center willbe randomised to receive hypnosis (intervention group) or attention-distracting techniques (control group). Endpoints will be the sedative dose (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately after surgery (recovery) and after 24 hours. Randomization will be systematic in blocks depending on the day the surgery is programmed. Hypnosis will be delivered by an experienced anesthesist trained in the technique. Patients and families will be informed of the special treatment during surgery, but will be unaware of whether the patients are experiencing distraction or hypnosis techniques. Distraction is already a useful technique, and it is expected that patients will be satisfied with the procedure; however, the hypothesis to be tested is that hypnosis reduces the need for sedation and analgesia compared to distraction techniques, as well as improves satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. A class I or II of anaesthetic risk according to the American Society of Anesthesiologists,
2. to be in a percentile between P3 and P97 in weight and height,
3. without known drug allergies, and
4. having fasted 6 hours for solids and 2 hours for water.

Exclusion Criteria:

1. Children with diagnosed mental retardation or attention deficit,
2. behavioural disorders,
3. previous treatment with hypnosis,
4. history of neurological pathology or psychomotor retardation,
5. previous pain-related pathology,
6. obstructive sleep apnoea syndrome (OSAS)
Virtual Visits for Results Disclosure

As part of this study patients who have undergone genetic testing in the Brigham and Women's Hospital Cardiovascular Genetics program will be randomized to receive the results of their genetic testing either by telephone call or virtual visit. At the completion of the telephone call or virtual visit patients will receive a survey to assess their understanding of their results and their satisfaction with their care.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergoing genetic testing at BWH Cardiovascular Genetics clinic

Exclusion Criteria:

* Reside outside of Massachusetts
* Telephone or internet access unavailable
Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).

This research is being done to study a combination of drugs for relapsed Hodgkin's Lymphoma (HL) that may be easier to tolerate than standard therapies and that does not involve an autologous blood or marrow transplant (BMT, also called a stem cell transplant).The study is for people with HL who have never received treatment for relapsed lymphoma, except for radiation therapy. Usually, when HL relapses for the first time, the standard is to receive combinations of chemotherapy, including an autologous blood or marrow transplant (BMT, also called a stem cell transplant) which has about a 40% cure rate. BMT may cure the HL, but also may be associated with serious side effects and risks. This research looks at a combination of drugs for relapsed HL that may not have the side effects of standard therapies and that does not involve BMT. The goal is to treat the lymphoma effectively with drugs that we expect will have fewer side effects, while avoiding a treatment like BMT.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 16 years
* Biopsy-proven diagnosis of classical Hodgkin Lymphoma (regardless of HRS cell CD20 expression) per the World Health Organization classification criteria24; lymphocyte predominant histology is excluded
* Untreated relapse of classical Hodgkin Lymphoma (with the exception of steroids) as follows:HL that relapsed \> 3 months after completion of first-line chemotherapy or combined modality therapy, and has not yet been treated with salvage chemotherapy, Stage I-II HL that relapsed \> 3 months after first-line chemotherapy, then relapsed after radiation therapy delivered with curative intent, and has not yet been treated with salvage chemotherapy
* Radiographically measurable disease (\> 1 focus of lymphoma measuring \> 1.5 cm)
* Baseline laboratories: ANC \> 1000/uL and platelets \> 75,000/uL, unless due to bone marrow involvement by lymphoma, Serum creatinine \< 2.0 mg/dL, Total bilirubin \< 2.0 mg/dL (excluding Gilbert's syndrome), unless due to lymphoma
* ECOG performance status 0, 1 or 2.

