cyrilzakka/clinical-trials huggingface dataset:
Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* ECOG status 0 - 1
* Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
* Dose expansion: CRC (KRAS-WT) and head \& neck cancer subjects only

  1. must be able to provide 2 fresh tumor biopsy samples
  2. must have failed one prior cetuximab-containing treatment

Exclusion Criteria:

* Symptomatic brain metastasis
* Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
* Any condition requiring chronic use of steroids
* Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
* History of glucose intolerance
* History of cetuximab infusion reactions
* Women of child-bearing potential unwilling or unable to use acceptable contraception methods
The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia

The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources. The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment. The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services. The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services.

The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention. The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success. The children were enrolled in the MOM Program at birth. The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years. The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school.

Eligibility Criteria:
Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent.

Exclusion Criteria: None.
Precise Gene Signature for Predicting Outcomes in PDAC

The current TNM staging system is not sufficient for prediction of prognosis and cannot precisely identify the patients who are in greater need of adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC). Tumor mutation and copy number variation (CNV) markers may have a higher predictive value. In this study, whole exosome sequencing was performed for patients with stage I-II PDAC undergoing R0 resection. The investigators aimed to identify genes with discrepant statuses of mutations or CNVs between patients with and without relapse within 1 year after R0 resection, and then to construct a support vector machine (SVM)-based prognostic classifier (the SVM signature) for PDAC using machine learning; the investigators then aimed to further validate the SVM signature in an independent cohort.


Eligibility Criteria:
Inclusion Criteria:

* Availability of hematoxylin and eosin slides with invasive tumor components
* Availability of clinicopathologic characteristics and follow-up data
* No previous history of cancer

Exclusion Criteria:

* No formalin-fixed, paraffin-embedded (FFPE) tumor sample of primary tumor
* Receipt of any neoadjuvant and/or adjuvant cancer-directed therapy
* Survival time \<3 months after resection
Influence of Soft Tissue Thickness on the Bone Level Around Implants

Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant.

Healthy soft tissue around the implant are considered as a biological seal to prevent inflammatory periimplant diseases and ensure healthy, stable and long-term survival of a dental implant. Due to the fact that the measurement methods in the literature differ, it is necessary to establish objective measurement method and to determine the minimum amount of tissue thickness to maintain a stable level of bone around the implant.

Purpose:

The aim of the study was to determine the effect of soft tissues in the implant area on the marginal bone level loss in the implant area and to define of the critical gingival thickness to minimize marginal bone level (MBL) loss.

Materials and methods:

75 bone level implants (Conelog® Camlog, Switzerland) were inserted in the aesthetic area. Thickening of soft tissues was performed both before and after implantation (group II and III), CTG and XCM were used (subgroup a and b). 12 months after the loading with final restoration, the thickness of soft tissues in the implant area was examined with ultrasonography (USG) device (Pirop®, Echoson, Poland), and each implant was subjected to Radiovisiography (RVG) RVG examination, where MBL loss was determined.

Eligibility Criteria:
Inclusion Criteria:

To qualify for the study, the patients had to be \>18 years and have missing teeth in the esthetic zone. Additional inclusion criteria were as follows:

* missing single or double teeth in the anterior area of their upper or lower jaw with a proper inter arch relationship (incisors, canines and first premolar) with a ridge width (bucco-lingual) greater than 5 mm at its narrowest point and a minimum keratinized gingiva height of 2 mm buccally.
* No previous soft tissue augmentation procedure at experimental site

Exclusion Criteria:

The criteria that disqualified patients from the study were previous grafting procedures in the area of interest and systemic or local diseases that could compromise healing or osteointegration. Smokers and patients with bruxism were also excluded from the study. Additional exclusion criteria were as follows:

* implants placed with an insertion torque of 35 Ncm or less;
* irradiation in the head and neck area;
* untreated periodontitis;
* poor oral hygiene (plaque score Approximal Plaque Index (API) 20%, bleeding score 10%) and
* poor motivation;
* fresh post extraction sockets
Enteral Nutrition in Liver Cirrhosis

Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality.

Long term prognosis after liver transplantation also depends on the nutritional status.

Therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. However, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion.

Specific aims: To investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

* Malignant comorbidity
* Encephalopathy
Appropriate Care of URI (ACURI): Early Head Start

The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.


Eligibility Criteria:
Inclusion Criteria:

* Attending an infant or toddler EHS group at participating site

Exclusion Criteria:

* Participant in pilot study
* Participant in community intervention regarding URI
Early Weight Bearing in Unicondylar Tibial Plateau Fractures

The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).

It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

Tibial plateau fractures are common sports injuries caused by accidents such as skiing and mountain biking. Thus, young adults with high functional and athletic demands are often affected. The best possible restoration of the original joint function and resilience is therefore particularly important for this group of patients. In addition, prolonged immobilization in this patient group poses a high risk of loss of earnings and a significant impairment in athletic performance.

These injuries usually require surgical treatment which is followed by 10-12 weeks without weight bearing. In recent years, there has been a shift towards earlier mobilization with many injuries. In addition, numerous studies showed the negative effects of prolonged immobility. Nevertheless, these negative effects must always be weighed against the possibility of osteosynthesis failure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, at least 18 years of age, max 65 years of age
* Unilateral tibial plateau fracture AO:41b/c
* Written consent to participate (consent can be revoked at any time without giving reasons)
* Surgery during the study period
* Follow-up on-site (Salt Lake City, Utah, United States)

Exclusion Criteria:

* Multiple injured or polytraumatized patients
* Other injuries or illnesses that impair the patient's mobility or gait
* Cognitive limitations such as dementia, delirium or similar disease
* Refusal to participate
* Severe underlying disease with significant limitations in the ability to regenerate e.g.

malignancies

* Pathologic or osteoporotic fractures
* Unable to attend clinic in person for follow-ups
* pregnant women and fetus
Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.


