cyrilzakka/clinical-trials huggingface dataset:
Investigation of Vitamin Levels During Phototherapy

Research project in which blood samples of patients undergoing UVB phototherapy for the treatment of different cutaneous diseases will be investigated for changes of folate levels and further vitamins over the course of treatment.

UVB phototherapy is used to treat a plethora of different dermatoses with a favorable side effect profile compared to systemic alternatives. One rarely mentioned issue related to phototherapy is the question of whether it holds potential to decrease folate serum levels, which is of particular interest to women of childbearing age, as birth defects, such as neural tube defects (NTD), cardiac defects, and facial clefting have all been noted to be increased in women with folate deficiency. Several studies, involving different patient groups and modes of phototherapy, have investigated the changes of folate levels throughout therapy showing mixed results. While two small open studies from Egypt showed a significant reduction of folate levels after 24 and 18 / 36 exposures (1-2), several other studies failed to show a significant change (3-6). In addition, there are also conflicting data on the influence of UVB phototherapy on vitamin D, vitamin B12 and homocysteine levels. Therefore, the presented prospective trial aims at investigating the changes of these vitamins during a routine course of phototherapy. The study will focus on the following specific aims: Measure the levels of folate as well as the levels of further vitamin parameters (including homocysteine, 25-OH-vitamin D3, 1,25-OH-vitamin D3, holotranscobalamin and methylmalonic acid) before and during phototherapy (at baseline, after 12, 24 and 36 exposures and/or at the end of treatment)

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing UVB phototherapy (narrowband UVB or broadband UVB)
* Male and female participants minimum 18 years old
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* Regular sunbed use
* Underlying disease with abnormal folate metabolism (e.g. thalassemia)
* Age below 18 years
* Patients who will not be able to attend regularly for treatment
MILES-02: Study of Chemotherapy Treatment and Toxicity in Elderly Patients With Advanced Non Small Cell Lung Cancer

The main purpose of this study is to describe activity and toxicity of single-agent gemcitabine given as prolonged infusion, and of two 2-drug combinations containing cisplatin (cisplatin + vinorelbine, and cisplatin + gemcitabine) in the treatment of elderly patients with advanced non small cell lung cancer

The study design includes three parallel phase II studies, all with the same rules for patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the three studies through a randomization procedure, to reduce selection biases.

Arm A: gemcitabine:

Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 \& 8 of each cycle, every 21 days, for a maximum of 6 cycles.

Arm B: cisplatin + vinorelbine:

Vinorelbine 25 mg/m² on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.

Arm C: cisplatin + gemcitabine:

Gemcitabine 1000 mg/m2,, on days 1 \& 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of each cycle, every 21 days, for a maximum of 6 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of NSCLC
* Stage IV or IIIB with pleural effusion or metastatic supraclavicular lymphoadenopathy
* Age \> o = 70 years.
* Written informed consent.

Exclusion Criteria:

* Performance status (ECOG) ³2
* Previous chemotherapy.
* Symptomatic brain metastases requiring synchronous radiotherapy
* Previous radiotherapy (completed less than 4 weeks before enrollment)
* Previous or synchronous malignant disease (except adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) if diagnosed in the last five years before enrollment.
* Neutrophils \< 2.000/mm³ or platelets \< 100.000/mm³ or hemoglobin \< 10 g/dl.
* Serum creatinine \> 1.5 times the UNL.
* GOT and/or GPT \>1.25 times the UNL or serum total bilirubin \>1.25 times the UNL without hepatic metastases.
* GOT and/or GPT \>2.5 times the UNL or serum total bilirubin \>1.5 times the UNL with hepatic metastases.
* Other concomitant diseases contraindicating the study treatments.
* Refusal of written informed consent.
* Follow-up impossible.
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients

The purpose of this study is to evaluate effectness of Tramadol Hydrochloride/Acetaminophen SR Tab. and Tramadol Hydrochloride/Acetaminophen Tab. in patients with low back pain.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males/Females aged over 20 years
2. Patient with low back pain who needs analgesic administration
3. Patient with low back pain Who correspond with Class 1, 2 in Quebec Task Force Classification
4. Pain VAS Value over 40 mm
5. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Patients with severe GI tract disorder, liver disease, renal disease, heart disease, hypertension
2. Patients with obvious secondary cause(metastatic cancer, fracture, infectious disease)
3. Patients who had taken back surgery within 24 weeks from the screening point
4. Patients who had taken opioid drug, psychotropic drug within 4 weeks from the screening point
5. Patients who had taken steroid drug(oral, injection) within 4 weeks from the screening point
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding

In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:

1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy

11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.

Eligibility Criteria:
Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study

* Female
* Age ≥18
* Negative serum pregnancy test for women of child bearing potential
* Signed study-specific informed consent

Exclusion Criteria:

* Unable to perform breath-holding of adequate duration.
* Unable to lie prone for approximately one hour during the study procedure
* Breast implants
* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
* Positive serum pregnancy test
* Mastectomy
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

This is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.

