cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Folfox4 + Weekly Cetuximab vs Folfox 4+Biweekly Cetuximab by Metastatic Colorectal Cancer

To assess the efficacy of FOLFOX4 in combination with cetuximab, weekly and FOLFOX4 in combination with cetuximab, biweekly.

This multicenter randomized phase II study will enroll approximately 150 patients with metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy and safety data will be collected. The investigator will assess response to treatment every 8 weeks based on the imaging.

Following permanent treatment cessation, patients will be followed-up for survival.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female ≥ 18 years of age
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic colorectal carcinoma not suitable for curative-intent resection- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
* Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
* Karnofsky performance status of \> 80 at study entry
* Leucocytes ≥ 3.0 x 10 9/L and neutrophils ≥1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, and hemoglobin ≥ 9 g/dL.
* Bilirubin ≥ 1.5 x ULN
* ASAT and ALAT ≤ 2.5 x ULN (≤5 x ULN if liver metastasis are present)
* Serum creatinine ≤ 1.5 x ULN

Exclusion Criteria:

* Brain metastasis (known or suspected)
* Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy is allowed if the chemotherapy treatment free interval is \> 6 months.
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
* Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Any investigational agent(s) within 4 weeks prior to entry
* Previous exposure to EGFR-pathway targeting therapy
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
* Acute or subacute intestinal occlusion or history of inflammatory bowel disease
* Pre-existing neuropathy \> grade 1. In case of prior oxaliplatin containing adjuvant chemotherapy: pre-existing neuropathy ≥ 1.
* Known grade 3 or 4 allergic reaction to any of the components of the treatment.
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
* Pregnancy or lactation
* Inadequate contraception (male or female patients) if of childbearing or procreational potential
* Known drug abuse/ alcohol abuse
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
The Effect of Splint Usage in Laterognathic Cl III Orthognathic Surgery Patients

It is crucial to maintain the anatomic condylar positions during orthognathic surgery. Condylar positions are affected directly under general anesthesia because of joint and muscle relaxation. Possible unwanted changes in the joint position may cause incorrect positioning of the jawbones. This could affect the success of the surgery in terms of function and facial aesthetics causing the need for a second surgery. Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.

It is crucial to maintain the anatomic condyle positions during orthognathic surgery to prevent iatrogenic temporomandibular joint complications. Condyle shunts are affected directly under general anesthesia because of the joint and muscle relaxation. Surgical guidance appliances are prepared according to the TMJ records taken chairside while patients are in an upright position. During surgery, these appliances are applied in a supine position while the muscles are relaxed. Postoperative and long-term effects of TMJ and muscle relaxation obtained under general anesthesia in class III and asymmetric patients will be examined. Patients who had occlusal splint before records taken will be evaluated in terms of condyle location by MPI.

Our aim is to evaluate whether the use of MR Splint has a statistically significant effect on muscle relaxation-induced condyle position deviations under general anesthesia in Class III Laterognathia patients.

Eligibility Criteria:
Inclusion Criteria:

* being ready for orthognathic surgery
* must be able to give centric relation records

Exclusion Criteria:

* having any TMDsyndromes
* cleft lip and palate,
* have bruxism,
* TMJ or muscle disfunctions,
* under any medication of muscle relaxants,
* narcotics and antidepressants,
* usage of removeable prosthetics
* have toothless areas that can affect the wax impression for centric record
* used horizontal elastics within the last 2 months
Increasing Exercise Adherence After Percutaneous Coronary Intervention With the Fitbit Charge HR Device

Design: Single center, prospective, randomized study that will compare activity levels in patients who complete cardiac rehabilitation after clinically indicated percutaneous coronary intervention with and without use of the wrist-worn Fitbit Charge HR device and mobile platform application.

Primary Endpoint: The average number of steps taken per day will serve as the main marker of daily physical activity.

Control: Patients who do not receive the device (Fitbit Charge HR).

Secondary Endpoints: (1) change in daily energy expenditure (2) change in number of activity and sedentary bouts (3) change in sleep efficiency (4) change in weekly time of moderate/vigorous physical activity (5) change in quality of life (6) change in indicators of depression (7) change in medication adherence(8) change in HDL and LDL cholesterol (9) change in BMI and waist circumference (10) change in resting heart rate and blood pressure (11) change in exercise stress test performance (timeframe for all: baseline - 12 weeks)


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Willing and able to give informed consent
* Successful, clinically-indicated PCI with no plan for staged procedure
* Clinically stable and able to exercise
* Access to smartphone (Apple or Android platform)
* Completed 10 weeks of CR and is expected to graduate program.

