cyrilzakka/clinical-trials huggingface dataset:
Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus

This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Patients inadequately controlled by OAD
* Patients willing to sign informed consent
* Selection of study participants at the discretion of the physician
* Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
* Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
Retrospective Study of Surgical Complications in Patients With Defunctioning Stoma After Low Anterior Resection (LAR)

This study is being conducted to evaluate the incidence and type of surgical complications occurring in patients who have a defunctioning stoma after LARfor rectal cancer. The data from this retrospective study will be analyzed by the study Sponsor to aid in designing a prospective clinical trial for a new technology that offers a treatment alternative to standard of care defunctioning stoma in patients undergoing LAR for rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18 years of age or older at the time the LAR surgery was performed.
2. Having an open or minimally invasive colorectal resection with diverting loop ileostomy surgical procedure performed between January 15, 2015 and January 15, 2019 for treatment of a known or suspected malignant condition.
3. Availability of medical records for a postoperative visit occurring 12 months (± 3 months) after the LAR surgery.

Exclusion Criteria:

1. Planned surgical procedure is a Hartmann's procedure (surgical resection of the rectosigmoid colon with closure of the anorectal stump and formation of an end colostomy).
2. Having a documented medical history of inflammatory bowel disease prior to the LAR surgery.
3. Having a concomitant major surgical procedure performed in combination with the LAR surgery (e.g., colorectal resection with hepatectomy).
Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.

The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent
* Must satisfy the locally approved therapeutic indications for the Avonex PEN
* Decision to treat with Avonex PEN must precede enrollment
* Must have no more than two (2) injections with the Avonex PEN prior to enrollment

Exclusion Criteria:

* Inability to comply with study requirements
* Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
Treatment of Cervical Syndrome With Myofascial Therapies

This study aimed to investigate the effects of myofascial release therapy (MRT) for improving pressure pain thresholds (PPTs), range of motion and pain in patients with mechanical neck pain (NP).

Fifty-four participants with NP were randomly allocated to either an MRT (five sessions) or a physical therapy (PT) groups (ten sessions) during two weeks. Multimodal PT program included: ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage. Visual Analogue Scale (VAS), range of motion and (CROM) PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown

Exclusion Criteria:

- Patients who are pregnant, have pacemakers and surgically operated in the area to be treated
Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.

This will be an open label, phase IV study. After appropriate consent, 132 premature infants born at \<35 weeks gestation (i.e. up to 34 weeks and 6 days), 50% \<30 weeks gestation (i.e. up to 29 weeks and 6 days) will be randomised to 1 of 2 4CMen B schedules either at 2,4 and 12 months or 2,3,4 and 12 months. Babies will remain in the study for around 12 months, from recruitment to 13 months of age. All visits can be performed at the participant's home or in clinic, depending on the preference of the parents and study team.

Blood samples will be obtained at 5 months of age (post primary sample), 12 months (persistence sample) and 13 months (post booster sample). Reactogenicity and safety will be assessed by caregiver completion of a 7-day diary after each vaccine dose. Inpatients will be monitored for cardiorespiratory events for 72 hours after vaccination by healthcare staff and this information will be collected on the CRF. This will include details of oxygen saturations, heart rate, respiratory rate and details of any episodes of desaturation, bradycardia or apnoea. Particular emphasis will be placed on rates, timing and intensity of fever and other adverse reactions in the first 24 hours after vaccination, because this remains a cause of great concern amongst neonatologists.

Eligibility Criteria:
Inclusion Criteria:

* Premature infant born at \<35 weeks gestation
* No contraindications to vaccination according to the 'Green Book'
* Willing and able to comply with study procedures
* Written informed consent

Exclusion Criteria:

* Contraindication to vaccination according to the Green Book
* Life-limiting congenital abnormality or condition
* Prior diagnosis of an immunodeficiency syndrome
* Considered unlikely to complete expected follow up until the end of the study
The Effect of Nasal Carbon Dioxide (CO2) on Nasal Congestion in Subjects With Perennial Allergic Rhinitis

The purpose of this study is to evaluate the effect of nasal CO2 on nasal congestion and other symptoms related to Perennial Allergic Rhinitis.

A randomized study to evaluated the safety and effect of nasal carbon dioxide on nasal congestion using acoustic rhinometry in subjects with perennial allergic rhinitis. The acoustic rhinometry is an instrument that will be used to assess the levels of the nasal congestion in each subject. Approximately 20 men and women ages 19-65 years old who have a history consistent with perennial allergic rhinitis requiring pharmacology for at least 2 years and meet all other eligibility criteria will be enrolled in this study. There will be six (6) visits to the clinic. There will be a screening visit, four (4) treatment visits, and an end of study visit. A subject's participation in the study may last up to 58 days. There will be four different doses given in this study. Each subject will receive 3 different doses of the study drug and one dose of the placebo.

