cyrilzakka/clinical-trials huggingface dataset:
Specific Clinical Experience Investigation for Long-term Use of Bydureon.

To confirm the safety and efficacy of Bydureon in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

To confirm the safety and efficacy of Bydureon (hereinafter referred to as Bydureon) in long-term use in Japanese patients with type 2 diabetes mellitus under actual drug use.

1. Primary Objective To confirm the safety profile in Japanese patients with type 2 diabetes mellitus receiving Bydureon under daily practices.
2. Secondary objective As the secondary objective of this S-CEI, the following items are to be investigated.

   * Frequencies of AEs related to cardiovascular events, hypoglycaemia, digestive symptoms, and injection site reaction.
   * Development of pancreatitis, renal impairment (especially acute renal failure), hypersensitivity reaction, and malignant tumour (especially thyroid tumour and pancreatic malignancy)
   * Safety in patients with mild or moderate renal impairment
   * Changes of weight, blood pressure, pulse rate, fasting blood sugar, fasting insulin, HbA1c, and blood lipids
   * Bydureon administration under daily practices focusing on the patient's demographics and clinical characteristics of diabetes mellitus (duration of diabetes mellitus, treatment duration, complications, Bydureon administration, etc)
   * Anti-exenatide antibody titer in AE cases (hypersensitivity, loss of control of blood sugar)

Eligibility Criteria:
Inclusion Criteria:

- The patients with type 2 diabetes mellitus who inadequately respond to sulfonylurea, biuguanides, and/or thiazolidines (monotherapy or combination use) in addition to diet and exercise.

Exclusion Criteria:

* No past history of hypersensitivity to the components of Bydureon.
* Not the patient with diabetic ketoacidosis, diabetic coma/ precoma, and/ or type 1 diabetes mellitus.
* Bydureon will not be administered to the patient in an emergency situation such as severe infection and operation.
* Not the patient with severe renal impairment, including those receiving dialysis.
A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456 in patients with constipation-predominant irritable bowel syndrome.

This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after oral administration of ASP0456.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period.
* Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and \<25% of them loose (mushy) or watery during the 3 months before the screening examination.
* Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes.

Exclusion Criteria:

* Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
* Patients with other concurrent diseases that may affect the digestive tract passage or large intestinal function
* Patients with other concurrent diseases that may affect the assessment of abdominal pain/discomfort
* Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at the time of screening examination that was rated as Grade 2 or greater on the "Severity Criteria for Drug Adverse Reaction" and judged to be clinically significant
Routine Electronic Patient-reported Outcome Measures During and After Radiotherapy: A Randomized Controlled Study

Patients in this study will be asked to periodically self-report their symptoms using their smartphones during the radiotherapy period and during the acute phase (3 months) after treatment, and radiation oncology physicians will evaluate the impact on cancer patients' quality of life and determine whether they can improve health outcomes by using this data in their practice.

The purpose of this study is to determine the efficacy, feasibility, and acceptability of routine PROM reporting using smartphones during treatment and during the acute phase after treatment in patients undergoing radiotherapy.

Subjects who voluntarily consent to the study will be assigned to either the test group or the control group through randomization.

• Test group: REPROM group Subjects in the test group will self-report symptoms that occur using smartphones before radiotherapy, once a week during treatment, at the end of treatment, once a week until one month after treatment, and at 1 month and 3\~6 months after treatment (PRO-CTCAE, Pain NRS). The radiation oncologist will identify the symptoms reported in the REPROM and take appropriate medical measures to improve the symptoms based on this.

A survey alert is sent to the patient at the time of REPROM implementation, and the subject uses a smartphone to conduct a self-report questionnaire on patient symptoms sent through the mobile messenger KakaoTalk as shown in the screenshot below. The survey data is automatically sent to the EMR and can be checked by the attending physician at the time of consultation. A score of 4 or higher will be automatically alerted to the attending physician and the research nurse, and the research nurse may contact the subject if necessary and recommend additional care to the attending physician.

• Control group: Usual care group Control subjects receive usual care without self-report of REPROM. Subjects in both groups may receive appropriate medical attention for the symptoms observed at the time of treatment. Subjects in both groups will be asked to take HR-QOL questionnaires (EORTC-QLQ-C30, EQ-5D-5L, EQ-VAS) before radiotherapy, at the end of treatment, at 1 month after treatment, and at 3\~6 months after treatment.

\*Study design: a prospective randomized parallel-group pilot study

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Histologically confirmed diagnosis of cancer
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* The ability to own and use a smartphone

Exclusion Criteria:

* Terminal cancer
* Cognitive impairment
* Not using your smartphone
Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis

Lateral epicondylitis is painful tendinosis of the main extensor tendon that occurs at the fibro-osseous junction of the outer elbow region. Histopathological samples in patients with chronic lateral epicondylitis show that there is angiofibroblastic degeneration and failure in the normal tendon repair process rather than acute inflammation in this region. It has begun to be accepted that the main factor in lateral epicondylitis is not the inflammatory events but the degenerative process. There are many treatment methods that trigger structural healing in tendinopathies.

