cyrilzakka/clinical-trials huggingface dataset:
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto

Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic radiotherapy in patients with an advanced cervix cancer.

To determine the maximum and the recommended tolerated dose of irinotecan with increasing doses associated with weekly cisplatin and combinated with pelvic radiotherapy in patients with an advanced cervix cancer, IIB-IVA FIGO stage.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primitive epidermoid or andenocarcinoma Cervix
* FIGO stage IIB (obviously parameter attack), III or IVA
* No previous chemotherapy nor radiotherapy
* Patient for whom a radiochemotherapy is envisaged as first intention treatmentof her cervix carcinoma
* PS ECOG \< 2
* Life expectancy \> 12 weeks
* Written consent given

Exclusion Criteria:

* Other malignant cervix tumor histology
* Visceral remotly metastasis
* Other malignant tumor since 5 years, except spino or baso-cellular treaten and cured cancer
* Anormal labs values
* Peripheric neuropathy CTC \> 2
* Auditory loss \> 2
* Cardiopathy
* Inflammatory digestive pathology
* Evolutive infection
* Other experimental concommitant treatment
* Lacting or pregnant women
Optical and Biochemical Biomarkers in Early Pancreatic Cancer

The purpose of this study is to develop a test for detection of pancreatic cancer by looking at the subject's DNA.

Pancreatic juice collection is performed by intravenous injection of FDA approved synthetic human secretin (ChiRhoClin Inc., Burtonsville, MD) at a dose of 0.2 µg/kg will be administered while the endoscope is positioned in the second portion of the duodenum. From within the duodenum and without cannulation of the papilla of Vater, a 2.3-mm plastic aspiration catheter (Olympus, Tokyo, Japan) will be passed through the biopsy channel of the endoscope until visible on screen in the endoscopic monitor. Once active visible secretion via the papilla has begun, the first 10 ml of pancreatic juice will be collected via suctioning. This entire process from secretin injection to sample collection takes an average of 5 minutes. The sample is then aliquoted into 2 ml ampules, which are snap-frozen in liquid nitrogen (or portable rapid-freeze freezer) and freezer-stored until the assays are performed. The top 10 candidate markers from discovery and validation on tissue (AUCs \>0.95) and from pilot pancreatic-juice testing (AUCs \>0.9) will be evaluated in this study. Following extraction from an equivalent of 0.4 ml pancreatic juice, DNA will be bisulfite treated using optimized methods. Then, an assay of aberrant methylation on target genes will be conducted using the QuARTS technique. Results will be normalized to either a human DNA marker (eg, beta-actin) or a methylated DNA marker identified for normal pancreatic epithelium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are referred for the evaluation of pancreas cancer, pancreatic cystic neoplasm, and family history of pancreas cancer.
* International normalized ratio (INR) less than 1.5
* Platelet count \>50,000

Exclusion Criteria:

* Any medical condition that preclude the patient from having a therapeutic procedure regardless of the Endoscopic ultrasound (EUS) finding
* Pregnant patients
Objective Assessment of Adherence to Inhalers by COPD Patients

Rationale: Objective adherence to inhaled therapy by patients with chronic obstructive pulmonary disease (COPD) has not been reported.

Objectives: To objectively quantify adherence to preventer Diskus inhaler therapy by patients with COPD with an electronic audio recording device (INCA).

Methods: This was a prospective observational study. On discharge from hospital patients were given a salmeterol/fluticasone inhaler with an INCA device attached. Analysis of this audio quantified the frequency and proficiency of inhaler use.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised with an exacerbation of COPD
* FEV1/FVC \<70% or FEV1 \<80%
* Age\>40 years
* smoking history
* Previously prescribed fluticasone/salmeterol inhaler

Exclusion Criteria:

* No exacerbations in previous year
* Outpatients
Tui na for Peripheral Neuropathy Among People With HIV

Peripheral neuropathy (PN) is a common neurological complication in people with human immunodeficiency virus (PHIV) with no Food and Drug Administration-approved treatment. Medications commonly used to treat HIV-related PN are not effective and have many side effects. HIV-related PN symptoms may be alleviated or treated with therapeutic Chinese foot massage (TCFM), a non-invasive, relatively safe, non-pharmacological intervention.

This is a prospective, two-arm, double-blinded, randomized controlled trial. Aim: This trial aims to assess the effectiveness of TCFM on HIV-related PN in people with HIV (PHIV).

Eligibility Criteria:
Inclusion Criteria:

1. have confirmed HIV diagnosis
2. self-report PN-related symptoms in their lower extremity, such as sharp, jabbing, throbbing, or burning pain, numbness, decreased sensation to pinprick, prickling or tingling feeling, lack of coordination and falling muscle weakness, and extreme sensitivity to touch
3. are not taking any medications, including pain medicine, to alleviate PN
4. age 18 years and older
5. can communicate with researchers in English or Mandarin Chinese
6. are not pregnant or lactating
7. are not concurrently enrolled in other clinical trials.

