cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi

This is a randomized, 12-week, open-label, active-controlled, parallel group study that will collect data of real-time continuous glucose monitoring for seven days at baseline and the end of study from adults with Type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs transiting to their first injectable therapy, iGlarLixi. A total of 40 patients will be recruited in Taipei Veterans General Hospital and randomized to use Mallya or receive standard care. The study is designed to demonstrate the efficacy of Mallya compared to standard care in terms of time in range (glucose level of 70-180 mg/dL), time above range (glucose level ≥180 mg/dL), time below range (glucose level \<70 mg/dL), glycemic variability indices, changes in HbA1c and percentage of patients with HbA1c ≤7.0% at endpoint, time to stable dose, and diabetes treatment satisfaction. The result of the current study will provide insights into the utility of Mallya as a treatment monitoring solution to improve glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years-old
* T2DM ≥ 180 days
* HbA1c ≥ 7.0% at screening
* Under stable doses of OADs for ≥12 weeks prior to screening
* Insulin naïve (except short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes)
* Not currently using real time continuous or flash glucose monitoring
* Not currently using Mallya

Exclusion Criteria:

* Known or suspected hypersensitivity to randomized treatment or related products
* Previous participation in this study (Participation is defined as signed informed consent);
* Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening (except for COVID-19 study);
* Female who is pregnant, breast-feeding or intends to become pregnant
* Presence of severe gastrointestinal disorders, such as severe gastroparesis;
* Presence of severe renal dysfunction (eGFR \<30 ml/min/1.73 m2) or end-stage renal disease on dialysis;
* Presence of severe hepatic dysfunction (AST or ALT level ≥ 200 U/L);
* Patients with a history of pancreatitis;
* Patients receiving systemic corticosteroids
* Patients with active cancer within the past six months.
1% Metformin in Moderate and Severe Periodontitis

This study evaluates the efficacy of 1% Metformin gel in treatment of moderate and severe periodontitis subject.

Metformin (MF) has stimulating effect of osteoblastic lineages. In the present study seventy subjects were categorized into two treatment groups: Scaling and root planing (SRP) plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline, 3, 6 and 9 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). Radiologic assessment of intra bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 9 months interval using computer-aided software. PD, CAL and defect depth reduction was evaluated in initial pocket depth of ≥5mm and ≥7mm subgroup within placebo and MF group.

Mean probing depth reduction and mean clinical attachment level gain was found to greater in MF group than placebo group at all visits. Significantly greater mean percentage of defect depth reduction was found in MF group than the placebo sites in both ≥5mm and ≥7mm of initial periodontal pocket depth. In MF group improvement in clinical parameter were similar in both the sites, with slightly better improvement in clinical parameters in initial pocket depth ≥7mm with respect to CAL, IBD and DDR% while PD was significantly reduced in initial pocket depth of ≥7mm.

There was greater decrease in mSBI and PD and more CAL gain with significant IBD depth reduction at the sites treated with SRP plus locally delivered MF in chronic periodontitis subjects with intrabony defects as compared to placebo and effect of MF was similar in initial moderate periodontal pockets and deep pocket depths.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy subjects, Pocket depth ≥ 5 mm, Clinical attachment level ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months.

Exclusion Criteria:

* subjects allergic to MF, those on systemic MF therapy, subjects with aggressive periodontitis, immunocompromised subjects, use of tobacco in any form, alcoholics, lactating and pregnant females.
Patient Characteristics, Treatment Patterns and Outcomes of Patients Enrolled in the Tezepelumab Patient Access Programme; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres

This is a retrospective, observational chart review that will include patients with severe asthma (SA) who have participated in the tezepelumab patient access programme (TPAP). Electronic case report forms (eCRFs) will be used for data abstraction of clinical information from the health records of patients enrolled in the TPAP from eight NHS acute trusts.

Approximately 200 patients with SA who took part in the TPAP with an index date (defined as the date of administration of the first dose of tezepelumab) between 1st January 2023 and 19th July 2023, and who meet the study eligibility criteria will be recruited to the study. Participation in the study does not affect the patients' treatment decisions since all data will be collected retrospectively from medical records. Key study definitions include:

* Index date - the date of tezepelumab initiation (i.e., the date of first dose).
* Pre-index period - defined as any time prior to tezepelumab initiation
* Baseline period - defined as the 52 weeks prior to the index date
* Outcomes period - defined as the 52 weeks post-index date.

Patients will be followed up from their index date until the first of the following events (whichever is first): reach 52 weeks post-index, they switch to a different biologic treatment, die, or are otherwise lost to follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled on the TPAP who received their first dose of tezepelumab between 1st January 2023 and 19th July 2023
* Patients aged ≥18 years at index

Exclusion Criteria:

* Patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 52 weeks prior to the index date.
Early Use of Opioid in Radiation Mucositis

This study is a superiority research to evaluate the safety and effectiveness of early use of oxycodone control release tablet for radiation mucositis in nasopharyngeal carcinoma patients.

