cyrilzakka/clinical-trials huggingface dataset:
Chronic Pain in Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

RATIONALE: Learning about chronic pain in women who have undergone surgery for breast cancer may help improve the quality of life for these patients and may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying chronic pain in women who have undergone surgery for stage I, stage II, or stage III breast cancer.

OBJECTIVES:

* Identify which preoperative psychological risk factors, after controlling for demographic and clinical factors, are associated with chronic pain at 4 and 9 months after breast cancer surgery.
* Assess the incidence of chronic pain at 4 and 9 months after breast cancer surgery.
* Determine whether pain status at 4 and 9 months after breast cancer surgery is associated with changes in psychological well-being and health-related quality of life over time.

OUTLINE: This is a multicenter study.

Patients complete a preoperative pain questionnaire that includes the McGill Pain Questionnaire, a full body map, and the self-report Leeds Assessment of Neuropathic Symptoms and Signs scale. Only those patients with preoperative pain are asked to compete the full pain section of the questionnaire to assess location, severity, and type of pain. Acute postoperative pain during the first week after surgery is assessed using a visual analog scale (0-10). Patients then undergo telephone assessment of intensity and timing of acute pain 7 days after surgery. Subsequent postoperative pain assessments are conducted by mail using questionnaires at 4 and 9 months after surgery. Patients reporting chronic pain in the region of the surgical site are asked to complete the detailed pain section of the questionnaire.

Demographic variables, including age, education level, marital status, and body mass index, are recorded at baseline. Psychological (anxiety and exaggerated negative beliefs about pain) and quality-of-life outcomes are recorded at baseline and at 4 and 9 months postoperatively.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer or carcinoma in situ of the breast by core biopsy or fine needle aspiration

  * Newly diagnosed disease
  * Stage I-III disease
  * Resectable disease
* Being treated in the Aberdeen, Dundee, Perth, or Inverness Breast Unit

  * Planning to undergo primary surgical excision of the tumor (e.g., breast conservation surgery or mastectomy with or without axillary surgery \[sentinel node biopsy, axillary sample, or axillary clearance\])
  * Planning to undergo standard adjuvant therapy after surgery, including radiotherapy, chemotherapy, and/or hormonal therapy, as per existing standard protocols
* No detectable metastatic disease

PATIENT CHARACTERISTICS:

* Not pregnant
* Speaks English
* No history of mental illness

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS

My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis (MS).

This study is evaluating various aspects of My MS Toolkit plus coaching and how it impacts symptom self-management in multiple sclerosis. The research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.

Study participants will be asked to use a newly developed web-based symptom self-management program, called the My MS Toolkit, for 8 weeks.

The My MS Toolkit includes 8 modules that describe symptom self-management strategies. Participants will explore the My MS Toolkit, following the prompts and guides built into the program, and meet with a study coach weekly for 15 to 30-minute telephone-delivered coaching sessions. Participants are encouraged to practice and apply the skills learned.

The study can be done from participants' homes using a reliable internet-connected device. No travel is required.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis
* Have access to a reliable, internet-connected device (e.g. computer, tablet). (Note: this study is conducted electronically and is not location dependent.)
* One or more of the following:

  1. Moderate/moderately severe depressive symptoms
  2. Chronic pain
  3. Presence of significant fatigue symptoms
* Read, speak and understand English.

Exclusion Criteria:

* Significant cognitive impairment
* Current psychotherapy for symptoms
Hepatic Transplantation Registry

The objective is to provide a mechanism to store information regarding the demographic characteristics; pre-, intra-, and post-transplant laboratories; treatment strategies; complications; and outcomes in patients undergoing hepatic transplantation.

This study will be conducted at Methodist Dallas Medical Center and include data from hepatic transplant patients beginning in January 2019 and continuing until statistical significance is achieved. Patients will be identified based on ICD-10 procedure codes which are only available post-discharge in the EMR. Data will be collected once patient is discharged and no additional procedures are necessary. All cases meeting the inclusion criteria are expected to be included in this study

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135

Exclusion Criteria:

* Does not meet inclusion criteria specified in 3.1
Exploratory Clinical Study of MT-2301

The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged ≥2 and \<7 months at the first vaccination of the study drug
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

* With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug
* With known serious acute disease
* With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease
* With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
* History of anaphylaxis due to food or pharmaceuticals
* With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis
* With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent
* History of convulsions
* Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination
* Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
* Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) continuously for more than 1 week
* Participated in other studies within 12 weeks before obtaining consent
Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty.

The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.

Eligibility Criteria:
Inclusion Criteria:

* Elective total hip arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding
* Opioid intolerance
* Obesity defined as BMI\>40 kg/m2
* Diabetic neuropathy and rheumatoid arthritis
The MORDIS Study Clinical Investigational Plan

To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.