Exclusion Criteria:

* Active concurrent malignancy with the exception of superficial non-melanoma skin cancer and cervical carcinoma in situ.
* Primary induction failure, defined as failure to achieve CR with first-line chemotherapy or chemoradiation, disease progression during first-line chemotherapy or chemoradiation, or progression or biopsy-proven disease persistence within 8 weeks of first-line therapy completion
* Prior brentuximab vedotin or rituximab for lymphoma
* Grade \> 2 peripheral neuropathy
* HIV infection, active hepatitis B infection, or active hepatitis C infection
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent by parent(s) or legal guardian as required by local laws.
2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).
3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
4. In good health as judged by the Investigator.
5. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
2. Has unstable AD or any consistent requirement for high potency topical steroids.
3. Subjects who are unwilling to refrain from prolonged sun exposure for 4 weeks prior to Baseline/Day 1 and during the study.
4. Previous treatment with ARQ-151.
5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
6. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) subjects living in the same house.
Human Epidemiology of Newly Identified Arboviruses

A local network is being set up to study the impact of arboviruses in our region. It is committed to a one-health approach, in particular with research without a priori for new viruses hosted among vectors and wildlife. The candidates identified by high throughput sequencing approaches will serve as a basis for the development of serological and molecular tools for their detections. These tools will be used to assess the possible circulation of these new viruses in humans in biological collections created within the framework of this project Arbodocc

.


Eligibility Criteria:
Inclusion criteria:

- Patients admitted at the Monpellier University Hospital for any infectious syndrome compatible with an arboviral infection with samples available

Exclusion criteria:

- Informed consent non obtain for samples used
Feasibility Trial in Men With Hormone Sensitive Oligometastatic Prostate Cancer

Patients with hormone sensitive oligometastatic prostate cancer (≤ 5 metastatic tumours outside of regional pelvic nodes with no more than 3 in any organ system) and no previous treatment to prostate will be treated with intermittent androgen deprivation therapy +/- chemotherapy, stereotactic radiotherapy to all metastases, and either radical prostatectomy or radiotherapy.

Investigators propose to do a randomized feasibility trial comparing RP vs RT to the prostate in the setting of hormone sensitive oligometastatic prostate cancer. SBRT will be used to treat all of the metastases, and this will be combined with an intermittent ADT approach. Adding systemic chemotherapy will be allowed. Given the past difficulties of randomizing patients between RP and RT in localized prostate cancer studies (like SPIRIT), investigators feel a small feasibility project is the first step. In the setting of metastatic disease, where radical treatment is not routine standard of care, we hope that patients will be more inclined to accept randomization. If patients do not accept their assigned randomization (ie they prefer RP even though they are randomized to RT, or vice versa), they will still be treated with their prostate intervention of choice and followed for their outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* Histologic confirmation of prostate adenocarcinoma.
* Stage IV disease with ≤ 5 metastases outside of the pelvis.
* ≤ 3 metastases in any one organ system.
* ECOG performance 0-1.
* All metastatic tumours amenable to SBRT.
* Patient eligible for either RP or RT to the prostate.

Exclusion Criteria:

* Castration resistant prostate cancer.
* Previous RP or RT to prostate.
* Inability to treat all metastases with SBRT.
* Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed.
Assessment of Mandibular Osseous Changes in Patients With End Stage Renal Failure

This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT.

This study will be observational study. The goal of this study is to evaluate the quality of mandible and to assess the correlation between the jaw bone quality in a sample of Egyptian patients with chronic renal failure and duration of dialysis using CBCT. Twenty-six subjects will be included in this study. These will comprise (13) CKD patients "the study group" and (13) healthy patients "the control group" recommended for CBCT imaging for implant placement. The control group will be selected from the Prosthodontic department and Oral Medicine department of Faculty of Oral and Dental Medicine, Cairo University, the study group will be selected from Nephrology and the artificial kidney unit El Kasr -Al Ain Hospital, Cairo University.

Eligibility Criteria:
Inclusion Criteria:

* End stage renal failure (in study group)
* Undergone hemo-dialysis, three times/week (in study group)
* Duration of dialysis (≥1 year) (in study group)
* PTH (140-630)
* Age group (18-40 years)
* Mandible
* Free from any other systemic disease affecting the bone quality
* Egyptian population

Exclusion Criteria:

* Early stage of renal disease
* Patients with diabetes, hyperthyroidism, postmenopausal osteoporosis
* Maxilla
* Other language
* Completely Edentulous patients.