The present study is a prospective, randomizing, case-controlled, multi-center clinical trial. 174 firstly diagnosed nasopharyngeal carcinoma patients who need radical radiation therapy will be randomly divided into either early intervention or common intervention group. oxycodone control release tablets will be used to control the pain caused by radiation oral mucositis when the pain level is mild or moderate, respectively. The primary outcome measurement is nutrition status. Quality of life (QOL), the clinical outcomes, and the adverse effects are also to be observed.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmed nasopharyngeal carcinoma;
2. Without historic chronic pain, no depend on analgesic drugs, no historic opioids intake;
3. Plan to receive radical radiation therapy, newly to radiation for head and neck;
4. Aged older or equal to 18 years old;
5. Could understand and cooperate to accomplish pain evaluation and observation scales;
6. Sufficient liver and kidney function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5\* upper limit of normal (ULN), serum creatinine less than 1.5\*ULN;
7. Without other serious critical organ dysfunction, such as heart or lung dysfunction;
8. Performance status (PS) score less than 2;
9. Voluntary to participate and sign informed consent document;
10. Obey the rules of trail; could be followed-up on time.

Exclusion Criteria:

1. Excluded by inclusion criteria;
2. Known or suspected allergy to nonsteroidal anti-inflammatory drug (NSAID) or opioid medicine;
3. Unable to complete the follow-up;
4. Severe uncontrollable infections of medical disorders;
5. Major organ including heart, lung, kidney, or liver dysfunction;
6. With pathophysiological factors affecting drug absorption, distribution, metabolism or excretion.
Immune Profile of Acute VKH Patients PBMC

The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.


Eligibility Criteria:
Inclusion Criteria:

1. Acute VKH patients, meet a criterion of VKH, no recurrence.
2. Age range from 18 to 50 years old.

Exclusion Criteria:

1. Patients with Severe Cardiovascular and Cerebrovascular Diseases
2. Patients allergic to steroid or contrast agents;
3. A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases
4. having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases
5. Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.
Implementation of CBT-I in Cancer Clinics

Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics.

This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.


Eligibility Criteria:
Inclusion Criteria:

* have received a diagnosis of non-metastatic cancer (any type)
* to be aged 18 years and older
* to be readily able to read and understand French or English
* having the minimum cognitive abilities to read, understand and memorize information
* having access to Internet

Exclusion Criteria:

* having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
* having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
* having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)
Validating eNose Measurement of Daily Fiber Intake

Monitoring dietary intake and digestion is important for both medical monitoring and assessing the wellness of individuals. Fiber is an important nutrient that is not focused on enough, despite it being an essential nutrient for the bacteria and other micro-organisms that reside in our GI Tracts, known as the microbiome. Ingestion of fermentable soluble and insoluble dietary fiber has been shown to result in the production of short-chain fatty acids (SCFA) by the colonic microbiome. These SCFAs are volatile organic compounds (VOCs) and can be detected in the atmosphere of a bowel movement. We have developed an e-Nose device that once placed in the bathroom records volatile organic compounds (VOCs) from the ambient air. We have demonstrated in an "N of 1" study a strong correlation between the eNose output and grams of daily fiber intake.

The current study is being proposed to validate the e-Nose device on a larger population. This is a nonmedical device that is not regulated by the FDA. A total of 40 subjects are invited to participate in this 3-week study. Participants will be asked to complete questionnaires and provide stool and blood samples. The subjects will place the eNose device in their bathroom and record their daily food intake over a 3-week period.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age 21-65, with no chronic medical diseases (mild and controlled hypertension, and controlled hyperlipidemia are acceptable).
2. Willingness to eat 2 prebiotic bar per day for two weeks and collect stool samples three times, provide blood samples twice and complete questionnaires.

Exclusion Criteria:

1. Patients on a restricted diet (e.g., gluten-free diet, Paleo diet, vegetarian or vegan diet)
2. Allergy to almonds, flax seed, or coconuts
3. Chronic GI disorders (Inflammatory bowel disease, Irritable Bowel Syndrome on regular therapy taking fiber or MiraLAX is acceptable to be enrolled; celiac disease, colon cancer, intestinal resection,)
4. Chronic NSAID use (more than 3 days per week)
5. Antibiotic use in the last 12 weeks
6. BMI \> 35 or \< 18
7. Inability to sign an informed consent form
8. Non-English speaker
Restoring Anatomy of Ruptured Achilles Tendon

The goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation .

We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician.
* Presented within 14 days from injury.
* Understands and reads Danish.
* No contraindications for MRI.