Exclusion Criteria:

* Plan for PCI or other major surgical procedure, which would limit exercise capability, within the 14 weeks following study enrollment.
* Home oxygen requirement
* Amputation, peripheral arterial disease, other musculoskeletal or neurological disease affecting mobility
* End-stage renal disease
* Ongoing Unstable angina or CCS IV angina
* NYHA IV heart failure
* Terminal illness
* Dementia
* Fall risk (inability to hold semi-tandem stance for 10 seconds)
* Pregnant women and prisoners
* Any other criteria that in the opinion of the investigator would preclude patient participation in the study and/or impact exercise capability.
Clinical Investigation for New Filter to Ostomy Bags

The aim of the current clinical investigation is to evaluate a new filter.

The new filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age and have full legal capacity.
* Have given written informed consent.
* Be able to fill in the Case Report Form.
* Be colostomy operated and have had a stoma for at least 6 months.
* Experience ballooning at least once per week.
* Be able to manage the bags themselves (application, removal).
* Be able to use a flat base plate.
* Have a stoma with a diameter less than 60 mm

Exclusion Criteria:

* Persons who irrigate
* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).
* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
* Pregnant or breastfeeding.
* Participate in other test at the same time.
Malnutrition and Outcome in Hospitalized Children in Europe

Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed.

One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.


Eligibility Criteria:
Inclusion Criteria:

* Children admitted to the participating hospitals during the study period
* Age between 1 month and 18 years
* Expected hospital stay exceeding 24 hours
* Parents/caregivers, as well as those patients capable to comprehend, agree to participation and sign the informed consent form

Exclusion Criteria:

* Infants with premature birth (\<37 weeks gestational age) during the first 12 months of life
* Infants \< 1 month of age
* Patients ≥ 18 years of age
* Children in need of intensive care
* Children admitted to day-care (LOS \< 24hours)
* Patients admitted for elective reasons with an expected hospital stay \<24 hours
Bone Anchored Carriere Motion Appliance

Carriere Motion appliance (CMA) was designed to change a Class II molar relationship into a Class I relationship by distalizing the whole posterior maxillary segment by means of class II elastics and mandibular anchorage. To eliminate the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with intra-arch anchorage using infrazygomatic miniscrews. The aim of this study is to evaluate skeletaly anchored CMA for distalization of the maxillary buccal segment vs. conventionally anchored CMA by comparing skeletal and dental measurements obtained from lateral cephalometric radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

Thirty-two class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer.
2. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic miniscrews. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, closing coil spring will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age (11-16) years.
2. Full permanent dentition.
3. Class II malocclusion with at least an end-on Class II molar relationship bilaterally.

Exclusion Criteria:

1. Systemic conditions that may interfere with the treatment.
2. Bad habits that might jeopardize the appliance.
3. Transverse discrepancy.
4. Previous orthodontic treatment.
Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months

The primary hypothesis being tested in this trial is that ischemic stroke patients with prior ischemic stroke within 3 months will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). Patients with AIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified in the guideline
2. Patients with prior ischemic stroke within 3 months
3. Patients ≥ 18 years old
4. Informed consent has been obtained depending on local ethics requirements.

Exclusion Criteria:

(1) Plan to receive endovascular treatment (2) Pre-stroke mRS score \> 2 (3) Contraindications for IVT：

1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
2. Previous history of intracranial hemorrhage
3. Severe head trauma or stroke history within the last 3 months
4. Intracranial tumors, giant intracranial aneurysms
5. Intracranial or spinal surgery within the recent 3 months
6. Major surgical procedures within the last 2 weeks
7. Gastrointestinal or urinary tract bleeding within the last 3 weeks
8. Active visceral bleeding
9. Aortic arch dissection
10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
12. Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions
13. Received low-molecular-weight heparin treatment within 24 hours
14. Oral anticoagulants (warfarin) with INR \> 1.7 or PT \> 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.
15. Blood sugar \< 2.8 or \> 22.22 mmol/L
16. Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator
Comparison of the Radiological Pattern Between the Cerebral Stroke of Arterial and Venous Origin

There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with CVT
* parenchymal lesions on magnetic resonance imaging

Exclusion Criteria:

* No CVT
Pre-sleep Protein Supplementation in British Army Recruits

Dietary protein has been shown to be important to support physical training. For occupational demands such as military training, new recruits often fail to meet the recommended protein intake during basic training (BT), with negligible amounts consumed in the evening. As such, individuals undertaking BT may require higher intakes than the general population.This study assessed the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in British Army recruits.

