cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of CKD-501 Added to D150 Plus D745 10mg Therapy in Patients With Type 2 Diabetes

The purpose of this study is to prove that the group treated with CKD-501 in combination added that the reduction of glycated hemoglobin superior to placebo treated group added in combination.

The aim of this phase III study was to evaluate the efficacy and safety of additional combined CKD-501 administration for 24 weeks in patients with type 2 diabetes who were not adequately controlled for blood glucose by the combination of D150 and D745 10mg .

Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Eligibility Criteria:
Inclusion Criteria:

* Between 19 years and 75 years old(male or female)
* Type Ⅱ diabetes mellitus
* The patient who has been taking oral hypoglycemic agent at least 8weeks with HbA1c 7 to 10% at screening test
* BMI between 21kg/㎡ and 40kg/㎡
* C-peptide level is over 1.0 ng/ml
* Agreement with written informed consent
* HbA1c 7 to 10% after Run-in period

Exclusion Criteria:

* Type I diabetes or secondary diabetes
* Continuous or non continuous treatment(over 7 days) insulin within 3 months prior to screening
* Treatment with TZD within 3months or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with TZD, SGLT2, BU
* Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
* Treatment with anti-obesity drugs within 3months
* Past history: lactic acidosis or metformin contraindication
* Acute or chronic metabolic acidosis including diabetic ketoacidosis
* History of proliferative diabetic retinopathy
* Severe infection, severe injury patients, patients of pre and post operation
* Patients with urinary tract infection including urinary tract sepsis and pyelonephritis
* Malnutrition, weakness, starvation, hyposthenia, pituitary insufficiency or adrenal insufficiency
* History of malignant tumor within 5years
* Drug abuse or history of alcoholism
* Severe pulmonary dysfunction, severe GI disorder
* History of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage or unstable angina within 6 months
* Fasting Plasma Glucose level is over 270 mg/dl
* Triglyceride level is 500 mg/dl and over
* Significant abnormal liver dysfunction
* Anemia
* Abnormality of thyroid function(out of significant normal TSH range )
* eGFR is less than 60ml/min/1.73m\^2
* Pregnant women or nursing mothers
* Fertile women who not practice contraception with appropriate methods
* Participated in other trial within 4 weeks
* Participating in other trial at present
* In investigator's judgment
A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma

Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in combination with trametinib and dabrafenib in subjects with metastatic melanoma followed by a direct comparison of AMG 232 combined with trametinib and dabrafenib versus trametinib combined with dabrafenib alone.

The study will be conducted in 3 parts: Part 1 - Dose Escalation, Part 2 - Dose Expansion and Part 3, a randomized Phase 2a.

In both part 1 and 2, subjects will be enrolled open-label into 1 of 2 arms. For both Arm 1 and Arm 2, the part 1 dose escalation is aimed at determining an AMG 232 maximum tolerated dose (MTD) with a fixed dose of the combination drug(s) and evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of each combination. Part 2 dose expansion will enroll subjects to receive therapy with a dose and schedule of AMG 232 selected from the corresponding part 1 dose escalation. In part 2 subjects will be enrolled to confirm safety and tolerability and to assess clinical activity prior to proceeding to Part 3, Phase 2a. In Phase 2a, Subjects will be randomized open-label in a 1:1 ratio to receive AMG 232 in combination with trametinib plus dabrafenib versus trametinib plus dabrafenib alone.

Only Part 1 of the study was enrolled and the study did not proceed into Phase 2.

Eligibility Criteria:
Inclusion Criteria: Subjects must have histologically or cytologically confirmed metastatic cutaneous or mucosal melanoma, Able to swallow and retain orally administered medication, Adequate hematological, renal, hepatic, and coagulation laboratory assessments Exclusion Criteria: Clinically significant bleeding within 4 weeks of screening, Current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors, Infection requiring anti-infective treatments within 1 week of study enrollment, Anti-tumor therapy, Major surgery within 28 days
Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women

Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.

Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.

Eligibility Criteria:
Inclusion Criteria:

1. subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
2. Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
3. Patent Fallopian tubes as confirmed by hysterosalpingography
4. Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).

Exclusion Criteria:

1. women with BMI \>30,
2. age \< 18 years or \> 39 years,
3. women with ovarian cysts identified by transvaginal ultrasound
4. male factor infertility
5. Tubal factor infertility as suggested by hystrosalpingogram (HSG)
6. Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.
Immediate Effects of Self-myofascial Release on Latent Trigger Point Sensitivity

Latent myofascial trigger points (LMTRP) which impair neuromuscular performance occur in both, patients and asymptomatic subjects. As evidence suggests that LMTRP can transform into active trigger points, therapy seems warranted. Besides other modalities, self-massage using foam rollers (self-myofascial release) has been applied as a treatment. However, there is no data on the efficacy of this method concerning LMTRP. Thus, the present study aims to evaluate the effects of different forms of self-myofascial release on LMTRP pain.

