cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2D 3 months prior to the Screening Visit.
* Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
* Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).

Exclusion Criteria:

* History of type 1 diabetes.
* Prior participation in a clinical study involving ITCA 650.
* Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
* History or evidence of acute or chronic pancreatitis.
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
* Treatment of medications that affect GI motility.
* History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
* Women that are pregnant, lactating, or planning to become pregnant.
* Chronic (\>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
Impact of HPV Vaccine On The Prevalence Of HPV In Norway

The overall aim of the study is to assess the effect of school-based Human Papillomavirus (HPV) vaccination by comparing type-specific HPV prevalence between vaccinated and non-vaccinated women born in 1997. Women born in 1997, residence to Norway in 2009 (the year of vaccine initiation of the 1997-cohort) are invited to participate in the study.

This cohort is amongst the first that was offered HPV vaccine in an organized vaccination programme globally. The women will be recruited through Facebook ads. The study will enable us to measure differences in the prevalence of HPV types in vagina and the mouth between vaccinated and non-vaccinated young women in Norway.

The womens vaccination status will be validated by linkage to the Norwegian Immunisation Registry (SYSVAK) and their residence status will be validated through linkage to the Norwegian Population Registry.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Born in 1997
* Resident of Norway in 2009

Exclusion Criteria:

* Male
* Born before or after 1997
* Non-resident of Norway in 2009
HFNO in Pneumonia Patients Presenting With Acute Hypoxemic Respiratory Failure

High-flow nasal oxygen (HFNO) therapy is an upcoming and beneficial modality for patients with acute hypoxemic respiratory failure (AHRF).

To evaluate whether early use of HFNO in pneumonia patients with (AHRF) can reduce the need for invasive ventilation.

* Pneumonia adults patients (age\>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
* The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.

Eligible patients were randomized to receive either HFNO or NIV respiratory support throughout the hospitalization period. Randomization was stratified by a laboratory scientist not involved in the study using the technique of shuffled sealed envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Pneumonia adults patients (age\>18 years) with AHRF were eligible for this study after conventional oxygen therapy failure.
* The criteria for diagnosing AHRF were defined as the presence of a respiratory rate (RR) more than 25 breaths/min with SpO2 less than 92%, and/or the arterial oxygen partial pressure (PaO2) to FiO2 ratio less than 300 mmHg while breathing oxygen delivered by a conventional venturi device at a fraction of inspiration oxygen of 0.5 (as per maximum for Venturi mask) administered for at least 60 minutes.

Exclusion criteria:

* Patients requiring emergency intubation,
* Recent esophageal, facial, or cranial trauma or surgery,
* Severely decreased consciousness (Glasgow coma scale \[GCS\] of 11 or less),
* Severe hemodynamic instability (patient on inotropic or vasopressor support), ° Severe ventricular arrhythmia or myocardial ischemia,
* Tracheotomy or other upper airway disorders,
* Active upper gastrointestinal bleeding, and
* Inability to clear respiratory secretions .
Evaluating Additive Effects of Including Canines in Regulating Together

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD).

Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard.

Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard.

Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

Children between the ages of 8 years 0 months and 15 years 11 months with Autism Spectrum Disorder (ASD) and emotion dysregulation (ED) and their caregivers will participate in 5 research visits and 10 group intervention sessions. They are randomly assigned to either Regulating Together-Standard group (no dog), or Regulating Together-Canine group (with dog). Characterization measures will be completed at Screen (T1). All outcome measures will be completed at Baseline (T2), Post-treatment (1-2 weeks following treatment completion, T3), 10 week post treatment completion follow up (T4), and 6 month post treatment completion follow up (T5).

Eligibility Criteria:
Inclusion Criteria:

* Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
* Diagnosis of autism spectrum disorder (ASD)
* Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)
* A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
* English is the primary language
* Family willing to keep prescribed medication stable over the course of the study period

Exclusion Criteria:

* Participant has a phobia toward or is allergic to canines
* Participant has a history of aggression toward animals
* Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury
* Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others
* Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
* A legal guardian is not available to provide informed consent
Correlation Between Radiculopathy And Quality Of Life In Patients With Chronic Lumbar Spondylosis

This study will be conducted to answer the following question:

Is there a Correlation Between Lumbar Radiculopathy and Quality of Life in Patients with chronic lumbar spondylosis?

