cyrilzakka/clinical-trials huggingface dataset:
Elderly CAncer Patient: Qualitative and Quantitative Factors of Inclusion Failure in Clinical Trials

The transposition of the results of biomedical research to medical management of patients in real-life setting depends highly from patient's selection. In Europe and the United States, the majority of cancers occur after 65 years. In France, 45% of cancers diagnosed in 2012 were after 70 years or 158,722 in absolute value. In this context, the median age at diagnosis was 72 years old. Disease particularly affecting the elderly, cancer is also characterized by the importance of biomedical research devoted to it. Despite the dynamism of the research activity in oncology and therefore the number of affected patients, the elderly are paradoxically sparsely included in clinical trials. Numerous studies have focused in recent years, to identify possible causes of under-representation of elderly patients in clinical trials but most of them focused on eligibility criteria and few on barriers related to non-invitation or non-inclusion in eligible patients.

The investigator postulate that a qualitative survey based on an structured epidemiological device will able to objective evidences of reasons related to the patient, participant familial caregivers, participant physician and the clinical center organization for participating or not to a clinical trial and the interrelations between the identified reasons.

The main objective is to assess reasons of non-participation of older patients with cancer in clinical trials, from the physicians, patients and family caregivers' perspectives using qualitative and quantitative methods.

The secondary objectives are:

To investigate the social representation and construction of being "aged" from the patient, physician and family caregiver perspective (qualitative part).

To compare the reasons of non-participation regarding age class (old and very old), localized versus metastatic disease and tumor site (quantitative part).

To characterize the profiles of participants and non-participants to clinical trial among older patients with cancer thanks to qualitative and quantitative data.

Method Quali SAGE is a French, socio-epidemiologic, multicenter prospective study that includes patients aged 70 years or over, with solid tumor (irrespective of the stage) in French hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or over
* With solid cancer irrespective of the stage
* Pre-screened or screened for at least one ongoing clinical trial in the center
* Informed oral consent (patient, his/her legal representant, trustworthy person or family member)
* Social security affiliation

Exclusion Criteria:

* None
Analysis of the Pharmaceutical Validation of Picc Line Installation Requests at the Nîmes University Hospital

The picc line is a central venous catheter inserted peripherally into a deep vein in the arm (cephalic, basilic or axillary) whose distal end is located at the junction of the superior vena cava / atrium.

It is installed for a minimum of 7 days (1), and can be stored for up to 6 months or more if it is functional. For treatments with an indication of more than 3 months, it is common practice to place an implantable catheter chamber. The main indications for picc line placement are: long-term antibiotic therapy, parenteral nutrition, chemotherapy or long-term venous approach when difficulties are encountered in applying a peripheral venous route to the patient.

Quickly adopted by medical teams, picc lines are not without risk, however, and three complications are mainly reported: catheter obstruction, deep vein thrombosis and infections.

In order to avoid any risk of unnecessary complications, it therefore seems appropriate to target the most appropriate device upstream of the procedure according to the provisional indication.

An inventory of pharmaceutical interventions carried out during picc line requests would make it possible to lay the foundations for considering actions to be implemented with the various services requesting picc line and proposals for improvement for the follow-up of patients with picc line to reduce the risk of complications.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over, hospitalized at the University Hospital of Nîmes
* Benefiting from a pharmaceutical validation of the demand for picc line connected

Exclusion Criteria:

* The patient is opposed to participating in this study
CGRP Induced Migraine Attacks in Patients With High and Low Genetic Load

The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by calcitonin gene-related peptide (CGRP) compared to patients with few genetic loci associated with migraine (low genetic load).

Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of these genetic loci in humans are yet unknown.

Calcitonin gene-related peptide (CGRP) is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. CGRP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway and CGRP antagonism is efficient in the treatment of migraine attacks. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks. However, CGRP does not cause migraine attacks in familial hemiplegic migraine (FHM), an autosomal dominant subtype of MA.

The phenotype of the migraine inducing effects of CGRP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified. One of the genetic loci (rs13208321) is located in a gene (FHL5) that is associated with the regulation of cAMP-responsive elements.

Eligibility Criteria:
Inclusion Criteria:

- Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

Exclusion Criteria:

* Other primary headache
* A history of cerebrovascular disease and other CNS- disease
* A history suggesting ischaemic heart disease
* Serious somatic and mental disease
* Hypo- or hypertension
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.
A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients

The purpose of this study is to determine whether the improved responsiveness to treatment achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be explained by CsA's inhibitory action on the circulating suPAR expression.


