cyrilzakka/clinical-trials huggingface dataset:
Impact on the Nutritional State and the Quality of Life

The prevalence of malnutrition in cancerous patients varies between 50% and 80%. It is variable in function: the location and the extension of the tumor, of the general state , of age, of the socio-economic class and the pain. The health consequences of a malnutrition are very important: aggravation of the state of health, complications of treatment, hospitalization, alteration of the quality of life and decrease the survival, and the treatment response.

Nutrition being very important in patients, there are recommendations for the nutritional care of these patients, formulated by the European Society for Clinical Nutrition and Metabolism. The investigators do not know to what extent these recommendations are respected in practice and their influence on the nutritional status and the quality of life of patients.

The investigators therefore propose to assess the conformity of the nutritional care patients in clinical practice in relation to the European recommendations and in a second time to assess the influence of this compliance or non-compliance on the nutritional status clinical and biological of cancerous patients under chemotherapy, on their quality of life, on their response to treatment and on their survival.

The investigators will try to identify factors that may be linked to the non-compliance such as the characteristics of the cancer disease, socio-demographic characteristics of the subject and the factors related to the structure in which it is supported.


Eligibility Criteria:
Inclusion Criteria:

* 18-year-old subject in 85 years in the inclusion
* Subject presenting a cancerous pathology requiring a systematic treatment by exclusive chemotherapy for a minimal duration of three months with a plan of 3 cures of chemotherapy with an interval between the cures of 21 days
* Presenting subject one of these 4 cancerous pathologies: cancer of the aéro-digestive ways superiors, sarcomas, colorectal cancers, broncho-lung cancers
* Subject having the capacity of lira and to understand(include) French
* Subject having signed lit(enlightened) consent
* Subject taken care for its cancerous pathology in one of the partner services of the project
* Subject affiliated to the national insurance scheme

Exclusion Criteria:

* Subject having benefited from a major surgical operation in 4 weeks preceding the inclusion
* Subject having benefited from a radiotherapy in two weeks before the inclusion
* Subject minor(miner), pregnant woman, subject incapable to give its consent, subject under supervision(guardianship) - guardianship
Pharmaco-economic Study of a New Medical Device Performed From the Perspective of the Hospital

The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years

Patient receiving:

* Conditioning of autologous bone marrow transplantation by high dose melphalan (HD) as part of the management of myeloma or BEAM in lymphoma.
* A conditioning allogeneic bone marrow transplantation with reduced or intermediate busulfan IV
* Patients belong to a schema of social security, having signed the written informed consent.

Exclusion Criteria:

* patients:
* To receive or have received KGF
* With previous history of RT with the exception of patients who received spinal analgesic therapy in the treatment of myeloma
* Unable or unwilling to complete the self assessment questionnaire
* With previous history of allergy to any component of the products under consideration
* Minor
* Adults under guardianship
* Pregnant women
* Patients who have not signed the consent form
* Creation of mouthwash out of the study
MUSIC Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.

Exclusion Criteria:

* a prior pregnancy greater than 20 weeks of duration

  * currently pregnant or were pregnant within 6 weeks of study entry
  * had a prior attempted or successful IUD insertion
  * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis
  * undiagnosed abnormal uterine bleeding
  * pelvic inﬂammatory disease within the last 3 months
  * ﬁbroids or other uterine abnormalities distorting the uterine cavity
Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).

The SCORE study is a international multicentre cohort study investigating the local recurrence free survival outcomes in patients undergoing transoral robotic surgery with and without adjuvant therapy for early stage (T1-T2) oropharyngeal squamous cell carcinoma (OPSCC). Important secondary objectives include assessment of other survival measures (overall, disease free and disease specific), determination of a safe margin "cut off" that minimises the risk of local recurrence, and reporting the rate of early post-operative complications and mortality.

Retrospective SCORE patients will optionally contain an exploratory radiomic and radiology morphological analysis to ascertain high risk features of positive margins and local recurrence following TORS for early oropharyngeal cancer.

Additionally, the SCORE study will contain a prospective exploratory molecular analysis of consenting patients to help further define OPSCC molecular characteristics in those who experience recurrence and those who do not, in addition to assessing levels of circulating tumour DNA in before and after TORS procedures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* Primary tumour within the oropharynx (defined as tonsil, soft palate, tongue base, lateral and posterior oropharyngeal walls)
* Histologically confirmed squamous cell carcinoma.
* P16 positive or negative tumours
* Index cancer treated with TORS with or without adjuvant therapy.
* Early pT1-T2 stage oropharyngeal SCC
* TORS performed on or before 31st December 2021

For the exploratory analysis only:

* Ability to consent to molecular analysis study
* Ability to consent to radiomic/ imaging study (as required for international centres)

Exclusion Criteria:

* Moderate to advanced stage T3-T4 oropharyngeal SCC
* TORS performed for diagnostic, recurrent, or palliative intentions.
* Prior history of head and neck cancer or radiation therapy at any time
* Known distant metastatic disease.
* Nasopharyngeal, thyroid, cutaneous, and non-SCC head and neck cancers.
A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery

This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery.

