cyrilzakka/clinical-trials huggingface dataset:
Lispro Mix 25 vs. Glargine in Type 2 Diabetics

In patients with type 2 diabetes who have not been on insulin therapy before the study will achieve better glycemic control by the treatment regiment consisting of two times daily insulin lispro mix 25 than by the treatment regiment with consisting of one time daily injection of insulin glargine. Improved glycemic control will be compared by the fasting plasma glucose and blood glucose excursions 2 hours after breakfast.

The objective of this study is to investigate which type of insulin regimen is the best way to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control will be compared by the between treatment difference in fasting plasma glucose and 2h postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Males or females who have type 2 diabetes between 1 and 10 years
* Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the treatment of their diabetes
* Have not been on insulin treatment within 3 months before entry into the study
* Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory within 4 weeks prior to or at Visit 1
* Have a body mass index below 40 kg/m²

Exclusion Criteria:

* Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to Visit 1
* Have a known allergy to insulin
* Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local laboratory
* Have known proliferative retinopathy
* Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to entering the study
An Intervention to Reduce Inappropriate Prescriptions for Elderly Patients in General Practice

This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients \> 70 years.


Eligibility Criteria:
Inclusion Criteria:

* General practitioner
* Specialist in general practice
The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults

The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults

Hypertension and stroke remain leading causes of mortality across the world (1). Hypertension affects more than 1 in 4 adults and is the 3rd biggest risk factor for premature death and disability in the UK (2). Cerebrovascular disease is ranked 4th in the list of leading causes of death in the UK (3). At present, the treatment of these conditions largely involves chronic pharmacotherapy. In parallel, it is increasingly appreciated that polypharmacy poses a significant challenge to our older adult population. Guthrie et al showed that the number of people prescribed \>5 medications in an area of the UK doubled between 1995 and 2010 (from 11.4% to 20.8%) (4). Age is significantly associated with polypharmacy, with an odds ratio of 118.3 when those aged 20-29 are compared to those \>80. What's more, it has been estimated that adverse drug reactions account for 6.5% of hospital admissions (5), with age correlating significantly with admissions for this reason. Therefore, discovering a non-pharmacological intervention for hypertension and cerebrovascular disease could greatly benefit the population, particularly the elderly, both in terms of treating the diseases themselves and reducing the harmful effects of polypharmacy.

Remote ischaemic preconditioning (RIPC) is the induction of non-lethal ischaemia in one organ or tissue, with the aim of conditioning a distant organ or tissue against ischaemic events. It is achieved via inflation of a blood pressure cuff to supra-systolic pressures for a short period of time. A recent meta-analysis showed that chronic RIC, but not acute RIC, significantly lowered diastolic and mean arterial blood pressure (6). The studies included in this review were small and performed in a younger population, hence larger studies are needed to clarify the effect of RIC in the field of hypertension and, importantly, the elderly.

Eligibility Criteria:
Inclusion Criteria:

* Participant is aged \>65y and \<85y.
* Participant is willing and able to give informed consent for participation in the study.
* Participant is physically able to perform RIPC.

Exclusion Criteria:

* A BMI \<18 or \>35 kg/m2
* Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP \> 160/100), active angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke.
* If history of hypertension, no recent alteration to antihypertensive medication (3 months).
* A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy

The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.

A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.

Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age
* Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
* Pain posterior and/or superior to the medial malleolus, aggravated by activity
* Pain present for at least 3 weeks
* One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
* Pain when performing the Hell Rise Test or performed incorrectly.
* Signs of tenosynovitis on ultrasound examination.

As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.

Exclusion Criteria:

* Previous surgery on the affected foot, leg or knee.
* Disabling osteoarthritis of the knee on the affected side.
* Fixed hindfoot deformities.
* Recurrent ankle sprains on the affected side.
* Ligament tears or bony abnormalities of the affected foot.
* A physical or medical condition that contraindicates the testing protocol.
* Pregnancy.
* FCD or FLH tendinopathy.
Tryptophan Supplementation to Improve Night Shift Workers' Health

This randomized cross-over double-blinded trial aims to investigate the health effect of oral l-tryptophan supplementation on workers who rotate night shift work, and to examine the influences of different frequencies and timings of supplementation on the health effects.

This study aims to investigate the health effect of oral l-tryptophan supplementation on workers who rotate night shift work, and to examine the influences of different frequencies and timings of supplementation on the health effects. Night shift work affects melatonin and cortisol variation, insomnia, mood issues, and metabolic syndrome. Short-term tryptophan supplementation was shown to improve melatonin, sleep quality, and cortisol response to acute stress. Little is known whether a longer term of longer-term tryptophan supplementation would alleviate the health impacts of night shift work. Nevertheless, melatonin and cortisol have their normal circadian patterns. Nothing is known about what temporal structure of tryptophan supplement would maximize its health effects on night shift workers melatonin and cortisol levels. We will conduct a double-blind cross-over randomized controlled trial to examine the benefits of oral tryptophan administration (3g/day, t.i.d.) on night shift workers' health outcomes: melatonin and cortisol levels, sleep quality, moods and work performance. We expect to reveal the health effect of tryptophan supplementation in night shift workers by using sophisticated study design.

