cyrilzakka/clinical-trials huggingface dataset:
Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting

This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:

* Sutent (prospective) - Inlyta
* Sutent (retrospective) - Inlyta
* Sutent - not further active treatment (supportive care)
* Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. Therefore for some patients there will be a retrospective Sutent data collection. The primary endpoints of this study in patients with adv/mRCC are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age and over
* Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1
* Patients being treated with Sutent in 1st line according to the European therapeutic indication and/or being treated with Inlyta in 2nd line according to the European approved therapeutic indication (except post cytokines)
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients being treated with cytokines or any other treatment outside of Sutent in 1st line
* Patients receiving anti -tumor treatment beyond a second line
* Patients already under Sutent, already under Inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)
Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients with Severe Acute Brain Injury

Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. It is common clinical practice, but the interaction between the body's sugar levels and the brain's sugar levels is not sufficiently elucidated.

The study will investigate the relationship between the body's sugar levels, measured in arterial and venous blood, and the brain's sugar level, measured by microdialysis, in patients with severe acute brain injury.

Furthermore, we hope to be able to use our measurements to set up a mathematical model for the brain's sugar uptake.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Admission to the neuro-ICU at Rigshospitalet.
* Multimodal neuromonitoring

Exclusion Criteria:

* Closest relative does not understand written and spoken Danish or English.
* Patients with known diabetes mellitus upon admission.
The Effect of the SNS-Based Feeding on Transition to Exclusive Breastfeeding in Preterm Infants

This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants

Nutrition is a critical problem in preterm infants. They should initially be enterally fed because they have poor sucking-swallowing-breathing coordination. Once a preterm infant develops that coordination, enteral feeding should be discontinued immediately. Then, the preterm should switch to oral feeding (breastmilk). However, preterm infants are not good at sucking because they get tired too quickly, have poor sucking skills, and lack enough experience. Therefore, we must use alternative supplemental feeding methods (bottle, spoon, dropper, cup, breastfeeding support system, and finger feeding) until preterm infants mature enough to meet their daily nutritional needs by breastfeeding alone (exclusive breastfeeding).

The Supplemental Nursing System (SNS) is an alternative supplemental feeding method that supports the development of sucking skills while providing the preterm infant's nutritional needs. This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* being between the gestational ages of 30 to 34 weeks
* having a birthweight of ≥1000 g
* having an APGAR score of \>6
* having stabilized for 48 hours after receiving mechanical ventilator or continuous positive air pressure or both
* being exclusively gavage-fed with breast and/or formula and ready to switch to oral feeding
* being willing to breastfeed

Exclusion Criteria:

* having a congenital malformation that may cause asphyxia and affect breathing
* having an intraventricular hemorrhage, intracranial hemorrhage, or periventricular leukomalacia
* having intestinal anomalies or hyperbilirubinemia requiring exchange transfusion
* having respiratory distress syndrome, bronchopulmonary dysplasia, or other chronic lung diseases.
AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)

The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Females must be of non-childbearing potential.

Exclusion Criteria:

* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was \< 24 hours) of the first administration of study drug
* Plasma or blood product donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening.
A.L.P.S. Clavicle Plating System PMCF

A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and the instrumentation used during surgery.

The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its instrumentation by analysis of fracture healing, functional outcome and adverse events.

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws.
* Unilateral or Bilateral fractures.
* Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up.
* Patient must have a signed IRB/EC approved informed consent.

Exclusion Criteria:

* Active infection.
* Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone.
* Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions.
* Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
* Patient is a current alcohol or drug abuser
* Patient is a prisoner
* Patient known to be pregnant or breast feeding
* Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study)
* Not expected to survive the duration of the follow-up program
Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT)

This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test.

Depressive disorder malingers are prevalent, and it is difficult to recognize. As an objective and scientific endophenotype of depressive disorders, the blunted features in NSRT are determined by genetic factors and are not influenced by the mental state of individual subjects at a particular moment, which can provide a reliable retrospective biological index for the determination of mental and psychological state of depressive disorder malinger.

This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger, explore the application prospects of this technology in the field of biological identification, and establish a high-specificity biological diagnostic model for depressive disorder malinger and validate and optimize it, so as to provide a biological basis for the accurate and efficient identification of depressive disorder malingers using objective indexes in the process of clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Depressive Disorder Malinger Group:

1. Clinical complaints meeting DSM-5 criteria for the diagnosis of depressive disorder;
2. Patients with first-episode fraudulent disease who meet the DSM-5 criteria for the diagnosis of Z76.5;
3. Age 18-60 years, Males;
4. Voluntary informed consent.

