cyrilzakka/clinical-trials huggingface dataset:
Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.

This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.

Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Has provided written Informed Consent for participation in this trial
* Histologically confirmed muscle invasive bladder cancer.
* Transitional cell, squamous cell, adenocarcinoma or mixed histology. Stage T2-4 N0 M0.
* An ECOG performance status score of 2 or less (see appendices).
* Life expectancy greater than 6 months.
* Considered suitable for radical radiotherapy.
* Participants capable of childbearing are using adequate contraception.
* Radiotherapy must be able to be commenced within 12 weeks of surgery.
* Available for follow up.

Exclusion Criteria:

* Women who are pregnant or lactating.
* Previous pelvic radiotherapy
* Previous cystectomy
* A small contracted bladder
* Unilateral or bilateral hip replacement
* Small cell histology
* Clinical or radiological evidence of nodal or distant metastases
* Presence of indwelling urinary catheter
Multiple Sclerosis: Chi3L1 and Treatment Efficacy

Chitinase 3-like 1 (Chi3L1) is a Human protein synthetized by inflammatory cells. Its serum level increases in case of autoimmune diseases, and especially during multiple sclerosis (MS). There is a need for biological markers predictive of treatment efficacy. MS outcomes one year from treatment initiation are predictive of long-term treatment efficacy. The hypothesis is that serum Chi3L1 level before treatment initiation could predict one year MS outcomes.

Primary objective: to show an association between the serum Chi3L1 level at diagnostic assessment and the clinical and radiological efficacy one year from initiation of the first disease modifying treatment (interferon beta, dimethyl fumarate or teriflunomide) in relapsing-onset multiple sclerosis (MS).

Secondary objectives: to determine the threshold value of the serum Chi3L1 level predicting the efficacy of treatment, and the added value of other potential biomarkers in cerebrospinal fluid collected at diagnostic assessment: Chi3L1, light chains of neurofilaments and interleukin 6.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-onset multiple sclerosis according to the 2017 McDonald criteria
* Blood and cerebrospinal fluid samples collected at diagnostic assessment from 2012 January 1st and kept in the Centre de Ressources Biologiques Lorrain
* First platform disease modifying drugs : interferon-Beta, dimethyl fumarate or teriflunomide, introduced during the first 3 months after the diagnostic assessment
* Disease modifying drugs maintained at least 3 months
* Follow-up during at least 15 months after the first disease modifying drug initiation
* At least one brain magnetic resonance imaging with gadolinium injection between months 3 and 15 after disease modifying drug initiation

Exclusion Criteria:

* Objection to the use of personal data for research purpose
Outcomes of HCC (Hepatocellular Carcinoma) Patients Treated With TACE (Transarterial Chemoembolization) and Early, Not Early or Not at All Followed by Sorafenib

This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically/cytologically documented or radiographically diagnosed HCC. Radiographic diagnosis needs typical findings of HCC by radiographic method i.e. on multi-dimensional dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP) or MRI.
* Patients with BCLC (Barcelona clinic liver cancer staging) stage B or higher.
* Patients in whom a decision to treat with TACE has been made at time of study enrollment. Patients that have received one TACE in the past also can be enrolled, if the TACE was done at the same site and all required data about such previous TACEs are available. TACE includes both conventional TACE with lipidiol (or similar agents) and chemotherapeutic agent(s) and TACE with DC Beads excluding TAE without chemotherapeutic agent.
* Patients with unresectable HCC (incurable with curative treatments including resection or ablation or not eligible for resection or local ablation)
* Patients must have signed an informed consent form
* Patients must have a life expectancy of at least 8 weeks

Exclusion Criteria:

* Patients who have received TACE in the past but the data about TACE required in this protocol are not available
* Patients who received any systemic anti-cancer therapy prior to the first TACE
* Patients who are treated according to a trial protocol for intervention including a locoregional therapy or systemic therapy
* Hospice patients
* All contra-indications according to the local marketing authorization should be considered.
Breast Re-irradiation After Second Ipsilateral Lumpectomy

The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ER+HER2- breast cancer
* Provision of signed and dated ICF
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age ≥ 40 years
* Oncotype \< 26 (postmenopausal) \<16 (premenopausal), Low, or Ultra-Low index.
* Minimum interval of 18 months from last breast radiotherapy session.
* Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available.
* Ipsilateral recurrence, unifocal \< 3 cm with negative margins, N0, Tis and invasive (pathological staging)
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Planning target volume: whole breast (PTV: WB) ratio \< 1/2
* Life expectancy \> 12 months
* Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.

A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

1. Has not undergone a hysterectomy or bilateral oophorectomy; or
2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)

Exclusion Criteria:

* BRCA1/2 mutation or any other receptor subtypes
* Individuals assigned male at birth with breast cancer
* Pregnancy or breastfeeding
* Skin involvement
* Distant metastasis
* Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms.
* Other malignancies (except skin)
* Connective tissue disorder (e.g., scleroderma, lupus)
* Any other condition that may put a participant at higher risk, at the discretion of the investigator.
Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Eligibility Criteria:
Inclusion Criteria:

* Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time \> 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

* Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.
Spot Reduction in Male Adults

Spot reduction, referring to local body fat reduction, pertains to subcutaneous adipose tissue utilization from specific body parts during exercise. Its existence has been keenly debated, although generally accepted not to occur during exercise. However, it is based on not only equivocal data - commonly the training protocol typically applied is based on strength rather than endurance training. The investigators sought to test this assumption by utilizing endurance based exercise controlling for energy expenditure and using dual x-ray absorptiometric measures to assess body composition before and after training.