Eligibility Criteria:
Inclusion Criteria:

* Have a history consistent with minimal 2 year history of perennial allergic rhinitis requiring pharmacotherapy.
* Positive skin test to perennial allergens (e.g. cats, dogs, house dust mite, etc.)
* Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test

Exclusion Criteria:

* History of asthma (other than mild or intermittent)
* Clinically significant nasal disorders
* Acute or significant sinusitis or upper respiratory infection within 14 days of randomization
* Have an existing serious medical condition (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
* Use of certain medication s prior to randomization and during study participation
* Participation in prior study with Nasal CO2
* Participation in another clinical study within 30 days of planned randomization date and for the duration of the study
A Specific Cervicograph for Women Attempting at Vaginal Delivery After Cesarean Section

The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to this specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines). The primary outcome is appropriate detection of dystocia.

Appropriate management of labor is essential to minimize the risk of uterine rupture in case of attempt at vaginal delivery after a cesarean section (VBAC). Dystocia is a known risk factor for uterine rupture during labor in women with previous cesarean section. Some studies have shown that this risk increases after 2 hours at the same cervical dilation during labor. The cervicograph is an important tool to detect dystocia during labor. There is currently no specific cervicograph for pregnant women with a history of cesarean section, and no study evaluated the cervicograph in the monitoring of labor for women with a scarred uterus.

The main objective is to evaluate a specific cervicograph (the graph describing the cervical dilation, included in the partograph) for pregnant women with an history of cesarean section, to improve the management of labor for women attempting at a vaginal delivery (VBAC). Women will be randomly assigned to a specific cervicograph (including an action line 2 hours after the alert line), or to the normal cervicograph (no lines).

The outcomes of this randomized trial are: appropriate detection and management of dystocia; uterine rupture; and success of VBAC.

Eligibility Criteria:
Inclusion Criteria:

* Women in labor, admitted for a VBAC at a gestational age of 37 weeks or more
* Single pregnancy
* Cephalic presentation

Exclusion Criteria:

* More than 1 previous cesarean section
* Multiple pregnancies
* Presentations other than cephalic
* History of low vertical uterotomy, classical or inverted T-shaped
* Past history of myomectomy
* Fetal death
* Fetal anomalies
* Placental anomalies
Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease

The purpose of the study is to learn more about how advanced glycation end-products can affect insulin resistance, inflammation and blood vessel health in people with kidney disease.

Advanced glycation end-products (AGEs) are compounds that form when sugars abnormally attach to proteins or lipids. High levels of AGEs in the blood may cause inflammation, problems with controlling blood sugar, and problems with the health of blood vessels. Many of the foods we commonly eat have high amounts of AGEs, which may increase AGEs in the blood of people with kidney disease. The amount of AGEs in foods can be lowered when prepared using special cooking techniques such as using moist heat or longer cooking times at lower temperatures. New research has shown that preparing food in this way can lower inflammation and improve blood vessel health in people with normal kidney function.

In this study, the investigators would like to examine the effect of lowering the AGE content of foods on inflammation, blood sugar control, and blood vessel health in individuals with mild to moderate chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).

Exclusion Criteria:

* Current or past use of anti-glycemic medications
* Fasting glucose \> 126 mg/dl on screening visit or positive glucose on urine dipstick
* Nephrotic-range proteinuria (≥ 3.5 grams per day as assessed by a spot urine albumin to creatinine ratio obtained at the screening visit)
* Pregnancy or breast-feeding
* Clinical need for a specialized diet (low sodium, low potassium, etc.) or religious dietary restrictions.
* New or recent change (\< 3 months) in dosage of medications known to affect vascular reactivity- angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, calcium channel blockers, HMG-CoA reductase inhibitors, etc.
* Current smoking or recent (\< 6 months) cessation of smoking.
* Poorly controlled hypertension (≥ 140 mm Hg systolic or 90 mm Hg diastolic), or prior history of malignant hypertensive episode (SBP \> 200) off of blood pressure medications.
* Participants with rapidly advancing renal failure.
* Severe anemia, defined as a hemoglobin \< 8 g/dL for men and \< 6 g/dL for women.
Effect of PADMA 28 on Endothelial Function, Autonomic Nervous System and Biomarkers in Patients With Coronary Artery Disease

This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

Background

This randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of PADMA 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. PADMA 28 contains 20 herbs from Tibet. The endothelial function will be measured by EndoPAT 2000, the autonomic nervous system by an ambulatory electrocardiography during the orthostatic reaction and the biomarkers will be analyzed with taking a blood sample. The investigators hypothesize that PADMA 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

Objective

To assess the effect of PADMA 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease.