Depressive Disorder Group:

1. Patients with a first depressive disorder meeting DSM-5 criteria;
2. Age 18-60 years, Males;
3. Voluntary informed consent.

Healthy control group:

1. M.I.N.I scale rating without any mental disorder;
2. PHQ-9 \<5 ;
3. No history of mental illness, no family genetic history;
4. Age 18-60 years old, Males;
5. Voluntary informed consent form.

Exclusion Criteria:

1. History of traumatic brain injury;
2. Continuous use of non-steroidal anti-inflammatory drugs within the last two weeks.
Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX

To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single dose administration.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. overweight or obese

Exclusion criteria:

1. Any relevant deviation from healthy conditions
The Standing and Sitting Spino-pelvic Sagittal Alignment in Chinese Population

This study is aimed to demonstrate the standing and sitting spino-pelvic sagittal alignment in Chinese population, then to explore the influence of spinal fusion on the changes when moving from standing to sitting positon.


Eligibility Criteria:
Inclusion Criteria:

Group 1 90 Healthy Volunteers - age \>40 years, no history of neck pain, back pain, or radicular pain in the previous six months, no history of chronic neck or back pain lasting more than three months, no history of spinal disease or surgery, no spinal deformity or lumbar spondylolisthesis, no history of hip or knee arthroplasty or other realignment surgery of the lower extremities, and no history of neuromuscular disorders.

Group 2 126 patients Clinical diagnosis of Lumbar degenerative disease

Exclusion Criteria:

Group 1 90 Healthy Volunteers

- pregnant

Group 2 126 patients

* Neuromuscular diseases
* Arthritis
* Tumor
* A previous history of lumbar fusion surgery
Different Techniques for Prevention of Complications After Septoplasty Operation

the aim of the study is to compare complication of trans-nasal quilting sutures, nasal pack and intra intranasal silicon splint in endoscopic septoplasty

Septoplasty is the recommended procedure for treating deviated septum and many surgeons are adopting an increasingly conservative approach to septal surgery, such that only the deviated portion of the septum is addressed by the surgery.

The surgical methods utilized in this procedure differ, though the procedure typically involves removal of the deviated cartilage and bony septum that creates a dead space between the mucosal flaps. Although rare, complications such as septal hematoma and consequently abscess formation, adhesions and perforation can occur post-operatively. Three main methods have been employed to prevent such complications. These are intranasal occlusive packing, intranasal silicon splinting, and trans-septal quilting suturing.

However, the totally occlusive nasal packing has many temporary negative effects on the patients' quality of life, which are well studied in the literature. The main disadvantages include: sleep disturbance, patient's discomfort, local pain, headache, dysphagia, breathing difficulty, anxiety and more severe pain on pack removal(6). Bilateral nasal packing may affect the respiratory function due to inadequate oral breathing causing nocturnal hypoxia, which may become more apparent in patients with obstructive sleep apnea or chronic lung diseases. Eustachian tube dysfunction, intranasal infections, toxic shock syndrome, laryngeal or bronchial spasm, myocardial infarction, cerebrovascular accidents has been reported. In addition, the mucosal damage caused by nasal packing may lead to loss of cilia and affects the mucociliary clearance during the healing period.

Intranasal silicone splinting is fast, technically simple and can be used for cartilage support. However, it can cause discomfort in terms of frequent sneezing and epiphora and has a potential risk for bacterial colonization.

The most important advantages of the suture technique include: the non-obliteration of the nasal cavities and the absence of agony associated with pack removal, so it highly decreases patient's discomfort and anxiety related to breathing and pack removal.

the aim of the study is to compare complication of trans-nasal quilting sutures, nasal pack and intra intranasal silicon splint in endoscopic septoplasty

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patient of different ages from 16 to 60 year-old with symptomatic deviated nasal septum

Exclusion Criteria:

* Patient with nasal polyposis or nasal tumors or patients with sinusitis not responding to medical treatment.
* Patient with previous septal operation
* Patient who is planned to do partial inferior turbinectomy or turbinoplasty with septoplasty
* Patients with contraindications for general surgery
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

Eligibility Criteria:
Inclusion Criteria:

1. 18-90 years old
2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
3. First time stroke patient
4. Upper limb hemiparesis
5. English-speaking
6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion Criteria:

1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
2. Patients with hemicraniectomy
3. Current uncontrolled seizures
4. Active infections requiring contact precautions
5. Cognitively unable to participate
6. Vision loss limiting ability to participate with VR therapy
Post-Hospital Intervention for Veterans With Comorbid Bipolar and Substance Use Disorders

This trial aims to evaluate the effectiveness of a novel intervention for Veterans with co-occurring bipolar and substance use disorders following a psychiatric hospitalization. Half of the participants will receive a specialized psychosocial intervention program, while the other half will receive an enhanced safety monitoring program, both provided in addition to their routine care.