Healthy patients with LMTRP in the calf are randomly allocated to one of three groups: 1) 90s static compression of the most sensitive LMTRP by means of the foam roll, 2) dynamic self-myofascial release rolling back and forth on the calf muscles for 90s using a foam roller, 3) placebo laser acupuncture of the most sensitive LMTRP. All subjects participate in a familiarization session with the foam roller one week prior to treatments. As an outcome, pressure pain threshold is assessed with an algometer. The investigators hypothesize, that static compression can reduce pressure pain of LMTRP more effective than dynamic self-myofascial release. The investigators further expect that placebo treatment will be the least effective method.


Eligibility Criteria:
Inclusion Criteria:

* at least one diagnosed latent myofascial trigger point in the calf
* age 18 to 65 years
* written informed consent

Exclusion Criteria:

* active myofascial trigger point in the calf
* regular intake of drugs or within past 48 hours
* severe psychiatric, neurological, orthopaedic, cardiovascular or endocrine diseases
* pregnancy or nursing period
* any condition that negatively influences current quality of life
A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with persistent asthma.
* Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
* Female subjects must not be fertile or must use effective contraception.
* Subject must be able to comply with the use of the questionnaires in the local language.

Exclusion criteria:

* Known or suspected Chronic Obstructive Pulmonary Disease.
* Pregnant or lactating.
* Participating investigator, employee of an investigator, or family member of any of the aforementioned.
* Smoking history: Pack-years \> 10 years.
* Have known clinical or laboratory evidence of a serious uncontrolled systemic disease.
* Known hypersensitivity to any substance contained in investigational product or as-needed medication.
* Treatment with oral corticosteroid within 2 months prior to the screening visit.
* Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit.
* Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.
Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone

This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.

The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.

The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.

CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis).

All adverse events related to the sternal closure procedure or the devices used for closure will be collected.

Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).

Eligibility Criteria:
Inclusion Criteria:

1. The subject is age 18 or over.
2. The subject has a planned full median sternotomy.
3. The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.

Exclusion Criteria:

1. The subject is having a re-operative sternotomy.
2. The subject is having an emergency or salvage operation.
3. The subject has an unplanned sternotomy incision.
4. The subject had an incomplete sternotomy.
5. The subject has chronic pain syndromes or chronic narcotic administration.
6. The subject has a history of chest irradiation.
7. The subject is unwilling to comply with study follow-up visits and surveys.
8. The subject has a sternal infection or suspected sternal infection.
9. The subject has any known comorbidity that will influence the outcomes.
10. The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).
Airway Management Practice Patterns in Paediatric Anaesthesia: A Survey

Respiratory adverse events continue to be the leading reason for perioperative critical events in children. It is crucial for the anaesthesiologist to anticipate, recognize and treat these respiratory adverse events. Respiratory adverse events are one of the major causes of morbidity and mortality during paediatric anaesthesia. To avoid trouble, one must be prepared for trouble: if a difficult airway is very likely, anaesthesia should be administered by experienced anaesthesiologists and should only be performed in a protected well-equipped area where the personnel adequately trained.

This survey focuses on assessment and management of paediatric airway and highlights the unique challenges encountered in children.

Airway management is one of the key areas of paediatric anaesthesia practice. The paediatric patients have significant anatomical and physiological differences compared with adults, which impact on the techniques and tools that the anaesthesiologist might choose to provide safe and effective control of the airway. Furthermore, there are a number of pathological processes, typically seen in the paediatric population, which present unique anatomical or functional difficulties in airway management. The presence of one of these syndromes or conditions can predict a "difficult airway".

Respiratory adverse events continue to be the leading reason for perioperative critical events in children. New developments in airway management in paediatric patients can only improve perioperative outcome if anaesthesiologists who are fully acquainted with these fundamental aspects of paediatric anaesthesia care for these children.

This survey was taken out within members of the Community of European Anaesthesiologists, to describe and explore current patterns of their airway management in paediatric anaesthesia.

The purpose of the study was to see whether there are more uniform practice patterns among anaesthesiologist with paediatric experience than those without paediatric experience.

Secondarily, the survey also explored anaesthetists'' knowledge about the risks of respiratory adverse events and, and about national organizations' recommendations.

Therefore, this survey highlighted some of the important anatomical and physiological differences and their implication in daily anaesthesiological practice.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthesiologists currently working in the operating rooms.

Exclusion Criteria:

* unwilling to join the study
Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion

This study will evaluate the safety and efficacy of Microplasmin administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for vitrectomy. This clinical study is justified because the study sponsor believes the potential benefits outweigh the potential risks, as outlined below.


