cyrilzakka/clinical-trials huggingface dataset:
The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* HbA1C: 7.0-11.0%
* Previous diabetes treatment for at least 6 months
* BMI max. 35 kg/m2
* Treatment with an oral anti-diabetic drug (OAD)

Exclusion Criteria:

* Type 1 diabetes
* Receipt of any investigational drug within the last three months prior to this trial
Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

OBJECTIVES Primary

1. Overall survival
2. Tumor response using RECIST criteria

Secondary

1. Determine the toxicity of the proposed treatment in this patient population.
2. Progression free survival
3. Locoregional control
4. Distant failure

STUDY DESIGN

Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer.

Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination.

Outcome Measures Primary Outcome Measures

1. Overall survival
2. Tumor response using RECIST criteria

Secondary Outcome Measures

1. Locoregional control
2. Distant Failure
3. Progression free survival

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.
2. Patients will be included in the study based on the following criteria:

   * Patients must be older than 18 years old.
   * Patients must have a Zubrod performance status of 0 to 2
   * Patients with adequate bone marrow function
   * Patients with adequate renal function
   * Patients with adequate hepatic function
   * Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
   * Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
   * Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

1. Disease-Specific Exclusions

   * Superior sulcus tumors
   * Atelectasis or obstructive pneumonitis of the entire lung
   * Malignant pleural effusion
2. General Medical Exclusions

   * Surgical candidates
   * Patients who are pregnant at the time of diagnosis
   * Serious concomitant systemic disorders incompatible with the study
   * Inability to comply with study and/or follow-up procedures
   * Life expectancy of less than 12 weeks
   * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
   * Patients with septicemia or severe infection.
   * Patients who have circumstances that will not permit completion of this study or the required follow-up
   * Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel
Effectiveness of Black Tea Mouthwash on Plaque Formation

The study was conducted to measure the effectiveness of Black Tea in reducing the deposits on teeth. It also compares the effect between use of black tea mouthwash and green tea mouthwash to that of chlorhexidine in reducing plaque deposition on teeth in a two weeks long clinical trial among adults of 18-40 years of age.

The study titled "Effectiveness of Black Tea Mouthwash on Plaque formation: A Randomized Controlled Clinical Trial" conducted at Department of Periodontics,during February 2015 till July 2015 included three interventional arms with 15 subjects each who had chronic generalized plaque-induced gingivitis. All subjects underwent scaling and randomly allocated into three groups as Black tea,Green tea and Chlorhexidine. Those in black tea, green tea and Chlorhexidine groups advised to rinse with 0.5% Black tea, 0.5% green tea and 0.12% Chlorhexidine aqueous based solutions for 30 seconds twice daily half an hour after brushing teeth respectively. Gingival Index (Loe and Silness 1963) and Plaque Index (Silness and Loe, 1964) recorded at baseline and 2 weeks after intervention in all subjects. Results were analyzed using SPSS Statistical software version 20.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old. subjects with at least 20 natural teeth. diagnosed with chronic generalized plaque induced gingivitis.

Exclusion Criteria:

* subjects with systemic illness. subjects on antibiotic in the previous six months. subjects with allergy to tea. subjects on medications with effect on periodontium (Eg:anti-osteoporotic drugs).
Optimization of TKIs Treatment and Quality of Life in Ph+ CML Patients ≥60 Years in Deep Molecular Response