This randomized controlled trial will evaluate the effectiveness of a psychosocial intervention designed to improve treatment adherence in Veterans with comorbid bipolar disorder and substance use disorders (BP-SUD) following a psychiatric hospitalization. Participants will be randomized to either the specialized psychosocial intervention or an enhanced safety monitoring program, both as adjuncts to VA treatment as usual. Veterans with BP-SUD will be recruited from the Providence VAMC inpatient psychiatric unit and assessed at baseline and at 3 (mid-treatment), 6 (post-treatment), and 9-month post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a mood disorder
* Diagnosis of a substance use disorder (drug and/or alcohol)
* Taking at least one psychiatric medication

Exclusion Criteria:

* Unable to speak and read English
* Younger than age 18
Use of a Monitor in ME/CFS

The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.

A cohort of 50 patients suffering from chronic fatigue syndrome will be given an informed release form. Have a signed the informed release they will be given a Fitbit activity monitor. These monitors will be evaluated on a weekly interval by computer interface. The activity will be calculated to determine the online of activity and whether there is increase or decrease in activity during the time of the study. The study is an observational rather than an interventional study. There is no invasion or intervention in the patient's normal activities

Eligibility Criteria:
Inclusion Criteria:

Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome

Exclusion Criteria:

Acute disease and exclusion conditions in Fukuda criteria
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients

The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular \[LV\] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.

The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.


Eligibility Criteria:
Inclusion Criteria:

* Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)
* Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
* Have a ventricular conduction delay manifested as a QRS width \>= 130 ms
* Have a left ventricular end diastolic diameter (LVEDD) \>= 55 mm
* Have a left ventricular ejection fraction (LVEF) \<= 35%

Exclusion Criteria:

* Have a CRT device already implanted
* Have a standard indication for bradycardia pacing
* Have a history of chronic atrial fibrillation \[AF\] (continuous AF lasting \> 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)
* Have the ability to walk \> 450 meters during the 6-minute walk test
* Have uncorrected primary valvular disease
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty \[PTCA\] or coronary artery bypass graft \[CABG\]) within 1 month of enrollment
* Have had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
* Have a life expectancy of less than one year
* Are unable to comply with the follow-up schedule and tests
* Are minors (age below 18 years)
* Are pregnant or are planning for pregnancy in the next 6 months
Atropin and Glucose Stimulated Insulinsecretion and the Cephalic Insulin Response

The aim of this study is to investigate the role of transmission of vagal cholinerg for the GLP-1 potentiation of the glucose stimulated insulin secretion and the cephalic insulin response by using atropin administration.

The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the investigators will research individuals with an intact nervous supply with and without atropin administration.

GLP-1 is a importent enterogastron and incretin hormone. Rapid degradation of GLP-1 by dipeptidyl peptidase 4 (DPP-4) suggests that GLP-1 may act locally (through vagal afferents) before being degraded. We aimed to clarify the role of vagal innervation on the incretin effect.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 45 years
* normal fasting plasma glucose
* normal hemoglobin
* informed consent

Exclusion Criteria:

* diabetes mellitus
* body mass index above 30
* inflamatoric bowel disease
* intestinal surgery
* serum creatinine above 250 microM
* ALAT above to times normal value
* treatment with medicine wich cannot be paused for 12 hours
* contraindication for treatment with atropin
Protozoans in Biofilm From Patients With Periodontitis

The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.

Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .

Others microorganisms such as protozoans could have an impact on this disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years-old
* consulting in periodontal department of CHRU
* Patients with moderate to severe periodontitis
* At least 2 periodontal sites with PPD ≥ 5mm and one healthy site
* No scaling root planing in the last 6 months
* Patients insured under the Franch social security system

Exclusion Criteria:

* Pregnants patients
* Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months
* Tooth with endodontics periapical lesion
* Patients having a scaling root planing in the last 6 months
* Patients with guardianship