cyrilzakka/clinical-trials huggingface dataset:
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)

A Study to assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring (RT-CGM) and targeted learning modules versus self monitored blood glucose (SMBG) testing.

The study is referred to as "Continuous Glucose Monitoring and Management in Type 2 Diabetes" also known as The COMMITED Study" and will assess if patients with Type 2 diabetes (T2D) who have suboptimal glycemic control using 2 or more multiple oral agents are able to make lifestyle changes resulting in improved glycemic control by use of real-time continuous glucose monitoring and targeted learning modules.

At time of enrollment, participants will undergo a run-in period of blinded CGM for a duration of 10 days to collect baseline data. Baseline Patient Report Outcome (PRO) surveys will be administered at the start of run-in.

The study design includes a run-in phase, a study phase and a follow up visit. During the study phase, participants will be randomized into two groups - CGM Group or SMBG Group. For the RT-CGM Group, the study comprises of 4 scheduled clinic visits at baseline (after Run-In), week 4, week 8, and week 12 to collect data on episodic RT-CGM use. During these visits, RT-CGM insertions will take place at baseline, week 4 and week 8 clinic visits, with each wear period lasting a duration of 10 days. For the SMBG Group, the study comprises of 3 scheduled clinic visits at baseline (after Run-In), week 8 (to collect data on episodic blinded CGM use) and week 12. CGM insertions will take place at week 8 with a wear period of 10 days. Both groups will have HbA1c collected at week 0 and week 12. The same PRO surveys administered at start of run-in will be administered again at week 12. There will not be therapeutic changes during the study phase unless needed for safety.

There will be phone/remote visits by a study site clinician at weeks 2, 6 and 10 in both groups to review the SMBG or CGM data. During these remote visits, there will be discussions about what the subjects have learned from their glucose monitoring and what the study clinician has observed.

All subjects will be scheduled for a follow up visit at Month 9 to obtain local lab or POC HbA1c. Diabetes medications (classifications only) will also be collected.

Eligibility Criteria:
Major Inclusion Criteria:

* Age at least 30 years
* Diagnosis of T2D treated with 2 or more oral anti-diabetic medications
* HbA1c ≥ 7.8 and ≤10.5% by local lab or POC

Major Exclusion Criteria:

* Using insulin
* Pregnancy
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them

Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique

The investigators will address the following objectives:

* Primary Objective: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique
* Secondary Objectives: 1) Evaluate the interactions between performances in metaphor comprehension and individual differences in psychopathology, cognition, ToM and functioning; 2) Test if the altered neurophysiological patterns associated to the fragility of metaphor comprehension in schizophrenia can be restored through a rehabilitative training

The investigators will enroll 32 schizophrenic patients and 32 healthy subjects as control sample.

Participants will undergo an initial visit with a specialist psychiatrist who will verify that their conditions meet the criteria required by the study. Then, subjects will be tested for metaphor comprehension, as well as for the other variables included in the study, and the electrical brain activity will be registered through a 128 channel EEG.

In the check-up visits (i.e., after the training) the following data will be collected:

* Scores relating to cognitive, pragmatic (understanding of metaphors), theory of mind and global functioning performance scores
* EEG recordings related to the process of understanding metaphors
* Scores on scales that evaluate psychopathological severity

Eligibility Criteria:
Inclusion Criteria:

For patients:

* Age between 18 and 65 years
* Diagnosis of Schizophrenia according to DSM V criteria
* Ability to provide informed consent

For healthy controls:

* Age between 18 and 65 years
* Ability to provide informed consent
* Absence of psychiatric pathologies
* Ability to speak Italian

Exclusion Criteria:

For patients:

* Intellectual disability
* Neurological disorder

For healthy controls:

* Presence of psychiatric pathologies
* Difficulties in speaking Italian
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease

The overall aim of the study is to determine the clinical efficacy and mechanisms of action of anti-IL-4a (dupilumab) as treatment for patients with Aspirin-Exacerbated Respiratory Disease (AERD).