Methods

80 patients with coronary artery disease will be recruited for the study. To measure endothelial function, the investigators use EndoPAT 2000. The autonomic nervous system will be analysed with ambulatory electrocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Male patient with coronary artery disease
* Stable medication
* Physically stable
* Psychologically stable
* Written informed consent
* Willing and able to comply with all trial requirements
* Must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin

Exclusion Criteria:

* Acute coronary syndrome within the last three months
* Abnormal high hepatic enzymes
* Renal insufficiency with compensated retention
* Intake of medication which may affect endothelial function
* Currently smoking
* Current malignant diseases, which may reduce the expectancy of life
* Chronic heart failure
* Insulin-dependent diabetes
* Known hypersensitivity against any ingredient of PADMA 28
* Longterm intake of supplements
* Serious mental health issues
* Alcohol and/or drug abuse
* Simultaneous participation in another clinical trial
Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

Colorectal cancer (CRC) is a common and life threatening condition that will affect one in thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords an opportunity for cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit colonoscopy effectiveness. Historically, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, non-pharmacological factors have been found to have significant increases in bowel preparation quality. The purpose of this study is to evaluate the effectiveness of web-based instructions vs. the historical phone/letter instructions given to patients planning to have a colonoscopy.

This study is a prospective randomized trial. Four hundred and fifty consecutive eligible patients will be randomized to ideally have two hundred and twenty five patients in each arm. Those who will have traditional paper based instructions and those who will be using an online system. Both groups will receive their instructions by the research assistant prior to leaving the office after being consented. The paper based instructions will be given as a handout and those in the online group will receive their bowel preparation instructions via an email sent by a scheduling assistant

Eligibility Criteria:
Inclusion Criteria:

* Age 19 or greater
* Patients scheduled for a colonoscopy using a doctors "normal prep" as outpatients
* Willing to participate by filling out the survey
* Must be able to read and understand English
* Must have ability to use email, have a functioning email account, and are willing to be contacted by email.

Exclusion Criteria:

* Unable to speak English
* Unwilling to participate in reading online materials
Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation

Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic lumbar disc herniation with the application of a randomized controlled trial. Will be measured pain, disability and functional flexibility.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with chronic symptomatic lumbar disc herniation

Exclusion Criteria:

Patients who work with severe overloading of the spine, patients with central neurological pathology, wheelchair users, patients who use bracing and support those who submit two consecutive absences to the treatment
Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

Background: The objective of this study will be to evaluate the effect of Intravascular Irradiation of Blood (ILIB) combined with myofunctional exercises for sleep bruxism in pediatrics. Methods: This study will be a randomized controlled clinical trial. A triage of individuals between 4 and 17 years old with a diagnosis of sleep bruxism will be carried out at the clinic of the Catholic University of Uruguay, and in a private office referred by different private care centers. The selected participants will be evaluated before and after treatment by means of questionnaires on bruxism, sleep quality and nocturnal oxygen saturation measurement. For this, 46 patients with sleep bruxism will be recruited, who will be divided into 2 groups: control group (CG), which will undergo an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol; and na ILIB group, which will carry out an active application of ILIB and an exercise protocol, this being once a week for 8 weeks. The laser treatment (808 nm) will be performed twice a week for 8 weeks. The values will be tested for normality by the Kolmogorov-Smirnov test. For the comparison between the groups, T-test will be carried out, considering a level of significance of 0.5% (p\<0.05). Discussion: Although local photobiomodulation (PBM), acupuncture PBM and physiotherapy have been studied in the treatment of bruxism, this is the first study to evaluate the effect of ILIB combined with myofunctional exercises for sleep bruxism in pediatrics.


Eligibility Criteria:
Inclusion Criteria:

* in the mixed dentition phase (permanent incisors and first molars erupted);
* adolescents with an established permanent dentition.

Exclusion Criteria:

* People with dental caries;
* Those taking medications, such as inflammatory agents, muscle relaxants, corticosteroids, anticonvulsants, and antidepressants;
* Those with chronic diseases that affect muscles or motor coordination, and those who do not cooperate during the evaluation will be excluded from the study;
* Children with cerebral palsy;
* Patients whose guardians do not sign the informed consent or the user does not sign the assent.