To demonstrate the performance of the WavSTAT4 Optical Biopsy System when used at multiple centers.

Endpoint targets are based on the ASGE PIVI recommendations on real-time endoscopic assessment of the histology of diminutive colorectal polyps.

* Primary endpoint: To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV \> = 90% for diminutive colorectal lesions.
* Secondary Endpoint: To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps \>5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female \> 18 years
* Standard indication for colonoscopy OR CRC screening OR follow-up examination after the diagnosis of one or more established polyps OR polypectomy (analysis of polyps other than the intended polypectomy)
* Written informed consent

Exclusion Criteria:

* Inflammatory bowel disease
* Hereditary/genetic polyposis syndromes
Induction of Labour With a Double Balloon Catheter

The objective of this study is to provide a comprehensive analysis of various time intervals (1:1). In addition to evaluating the time interval until delivery after completion of induction, the study also aims to investigate the rate of vaginal births and the type of combination therapy used (including the method of implementation and subsequent induction).

Approximately 22% of births in Germany are induced annually using either medicinal, mechanical, or sequential mechanical/medicinal methods, with oxytocin and prostaglandins being the available drug options. Double balloon catheters have been used in clinics for over a decade for mechanical induction of labour, resulting in cervical ripening and possible onset of labour through endogenous prostaglandin release. This method is associated with low rates of uterine tachysystole and maternal and neonatal morbidity.

The recommended placement time for the double balloon catheter is 12 hours, typically performed at night in an inpatient setting, which may cause early exhaustion and fatigue for patients. However, a study has shown that a shorter insertion time of 6 hours is equally safe and effective, without any time savings beyond the shortened insertion time.

This study aims to investigate the feasibility and effectiveness of shortening the induction birth interval from 12 to 6 hours. The investigators hypothesize that this will result in a shorter induction birth interval with comparable maternal and neonatal outcomes. This analysis will test the effectiveness of the shortened induction birth interval.

Eligibility Criteria:
Inclusion Criteria:

* destational age above or equal 37/0 weeks of gestation
* desired spontanous delivery
* Bishop-Score below or equal to 5
* cranial position
* single pregnancy

Exclusion Criteria:

* unable to consent
* pathological CTG according FIGO criteria
Overcoming Barriers to Performing CPR Using a Novel, Interactive CPR Game System

The goal of this prospective trial is to compare CPR skill and attitudes in adolescent students. The main question\[s\] it aims to answer are:

* Does a gamified CPR experience improve CPR skill retention compared to standard classroom CPR training?
* Does a gamified CPR experience improve attitudes/knowledge relating to barriers for women and minorities receiving CPR?

Participants will

* Answer pre-training questionnaires
* Participate in CPR training
* Participate in CPR skills testing on the day of training, and at 4-6 months
* Answer post-training questionnaires

Researchers will compare standard CPR classroom training to the novel gamified CPR training experience, which includes an interactive film, a CPR Trainer spring, and a mobile device app.

We will investigate the effectiveness of the gamified CPR experience (Trainer + app + film + software). The study will be a prospective, cluster-randomized controlled trial with 2 arms: control (standard instructor-led CPR training), and gamified experience. The intervention and cluster randomization will occur at the classroom level and outcomes reported at the individual level. We assume negligible intra-class correlation because classes will be randomized in an alternating fashion to eliminate time-of-day differences. For example, 1st period is randomized to control, 2nd period to game.

CPR training (control or game method) will occur at the beginning of each semester in 8th or 9th grade Health class. Immediately after training, students will perform 2-min of CC, while the app silently measures CC rate and depth. Pre- and post-training questionnaires assessing knowledge and response to female-specific and ethnic CPR barriers will be administered via paper-pencil. At the end of the semester (4 months), students will again perform 2-min of CC and answer questionnaires. All data will be collected on-site in paper-pencil format, and entered into Excel by research coordinator off-site. All data will be de-identified and reported in aggregate form

Eligibility Criteria:
Inclusion Criteria:

* All 8th and 9th grade students at participating schools enrolled in Health Class.

Exclusion Criteria:

* Previous CPR training (will be included in the CPR training but excluded from analysis)
* Physical injury which prevents performing CPR
* Student or parent opt-out
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.

Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study.

However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine tumor with radiological evidence of disease progression since last treatment
* Refractory disease to treatment with mTOR inhibitor
* Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
* Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as a systemic treatment.
* WHO PS ≤ 1
* Adequate bone marrow function or organ function

Exclusion Criteria:

* Previous treatment with any PI3K or AKT inhibitor
* Discontinuation prior mTOR inhibitor therapy due to toxicity
* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
* Radiotherapy, or major surgery within 4 weeks prior to study treatment start
* Hepatic artery embolization or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of study treatment start.
* More than 3 prior systemic treatment regimens (including cytotoxic chemotherapy, targeted therapy, immunotherapy)
Optimizing Intervention Effects in Children and Adolescents

Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term.