The protocol involves an 8-week trial of dupilumab in patients with AERD. Participants will have 4 total doses of dupilumab administered, with each dose administered every 2 weeks. There will be full clinical assessments and biospecimen collections at Baseline (Visit 1), Week 2 (Visit 2), and Week 8 (Visit 3).

Eligibility Criteria:
Key Inclusion Criteria:

1. History of AERD, defined as meeting the diagnostic triad with:

   1. History of physician-diagnosed asthma and
   2. History of physician-diagnosed nasal polyposis and
   3. History of pathognomonic reactions to aspirin or other nonselective COX inhibitors.
2. Visible nasal polyps bilaterally on otoscope physical exam at the time of screening.
3. Evidence of sense of smell impairment, with a University of Pennsylvania Smell Identification Test (UPSIT) score of \<34.
4. Stable asthma (no glucocorticoid burst for at least 4 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 3 months).
5. Consistent (daily) use of an intranasal steroid for at least 4 weeks prior to Screening.
6. No current smoking (not more than one instance of smoking in the last 3 months).
7. For females: Practicing FDA-approved methods of birth control for the duration of the study. Female participants of childbearing potential must have a negative pregnancy test upon study entry.

Key Exclusion Criteria:

1. Use of investigational drugs within 12 weeks of Screening.
2. Use of any biologic agent within 4 months prior to Screening.
3. Use of systemic (enteral or injected) glucocorticoids within 4 weeks prior to Screening.
4. History of any sinonasal surgery within 4 months prior to Screening
5. Current use of zileuton
6. Current use of high-dose aspirin therapy (no more than 325 mg aspirin per day will be allowed)
7. Pregnant, nursing, or planning to become pregnant

Note: Other inclusion and exclusion criteria apply.
Comparative Effects of Cervicothoracic Junction Mobilization and Thoracic Manipulation in Subachromial Impinegment Syndrome

The aim of this study is to investigate the comparative effects of high velocity low amplitude thrust manipulation of upper thoracic spine and spinal mobilization with arm movement on the subjects with the subacromial impingement syndrome.

Subacromial impingement is the condition, in which the tissue underlying subacromial spaces are compressed between the head of the humerus and the acromion, is one ofthe main diagnoses of shoulder pain. Subjects frequently experience pain when engaging in anyoverhead activity.In general, medical practice, pain in the glenohumeral region is commonmusculoskeletal problem has almost 48% prevalence. Cervicothoracic junction refers to atherapeutic technique or manual therapy approaches that focuses on improving mobility andfunction in this area where the cervical neck and upper back spine meet. Upper thoracic manipulation refers to a manual technique used to address dysfunctions or restrictions in the upper portion of the thoracic vertebral region, which is the area of the thoracic vertebrae located between the cervical and mid back regions.Previously, studies were conducted individually to determine effectiveness of upper thoracic mobilization and cervico-thoracic mobilization with arm movement for treatment of subacromial bursitis. However, fewer studies were previously conducted to compare the effects of both treatment methods (mobilization and manipulation). This study specifically focuses on the comparative effects of upper thoracic and cervico-thoracic mobilization.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18-40
* Both males and Females
* Positive Hawkins and Neer's impingement test positive
* The subjects primarily report unilateral shoulder pain.

Exclusion Criteria:

* Patients with diagnosed case of co morbidities such as malignancies, RA, or fracture, that causes bilateral shoulder discomfort.
* Diagnosed case of cervical radiculopathy, glenohumeral osteoarthritis, and adhesive capsulitis
Serum Concentration of lgG in Patient With Acute Coronary Syndrome

The aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction and the relationships between its change and prognosis.

Immunoglobin G (IgG), a highly abundant glycoprotein in serum, is known to participate in blood immune responses.It has been an increasing interest in the analysis of the abnormal glycosylation of human lgG in healthy and disease states, such as autoimmune diseases and cancer.However, there is few relevant studies about the changes in glycopeptides of serum immunoglobulin G in patients with acute myocardial infarction. This study was performed for the frst timeto assess the quantitative changes of serum IgG glycosylation in patients with acute myocardial infarction and the relationships between its change and prognosis.