In this study, the investigators aimed to evaluate the effect of the dry needling method of the lateral epicondyle region.

Lateral epicondylitis occurs as a result of micro-tears and progressive degeneration caused by repetitive tension, especially at the attachment of the main extensor tendon to the lateral epicondyle. The treatment modality to be used, which causes an increase in functional cells, can prevent the apoptotic process; Thus, it is suggested that there are methods that can reconstruct tendon structure and function. Inflammation can have a positive effect on the healing process in the treatment of lateral epicondylitis. Methods such as prolotherapy and platelet-rich plasma therapy are among the methods that trigger the inflammation process in the lateral epicondyle region and subsequently contribute to the regeneration process. In all these treatments, there is evidence that the local healing process is triggered by the 'needle effect'.

Dry needle therapy is a method that has been widely used in musculoskeletal diseases for many years, and it is one of the safe and cost-effective applications.

In this study, the investigators planned to evaluate the clinical efficiency of dry needling of lateral epicondyle area those are the origin of the extensor muscle groups of the wrist in addition to the home exercise program and to compare the groups in terms of pain severity, functionality, and improvement in handgrip strength with the participants applied for the only home exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Tenderness and pain over lateral epicondylitis and provocation of the lateral elbow pain with one the following tests; resisted middle finger extension, resisted wrist extension, the passive stretch of wrist extensors.
* Participants had a direct radiograph of the elbow within the last 3 months
* Epicondylitis bandage users

Exclusion Criteria:

* History of injection for lateral epicondylitis in the last 6 months
* Radial nerve compression
* History of arm/forearm fracture
* Pregnancy/lactation
* Thrombocytopenia
* Coagulopathy
* Bleeding diathesis
* Neuropathy
* Use of anticoagulants
* Widespread pain syndrome
* History of inflammatory arthritis
* Presence of trauma to the elbow region in the last 3 months
* Statement of the participant that he/she will not be able to continue the follow-ups for the research
* Fear of injection
* Untreated psychiatric illness
* Presence of drug/substance abuse
Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial.

Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.

In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.


Eligibility Criteria:
Inclusion Criteria:

* neonates fed with their mother breast milk,
* gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
* postnatal age ≤ 10 days
* birth weight greater than the 5th percentile according to Olsen curves et al.
* clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
* the two legal representatives must have signed an informed consent.

Exclusion Criteria:

* neonates for whom no video was recorded during the venipuncture
A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem

This is a multicenter, non-controlled, prospective study. 303 subjects (GTS standard and lateralized) have been recruited. Study will be conducted in centers across Europe.

The objective of this prospective clinical study is to obtain multi-center, long-term (10-year) clinical data on the new GTS® femoral stem in its standard and lateralized versions as part of Post Market Surveillance requirements.

The initial study assessment period will be 12 years; 24 months recruitment and the follow-up clinical reviews for all patients will be at 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.

Eligibility Criteria:
Inclusion Criteria:

Patients inclusion criteria for this evaluation are be in accordance with the indications of the GTS® stem and specifically

* Primary osteoarthritis or secondary coxarthritis
* Inflammation of the hip: rheumatoid arthritis, etc.
* Femoral neck fracture
* Avascular necroses of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia

Additional inclusion criteria include:

* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understood study information and provided an informed written consent (specific local regulatory requirements)

Exclusion Criteria:

Exclusion criteria are in accordance with absolute and relative contraindications for use for GTS® stem

Absolute contraindications include:

* Local or systemic infections.
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality that is likely to affect implant stability(Paget's disease, osteoporosis, etc.)
* Concomitant disease likely to affect implant function
* Allergy to any of the components of the implant
* Patients weighing more than 110 kg

Additional exclusion criteria:

* Subjects unable to co-operate with and complete the study
* Dementia and/or inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision
Arthroplasty Cements Outcomes - A Post-market Follow-up

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels.

Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting.

The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

It is admitted that:

* Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability;
* These procedures may be done with the help of a bone cement (PMMA) to fix the prosthesis to the bone (cemented fixation);
* Most common reasons for primary joint replacement are osteoarthritis, osteonecrosis and trauma;
* Most common reasons for revision of joint replacement are dislocation, infection, fracture and prothesis loosening;
* Quality of bone cement have a large influence on long-term implant stability.

TEKNIMED has developed several bone cements and a cement restrictor currently used in arthroplasty procedures.

With the increasing use of these procedures, there is a need of real-life long-term safety and efficacy data on the bone cements.

This retro- and prospective study is performed to assess the safety and performance of TEKNIMED arthroplasty products in their current clinical use.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older.
* Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study
* For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).
* For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).
* Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).