Eligibility Criteria:
Inclusion Criteria:

* Have asthma and/or EIB
* Able to perform maximal exercise
* Able to communicate sufficiently using the English language

Exclusion Criteria:

* Allergic to salbutamol (also known as Ventolin)
* Pregnant or potentially pregnant
* Have a history of smoking
* Had an upper respiratory tract infection within the last 4 weeks
* Have a chronic respiratory disease other than asthma or EIB
AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study

This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
* Patient is willing and able to give informed consent to participate in the follow-up program
* Patient is suitable for surgery and able to participate in the follow-up program.
* Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)

Exclusion Criteria:

* Acute systemic or chronic infection
* Skeletal immaturity
* Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
* Bone condition that may compromise the stability of the implant.
* Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.
Comparing the Efficacy of King Vision in Infants

The primary objective of this study is to find out whether the intubation success rates of Kingvision video laryngoscope is better than that of the conventional laryngoscopes in children \< 1 year of age?

Securing the airway by tracheal intubation is one of the most critical steps during administration of general anesthesia to infants. Failure or a delay in tracheal intubation leads to severe hypoxic insult to infants as the oxygen consumption is high in them when compared to adults.Smaller caliber of the pediatric airway, relatively large tongue, anteriorly located larynx, floppy and relatively large epiglottis predispose young children to airway obstruction during Anaesthesia. In addition, the large occiput of the infant places the head and neck in the flexed position when the patient is placed recumbent, further exacerbating airway obstruction

Direct laryngoscopy requires a direct line of sight for proper glottis visualization which is achieved by proper alignment of airway axes (oral-pharyngeal-laryngeal). These manipulations can lead to significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues and dental damage. In contrast to direct laryngoscopy, video laryngoscope utilizes indirect laryngoscopy via its camera and helps improve glottic visualization, thereby minimizing complications

New age videolaryngoscopes with their unique design provide better glottis visualization without the requirement of proper alignment of oral-pharyngeal-laryngeal axes, thereby minimizing the complications associated with excessive manipulation and hence provide a decent edge over the conventional indirect laryngoscopes routinely used. With the above mentioned advantages these videolaryngoscopes can be efficiently used in both elective as well as emergencysettings in infants for intubation The investigators in this study will be evaluating the efficacy of King vision video laryngoscope when compared to the conventional laryngoscopes in routine use for infants.

Eligibility Criteria:
Inclusion Criteria

* Patients of the age group 0-1 years undergoing elective or emergency surgeries belonging to American Society ofAnaesthesiologists(ASA) physical status classification 1-2 and requiring administration of General Anaesthesia with orotracheal intubation

Exclusion Criteria:

* Patients with anticipated difficult airways
* Patients with aspiration risk or requiring Rapid sequence induction (RSI)
* Patients with laryngeal or tracheal pathologies
* Cervical spine injury
* Active respiratory infection or lung disease
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter (IDC) and bladder surgery.

Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Participants with acquired spinal cord injury
* Participants with neurogenic bladder
* Participants must be undergoing or starting at least one of the following bladder management treatments at the time of enrollment. a) Clean intermittent catheterization (CIC) b) Have an indwelling catheter (IDC) c) Spontaneous voiding, and d) Have undergone bladder surgery
* Age 18 or older
* Willingness and ability to comply with study engagement
* Able to provide consent

Exclusion Criteria:

* Degenerative spinal cord issues, such as multiple sclerosis, neuromuscular dysfunction
* Congenital spinal cord issues, such as spina bifida, myelomeningocele, or cerebral palsy
* Participants that belong to a vulnerable population (pregnant, prisoners, mentally handicapped, etc)
* Participants less than 18 years of age
Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 60 days prior to screening with metformin equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measure as required by local regulation or practice) - Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days before screening. An exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Comparison of Surgical Outcomes Between Avulsion Fracture of the AT and Conventional ATR--a Retrospective Study

To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.

Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.

Eligibility Criteria:
Inclusion Criteria:

* patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture

Exclusion Criteria:

* neuromuscular related diseases
* other injuries of ankle joint
Emotional Regulation in Individuals With Autism

The objective of the study is to learn about and manage emotions such as anxiety and anger. The activities are aimed at identifying and managing emotions such as anxiety and anger, through the recognition of the changes that occur at a physiological, cognitive, behavioral and communicative level. In the first sessions, children will be exposed to the emotion of happiness through pleasant activities and involved in relaxation exercises. In subsequent sessions, anger and then anxiety will be addressed first. Social tools will be introduced and ways of thinking and perspective useful to children will be addressed. Furthermore, they will learn to use all the tools and strategies necessary to face and overcome the various emotions and situations in a functional manner. In the final sessions, children will work to design a cognitive-behavioral intervention program for themselves and other group members to improve the management of anxiety and anger. The expected results concern the acquisition of adequate emotional regulation; the construction of functional thoughts, social tools, thinking and perspective tools, adequate strategies for managing emotions; the design of a cognitive-behavioral intervention program in daily life and the strengthening of relational, social, empathic and resilient skills within the peer group and families.


Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of autism;
* QS ≥ 75;

Exclusion Criteria:

* presence of other medical disorders