Eligibility Criteria:
Inclusion criteria:

* Age: adults \>=20 y/o
* Adults who had night shift schedule \>1 month before enrollment, and will have similar night shift schedule in the following 2 months. (Eligible night shift schedule: \>1 day of evening or night shift in a week)
* People who will not have plans to travel to another time zone in the following 2-3 months
* People who will plan to stay in the same job position for the following 3 months
* People who have no experience in taking tryptophan or melatonin supplement in the past month
* Body weight \>= 50kg and \<=80kg
* Non-pregnant, non-breastfeeding, not taking contraceptives
* Not under treatment of steroids, not taking sleeping pills

Exclusion criteria:

* diagnosis of renal or liver diseases
* diagnosis of Cushing's Disease, Addison's disease
* psychiatric diagnosis, such as depression and anxiety disorders
* neurological diseases such as dementia, epilepsy, Parkinson's disease
Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals

An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Retrospective record reviews in several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one or more AEs. A patient with an AE may require a higher level of care. Although all AEs are important, preventable AEs that result in an upgraded level of patient care are of particular concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the incidence of (preventable) adverse events requiring ICU admission or MET intervention and to assess the level of harm of each AE.


Eligibility Criteria:
Inclusion Criteria:

* All patients being transferred to a higher level of care during the study period (November 2011 - May 2012)
* In practice, the higher level of care means
* (1) (re)admission to the Intensive Care Unit from other care units in the hospital providing lower intensity care,
* (2) to an intervention by a Medical Emergency Team due to an unanticipated change in the patient's clinical status

Exclusion Criteria:

-
Acupuncture for Obesity With Prediabetes

The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes.


Eligibility Criteria:
Inclusion Criteria:

-

Subjects are eligible to be included in the trial only if all of the following criteria apply:

1. Meet the diagnostic criteria of obesity and pre-diabetes;
2. Aged 18-64 years old;
3. Informed consent obtained before any trial-related activities.

Exclusion Criteria:

-

Subjects are excluded from the trial if any of the following criteria apply:

1. Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
2. impaired glucose regulation due to hyperthyroidism, endocrine tumors and extensive liver damage;
3. Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator;
4. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), antidepressants, antipsychotic, mood stabilizers, antiepileptic and hormone contraceptive;
5. History of pancreatitis or pancreatectomy;
6. Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device;
7. Current participation (or within the last month) in an organized weight reduction program or currently using or used medication for obesity or hyperglycemia within 3 months before screening: liraglutide, exenatide, pramlintide, orlistat, topiramate, phenteremine, or metformin (either by prescription or as part of a clinical trial);
8. A self-reported change in body weight \>5 kg within 3 months before screening irrespective of medical records;
9. Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, congestive heart failure, myocardial infarction, stroke, hematopoietic system diseases, progressive malignant tumor or other serious consumptive diseases); history of angina pectoris, transient ischemic attack, claudication, or acute limb ischemia within the past 6 months prior to screening;
10. Serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness;
11. Skin infection, blood coagulation disorders and other conditions that are not suitable for acupuncture;
12. Metal allergies or severe fear of needles;
13. Pregnant or breast-feeding women or planning to become pregnant during the study period;
14. Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.
Phase 2a Study of DaxibotulinumtoxinA-lanm for Injection in Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).

Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.

The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.


Eligibility Criteria:
Inclusion Criteria:

1. Be outpatient, male or female subjects, in good general health, 18 years of age or older
2. Have a score of moderate (2) or severe (3) GL during maximum contraction as assessed by the IGA-FWS
3. Have a score of moderate (2) or severe (3) FHL during maximum contraction as assessed by the IGA-FHWS

Exclusion Criteria:

1. Previous treatment with botulinum toxin type A in the face, or treatment with \>200 U of any botulinum toxin anywhere else in the body, in the past 6 months prior to screening
2. Pregnant, nursing, or planning a pregnancy during the study; or is a WOCBP but is not willing to use an effective method of contraception
3. Allergy or sensitivity to any botulinum toxin preparations or to any component of the investigational product
Improvement of the Nutritional Status Regarding Nicotinamide (Vitamin B3) and the Disease Course of COVID-19