Dietary protein is crucial for optimising physical training adaptations such as muscular strength and mass, which are key aims for athletic populations, including British Army recruits. New recruits fail to meet the recommended protein intake during basic training (BT), with negligible amounts consumed in the evening. This study aimed to assess the influence of a daily bolus of protein prior to sleep on performance adaptations, body composition and recovery in British Army recruits. The study will recruit a mixed cohort of \>120 new recruits from the United Kingdom (UK) British Army who will be randomised into a dietary control (CON), carbohydrate placebo (PLA), moderate (20g) protein (MOD) or high (60g) protein (HIGH) supplementation group. Supplements will be isocaloric and consumed daily on weekday evenings between 2000 and 2100h for 10 weeks during BT, alongside standardised dietary intake and BT activities. Performance tests (mid-thigh pull, medicine ball throw, 2km run time, maximal push-up and maximal vertical jump) and body composition will be assessed at the start and end of BT under standardised conditions. Dietary intake, energy expenditure, salivary hormones, urinary nitrogen balance, perceived muscle soreness, rating of perceived exertion, mood and fatigue will be assessed at the start, middle and end of BT. The underlying aim of this study is to assess whether inclusion of nocturnal protein supplementation will influence performance adaptations, body composition changes or acute recovery in British Army recruits.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled into British Army basic training
* Medically fit to start Army training

Exclusion Criteria:

* Not taking any other nutritional supplement
* Not currently pregnant
* Not dairy or lactose intolerant or have any specific dietary requirements .
Comparison of Recovery Profile After TIVA Between Remimazolam With Flumazenil and Propofol

This prospective, randomized, single-blinded study is designed to compare the recovery profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized by flumazenil can significantly shorten the time from the end of anesthetic administration to eye-opening compared to propofol-based TIVA.

Adult patients undergoing elective thyroidectomy are randomly allocated to receive propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including the time from the end of anesthetic administration to eye-opening, the time from the end of anesthetic administration to extubation, hemodynamic stability, stability of anesthetic depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using the quality of recovery-15 was assessed by an investigator. The primary outcome is the time from the end of anesthetic administration to eye-opening.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective thyroidectomy under general anesthesia
* American Society of Anesthesiologists (ASA)physical classification I-II
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* American Society of Anesthesiologists (ASA)physical classification III or more
* BMI \> 40kg/m\^2
* Allergies to anesthetic or analgesic medications (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, sugammadex, flumazenil)
* Patients who receive mechanical ventilation morethan 2 hours after surgery
* Patients who receive the following medications within 24 hours prior to general anesthetics: anxiolytics, antipsychotics, rifampicin, succinycholine, neostigmine, flumazenil, cyclosporin
* Patients with galactose intolerance or Lapp Lactase deficiency or glucose-galactose malabsorption
* Medical or psychological disease that can affect the treatment response
Evaluation of the Physiopathological Phenomena and the Haemodynamic and Cerebral Metabolic Effects From Semi-seated Position to Lying Position in Patients With Brain Trauma

Brain trauma is an important burden in traumatologic intensive care. In these patients the treatment is guided by a cluster of multimodal monitoring parameters. Despite this it is difficult to assess the actual physiopathologic status of the brain. Changing the position of these patients (semi-seated to lying position) causes changes in the hémodynamics brain conditions, so in monitoring parameters . The analysis of these changes can givr us valuable clinically informations.

Severe brain trauma (CGS \< 8 ) are included. PIC, PA, PVC, EKG, airway pressure, SjO2 and NIRSS are continuously monitored.

The patients are in semi seated (30°) position. Once a day they are in supine (0°) for 30 minutes. We record every parameters before and at the end of this supine period.

After time domain and frequency domain signal processing, this parameters are compared to deduct clinical relevant conclusions.

Eligibility Criteria:
Inclusion Criteria:

* patients with a severe head trauma estimated by the Glasgow Coma Scale and by the Glasgow Outcome Scale
* age \> 18

Exclusion Criteria:

* Other neurological pathology
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.

The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 18-65 years old;
2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
3. relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018;
4. Patients who signed the informed consent form.

Exclusion Criteria:

1. Patients who failed or intolerant to either adalimumab or tofacitinib;
2. patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
3. not well controlled diabetes;
4. uncontrolled heart failure od renal dysfunction(eGFR\<30ml/min);
5. Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
6. upper GI bleeding 3 months before enrolement;
7. refractory hypertension;
8. Pregnant or intended to be pregnant 3 months after the trial;
9. Severe coronary artery involvement demonstrated by CTA;
10. severe cranial or cervical or renal artery diseases that need surgery;
11. Patients that should not be included by the investigator.
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* all patients with high risk anastomoses