Eligibility Criteria:
Inclusion Criteria:

* males
* ≥ 30 years old
* classified as overweight (Body mass index ≥ 25 kg ∙ m-2)
* not participating in regular physical training

Exclusion Criteria:

* \< 30 years old
* Body mass index \< 25 kg ∙ m-2
* participating in regular physical training
Chemokine (CXCL13) as Anew Marker in Diagnosis of SLE

Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis

Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies . Lupus nephritis (LN) is the most common and serious complication in SLE patients characterized by proteinuria, hematuria, drop glomerular filtration rate, or renal dysfunction . It is known that B lymphocytes are involved in the pathogenesis of systemic lupus erythematosus in autoantibody-dependent mechanisms . The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), is a CXC subtype member of the chemokine superfamily. The receptor of CXCL13 is CXCR5, which is normally expressed on mature B cells and follicular T helper cells (Tfh). It has been demonstrated that CXCL13 is sufficient to induce secondary lymphoid tissues in peripheral organs. It is well known that different chemokines are involved in the pathogenesis of LN by orchestrating proinflammatory microenvironments, recruiting immune cell subsets into the kidney and by inducing local activation of immune effector cells . Local B-cell infiltration and related abnormal expression of ectopic lymphoid tissue (ELT) in the renal tissues of LN mice models was related to the severity of renal impairment .

Of interest, in regions of B cell infiltration a higher expression level of CXCL13 was found. Most B cells in this region expressed the corresponding receptor CXCR5, also supporting the hypothesis that CXCL13 induces B cell infiltration into the kidneys via its receptor CXCR5 .

In one study on 91Caucasian patients, CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis. It was found that serum CXCL13 levels correlated well with SLEDAI and median CXCL13 concentrations were higher in patients with renal involvement .

Eligibility Criteria:
Inclusion Criteria:

* SLE patients diagnosed according to ACR

Exclusion Criteria:

* patient with other autoimmune diseases.
Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed the TERMS study and received at least 1 study treatment injection
* Signed and dated statement of informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
* Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
* Non-compliant with TERMS study.
* Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
* Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.
* Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.
Endomina as an Aid for Endoscopic Full Thickness Resection

The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection.

Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.


Eligibility Criteria:
Inclusion Criteria:

1. Lesion untreatable with standard technique.
2. Age between 18-65 years;
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;

Exclusion Criteria:

1. Achalasia and any other esophageal motility disorders (for upper GI lesion)
2. Severe esophagitis (for upper GI lesion)
3. Gastro-duodenal ulcer (for upper GI lesion)
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction;
6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
7. Anticoagulant therapy;
8. Impending gastric surgery 60 days post intervention (Upper GI);
9. Currently participating in other study
Cleansing Efficacy of Waist-shaped Interdental Brushes.

The aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.

Brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the University Hospital of Dental Prosthetics and Restorative Dentistry were recruited. Each subject was asked to attend three appointments. In the first visit (day one), baseline plaque and bleeding indices were assessed. Each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. Primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.The odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Periodontitis stage 3
* Completion of active periodontal treatment
* Maximum probing pocket depths of 5 mm
* No site ≥ 4 mm with bleeding on probing
* Bleeding on probing \< 10%
* Open interproximal spaces both, in mandible and maxilla
* Presence of \> 23 natural teeth with no need for prosthetic rehabilitation.

Exclusion Criteria:

* Oral or systemic diseases other than Periodontitis
* Mucosal / periodontal swelling or Suppuration
* Pregnancy
* Minority
* Need for frequent drug consumption
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy

Prospective, multi-center, non-randomized study to assess the ability of the Cytuity device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is medically cleared for surgery
2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
3. Subject must be 18 years of age
4. Subject must be able to provide informed consent

Exclusion Criteria:

1. Contraindication to hysteroscopy
2. Acute pelvic inflammatory disease
3. Active or recent lower pelvic infection
4. Pregnancy
5. Delivery or termination of a pregnancy in the past 6 weeks
6. Known tubal obstruction
7. Tubal ligation
8. Invasive carcinoma of the cervix or endometrium
9. Intolerance of anesthesia
Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement

Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* • patient refusal infection at the site of intervention

  * local anesthetic allergy
CO2 Versus O2 Insufflation During ERCP Depending on Sedation Protocols

Endoscopic retrograde cholangiopancreatography(ERCP) and related procedures can cause abdominal pain and discomfort. Some clinical trials have indicated, using the visual analogue scale (VAS) score, that CO2 insufflation during ERCP ameliorates the suffering of patients without complications, compared with air insufflation. However, differences in patient suffering between CO2 and air insufflation after ERCP depending on sedation protocols have not been reported. We therefore planned prospective, double-blind, randomized, controlled study with CO2 and air insufflation during ERCP depending on sedation protocol.


Eligibility Criteria:
Inclusion Criteria:

* candidates for therapeutic ERCP

Exclusion Criteria:

* age\<18 years
* pregnant women
* total gastrectomy
* uncontrolled coagulopathy
* American Society of Anesthesiologist(ASA) Class V
* neurologic impairment
* known allergy to the drugs used
* history of complications with previous sedation, sedative
* alcohol abuse
* inability to provide informed consent
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy

The aim of the investigation was to investigate the performance and safety of a new ostomy product.


Eligibility Criteria:
Inclusion Criteria:

1. Are at least 18 years of age and have full legal capacity.
2. Has had an ileostomy for at least 3 months.
3. Has used a convex ostomy product for the last month.
4. Has given signed informed consent.
5. Has experienced seeping under the baseplate at least three times during the last two weeks.
6. Currently using a SenSura Convex product with midi, maxi or magnum bags.
7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.

Exclusion Criteria:

1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
2. Are pregnant or breastfeeding.
3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
6. Are currently participating in another clinical intervention study or have previously participated in this one.
7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
8. Has known hypersensitivity toward the test product.