Exclusion Criteria:

* Smoking
* Diabetes
* Other injuries affecting their lower limb function.
* Contralateral Achilles tendon rupture.
* Re-rupture.
* Anticoagulation treatment.
* Inability to follow rehabilitation or complete follow-up tests.
* Immunosuppressive treatment, including systemic corticosteroid treatment.
* Pregnant
Quantified Balance Measures During Stance and Gait: Multiple Sclerosis Patients. A Longitudinal Clinical Study

The primary objective of this project is to track changes over time in balance control parameters measured during stance and gait for different groups of multiple sclerosis (MS) patients. Our primary goal is to determine whether these changes in balance control over time predict transitions in MS progression to a more disease affected state, and are different from changes over time for patients with balance deficits due to vestibular sensory disorders. A part of this goal is also to determine whether these changes in balance control are correlated with changes in patients' self-reported deficits and are similar to those changes in balance control of patients with peripheral vestibular loss. The secondary objective is to determine for multiple sclerosis (MS) patients the relationship of their balance parameters to different gait speeds, in order to advise them on, and promote via feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better tracking of MS disease changes over time, earlier quantification of onset of symptoms suggesting a worsening of disease status, and, we assume, greater patient satisfaction knowing that quantification of symptoms fits subjective feelings of balance deficits during stance and gait. Achieving the second objective would lead to improved balance during gait. We aim to carry out these objectives using equipment (SwayStar) which we have proven is sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain than previously used quantification tools. We aim to investigate the balance deficits during gait in different MS patient groups using a multimodal approach with a SwayStar system (analysis of balance during stance and gait in terms of trunk-pelvis movements near the centre of mass) and patient questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Balance deficits due to inner ear disease or MS

Exclusion Criteria:

* Inability to walk without a walking aid
Back Pain Outcomes Using Longitudinal Data (BOLD)

The overall objective of BOLD is to establish a large, community-based registry (at least 5000 subjects) of patients aged 65 years and older presenting with new episodes of healthcare visits for back pain. BOLD's primary aim is to create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for back pain in older adults.

The BOLD registry identifies subjects at the time of a new episode of back pain and captures data in a longitudinal fashion for up to 12 months. The registry captures self-report outcomes data as well as comprehensive utilization data including pharmacy and imaging data through the electronic medical record system. We are applying for additional funding to continue follow-up for up to 4 years from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 65 years
* Primary care visit for low back pain based on ICD9 code
* No prior visits for low back pain within six months

Exclusion Criteria:

* Prior lumbar spine surgery
* Developmental spine deformities
* Inflammatory spondyloarthropathy
* Known spinal malignancy or infection
* Primarily nerve compression-related symptoms
* Serious medical co-morbid condition with life expectancy \< 1yr
* No telephone, or planning to move within a year
* Unable to understand English
* Severe mental impairment that would interfere with answering questions
Skin Surface and Intradermal Temperature Responses to Heat Stress

The purpose of this study is to compare surface and intradermal skin temperature responses to heat stress with and without evaporative and convective cooling.

Humans have important thermoregulatory responses aimed at maintaining body temperature within a narrow range. These responses are driven in part by receptors located in the skin that monitor temperature changes and provide feedback to the central nervous system. Given that skin temperature can affect the physiological responses to heat stress, it is important to accurately measure skin temperature in response to heat stress with and without evaporative (i.e., sweat) and convective (i.e., air flow) cooling. Skin temperature is most often measured on the surface of the skin; however, this temperature can be influenced by other factors such as the local environment. It is unclear how the temperature of the skins surface compares to the temperature within the dermal layer of the skin.

The study team will directly compare skin surface and intradermal temperature responses to heat stress and determine whether these responses area altered by evaporative or convective cooling methods. To accomplish this objective, healthy adults will be exposed to ambient heat stress (no higher than 47°C) with and without evaporative (water sprayed on the skin) and convective (electric fan) cooling. Thermoregulatory responses, inclusive of skin surface and intradermal temperatures, will be assessed throughout the heat trial.

Eligibility Criteria:
Inclusion Criteria:

* Free of any significant underlying medical problems based upon a detailed medical history and physical exam.
* Normal resting electrocardiogram.

Exclusion Criteria:

* Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc.; as well as serious abnormalities detected on routine screening.
* Individuals who are pregnant, planning to become pregnant, or breastfeeding.
* Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
* Current smokers, as well as individuals who regularly smoked within the past 3 years.
Analysis of the Evolution of SUVmax by Quantitative Analysis Method of Bisphosphonate Scintigraphy

Recently, treatment with tafamidis in patients with cardiac ATTR lead to a significant reduction in mortality. The Perugini score is commonly used on planar bone scans to differentiate cardiac ATTR from other amyloidosis or normal patients but fails to evaluate amyloid burden and patient prognosis. Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Cardiac amyloidosis is a cause of restrictive cardiomyopathy with preserved ejection fraction associated with amyloid fibrils deposits in the myocardium. Two types of amyloid commonly infiltrate the heart: immunoglobulin light-chain amyloid (AL), and transthyretin-related amyloid amyloidosis (ATTR). Cardiac imaging is currently used for the diagnosis of ATTR, including planar scintigraphy with bone seeking radiopharmaceuticals, cardiac magnetic resonance and echocardiography with global longitudinal strain assessment.Although semi-quantitative methods have been suggested to evaluate the amyloid burden, there a need for quantitative methods for longitudinal assessment of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age
* Patient diagnosed with transthyretin cardiac amyloidosis confirmed by scintigraphy
* Patient with signed consent

Exclusion Criteria:

* Patients with systemic AL amyloidosis
* Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant or breastfeeding woman