Eligibility Criteria:
Inclusion Criteria:

- diagnosed as STEMI.

* with left ventricular ejection fraction（LVEF）\>=45%
* written informed consents are obtained
* admitted within 24 hours after chest pain attacked

Exclusion Criteria:

* complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy

  * complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction
  * with acute or chronic infection, surgery or trauma in the last month
  * secondary hypertension, severe liver dysfunction,severe renal insufficiency
  * with abnormal thyroid function or allergy to iodine agent refusal to sign the informed consent
Effects of a Placebo Probiotic on Gut Health and General Well-being in Individuals With Mild Gastrointestinal Symptoms

The present study is aimed at exploring whether positive expectations of receiving a three-week treatment with a probiotic supplement (in fact a placebo) improve symptoms of gastrointestinal distress and promote physical and emotional well-being in healthy individuals with mild gastrointestinal symptoms. At first, a comparison is planned between (1) a classic deceptive placebo manipulation (Deceptive Placebo group, DP), and (2) a control condition (Control group, C), in which no placebo substance will be administered. After the three-week waiting list, the Control group will be invited to take the placebo probiotic pills in an "open-label" fashion (Open Label Placebo, OLP). Specifically, participants will be informed that the pills are inert placebos. An exploratory analysis will help to clarify whether the OLP paradigm leads to significant effects, based on a within-group (C- OLP) and between-group comparison (DP-OLP).


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65
* Individuals with mild gastrointestinal symptoms (e.g., digestive issues, acid reflux, constipation) such that normal every-day activities are not severly compromised.

Exclusion Criteria:

* Individuals with a diagnosis of functional gastrointestinal disorders (e.g., irritable bowel syndrome, ulcerative colitis, chronic inflammatory bowel diseases).
* Individuals suffering from neurodegenerative diseases and/or psychiatric conditions
* Individuals taking probiotic supplementation at the time of enrollment in the study
Non-small Cell Lung Cancer With Central Nervous System Metastasis

Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.


Eligibility Criteria:
Inclusion Criteria:

- A. Non-small cell lung cancer patients diagnosed with brain metastases or meningeal metastases on brain computed tomography (CT) or magnetic resonance (MRI) images.

B. Patients with non-small cell lung cancer who are about to undergo surgical brain surgery, such as brain tumor resection, lumbar abdominal drainage, Euclidean storage, or ventriculoperitoneal drainage.

Exclusion Criteria:

- A. Non-small cell lung cancer patients without brain metastases or meningeal metastases.

B. Physical condition does not allow surgical removal of the tumor.
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis

The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.

This is a Phase II single-center, double-masked, placebo controlled, randomized study of SCH1 for the treatment of infectious conjunctivitis. Approximately 30 subjects will be enrolled, who will be randomized in a 1:1 ratio between SCH1and placebo. Subjects will be assessed at day 1, day 3, and day 5 for efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Conjunctivitis (as defined below) within 72 hours of initial ocular symptoms.
* At least 18 years of age.
* Subjects capable of understanding the purpose and risks of the study, and able to give informed consent.
* Conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis- 1) bulbar conjunctival injection and 2) conjunctival discharge/exudates.
* A three-point rating scale (0=absent, 1=mild, 2=moderate, 3=severe) will be employed to grade conjunctival discharge/exudates.
* All patients will require a rating of 1(mild) or greater for conjunctival discharge/exudates.
* Patients will require a rating of 1 (mild) for bulbar conjunctival injection.

Exclusion Criteria:

* Conjunctivitis greater than 72 hours after initial ocular symptoms
* Corneal ulcer, endophthalmitis, or any other confounding infection of the eye
* Patients taking topical anti-inflammatory medications on a chronic basis
* Known steroid glaucoma responders
* Active herpes ocular infection
* Pregnant women
* Known allergy to chlorhexidine
Physician-Pharmacist Collaboration for Osteoporotic Patient Follow-up

The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.