TAS-120-404 is a nonrandomized, open-label, multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study.

Patients who are still receiving futibatinib as monotherapy or as combination therapy, are deriving clinical benefit with no undue risk as assessed by the investigator, and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
* Ability to take medications orally (PO) (feeding tube is not permitted).

Exclusion Criteria:

• Has met any discontinuation criteria within the antecedent futibatinib study.
Self-Monitoring Assessment in Real Time

The purpose of the study is to test the effectiveness of two different methods of mobile dietary self-monitoring for weight loss. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using an assigned mobile applications (for their smartphone), which will be randomly assigned.

This study will include an intensive phase for 6 weeks and a follow-up phase that will occur through the final 6 months of the study. Participants will attend one 1-hour orientation meeting at the beginning of the study and a 2-hour baseline assessment and training meeting. A final assessment will be conducted at the end of 6 weeks with a follow-up assessment at 6 months. Everyone in the study will be asked to listen to 2 podcasts per week. Each of the podcasts will take about 15-20 minutes to listen to and so participants should expect to spend 30-40 minutes each week listening to podcasts. Participants also will be randomized to track diet with one of the two mobile dietary tracking applications that will be used in the study. Participants will be encouraged to monitor their exercise and body weight.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18-65 years old
* Own and use a smartphone and/or a tablet with a data plan that is apple of Android compatible
* BMI must be between 25-49.9 kg/m2
* Must be willing to reduce caloric intake and increase physical activity
* Not currently participating in a weight loss study or has been in a weight loss study that involved podcasts or diet apps

Exclusion Criteria:

* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Diagnosed with stroke or heart attack
* Diagnosed with diabetes that is controlled using medication
The Prone Breast Radiation Therapy Trial

Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size.

After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life.

This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

The risk of moist desquamation in large breasted women remains unacceptably high and reactions tends to be severe and produce significant permanent and delayed side effects. Evidence suggests that the use of a prone breast IMRT technique has the potential to decrease the risk of moist desquamation in large breasted women to the levels that are now seen when average/smaller breasted women are treated with supine IMRT. As prone breast XRT is currently only offered at 6 of 15 of the Ontario Cancer Centres polled for the purposes of providing motivation for this study, a multicentre RCT is feasible to confirm and quantify the improvement provided by the prone technique and provide Level 1 evidence for it to be adopted world-wide.

Eligibility Criteria:
Inclusion Criteria:

* confirmed histological diagnosis of breast carcinoma or ductal carcinoma in situ (DCIS);
* treated with BCT;
* no indication for treatment of regional LN;
* Women with a bra size of 40 inches or greater, or a pre-surgery cup size of D or greater

Exclusion Criteria:

* Regional Lymph Node XRT indicated;
* Bilateral breast cancer;
* unhealed wound (skin not closed and/or infection);
* previous XRT to the same breast;
* unable to lie prone;
* presence of active connective tissue disease;
* pregnancy;
* unacceptable heart exposure (as measured by \> 10% of the heart receiving 50% of the prescribed dose, i.e. V25Gy \> 10%);
* adequate coverage of postoperative tumour bed not technically possible
DIAGALS: Relation Between Tar DNA Binding Protein(TDP)-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease

In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of several studies and the modulatory effect of TDP-43 on the Nrf-2 pathway. Since both TDP-43 and Nrf-2 proteins are present in the peripheral blood mononuclear cells (PBMC) of ALS patients and may be correlated with disease progression, the investigators wish to explore their relationship and their application in the clinic as potential blood biomarkers for ALS.


Eligibility Criteria:
Patients group :

Inclusion Criteria:

* Men and women ≥ 18 years old
* Person affiliated to a French social security scheme or equivalent
* ALS diagnosed according to El Escorial criteria
* Diagnosis of ALS \< 6 months
* Onset of symptoms \< 2 years
* Signed informed consent

Non-inclusion criteria :

* Pregnant or breast-feeding
* Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
* Unbalanced diabetes
* Long-term corticosteroid therapy
* Persons deprived of their liberty by judicial or administrative decision; Persons under legal protection: guardianship or curators
* Genetic mutations associated with ALS

Control group :

Inclusion criteria:

* Male or female volunteer aged 18 or over
* Person affiliated to a French social security scheme or equivalent
* Signed informed consent

Non-inclusion criteria :

* Pregnant or breast-feeding women
* Treatment with oral or injectable anticoagulants, antiplatelet agents (except aspirin at the maximum authorized dosage of 160 mg per day)
* Unbalanced diabetes
* Long-term corticosteroid therapy
* Neurological diseases
* Patient under legal protection (safeguard of justice, curators and guardianship), or in a situation of deprivation of liberty
* Genetic mutations associated with ALS
Art Therapy to Address Hospital Clinician Burnout

A structured group art therapy intervention, comprising six 60 - 90-minute weekly workshops.