Eligibility Criteria:
Inclusion Criteria:

* Age at entry is between 14 and 70 years
* biopsy-proven primary FSGS
* proteinuria \>=3 g/day
* without corticosteroids or CsA treatment before entry

Exclusion Criteria:

* Chronic Inflammatory Diseases
* malignant tumor
* diabetes mellitus
* contraindications for the treatment of corticosteroids or CsA treatment
* untolerate to or unwilling to accept corticosteroids or CsA treatment
Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

To evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between intrauterine procedures employing a suction cervical stabilizer (new device, FDA approved, atraumatic) or single-tooth tenaculum (standard, traumatic). This device, cleared by the FDA in 2023, was studied in Europe and showed pain reduced by up to 73% and bleeding reduced by 78% compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. The investigators seek to study this device in the United States, and trial it among all intrauterine procedures.


Eligibility Criteria:
Inclusion Criteria:

* • Age 18 years or older

  * Speaks and reads in English
  * Able to consent on their own
  * Will undergo any intrauterine procedure using the Carevix (for exposure group) or using Tenaculum (for Control Group)
  * Cervix at least 26 mm in diameter
  * Twenty providers performing this procedure

Exclusion Criteria:

* • Vaginal bleeding of unknown origin

  * Cervix less than 26 mm in diameter
  * Nabothian cyst on anterior lip of cervix
  * Cervical myomas
  * Cervical abnormalities
  * Pregnant
Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.


Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form;
* Habitual current daily disposable soft contact lenses wearer;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
* Lenses within the power range specified in the protocol;
* Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
* Acceptable lens fit with both study contact lenses;
* Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Currently wearing DT1 or TE sphere lenses;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
* Eye injury or surgery within 12 weeks immediately prior to enrollment;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Prior refractive surgery;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Participation in any clinical trial within 30 days of the enrollment visit;
* Other protocol-specified exclusion criteria may apply.
Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury

Percutaneous coronary intervention (PCI) remains the major revascularization strategy for patients with obstructive coronary artery disease (CAD).However,in a substantial number of PCI cases for acute coronary syndrome (ACS) and chronic coronary syndrome (CCS),periprocedural myocardial injury or myocardial infarction (MI) occurs,both these PCI-related complications may be associated with an increased risk of future major adverse cardiovascular events (such as death, re-infarction, and revascularization).The incidence of periprocedural myocardial injury varies according to the different definition and cardiac biomarker .For 4th UDMI criteria with hs-cTn, 78% to 85% patients who undergoing elective PCI may suffer from periprocedural myocardial injury.

Experimental and clinical evidence highlight the abnormalities of the coronary microcirculation is one of the causes of myocardial ischemia.Coronary microvascular disturbances (CMD) have been associated with early stages of atherosclerosis even prior to any angiographic evidence of epicardial coronary stenosis, as well as to other cardiac pathologies such as myocardial hypertrophy and heart failure.

In this study, we try to conduct a double blinded, randomized, placebo-controlled trial，the aim of our trial is: (1) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil could reduce the occurrence of periprocedural myocardial injury and infarction in CAD patients undergoing elective PCI.;(2) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective PCI.

Simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2019 to divide the patients to treatment group (Nicorandil and verapamil) and control group (Saline). The primary end points are the incidence of periprocedural myocardial injury and 4a MI and the level of the IMR,secondary end points include levels of hs-cTnI, CK-MB ,NT-proBNP and hs-CRP before, and 24 hours following PCI, and major adverse cardiovascular events at day 30. SPSS 26.0 will be used, and P-value \< .05 will be considered statistically signifificant.

Eligibility Criteria:
Inclusion Criteria:

* 1.diagnosis of CHD with FFR\<0.8;2.elective PCI;

Exclusion Criteria:

* Patients with AMI, lesion at the opening of the main coronary artery，kidney dysfunction, Liver dysfunction，blood coagulation disorder ,NYHA III-IV,Degree II-III atrioventricular block,and restenosis after PCI，CABG will be excluded.
Accuracy of a CAD/CAM Surgical Template for Mandible Distraction

The purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. Patients with hemifacial microsomia were enrolled. Virtual planning and simulation were performed on three-dimensional models. Distraction was simulated on virtual model and the new morphology of the mandible was predicted. The position and direction of the distractor was determined to achieve the optimal morphology. The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. The outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. Linear and angular differences for the distractor was measured.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled to undergo mandibular DO via intraoral approach
* Patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment
* Patients who agreed to participate in this study

Exclusion Criteria:

* Patients requiring more than one distractor of the mandible
* Patients with mandible defect
* Patients with previous mandibular trauma
Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis

124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.