Exclusion Criteria:

1) People who have received any non-pharmacological interventions, including massage to treat their PN symptoms in the past six months
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);;
* Aged 18-70, both sexes;
* ECOG score 0-1
* The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1;
* Adequate organ and bone marrow function, meeting the following definitions:

  1. Blood routine (no blood transfusion, no granulocyte colony-stimulating factor \[G-CSF\], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L;
  2. Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
* Expected survival time \> 6 months;
* Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment;
* Patients who volunteered to participate in this study and signed the informed consent form.

Exclusion Criteria:

* A history of fistula caused by primary tumor invasion;
* Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization);
* Known intolerance or resistance to chemotherapy specified in the trial protocol;
* have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy);
* Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
* History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease;
* Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment;
* Known history of HIV infection;
* Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years;
* Received live vaccine within 28 days before enrollment;
* while participating in another therapeutic clinical trial.
Genotype-phenotype Correlation Study of Presymptomatic and Symptomatic DFNA9 Patients

DFNA9 (Deafness Autosomal Dominant 9) is an autosomal dominant hereditary hearing loss which is associated with vestibular deterioration. The most recent genotype-phenotype correlation studies have been conducted more than 15 years ago. Meanwhile, emerging and valuable vestibular tests have been added to the vestibular test battery. These tests were not available at the time of the correlation studies. The aim of this study is to carry out a prospective cross-sectional study on symptomatic and presymptomatic affected carriers of the Pro51Ser (P51S) Coagulation Factor C Homology (COCH) mutation in order to correlate vestibular data using the complete vestibular test battery with the known data on hearing and vestibular function in relation to age.

Systematic review of the genotype-phenotype correlation studies in P51S carriers has shown an underrepresentation of presymptomatic affected subjects and the calculation of vestibular deterioration were based on just one vestibular parameter, whereas the combined evaluation of a complete vestibular test battery, covering the complete vestibular sensitivity range and all labyrinthine compartments separately, is nowadays considered standard practice in determining more accurate assessment of the vestibular function.

For this reason, a prospective cross-sectional study on pre- as well as symptomatic DFNA9 patients carrying the Pro51Ser (P51S) mutation in COCH gene is being carried out, in order to gain more realistic data on vestibular dysfunction, consisting of pure tone audiometry and a comprehensive vestibular test battery, including electro- or videonystagmography (VNG), C- and O-Vestibular-evoked myogenic potential (VEMP) tests, video Head Impulse Test (vHIT) and questionnaires (DHI (Dizziness handicap Index), oscillopsia questionnaire (OS), Quality of Life Questionnaire (EQ-5D-5L), activities-specific balance confidence (ABC) scale.

Eligibility Criteria:
Inclusion Criteria:

* subject must be 18 year of older
* subject is a family member of the family pedigree's proband(s) carrying a P51S COCH mutation

Exclusion Criteria:

* subject is younger than 18 years
* subject is not a family member of the pedigree's proband(s) carrying a P51S
* subject cannot undergo investigations (medical and/or mental reasons)
* subject is not willing to be enrolled into the study
* subject suffers other concomitant middle or inner ear disease
* subject has undergone middle ear or inner ear surgery
* subject suffers other concomitant vestibular disease than DFNA9
* subject has undergone vestibular surgery or other non-invasive vestibular treatment (gentamicin intratympanal injections for example)
Comparing Palliative Radiotherapy With or Without Carboplatin

The study population has locally advanced or metastatic bronchial or head and neck cancer.

This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.

The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.

The study population has locally advanced or metastatic bronchial or head and neck cancer.

Patients receive 10 injections of carboplatin (validated chemo-sensitizing molecule) or placebo (glucose) before 10 radiation sessions.

The overall duration is 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic bronchial or head and neck cancer
* Patient require palliative radiotherapy
* Age ≥ 18 years
* PS ≤ 2
* Obtaining the signed written consent of the patient
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Other chemotherapy or targeted therapy
* Prior radiation
* Patients with thrombopenia \< 100 000
* Patients with neutropenia \< 2000
* Patients with renal clearance \< 20 mL/min
* Known hypersensitivity to platinum salt
* Treatment with phenytoin or fosphenytoin
* In previous three months, a vaccination against yellow fever, live vaccin or live attenuated vaccine
* Unchecked diabetes
* hemorrhagic tumor
* Refusal of participation or inability to issue informed consent
* Person deprived of liberty or adult under guardianship
* Minor patients, pregnant or lactating women
* Participation in other interventional study
A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis

This open-label, single arm, multicenter long-term extension study will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment
* No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit
* Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment

Exclusion Criteria:

* Pregnant females
* Participants who have withdrawn prematurely from the WA19926 core study for any reason
* Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926
* Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
* Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
* Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
* Evidence of severe uncontrolled concomitant disease or disorder
* Known active or history of recurrent infections
* Active tuberculosis requiring treatment in the previous 3 years
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
Growth Hormone Treatment of Young Growth Hormone-Deficient Adults

Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. All these dysfunctions are partially or totally corrected by the GH prescription with patient deficient since adulthood.

However, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.

Primary objective of this study is to examine that fat mass significantly decrease due to GH treatment in adulthood for patient GH deficient since childhood, treated by GH during childhood but stopped since the end of adolescence.

We compare the body composition and others energetic metabolism parameters in two patient groups, one treated by GH during 18 months, and the other with no treatment. Body composition and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones).

This study will evaluate if the GH treatment of young GH deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18-35 years)
* Stable body mass +/- 5 kg in 3 months
* GH deficiency since childhood, treated by GH during childhood, having stopped GH treatment at the end of adolescence
* Want to receive again GH treatment or refusing new GH treatment
* GH deficiency confirmed at adulthood by GHRH-Arginine test
* Women receiving GH treatment must have a efficient contraceptive method
* Have given a writing informed consent

Exclusion Criteria:

* Somatotropic insufficiency
* All pathologies or treatment modifing energetic metabolism, excepted diabet mellitus and obesity
* Participating to another clinical trial during the three months befor inclusion
* Pathologies modifing bone metabolism
* Pregnancy/Feeding
* Refusal to consent
Investigating Prevalence of Disordered Eating in Children With GI Disorders

Gastroenterological disorders are disorders affecting the stomach, intestines and associated organs. Symptoms of these types of disorders vary but often include vomiting, diarrhoea, weight loss and loss of appetite. Due to the nature and symptomatology of these disorders research has suggested that sufferers may be vulnerable to developing disordered eating behaviours. Treatment of such disorders often requires dietary restriction which has been found to lead to an obsessive preoccupation with food and in some cases to an increase in binge eating. Further to this, symptoms of Gastroenterological disorders such as vomiting have also been suggested to be linked with disordered eating. At the present there is limited research in this area and as such evidence is inconclusive. Particularly little research has looked at this area in relation to adolescents, who have been recognised as being at increased risk for the development of disordered eating . Gastroenterological disorders are likely to affect the typical development of eating habits and therefore it seems plausible they may also predispose adolescents to developing abnormal eating behaviours /weight concerns.

The aim of this study is to further investigate the possibility that Gastroenterological disorders may be a risk factor for disordered eating in children and adolescents. This study will recruit children/ adolescents aged 5-17 and their parents, who are attending Great Ormond Street Gastroenterology Clinic and ask them to complete a screening questionnaire. The recruitment process will be on going for around 5 months until the study has around 300 participants. Following this initial questionnaire, participants who are categorised as screening positively for disordered eating and a 10% sample of participants that screen negatively, will be contacted to complete a further questionnaire interview that will look more specifically into this area.


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents between the age of 5-17 and their parents who are attending the Gastroenterological Clinic. We will recruit all patients that fall within the age range, including both new patients and existing patients.

Exclusion Criteria:

* Parents/ adolescents unable to communicate English will be excluded from the current study.
* Children under the age of 5 and over the age of 17 will also be excluded.
Opioid-Free Study in Arthroscopic Rotator Cuff Repair

The purpose of this study is to develop and test an opioid-free pain control protocol for patients undergoing arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

* All patients over the age of 18
* clinically indicated for an Arthroscopic Rotator Cuff Repair (ARCR)

Exclusion Criteria:

* Patients with irreparable rotator cuff tears
* allergic or sensitivity to the study medication
* intolerance to pain protocol
* history of gastrointestinal issues
* renal disease
* any evidence of glenohumeral arthritis
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland

The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD \[including Ulcerative Colitis (UC) and Crohn's Disease (CD)\].

This is a non-interventional, prospective study of participants with moderately to severely active IBD (UC or CD) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting.

The study will enroll approximately 160 participants: 100 participants with UC and 60 participants with CD. The data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

•Participants with IBD

This single center study will be conducted in Poland at public hospitals and institutions that treat UC and CD. The overall duration of the study will be at least 24 months. Data will be collected at baseline, every 3 months within the first year and every 6 months within the second year, and at the time of switch, discontinuation and/or at routine follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1.Participants with moderately to severely active IBD (UC or CD), initiating or ongoing IV induction treatment with vedolizumab in accordance with the current SmPC and National Drug Program (NDP) at baseline OR IBD participants receiving ongoing/maintenance IV vedolizumab treatment, with the option to switch to SC vedolizumab maintenance treatment.

Exclusion Criteria:

1. Prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy) to vedolizumab therapy as defined in the current SmPC.
2. Current or planned participation in an interventional clinical trial for CD or UC.
3. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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