The CHArt group art therapy intervention builds on a 6-week art therapy group intervention piloted with Barts Health oncology and palliative care doctors (Tjasink, M. 2019). It incorporates elements of workshops delivered for staff support by Barts art therapists during the Covid-19 pandemic (Tjasink, M., Stevens, P. 2022).

The intervention is broadly informed by affective neuroscience and evolutionary psychology theories with an emphasis on compassion-focused and resource-oriented therapeutic practice. Whilst the intervention draws on diverse influences, it aligns with the principles of Compassion Focussed Therapy (CFT), an integrative, bio-physiological psychological model underpinned by evolutionary theory.

Intervention elements include psycho-education, individual art making, collaborative group art making, art making in pairs, exploring a range of art materials and techniques (including clay, paint, natural objects and non-traditional mark - making materials), art-based grounding exercises and reflective discussion.

The intervention manual was developed by the study's Chief Investigator with input from a group of three art therapy experts (Health and Care Professions Council (HCPC) accredited art therapists working in National Health Service (NHS) medical contexts with experience of delivering art therapy - based staff support) and three experts by experience (Health Care professionals with experience of participating in art therapy - based staff support groups at work). Adherence to the intervention will be monitored through two adherence tools (therapist self reported and independent observer).

Eligibility Criteria:
Inclusion Criteria:

* • Healthcare professional employed in a patient facing clinical role by Barts Health NHS Trust or Barts Bank partners

  * 18 years or older
  * Willing and able to provide informed consent
  * Able to attend the group intervention sessions
  * Moderate to severe risk scored on any of the three MBI - HSS subscales or on the PSS 10:
  * emotional exhaustion score of ≥17, or
  * depersonalization score of ≥7, or
  * personal accomplishment score of ≤ 38 or
  * perceived stress (≥ 14)

Exclusion Criteria:

* • Unwilling or unable to give consent

  * Diagnosed with or treated for a serious depressive condition, a personality disorder or psychosis in the past 12 months. (Self-reporting through screening.)
  * Attempted suicide or made plans to commit suicide in the past 12 months. (Self-reporting through screening.)
  * Individual does not provide direct patient care for Barts Health NHS Trust
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.


Eligibility Criteria:
Inclusion Criteria:

* History of erectile dysfunction for at least 3 months.
* Currently have diabetes mellitus of at least 3 months duration.
* Agree to not use any other ED treatment during the study.
* Anticipate the same female sexual partner for the study.
* Must be willing to make the required number of sexual attempts.

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates or potent CYP3A4 inhibitors
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Have kidney or liver problems
Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of invasive ductal or lobular breast cancer.
* Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
* no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
* Performance Status ECOG \<2
* Age \> 18 years
* Tumor \> 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky \>50%
* Lab test :

  * Absolute neutrophil count \> 1,500/mm3

    * Total Bilirubin ≤ 2×ULN
    * AST and ALT ≤ 2.5×ULN
  * serum creatinine ≤ 1.5×ULN

Exclusion Criteria:

* Pregnant or breast feeding patients are excluded
* stage Ⅳ breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* uncontrolled cardiac disease
* Active infection or chronic infection requiring chronic suppressive antibiotics
* History of hypersensitivity reaction to investigating drugs
Robotic Knee Orthosis-assisted Walking in CP

Robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. These devices can assist in overcoming gravitational forces and reduce energy consumption. Agilik is one such device intended for children with neurological disorders. However, Agilik is relatively new, and its efficacy in children with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for children with CP and crouch gait. In this pilot study, ten children with CP, GMFCS level II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in children with CP.

Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in children with CP is unknown. This study aims to assess the effectiveness of Agilik as an assistive device for children with CP. Ten children with CP, ages 8 to 17 years, and at GMFCS level II, will be recruited for this pilot study. Each child will participate in a total of four visits over four weeks duration. The first three visits will also include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclamation. The walking practice will last up to 30 minutes. A two-minute walk test (2MWT) will be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/practice visits. The fourth and final visit will include 2MWT and 3D motion capture of shod and RKO-assisted conditions and may take up to 3 to 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cerebral palsy at GMFCS level II
* Exhibits crouch gait
* Between 8 to 17 years of age
* Hip flexion contracture less than 5 degrees
* Knee flexion contracture less than 20 degrees when measured in prone with hips extended
* Thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone
* Can walk a minimum distance of 10 meters without stopping

Exclusion Criteria:

* Plantarflexion contracture, when measured in neutral foot alignment
* No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries
* The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain
* Inability to participate in the study because of recent orthopedic surgery (within twelve months) or botox intervention (within six months)