Treatments allow decreasing the personal fracture risk from 48% to 85% provided that the treatment period is continued at least 3 to 5 years and that hygienic and dietary measures are applied: optimization of the dietary calcium intakes (much more efficient and less dangerous than the medicinal intakes), preservation of a physical activity, fall prevention. The ability of bisphosphonate for decreasing significantly the number of fractures was proved, but the lack of lasting adhesion (persistence) and of flanking measures leads to believe their efficiency may be enhanced: the hip-fracture rate decreases from 2.1% for the non-adherents to 1,3% for the patients with observance, which represents a one-half reduction.

The cost of surgery for a femoral neck fracture is estimated at 8500 euros. So the prevention of only one femoral neck fracture entails a huge economy.

However, 50% of women stop their treatment before a year and the implementation of hygienic and dietary measures leads to a lifestyle change, and faces long time ingrained habits. Only 42% of patients continue their treatment after two years, and only 16% after three years.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* having an osteoporosis treatment
* following a Therapeutical Education for Patient

Exclusion Criteria:

* opposition for anonymised data gathering
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions

The goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. The comparison will be made against conventional mammography acquired as a part of a standard clinical workup. One hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. A reader study will be performed to evaluate the ROC characteristics of the system.


Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years old.
* Scheduled for breast biopsy of at least one breast lesion.
* Lesion detected on mammogram.
* Symptomatic by patient self-report, patient self-breast exam or clinical exam.
* Able to provide informed consent.

Exclusion Criteria:

* Male. (It is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents \<1% of newly diagnosed breast cancer)
* Less than 18 years of age.
* Patient unable to give consent.
* Institutionalized subject (prisoner or nursing home patient).
* Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating
A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE

The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.

A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.

Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.

Approximately 125 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be enrolled in the study at approximately 20 sites in the US to treat approximately 100 participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants with confirmed unresectable HCC
* Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume
* Participants with no evidence of extrahepatic disease on any available imaging
* Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
* Participants having Child-Pugh score class A.
* Participants having ECOG performance status of 0 or 1 at enrollment
* Adequate organ and marrow function

Exclusion Criteria:

* Disease amenable to curative surgery, ablation or transplantation.
* Participants co-infected with HBV and HDV
* Any history of nephrotic or nephritic syndrome.
* Clinically significant (eg, active) cardiovascular disease
* Participants with uncontrolled hypertension
* History of hepatic encephalopathy
* Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
* Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
* Participant has received any prior anticancer systemic therapy for unresectable HCC.
* History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
* History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation

1. Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.
2. To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation
3. Observe the changes of perioperative inflammation and immune indexes after lung transplantation


Eligibility Criteria:
Inclusion Criteria:

Prosedure of lung transplantation, Aged more than 18 years old

Exclusion Criteria:

Secondary lung transplantation, multiple organ transplantation, refusal to participate
Investigating the Effects of Smartphone Use on the Masseter Muscle

The aim of this study was to determine the short- and long-term effects of smartphone use on the masseter muscle. In the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use.

A total of 120 healthy university students aged 18-30 years at Bandırma Onyedi Eylül University will be included in our study. Descriptive data form, Smartphone Addiction Scale - Short Form, Edinburg Hand Preference Inventory, pressure pain threshold, muscle activity, lateral grip strength, hand grip strength will be evaluated in the participant students.

Eligibility Criteria:
Inclusion Criteria:

* Smartphone users students between the ages of 18-30 years
* Students whose voluntary informed consent was obtained

Exclusion Criteria:

* Individuals undergoing masseter botox application
* Individuals diagnosed with TMJ disorder and/or bruxism
* Individuals with musculoskeletal problems with evidence of a systemic, specific pathologic condition such as fracture of the hand, finger, upper extremity and/or TMJ, rheumatoid disease
* Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
* Individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or TMJ
* Individuals with facial paralysis
* Individuals with diagnosed psychiatric illness.