In this phase III clinical randomized study, "fixed" intermittent administration (one month ON/one month OFF) of TKIs (control arm), will be compared with "progressive" intermittent administration (one month ON/one month OFF for the 1st year; one month ON/two months OFF for the 2nd year; one month ON/three months OFF for the 3rd year) (experimental arm). Imatinib (Glivec), or Nilotinib (Tasigna), or Dasatinib (Sprycel) will be given intermittently at the same daily dose that was given daily at the time of the enrollment . Chronic phase Ph+ CML patients in stable major molecular response (MR3.0 or MR4.0) after ≥2 years of standard treatment with IM, NIL, or DAS will be randomized 1:1 to receive "fixed" INTERIM or "progressive" INTERIM. Randomization will be stratified by type of TKI (IM, NIL, or DAS,) and by depth of molecular response (MR3.0or MR4.0). The study is aimed to evaluate if a progressive increase of intermittent treatment discontinuation until 3 months is able to improve QoL outcomes with respect to "fixed" intermittent administration of TKIs (control arm) and to maintain MR3.0 / MR4.0 molecular response. Patients' self reported EORTC QLQ-C30 outcome measure will be assessed throughout the three years follow up period. The QoL results in this trial will be presented in accordance with high methodological quality criteria for documenting patient-reported outcomes (PRO) data in RCTs, including the CONSORT PRO recommendations. Furthermore, the study could give additional clinical and biological information to optimize TKIs therapy in elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a confirmed diagnosis of Ph+ CML in CP
2. Age ≥ 60 years old
3. Stable MR3.0/ MR4.0 after at least 2 years of treatment with standard (daily administration) IM, NIL, or DAS therapy; the stability of molecular response will be documented by at least 3 consecutive molecular analyses over the last 12 months.
4. Having completed the QoL baseline evaluation (i.e., before randomization)
5. Written informed consent prior to any study procedures

Exclusion Criteria:

1. Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP previously treated (i.e. IFNalpha+/- low dose Ara-C, Hydroxurea, allogeneic stem cell transplantation, etc)
2. Age \< 60 years old
3. Less than 2 years of treatment with standard (continuous administration) IM, NIL or DAS therapy

3. Absence of stable MR3.0/MR4.0 as documented by at least 3 consecutive molecular analyses over the last 12 months 4. No written informed consent prior to any study procedures. 5. Having any kind of psychiatric disorder or major cognitive dysfunction hampering a QoL evaluation (as judged by the physician).
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema

This is a Randomized, Active-Controlled, Double-Masked, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P42 in comparison with Eylea in Patients with Diabetic Macular Edema


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged ≥18 years.
* Patient with DME secondary to DM involving the center of the macula (defined as the Optical Coherence Tomography \[OCT\] central subfield) in the study eye.

Exclusion Criteria:

* Patient who has only one functional eye.
* Patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
The Effect of a High-fat vs. High-sugar Diet on Liver Fat Accumulation and Metabolism

Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease in the world. It is currently unclear why fat starts to accumulate in the liver, although both the amount and type of food consumed have been implicated. The majority of studies that have investigated the effects of dietary fat or sugar on liver fat have fed volunteers excess calories, which are known to increase liver fat. The effect of specific dietary components, when consumed as part of a diet not containing excess calories, on liver fat accumulation remains unclear.

This research aims to investigate the role excessive consumption of specific macronutrients may play in the development of NAFLD. This will be achieved by subjecting participants to two specific dietary interventions (high-fat, low-carbohydrate and low-fat, high-carbohydrate) in a randomized, crossover research design. Liver fat content, and whole-body and hepatic fasting and postprandial lipid metabolism will be assessed before and after the specific dietary interventions.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* BMI \>25 \<35kg/m2
* No medical condition or relevant drug therapy known to affect liver, lipid or glucose metabolism

Exclusion Criteria:

* Age \<30 or \>65 years
* Body mass index \<25 or \>35kg/m2
* A blood haemoglobin \<120mg/dL
* Any metabolic condition or relevant drug therapy
* People who do not tolerate fructose
* Smoking
* History of alcoholism or a greater than recommended alcohol intake
* Pregnant or nursing mothers
* Women prescribed any contraceptive agent or device including oral contraceptives, hormone replacement therapy (HRT) or who have used these within the last 12 months
* History of severe claustrophobia
* Presence of metallic implants, pacemaker
* Haemorrhagic disorders
* Anticoagulant treatment
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

A retrospective and prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

A retrospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). This study is collecting information on clinical outcomes up to 18 months post-treatment.

