cyrilzakka/clinical-trials huggingface dataset:
Colon Cleansing Quality of Polyethylene Glycol Compared With Polyethylene Glycol Plus Ascorbic Acid.

The purpose of the study is to assess whether a low volume polyethylene glycol (PEG) plus ascorbic acid based bowel preparation for colonoscopy is not inferior to a large volume polyethylene glycol preparation in subjects with past history of poor bowel preparation

Two key quality indicators for colonoscopy are the cecal intubation rate and the percentage of neoplastic lesions detected. Both factors are associated with adequate bowel cleansing. Poor cleansing ranged from 5% to 30% across studies, negatively affecting the efficiency of colonoscopy.

The most important factor associated with poor colonic preparation is the past history of poor bowel preparation. However, there are no recommendations on the proper type of preparation in those patients. In two non-randomized studies inadequate cleansing in the second colonoscopy ranged from 9.8% to 23%. Randomized studies comparing high volume (3-4 liters) with low volume (2 liters) PEG preparations, which are better tolerated by patients, are therefore needed before making any recommendations in this regard.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5.
* Signed informed consent

Exclusion Criteria:

paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure\> 180, dyastolic pressure\> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia. History of poor preparation in the previous colonoscopy, colon resection, less than 75% intake of the bowel preparation in the index colonoscopy, refusal to participate in the study, patients in whom a new colonoscopy is not indicated despite a poor bowel preparation(i.e. ileal Crohn disease with poor large bowel preparation), lack of compliance with the bowel preparation schedule.
PRO Survivorship Concerns ITA

Breast cancer survivors typically experience fatigue, pain, insomnia, depression, anxiety, difficulty in concentrating, memory impairment, body image problems, vaginal dryness, interest in sex decreasing, hot flashes, gain weight, and infertility. All of these problems affect quality of life (QoL) mainly during the early survival and they become even more important to understand and address if long-term effects could be prevented.

The use of PROs in care settings has demonstrated improvement in provider/patient communication, recognition of previously unrecognized issues, as well as patient satisfaction with care.

In order to allow to patients the use of the PRO "survivorship concerns" in their mother tongue, it is imprtant to have validated translations with transcultural adaptation. The main goals of this multicentric study are the translation, adaptability and transcultural validation of the PRO questionnaire "survivorship concerns" to put in evidence rehabilitation needs in breast cancer patients in early stage.


Eligibility Criteria:
Inclusion Criteria:

* During transcultural adaptability 80 representative patients will be recruited .

During the validation phase previus patients will be included and more other patients will be included (at least 280)

Exclusion Criteria:

* Patients with cognitive or memory impairment wil be excluded
Exclusive Intraoperative Radiation Therapy for Breast Cancer

Aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of Intra Operative Radiotherapy


Eligibility Criteria:
Inclusion Criteria:

* Non lobular epithelial breast carcinoma, excised with standard quadrantectomy
* Age ≥ 45 and \< 85
* Tumor major diameter ≤ 2.5 cm
* Negative surgical margins (≥ 5 mm)
* Willingness to undergo follow up examinations
* Willingness to undergo imaging examinations (MRI, mammograms, ultrasonography)
* Signed informed consent

Exclusion Criteria:

* Ductal carcinoma in situ or lobular carcinoma
* Extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion
* Serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
* Pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device)
* Collagen vascular disorders
Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study

The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system.

The Non-invasive Vagus Nerve Stimulation in Patients Undergoing Electrophysiological Study is a single center, pilot, prospective study that aims at evaluating the effects of auricular vagus nerve stimulation (aVNS) on the human cardiac conduction system. In this study, we will enroll 10 healthy individuals presenting to the electrophysiology laboratory for an electrophysiological study (EPS). Patients will undergo a standard EPS with 4 catheters (coronary sinus catheter, His catheter, right ventricular catheter, and right atrial catheter). Following the standard EPS, patients will be hooked up a Parasym device to provide transcutaneous electrical stimulation to the auricular branch of the vagus nerve.

Eligibility Criteria:
Inclusion Criteria:

* Primary indication for EPS for the evaluation of cardiac conduction system or supraventricular tachycardia.

Exclusion Criteria:

* Previous EPS with ablation
* Previous failed ablation
* Known conduction system disease, right or left bundle branch block on EKG
* Pregnant women
* History of postural orthostatic tachycardia syndrome
* Patients who have had prior cervical vagotomy
* Patients with skin on the tragus that is broken or cracked
* Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years) and patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
* Patients with an active implantable medical device, such as a cardiac pacemaker, hearing aid implant, or any implanted metallic, implanted vagus nerve stimulator or electronic device.
PK of Piperacillin/Tazobactam in Adults Undergoing ECMO

This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.

In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Initiated on VV ECMO for acute respiratory distress syndrome
* Receiving piperacillin/tazobactam

Exclusion Criteria:

* Pregnancy
* Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period
* Prisoners
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy

Exclusion Criteria:

* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Does Topical Lidocaine Decrease Sweat During Exercise in the Heat?

Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms. One arm will be pretreated with topical lidocaine, and the other will act as the control.

Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms. One arm will be pretreated with topical lidocaine, and the other will act as the control. Sweat will be collected via macroducts attached to each arm. Sweat production on each arm will be compared using t-tests.

Eligibility Criteria:
Inclusion Criteria: 18-35 years of age -

Exclusion Criteria: pregnant females

-
Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA

Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.


Eligibility Criteria:
Inclusion Criteria:

* Adults having to undergo carotid thromboendarteriectomy
* social security coverage
* provision of study information
* consent to participation.

Exclusion Criteria:

* Previous carotid artery surgery
* refusal to participate in the study
* or inability to give consent.
Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes

The incidence of cystic fibrosis related diabetes (CFRD) has risen significantly as patients' survival improves. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of lung function and nutritional status, both of which affect the patient's overall survival. The oral glucose tolerance test (OGGT) is the accepted method for detecting CFRD. The Cystic Fibrosis Trust guidelines (2004) recommend that patients with CF over the age of twelve years should be screened annually. Most hospitals use an annual OGTT. Performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests. In our centre, a selective approach is used. If patients have an abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia or unexplained weight loss then an OGTT will be performed.

The aims of this study are

1. To compare the clinical efficiency in the screening for CFRD in the two different methods: i)a selective approach , ii)an unselected annual OGTT for all patients.
2. To compare the cost effectiveness of the two approaches in the screening for CFRD.

CFRD affects 30% of all patients with cystic fibrosis (CF) by the age of twenty-five. Early diagnosis of CFRD is crucial to prevent the unnecessary deterioration of pulmonary function and nutritional status, both of which affect the patient's overall survival. The selective approach takes less patient time and is less expensive. If it is equally accurate it should be used routinely. The oral glucose tolerance test (OGTT) is the accepted method for detecting CFRD and the Cystic Fibrosis Trust guidelines recommend that patients with CF over the age of twelve years should be screened annually. Yung et al, questioned this approach and argued that performing OGTT on all CF patients is inconvenient and may not be cost effective, as patients have to starve overnight and need to spend an extra 2 hours in the hospital in addition to all the other annual review tests.

In this study, a selective approach in performing OGTTs in the screening for CFRD will be used; this includes the use of a combination of clinical and biochemical criteria that of abnormal random blood glucose and /or abnormal glycosylated haemoglobin (HbA1c) and/or symptoms of hyperglycaemia, or weight loss.

Eligibility Criteria:
Inclusion Criteria:

* first one hundred consecutive clinically stable patients with CF attending annual review from January 2009
* 16 years of age and over will be eligible for the study.

Exclusion Criteria:

* patients with an existing diagnosis of CFRD.
* patients with an infective exacerbation (i.e. on a new course of antibiotics)
AZD2624 Multiple Ascending Dose Study in Japan

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624


Eligibility Criteria:
Inclusion Criteria:

* Healthy young male Japanese volunteers

Exclusion Criteria:

* Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
* Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
* Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose
Proton Therapy for Locally Advanced Cervical Cancer

The purpose of this protocol is to determine toxicity and efficacy of proton therapy in combination with standard concomitant platinum-based chemotherapy and standard image-guided adaptive brachytherapy (IGABT) in patients with locally advanced cervical cancer (LACC). The over-all aim is to maintain a high disease control and at the same time reduce acute morbidity as well as late side effects after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  * Cancer of the uterine cervix considered suitable for curative treatment with definitive radio- (chemo) therapy including IGABT
  * Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
  * Staging according to Intenational federation of Gynecology and Obstetrics (FIGO) and TNM guidelines
  * T1-3N1M0 (FIGO stage IIIC1 (with ≥3 pelvic lymph node metastases) and IIIC2)
  * Para-aortic metastatic nodes below L1-L2 are allowed (FIGO stage IVB)
  * Magnetic Resonance Imaging (MRI) and Positron Emission Tomogaraphy-computerized Tomograpy (PET-CT) of the retroperitoneal space and abdomen at diagnosis
  * Patient written, informed consent
  * Age≥18 years
  * Patients must be able to understand a Danish or Swedish

Exclusion Criteria:

* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin
* Metastatic disease beyond para-aortic region (L1-L2 interspace)
* Previous pelvic or abdominal radiotherapy
* Combination of preoperative radiotherapy with surgery
* Patients receiving neoadjuvant chemotherapy
* Contra indications to MRI
* Contra indications to IGABT
* Contra indications to protontherapy
* Small cell histology (neuroendocrine tumors)
* Active infection or severe medical condition endangering treatment delivery
* Pregnant, lactating or childbearing potential without adequate contraception
* Human Immune Deficiency Virus (HIV)
* Patients with no possibility of follow up
Effects of Sugary Drink Warning Labels

The primary objective of this study is to determine to what degree sugary drink warning labels increase consumers' knowledge about the potential health harms of sugary drinks and reduce sugary drink intake. The study is designed to answer three additional questions: 1) Do some warning labels work better than others? 2) What is the effect of warning labels over time? 3) If warning labels influence behavior, is it because they increase knowledge or simply provide a salient reminder that some drinks are less healthy? This study will test the effect of repeated exposure to warning labels on total calories purchased over time and assess whether knowledge or salience better explain label effects.