Eligibility Criteria:
Inclusion Criteria:

* included gestational age (GA) of 28-41 weeks and 5-min APGAR score of ≥7, and neonatal age of \<7 days

Exclusion Criteria:

* including small for gestational age, presence of a chromosomal abnormality, multiple congenital anomalies, genetic syndromes, history of premature rupture of membranes, chorioamnionitis, neonatal asphyxia, and missed inclusion criterion.
Exercise in Anxiety and Posttraumatic Stress Disorders

Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise.

Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD.

Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c).

Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes.

Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.

The proposed research project is designed as a randomized controlled clinical trial with three arms. The efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on primary and secondary study outcome will be investigated (see Figure 1). Patients will be first screened by the outpatient-unit of the Department of Psychosomatics at the Medical University of Innsbruck or remitted through the treating staff network community. When assessed as eligible for the study, a group of up to ten out-patients will be randomly selected and invited to an informative meeting. Patients receive study information and time tables for their group attendances. The intervention will start within the following week and will end four weeks after beginning. Follow-up assessments will take place three and six months after intervention.

In addition to the AD/PTSD symptom screening, secondary study outcomes will be assessed:

* at study inclusion (t1)
* at the end of the intervention (t2)
* three months after the intervention (t3)
* six months after the intervention (t4)

Eligibility Criteria:
Inclusion Criteria:

* ICD-10 diagnosis of Anxiety Disorder or Post Traumatic Stress Disorder: F40, F41, F43.1;
* age range: 18-65
* written informed consent
* stable medication (if needed) for at least 3 weeks

Exclusion Criteria:

* acute psychosis or suicidal behaviour
* medical contraindication to physical activity (assessed by a clinician)
* cognitive deficits
* problems with German language
An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:

Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

Enrollment is closed for all groups.


Eligibility Criteria:
Inclusion Criteria:

* Refractory or relapsed and refractory multiple myeloma
* Measurable disease
* Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination

Exclusion Criteria:

* Solitary bone or extramedullary plasmacytoma disease only
* Active plasma cell leukemia

Other protocol defined inclusion/exclusion criteria apply
Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)

When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance.

The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate coronary lesion (between 50 and 70%)

Exclusion Criteria:

* Hemodynamic instability
* Adenosine hypersensitivity
* Asthma
* Severe chronic obstructive pulmonary disease
* Long QTc
* Wolff parkinson white
* High degree atriovenricular block
* Left-right shunt
* Carotid artery stenosis with hemodynamic insufficiency
* Pregnancy
MaSS - Maastricht Sarcopenia Study

The objective of this cross-sectional study is to obtain insight in the characteristics (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic community-dwelling older people. There is one measurement moment and measurements will take place at the participant's home.

* Characterization of sarcopenic older people (demographics, nutritional status, level of physical activity)
* Prevalence rates of sarcopenia in community-dwelling older people in the Netherlands
* Insight in differences and/or overlap between sarcopenia versus frailty
* Insight in the impact of sarcopenia on economic outcomes

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years old
* Have given informed consent
* Understand Dutch language
* Able to perform a walk test

Exclusion Criteria:

* Older people living in a nursing home
* Older people with active rheumatoid arthritis, post stroke status with evident lingering symptoms (paralysis, loss of motor functions), diseases of the nervous system like Parkinson and MS, active angina pectoris, dementia
* Older people in a wheelchair, with ICD or pacemaker
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial

The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.

Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.

Eligibility Criteria:
Inclusion Criteria:

Airway management events will be included in which:

1. Patient is admitted to the Medical Intensive Care Unit (MICU)
2. Planned procedure is endotracheal intubation
3. Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow
4. Administration of sedation and/or neuromuscular blockade is planned
5. Age ≥ 18 years old

Exclusion Criteria:

Airway management events will be excluded in which:

1. Operator feels specific patient positioning during intubation is required
2. Urgency of intubation precludes safe performance of study procedures
3. Operator feels an alternative pre-procedure checklist or no checklist is required