Primary hypothesis:

Bariatric patients who have stopped losing weight (\< 5 lbs weight loss in past month) 1-5 years post-surgery will be willing to participate in this 10-week intervention. The investigators expect a high adherence rate (\>70%) and no issues with meeting recruitment goals.

Secondary hypotheses:

Patients assigned to the MBI will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling).

Patients assigned to the MBI intervention will show greater improvement in biomarkers of stress and inflammation \[salivary cortisol, high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)\] as compared with a standard lifestyle intervention.

Food-related attentional bias as measured by the food-related Stroop task will be differentially affected among patients assigned to the MBI as compared with the intensive lifestyle intervention and standard lifestyle intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report)
2. Weight loss plateau (\< 5 lbs weight loss in past month) (by medical report and/or self report)
3. Ages 18-65 years (by medical record and/or self report)
4. Able to complete outcome assessments

Exclusion Criteria:

1. Prior experience with meditation course (past 6 months), current mindfulness/meditation practice, or regular meditation or mindfulness practice in past year ("Regular practice" defined as practicing formally 1 or more times a week for 2 months).
2. Plans to leave the study area within next 12 months
3. Serious psychiatric illness or personality disorder (by medical record and/or self-report)
4. Current alcohol and/or substance abuse
5. Pregnancy or plans to become pregnant in next year
6. Non-English speaking
7. \> 1 prior weight loss surgery (by medical record and self-report)
8. Gastric band removed prior to study contact.
NIV-NAVA vs NIV-PS/PC in Respiratory Insufficiency

This study evaluates the difference between Non Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NIV-NAVA) and Conventional Non Invasive Ventilation with Pressure Support (PS) or Pressure Control (PC). All the patients are ventilated in each mode for 4 hours. Afterwards they will be subjected to a semi-structured interview where they will be asked to compare the two modes. The hypothesis is that NIV-NAVA will correct patients power of Hydrogen (pH), PaCO2 og PaO2 more quickly than NIV-PS and NIV-NAVA is more comfortable for the patients.

Neurally Adjusted Ventilatory Assist (NAVA) is a ventilation mode where the diaphragm is controlling the amount of ventilatory assistance proportionally through a nasogastric tube containing electrodes which are sending the electrical activities of the diaphragm (Eadi) to the ventilator.

Whereas Conventional ventilation modes like Pressure support or Pressure Control are dependent on the pressure drop or flow reversal to initiate assist delivered to the patient. This is last step of the signal chain leading to inhalation and is subject to disturbances such as intrinsic positive expiratory end pressure (PEEP), hyperinflation and leakage.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted at the ICU with acute respiratory insufficiency and therefore have hypoxia(PaO2 \< 7 kPa on atmospheric air) og pH \< 7.35 with non-compensated hypercapnia (PaCO2 \> 6.0 kPa).
* Patients, which according to the departments guidelines are required to treatment with NIV

Exclusion Criteria:

* Patients under years of 18.
* Patients without the possibility to give informed consent.
* Patients with neuromuscular or neurological disease.
* Patients with a verified or suspected head trauma.
* Patients with a acknowledged hiatus hernia.
* Patients with an active or suspected active upper GI bleeding.
* Patients which have previously been in the study.
* Patients with a suspected or verified acute coronary syndrome.
Computer Intervention for Prevention of Weight Regain

Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. The two interventions being tested are a face-to-face group maintenance program and an Internet intervention. These interventions will be compared to a no-contact control group that receives quarterly newsletters. The primary outcome measure is weight regain from baseline to 18-months.


Eligibility Criteria:
10% weight loss in past 2 years
Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).

Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA).

Adults with CF were recruited through the Regional CF Centre. A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months. Demographics, ppFEV1, BMI, adherence (IA collection rates) and additional antibiotic use were collected during the study and for 6 months prior. Treatment Quality and Satisfaction (TQSM), self-reported adherence (Moriskey Medication Adherence Scale-8 (MMAS-8)), Quality Of Life (CF Questionnaire-Revised (CFQ-R)) and sputum Pseudomonas aeruginosa (Pa) density were assessed at each study visit. Statistical analysis compared outcomes pre and post-intervention and variation during the intervention period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients with a documented diagnosis of CF aged ≥18 years on the date of informed consent
2. Known chronic infection with Pa, as defined by the Leeds criteria
3. Has been prescribed inhaled colomycin and/or tobramycin and/or aztreonam for a minimum of 3 months prior to study enrolment
4. Able to provide written informed consent
5. Able to understand and comply with protocol requirements and instructions
6. Has been identified by the physician during routine appointments as having difficulties with adherence to their inhaled therapies

Exclusion Criteria:

1. Patients that do not expectorate sputum spontaneously
2. Inability to complete questionnaires
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis

The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25 and ≤ 40 kg/m2
* concomitant medical conditions associated with NAFLD

Exclusion Criteria:

* Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
* Any condition possibly affecting drug absorption
* Unstable liver function tests
* Recent cardiovascular event(s),
* Malignancies
Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease

This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.