Based on the literature, it seems likely that a nutritional intervention with nicotinamide (a form of vitamin B3) can support the therapy of SARS-CoV-2 infection (COVID-19). A pilot phase of the COVit trial showed an effect of nicotinamide on the time to complete resolution of COVID-19 symptoms. In addition, diarrhoea is a common symptom of COVID-19. Therefore, in a second part of the study, 420 symptomatic patients each with confirmed SARS-CoV-2 infection are to take 1,000 mg nicotinamide (500 mg conventional nicotinamide and 500 mg nicotinamide released in a controlled manner in the intestine) or corresponding placebos per day in a blinded fashion for 4 weeks. The primary endpoint of the trial is the occurrence of individual COVID-19 symptoms over time (primary analysis time point: week 2). Secondary endpoints focus on the severity of COVID-19 symptoms, the post-COVID-19 syndrome (PCS), anti-SARS-CoV-2 antibody levels, and the time to resolution of individual or all symptoms. Exploratory endpoints include the WHO clinical scale for COVID-19, development of severe COVID-19, fatigue, quality of life and biomarkers. Patients are approached after positive testing and give their informed consent online. After randomised distribution of the trial supplements, patients are interviewed by telephone about their disease course at baseline (week 0), week 2, week 4, week 6 and after 6 months. Stool samples are collected from up to 400 patients at the same timepoints. In addition to blood count and standard blood profile, various inflammatory markers and the metabolome, in particular tryptophan metabolism, are examined in the blood of up to 20 selected patients. In these patients, the viral strain is determined by sequencing from nasopharyngeal swabs. In selected patients, short-term pharmacokinetics of nicotinamide, nicotinic acid and nicotinuric acid as well as of metabolites of nicotinamide and tryptophan are investigated. In the stool, changes in the microbiome (in 100-300 patients) as well as metagenome and metabolome (in a subgroup) will be analysed. The study is expected to produce rapid results on whether nicotinamide supplementation can alleviate the disease course of COVID-19. Moreover, a follow-up interview, a smell test, a cognitive test and anti-SARS-CoV-2 antibody levels after at least 6 months will be used to investigate whether the supplementation has any influence on PCS as well as the immune reaction against SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

* The patient is of age (at least 18 years).
* SARS-CoV-2 infection confirmed by laboratory findings; the positive test must not date back more than 7 days.
* Relevant infection symptoms, e.g. in the respiratory or gastrointestinal tract.
* The patient has been able to give written consent via a website before any trial procedure is performed and can comply with the trial-dependent prerequisites and requirements.

Exclusion Criteria:

* Current participation in another trial.
* Pregnancy or breastfeeding.
* Vaccination against SARS-CoV-2.
Comparison Among Three Different Video Scope Guided Nasotracheal Intubation.

Nasotracheal intubation (NTI) has become the most optimal alternative to oral endotracheal intubation for oro-maxillofacial surgery because it can offer an excellent vision field of the mouth. Additional benefits include milder oropharynx stimulation, less airway secretions, and better tolerance for long term endotracheal intubation maintenance. Traditional NTI is performed under the guidance of indirect laryngoscope, which is often accompanied by longer maneuver time and adverse complications such as trauma and bleeding. The development of various visualization tools such as video laryngoscope, video fiberoptic scope and video rigid laryngoscope has greatly improved NTI. However, there is no consensus on which one is the best adjunctive device for NTI. Therefore, a study on a comparison of the clinical efficacy of the above three video scope guided methods for NTI will be conducted.

A total of 60 eligible patients will be enrolled in this prospective study, they are scheduled to undergo elective oro-maxillofacial surgeries under general anaesthesia with nasotracheal intubation in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. According to the kinds of video methods uesd to assist in nasotracheal intubation, patients will be randomly divided into video laryngoscope group, video fiberoptic scope group and video rigid laryngoscope group, 20 participants in each group. The data of the duration of catheter reaching oropharynx (T1), the duration of catheter reaching glottis (T2), successful intubation time (T3), the first-attempt intubation success rate, the total number of intubations for each participant, whether there is oral and nasal mucosa bleeding, whether the tracheal ring is pressed, whether the catheter is rotated, the heraodynamic changes, and the occurrence of throat complications within 2 hours after surgery, will be recorded respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Participants scheduled for elective oro-maxillofacial surgery under general anesthesia.
2. Age between 18 and 65 years old.
3. The American Society of Anesthesiologists (ASA) Ⅰ～Ⅱ.
4. Body mass index (BMI) 18.5～24.9kg/m2.
5. Mallampati Ⅰ～Ⅱ.
6. Able to give informed consent.

Exclusion Criteria:

1. Participants with severe intranasal diseases.
2. Participants with severe and uncontrolled clotting diseases.
3. Participants with skull base fractures and cerebrospinal fluid leakage.
4. Participants with unstable cardiovascular and cerebrovascular diseases, or with poor tolerance to vagal stimulation.
5. Participants who are deemed ineligible for participation in the clinical trial by the investigator.
6. Participants who have to receive the alternative therapy to establish ventilation after the several attempts for nasotracheal intubation.