This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention.

The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.


Eligibility Criteria:
Inclusion Criteria:

* Parents agree and support their children's weight loss, and students and parents have informed consent;
* Students in third grade aged 8 to 10 years old.

Exclusion Criteria:

* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
* obesity caused by endocrine diseases or side effects of drugs;
* abnormal physical development like dwarfism or gigantism;
* physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
* inability to participate in school sport activities;
* a loss in weight by vomiting or taking drugs during the past 3 months.
1% Metformin Gel-coated Implants and Osteointegration and Crestal Marginal Bone Loss

Achieving and maintaining a long term osseointegrated dental implant is a golden goal of success in field of dentistry. Osteointegration depends on surface treatment of dental implants. various techniques of implant coating have been introduced to enhance and accelerate osteointegration. The purpose of present study is to clinically and radiographically evaluate the osseointegration around hydrophilic dental implants coated with 1% Metformin gel Materials and Methods: We executed a randomized controlled clinical trial. The sample will include patients demanding dental implant treatment. Patients will be randomly allocated into the two groups of the study. The group A will be treated with 1% concentrated metformin gel coated hydrophilic dental implant. Group B will be treated with uncoated hydrophilic dental implant. The primary outcome variable will be implant osteointegration and crestal marginal bone loss around implants. It will be measured at time of implant placement and reevaluated after 4, 6-months with periapical x-ray and 3-dimensional imaging.


Eligibility Criteria:
Inclusion Criteria:

* Good general periodontal health and maintenance.
* Adequate amount of bone volume at implant site, allowing to perform the dental implant surgery procedure without bone grafting techniques

Exclusion criteria

* Heavy smokers who smoke more than ten cigarettes per day
* Diabetic patients who have received metformin as antidiabetic drug
* local or systemic conditions that will interfere with routine implant placement (uncontrolled diabetes mellitus or human immune deficiency virus infections, resonance therapy), bone disorders (hyperparathyroidism, osteoporosis, or Paget's disease
* Patients who had subjected to intravenous and/or oral bisphosphonate therapy.
Pharmacokinetics of Multiple Dose Methadone in Children Treated for Opiate Withdrawal

The purpose of this study is to learn more about how the study drug, methadone, prescribed by an infant's or child's physician as part of standard medical care, is processed in children and young adults. While this drug is used extensively in infants and children, it has not been extensively studied in this population.

Physicians do not have very much information on how long it takes for methadone to be removed from the blood circulation and passed out of the body. Physicians need more information to guide how much and how often we should give methadone to children/young adults to ensure they get the maximum effect with the minimum amount of drug. During this research study, the study team will collect information about how this drug is processed in infants and children.

A total of approximately 24 to 36 infants and children will participate in this study. This study will be done at five medical centers in the United States.

Treatment will be prescribed by the infant or child's doctor and not by the study team.

Participants will be divided into 3 groups based on age, ages 3 months to 2 years, ages 2 to 6 years, and ages 6 to 18 years. There will be approximately 8 to 12 participants enrolled in each group. Additionally, at least 6 overweight or obese participants between ages 2-18 years will be included in this study.

Information collected from each subject's routine medical care will include:

* Participant gender, date of birth, race and ethnicity
* Pertinent medical history
* Laboratory results (blood count and chemistries) from routine testing ordered by the infant or child's regular doctor
* Medications of interest the child was given within the 72 hours prior to first dose of methadone administered after consent
* Time and dose of methadone administered to the child up to 14 days prior to enrollment

Study specific information collected will include:

* Blood sample collection to measure level of methadone
* Baseline WAT-1 score (sedation withdrawal assessment of the infant or child used to assess symptoms the child/infant may experience when opioid drugs are discontinued).

The duration of the study will be up to 10 days, comprised of a maximum 5 day treatment period a 5 day observation period.

Eligibility Criteria:
Inclusion Criteria:

* \>90 days - \< 18 years of age at the time of first dose of study drug
* Receiving enteral methadone as standard of care
* Signed informed consent/HIPAA documents by the parent/legal guardian and assent (if applicable)

Exclusion Criteria:

* Previous participation in the study
* Subject is receiving ECLS (Extracorporeal Life Support)
* \< 36 weeks gestational age at birth for children \<1 year of age at time of enrollment
* Any other condition or chronic illness that in the opinion of the Principal
* Investigator makes participation unadvised or unsafe