On January 6, 2025, VOTER was changed from prospective to retrospective.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 90 years of age
2. Patient has experienced a posterior circulation ischemic event
3. Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis).
4. Patient has \>50% stenosis on the side being targeted for therapy

Exclusion Criteria:

1. Pregnant women
2. Contrast Indication to the use of anti-platelet drugs
3. There is tandem vertebral or basilar artery stenosis
4. The serum creatinin is \>2.5
5. Baseline modified Rankin score is \>3
6. \< 5 years life expectancy
Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers

Population in study will be selected from students and staff of the University of Pisa. Right carotid artery contour wave analysis will be performed during the application of different PEEP levels (from 0 cmH2O to 10 cmH2O) with applanation tonometry technique.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40, absence of any chronic diseases, no smoke, no drugs assumptions, no use of caffeine the day of the exam

Exclusion Criteria:

* pregnancy, chronic diseases, smokers, and intake of caffeine the day of the exam.
The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures.

The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.


Eligibility Criteria:
Inclusion Criteria:

* Recruits newly enlisted at a training base in September 2021.
* Agree to accept relevant inspections and serological research, and sign an informed consent form.

Exclusion Criteria:

* Suffer from diabetes, osteomyelitis and other diseases.
* Suffer from claustrophobia and other MRI examination contraindications.
* Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.
* A history of kidney disease.
* Allergic to any ingredient of the medicine.
Level of Agreement Between Clinical Defocus Curves and the Web-based Democritus Digital Acuity Reading Test wDDART

The primary objective of this study is to compare the level of agreement between clinical defocus curves and the web Democritus Digital Acuity Reading Test (wDDART), which is a web-based digital near and intermediate vision reading test.

The 'defocus curve' assessment technique aims to simulate different distances from near to far over which the patient's visual acuity (VA) is evaluated. Defocus curves are created by first measuring best-corrected distance and near VA of the examinee. Then, a series of positive- and negative-powered trial lenses are added to the best-corrected distance visual acuity (BCDVA) of the patient's eye. Viewing through the addition of a minus lens creates divergent light rays with the same refractive effect as bringing the eye chart closer to the viewer. For instance, a -2.50 D lens represents the distance of 40 cm.

The "defocus curve" assessment technique is a method used widely for the assessment of the functional vision range following multifocal intraocular lens (IOL) implantation. Since this method is a simulation of the near vision, it would be ideal if near vision could be evaluated objectively with a near vision chart. However, the conventional printed near vision charts are not available for a variety of reading distances. In addition, the measurement of near VA at different distances with a printed reading chart intended for one predefined distance (e.g. printed chart for 40 cm) and the transformation of the reading score at 40 cm to an equivalent score for the examined distances is impractical in clinical setting.

For this reason, a digital reading test that allows the text calibration for all reading distances could be a practical method for the rapid and ease evaluation of the near VA, especially in patients implanted with multifocal IOLs. The web-based digital near and intermediate vision reading test wDDART offers the ability to estimate VA at different distances with automated measurement of the patient-screen distance.

Therefore, the present study aims to investigate the level of agreement between clinical defocus curves and the web-based digital near and intermediate vision reading test wDDART.

Eligibility Criteria:
Inclusion Criteria:

* Previous cataract lens extraction, age\> 40 years, monocular best corrected distance visual acuity \> 7/10

Exclusion Criteria:

* Glaucoma, corneal diseases, macular diseases, postoperative opacification of the posterior capsule, former mental diseases
CMO Letter to Reduce Unnecessary Antibiotic Prescribing March 2018

This trial aims to reduce unnecessary prescription of antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels. Specifically, GPs in practices whose prescribing has increase by more than 4% over the past year will receive a letter stating that "The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%." The letter will also contain a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions. The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.

The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group; the statistical analysis will compare prescribing in March, April, and over the summer (treating May-September as a single data point).