Eligibility Criteria:
Inclusion Criteria: Participants must:

* be a primary caregiver of a child under 12 years old;
* be ≥18 years old;
* read and speak English;
* drink sugary drinks at least twelve times per month (\~three times per week) and have a child who does the same
* be the primary grocery shopper for their family;
* have regular internet access.

Exclusion Criteria:

* not a primary caregiver of a child under 12 years old
* \<18 years old
* cannot read and speak English
* does not drink sugary drinks at least 12 times per month and have a child who does the same
* is not the primary grocery shopper for their family
* does not have regular internet access
Behaviour of Tricuspid Valve Regurgitation in Volume and/or Pressure Loaded Right Heart

Right-sided heart disease has an important impact on the prognosis of patients with valvular heart disease. Up to now, Tricuspid Valve Regurgitation (TR) and right heart hemodynamics have not been extensively investigated. However, it is plausible that a significant degree of TR and the associated volume-overload of the right ventricle cause significant right ventricular wall stress. Although minor TR generally is well tolerated, major TR can lead to clinical symptoms, right ventricular dilatation and ultimately right ventricular heart failure. Up to now, the investigators do not dispose of any tools to diagnose and anticipate this unfavourable evolution. Nevertheless it is likely that right ventricular failure is preceded with a subclinical dysfunction of the right ventricle and a possibly reversible change in contractility of the myocardium.

Recently, new techniques to evaluate the systolic function, the contractility and the hemodynamics of the heart have become available.

First, this study will help us assessing the feasibility and accuracy of several imaging modalities in right-sided heart pathology with focus on TR and right heart myocardial performance.

Second, this study will contribute to a better understanding of the hemodynamic effect of volume-overload and/or pressure-overload of the right ventricle. It will clarify the behaviour of TR, the evolution of right ventricular myocardial contractility and dysfunction during exercise and its impact on exercise capacity. By doing this, discrimination between well tolerated and ill-tolerated TR will be possible, thus identifying patients who might be eligible for treatment (medical, corrective, ...).


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Arterial Hypertension
* Pulmonic Valve Stenosis
* Pulmonic valve homograft
* Pulmonic valve insufficiency
* Atrium Septum Defect
* Ebstein's Anomaly
* Transvalvular RV pacemaker/ shock lead
* Control

Exclusion Criteria:

* age \< 16 years
* not fit for bicycle testing
Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy

The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

The study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.

The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).

The study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.

It will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated

Exclusion Criteria:

* other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis...)
* thoracic pathology such as kyphoscoliosis
* pleural effusion (unless part of pulmonary veno-occlusive disease)
* a large tumor lung mass
* EFR missing or uninterpretable because difficult to perform
* initiation of calcium channel blockers
* surgical treatment in chronic thrombo-embolic pulmonary hypertension
* no follow-up evaluation (lost to follow-up or died before reassessment)
Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy

This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial. After completion of the FANCOLEN-I study, eligible subjects will be followed for a total of 15 years post gene therapy treatment. No investigational drug product will be administered during this study.

This long-term follow-up protocol will evaluate the long term safety and efficacy of the infusion of autologous CD34+ cells transduced with lentiviral vector (LV) carrying the FANCA gene.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the FANCOLEN-I study
2. Treated with gene therapy in the FANCOLEN-I study
3. Able to adhere to the study visit schedule and protocol requirements
4. Provided written informed consent and, as applicable, assent to participate

Exclusion Criteria:

* There are no exclusion criteria for this study
HoPe: Home Treatment and Peer Support for Acute Mental Health Crisis

Home treatment (HT) is an effective treatment modality for patients with severe mental illness (SMI) in acute crisis that can often be considered equivalent to inpatient treatment in terms of treatment outcome. In Peer Support (PS) patients are supported by people with personal experiences in psychiatric crises. The current study investigates a combination of both approaches - a HT plus PS intervention - versus sole HT at different study sites throughout Germany. It is hypothesized that a peer-supported home-delivered treatment (HT plus PS) is more effective than a professional-led home-delivered treatment (HT alone) with respect to the time until hospital readmission, self-efficacy, psychosocial health, recovery orientation, internalized stigma and service satisfaction. Furthermore, it is hypothesized, that a peer-supported home delivered treatment (HT plus PS) is as effective as a professional-led home-delivered treatment (HT alone) with respect to disease severity and general functioning (secondary outcomes).


Eligibility Criteria:
Inclusion Criteria:

* severe mental illness with indication of hospital admission (F2, F3, F6, F41, F42)

Exclusion Criteria:

* primary diagnosis of F0 or F1 (Mental disorders due to known physiological conditions; Mental and behavioral disorders due to psychoactive substance use)
* acute suicidality
* verbal or cognitive impairment severe enough to be unable to give informed consent