This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.

Study medication: Sitafloxacin 100mg QD for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* (1) Diagnosed or clinically diagnosed with Mycobacterium abscessus pulmonary disease within 6 months prior to enrollment; (2) Voluntarily participate in this study and sign the informed consent form; (3) Agree to use contraception voluntarily.

Exclusion Criteria:

* (1) Received glucocorticoids or immunosuppressants within 90 days prior to enrollment; (2) Pregnant women or postpartum lactating women; (3) Patients with evidence of fluoroquinolone resistance or allergy.
A Study To Investigate The Taste Of Crizotinib Liquid In Trained Healthy Adult Volunteers

An oral-liquid, pediatric form of crizotinib designed for use by pediatric patients is being tested for its' palatability in adults.

Taste assessment of new formulation. Subjects will not ingest the drug.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non childbearing potential subjects between the ages of 18 and 75 years, inclusive.
* Subjects must be trained sensory panelists.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, product evaluations, laboratory tests, and other study procedures.

Exclusion Criteria:

* A history of clinically significant hematological, renal, endocrine, pulmonary , glaucoma, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (excluding untreated, asymptomatic seasonal allergies at the time of product evaluation) as evaluated through a medical history.
* A history of hypersensitivity to any inactive ingredients employed in the formulation(s).
* Receiving treatment with an investigational drug within 28 days preceding any of the product evaluations for this study.
* Participation in a product taste evaluation (ie, 'sip and spit' type taste evaluation) involving an active pharmaceutical ingredient (API) within 5 half lives of that API.
* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).


Eligibility Criteria:
Inclusion Criteria:

* Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
* Body Mass Index within the limits specified in the protocol.

Exclusion Criteria:

* History of esophageal, duodenal or gastric surgery
* History of severe liver disease.
* Any other significant disease or pathology judged to be clinically significant by the investigator.
Bevacizumab in Metastatic Renal Cancer

This is a non-interventional, multicenter study to evaluate efficacy and safety of intravenous bevacizumab (Avastin) in combination with interferon alpha-2a immunotherapy for first-line treatment in participants with advanced and/or metastatic renal cell cancer (mRCC) in daily routine.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced and/or metastatic renal cell cancer
* No contraindications for Avastin according to summary of product characteristics (SmPC)

Exclusion Criteria:

-
Isolated Liver Perfusion With Oxaliplatin

The primary goal of this research study is to determine a safe dose for the drug oxaliplatin when delivered by isolated hepatic perfusion. The second goal of this research study is to determine if isolated hepatic perfusion with oxaliplatin can improve the efficacy of standard hepatic arterial infusional (HAI) therapy with floxuridine (FUDR)/leucovorin.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included that are scheduled to undergo surgery for placement of hepatic arterial infusion pump for HAI therapy and
* Histologically or cytologically proven measurable metastatic colorectal cancer limited to the parenchyma of the liver with no evidence of unresectable extrahepatic disease by preoperative radiological studies. Limited resectable extrahepatic disease is acceptable.
* No chemotherapy, radiotherapy, or biologic therapy for their malignancy in the 4 weeks prior to the liver perfusion and must have recovered from all side effects.
* An ECOG performance standard of 0, 1 or 2 for 24 hours prior to surgery.
* Adequate hepatic function as evidenced by bilirubin \< 2.0 mg/dL and a PT \< 2 seconds greater than the upper limit of normal.
* Age equal to 18 years or older and greater than 30 kg.
* Platelet counts greater than 100,000, a hematocrit \> 27.0, a white blood count \> 3000/microliter, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of \> 60 mL/min. Patients with elevations in hepatic transaminases secondary to the presence of metastatic disease in the liver are eligible.
* Aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks and willing to sign an informed consent.
* The disease in the liver must be considered unresectable as defined by greater than three sites of disease in the liver, bilobar disease, and tumor abutting major vascular or ductal structures making anatomic resection with preservation of liver function impossible.

Exclusion Criteria:

* Pregnant patients and nursing mothers will be excluded due to the unknown effects of oxaliplatin on the fetus or newborn
* Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.
* Patients with active infections are not eligible.
* Patients with biopsy proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices on endoscopy, or radiologic studies showing significant collateral vessels around the organs drained by the portal venous system will be excluded.
* Patients with ischemic cardiac disease or history of congestive heart failure with an LVEF \< 40% will be excluded.
* Patients with COPD or other chronic pulmonary disease with PFT's indicating an FEV\< 50% predicted for age will be excluded.
* Patients with a history of veno-occlusive disease of the liver are ineligible.