Eligibility Criteria:
Inclusion Criteria:

* I. Male or female patients aged \> 18
* II. Presence of focal vitreomacular adhesion (ie, central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex
* III. BCVA of 20/32 or worse in the study eye
* IV. BCVA of 20/400 or better in the contralateral eye
* V. Written informed consent obtained from the patient prior to inclusion in the study

Exclusion Criteria:

* I. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection
* II. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye
* III. Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
* IV. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes.
* V. Patients with high myopia (\> 8D) or aphakia in the study eye

VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye VII. Patients who have had ocular surgery in the study eye in the prior three months VIII. Patients who have had a vitrectomy in the study eye at any time. IX. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months XI. Intravitreal injection of any drug in the study eye in the previous 3 months XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last visit at 6 months after the last injection XIV. Patients who have participated in an investigational drug study within the past 30 days XV. Patients with hypertension (either SBP \> 170 or DBP \> 100 mm Hg) XVI. Patients with a life expectancy less than 6 months XVII. Patients who have previously participated in this trial
Study to Evaluate the Presence of a Hangover Effect in Healthy Adults After Administration of Songha® Night Tablets

Study to determine the presence of a hang-over effect in healthy volunteers the day after the administration of Songha® Night


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female Caucasian subjects aged 20-60 years
* Normal outcome in Pittsburgh Sleep Quality Index (PSQI), below mean +2 Standard Deviation (SDs)
* No manifest sleep disorder diagnosed by polysomnography
* Normal pupillary function
* Willing and able to give written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to participation in the study and able to perform the study during the full time period of 36 days

Exclusion Criteria:

* Subjective sleep duration of less than 3 hours in the night before the test
* Caffeine, nicotine or alcohol on the day (from midnight) of the test
* Alcohol consumption on the evening before visits 3, 5 or 7
* Eye-drops or other drugs, taken orally or intravenously, influencing pupil size or motility
* Shift work
* Drug and alcohol abuse
* Use of psycho-active drugs during the past 30 days
* Any treatment that might interfere with the evaluation of the test drug
* Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450
* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
* Known hypersensitivity to any of the ingredients of the study drugs
* Pregnant or nursing women or inadequate birth control methods (this applies to female of childbearing potential only)
* Participation in another trial within the past 30 days
Effects of Progressive Muscle Relaxation and Mindfulness Meditation in Patients With Chronic Obstructive Pulmonary Disease

Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.

Previous reports have revealed that progressive muscle relaxation and meditation are decreasing symptoms burden in chronic disease. On the other hand, no study has been conducted to determine the effects of progressive relaxation exercise and mindfulness meditation on dyspnea, fatigue and care dependency in patients with COPD. The present study investigates the effects of progressive muscle relaxation and mindfulness meditation in a single-site, 3-arm, assessor-blinded randomized, controlled study of 65 COPD patients. Arm 1: meditation; Arm 2: relaxation; Arm 3: Control.The investigators hypothesize that Progressive muscle relaxation and mindfulness meditation will decrease the severity of dyspnea, fatigue and care dependency.

Eligibility Criteria:
Inclusion Criteria:

* older than 40 years
* diagnosed with stage III-IV COPD
* had at least primary school degree
* had no cognitive dysfunction, or communication problems
* were residing in Ankara.

Exclusion Criteria:

* history of cognitive dysfunction, or communication problems
* illiteracy
* applying any complementary and integrative approach during the study
* participating in a pulmonary rehabilitation program during the study.
Neuronal Processing of Diacritics: An fMRI Study

The purpose of this study is to determine brain function in reading arabic diacritics.

fMRI is a well established imaging technique that allows investigators to see regional brain function based off of actions like reading, speaking, playing music, etc. Even the type of language and format of that language can change the area of the brain that is active while performing that action. This study is meant to see the areas of the brain that become active both prior to and during the process of reading diacritic markings in arabic.

Eligibility Criteria:
Inclusion Criteria

Adult patients may be enrolled in this study if they meet the following inclusion criteria:

* Are male and are 18 years or older, inclusive;
* Consent from the patient
* First language is Arabic
* Must be able to speak and read English
* Right handed
* The subject must pass a dyslexia screen test (Attached to consent form).

Exclusion Criteria

Adult patients will be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions have been met:

* Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field;
* Are undergoing the MR exam in an emergency situation
* People with psychiatric disorders will be excluded from the study.
* Are claustrophobic and can not tolerate the imaging.
* People with neurological diseases
* Are on any medications for psychiatric, neurological, or chronic pain problems.
Predictive Value of a mRNA Signature and Liquid Biopsy in Diffuse Large B Cell Lymphoma

The purpose of this study is to determine the predictive value of a mRNA signature and liquid biopsy in patients with Diffuse Large B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* biopsy proved Diffuse Large B cell Lymphoma
* newly diagnosed between 2000-01 and 2015-12

Exclusion Criteria:

* patients with biopsy samples unavailable