Eligibility Criteria:
Inclusion Criteria:

* GP practices that increased the number of prescriptions in the financial year 2016/17, compared to the baseline of financial year 2015/16, by 4% or more

Exclusion Criteria:

* GP practices are excluded if their current level of prescription (doses per 1000 head of population) is classed as an outlier. The cut off for outliers is made at the 95th percentile of the distribution.
* Practices that have not been open since at least October 2013 will be excluded. This is because they will lack the historical data necessary to apply a control for seasonal effects to the main outcome variable.
* practices whose antibiotic prescribing rate is in the top 20% for their National Health Service (NHS) Local Area, controlling for relevant patient characteristics.
New Automated System for Continuous Real-time Monitoring of Transpulmonary Pressure

Patients admitted to Intensive Care Unit often are affected by acute respiratory failure at admission or during hospital stay, with a mortality of 30%.

Treatment remains largely supportive with mechanical ventilation as the mainstay of management by improving the hypoxemia and reducing the work of breathing; however, the mechanical forces generated during ventilation can further enhance pulmonary inflammation and edema, a process that has been termed ventilator induced lung injury (VILI). Consequently, in clinical practice the lung protective ventilation is mainly based on the reduction of the tidal volume, the airway and the transpulmonary plateau pressure. A good clinical practice is based on the assessment of changes in respiratory mechanics.

Aim of the study is to determine the accuracy of the OPTIVENT system in measuring transpulmonary pressure, comparing it with the systems currently in use in our Operative Unit.


Eligibility Criteria:
Inclusion Criteria:

* acute respiratory failure
* invasive mechanical ventilation.

Exclusion Criteria:

* haemodynamic instability
* presence of barotrauma
* esophageal disease.
Comparison of Multi-Round and Real-Time Delphi Survey Methods

A two-group parallel randomised trial of Delphi survey methods.

Aim:

The aim of this trial is to compare a multi-round Delphi survey method with a Real-Time Delphi method on prioritised outcomes included in a core outcome set (COS). This trial is embedded within the COHESION study which is developing a COS for interventions for the treatment of neonatal encephalopathy.

Methods:

Stakeholders (parents/ caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either a multi-round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects.

Eligibility Criteria:
Inclusion Criteria:

* parents or caregivers of infants that have been diagnosed with and received treatment for neonatal encephalopathy
* healthcare providers including:

  * neonatal nurse practitioners
  * midwives
  * obstetricians
  * neonatologists/paediatricians
  * neonatal/paediatric neurologists
  * general practitioners who provide long-term care for children with neonatal encephalopathy
  * policymakers
* researchers/ academics with expertise in neonatal encephalopathy treatment.

Exclusion Criteria:

• participants not meeting the inclusion criteria
Patient Survey as a Tool to Quality Assurance and Quality Improvement 2024

One goal of the investigators of the Department of Anesthesiology and Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin is a continuous improvement in the quality of care to the patients. One focus is the freezing preoperatively during surgery, and on the follow-up study to assess the perceived waiting times in the anesthesiology outpatient clinic.

The project aims to quality assurance and quality improvement of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin .

The primary objective of the survey is to assess the entire perioperative care with particular focus on the development of perceived waiting times in the anesthesiology outpatient clinic, re-evaluation of the preoperative freezing the preoperative thirst, pain, nausea and vomiting after surgery (PONV prophylaxis).

The survey will be repeated in a three-year interval (approximately 1000 - 2000 patients per survey) to monitor and improve the quality of the CharitéCentrum for Anesthesiology and Intensive Care Medicine 007, Charité - Universitätsmedizin Berlin from the patient point of view.

In order to achieve a meaningful data collection, a response rate of 50 percent should be achieved.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients who underwent a procedure in anesthesia and willing to take part in the Survey
* aged \>= 1 years

Exclusion Criteria:

* unconscious patients,
* refusal by patient / parents