Exclusion Criteria:

* Patient under trusteeship or guardianship,
* Women who are pregnant
* Patient unable to follow the protocol
* Patient whose vital prognosis is unfavorable (according to investigator's opinion)
Health-e-Access Telemedicine in Primary Pediatric Care

This study aims to take the existing model from the pilot of Telemedicine in Daycare and expand it to other suburban childcare centers and both urban and suburban elementary schools.

An assessment of the value of telehealth in the child programs will then be initiated to detail the impact of utilization and costs.

An assessment of the value of integrating telehealth into primary care practice will also be evaluated. The impact of continuity of care, well child visit rates, and immunization status will be among the various measures used in this evaluation.

This involves estimating the impact of reduced absence due to illness on parents and their employers and estimating the value of a telehealth visit to these stakeholders. An interview instrument was developed to administer before experience with telehealth and again after a family has had experience with the program. In addition program attendance (childcare or school) records will be collected to document changes in absenteeism pre and post telehealth service implementation.

This study involves a before and after research design including both historical and concurrent controls comparing a detailed utilization of health services including telehealth visits, emergency department services and illness related office visits. Analyses will include center-level analyses of service utilization on a weekly basis pre and post as well as a child-level analyses including utilization before enrollment in a participating childcare center or school through program participation and, eventually, telehealth participation.

This is a descriptive observational study of the feasibility and acceptability of integrating telehealth service into 10 primary care pediatric practices. This study will document the integration process by maintaining a log of key communications relating to decision making (meeting minutes, memos, written agreements, protocols) and by interviewing key staff such as residents, nurse practitioners, attending physicians, staff nurses, and administrative leaders following the study period.

Eligibility Criteria:
Inclusion Criteria:

* All children at participating childcare centers and elementary schools.

Exclusion Criteria:

* Foster care children, children whose parents have refused participation, or children whose parents are unable to appropriately comprehend the program for any reason.
Infections Related Central Venous Catheters

The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory response syndrome) and the infection associated with the use of central venous catheters at Critical Care center in National Defense Medical College, Japan.

The doctor would remove the inserted catheter from the patient, if the patient shows SIRS. At the same time, the tip of used catheter and blood from the patient are checked whether the pathogenic bacteria exists or not by general bacterial protocol and blood culture test on a routine application. Unfortunately, these tests not always clarified their cause of SIRS. Therefore we conduct this investigation to establish the useful protocol for pathogenic bacteria. We check the pathogenic bacteria not only tip but through the whole catheter in Central Venous Catheter using general bacterial protocol and SEM observation. Additionally, we compared that sputum, urine, skin and blood from the patient for bacteria check.

Eligibility Criteria:
Inclusion Criteria:

* A patient has been inserted with central venous line over 24 hours.
Genetics of Hypertension and Its Intermediate Phenotypes

To define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes.

BACKGROUND:

Hypertension, an exceedingly common trait in most developed countries, imparts an increased risk of cardiovascular, cerebrovascular and renal diseases. Nevertheless, the primary determinants of elevated blood pressure in most patients are unknown. Recognizing that a sizable portion of variation in blood pressure is genetically determined, one line of research has focused on identifying genetic variants that contribute to the pathogenesis of hypertension. However, standard genetic linkage analysis using "hypertension" as a phenotype may lack power due to the multifactorial nature of the disorder. A way to overcome this challenge is to subdivide hypertensive subjects into more homogenous subgroups.

DESIGN NARRATIVE:

The overall goal, which is to define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes, can be divided into three parts. First, the rural Chinese population will be characterized by the collection of intermediate phenotype data on 600 unrelated individuals with high diastolic blood pressure and on 100 normotensive controls. Intermediate phenotypes include: 1) non-modulation of adrenal and renal vascular responses to angiotensin II with changes in sodium intake; 2) altered urinary kallikrein excretion; 3) low plasma renin activity response to volume depletion; 4) increased free cortisol excretion; and 5) insulin resistance. Second, candidate genes will be chosen according to the underlying physiology of the intermediate phenotypes, and variations in the coding sequences of these potentially relevant genes will be identified. Finally, polymorphisms identified in the candidate genes will be tested through case-control analyses defined by the intermediate phenotypes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities

The purpose this research is to check the effect of Brazil Nuts consumption in oxidative stress, metabolic abnormalities and microvascular endothelial function dyslipidemic and hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* adults \> 20 years old
* Dyslipidemic
* Hypertensive

Exclusion Criteria:

* Allergy to nuts
* Consumption of nuts or vitamins/minerals supplement
* Loss weight before the research
* pregnancy
* Kidney chronic disease
Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial

The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.


Eligibility Criteria:
Gender •Female: only female participants are being studied

Minimum age

•18 years

Maximum age •N/A

Accepts Healthy Volunteers

•No

Eligibility Criteria

Inclusion criteria

* Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 - September 1, 2016 in Danish oncology clinics

Exclusion Criteria:

* More than six scheduled cycles of chemotherapy
* Not able to read and understand Danish language