Spondylosis is an age-related change of vertebrae and discs of the spine. These changes are often called degenerative disc disease and osteoarthritis. When this condition is in the lower back, it's called lumbar spondylosis.

Lumbar osteoarthritis, disc degeneration, degenerative disc disease, and spondylosis are some of the terms used to describe disc changes. In fact, the condition is called spondylosis. Whenever there is a degeneration co-occurrence in the disc, the lumbar spine, the formation of osteophytes and the associated changes in the nerves and the resulting symptoms of pain.Spinal osteoarthritis (OA) is a degenerative process defined radiologically by joint space narrowing, osteophytosis, subchondral sclerosis, and cyst formation.

Osteophytes included within this definition fall into one of the two primary clinical categories.

The first, spondylosis deforms describes bony outgrowths arising primarily along the anterior and lateral perimeters of the vertebral endplate apophyses. These hypertrophic changes are believed to develop at sites of stress to the annular ligament and most commonly occur at thoracic T9-10 and lumbar L3 levels.These conditions lead to nerve root compression, resulting in radiating pain down the leg, commonly referred to as sciatica. The impact of lumbar radiculopathy extends beyond pain, affecting muscle function and neuromuscular control. The involvement of nerve roots such as L4, L5, and S1 can particularly affect the muscles in the lower extremities, including the plantar flexor muscles, which are crucial for movements like walking, running, and maintaining balance

Eligibility Criteria:
Inclusion Criteria:

* All patient diagnosed and referred from a physician
* Patients suffered from lumbar spondylosis (L4: L5) with radiculopathy more than 3 months
* Participants will be from both gender
* Age will be ranged from 30 to 50.
* BMI of all participants ≤ 30 kg/m2

Exclusion Criteria:

* Pregnant and breast-feeding women
* Patients diagnosed with depression and anxiety
* Patient who had undergone lumbar spine surgery
* People with systemic illnesses or physical deformities
Determining the Ergogenic Effects of Carb10™ Supplementation on Carbohydrate-Rich and Carbohydrate-Restricted Diets

The study will examine the performance and body composition effects of ketogenic vs carbohydrate-based diets, determine the carbohydrate tolerance ("carbohydrate threshold") for active individuals on a ketogenic diet, and then, reexamine the performance and body composition effects when the diets are modified with supplemental carbohydrate up to the newly defined "ketogenic threshold."

Participants will be recruited from TWU and the Denton area and grouped in a semi-randomized fashion that considers dietary preferences. They will then undergo baseline testing, begin the diet and training interventions, followed by post-testing (phase 1) and a carbohydrate titration period in the ketogenic diet group (phase 2). In the following academic semester, the training intervention will be repeated with an adjusted dietary carbohydrate level, delivered as a pre-workout supplement, corresponding to Phase 2 (Phase 3).

Phase 1 will consist of diets at an energy level estimated by the Mifflin St. Jeor equation adjusted by 1.625 for exercise. The exercise intervention will be a supervised, periodized (daily undulating), 9-week concurrent resistance (3 days/week) and cardiovascular (2 days/week) exercise program designed to improve body composition and performance variables. During phase 2, the ketogenic diet participants will continue exercising with the same program while consuming incrementally greater quantities of carbohydrate pre-workout until the state of ketosis is lost. Phase 3 will be identical to Phase 1, but diets will be modified to include more carbohydrate. As of completing Phase 2, this amount has been determined to be 20g of Carb10 (pea starch).

Eligibility Criteria:
Inclusion Criteria:

* consistently exercising at least 3 days per week for the past 2 years, participating in both cardiovascular and resistance exercise at least once per week for the past 2 years, reported themselves as healthy, and were willing and able to comply with study protocols

Exclusion Criteria:

* using tobacco of any form, a history of medical events, reporting any supplement or medication use that may affect study outcomes, regularly consuming \> 7 alcoholic beverages per week, appearing unfit to handle the training program, inability to complete baseline testing, having a BMI \> 35 kg/m2, or becoming \< 80% compliant with training or dietary interventions.
Efficacy of Home-based Treatment for Breast Cancer-related Lymphedema

The goal of this clinical trials is to explore the effectiveness of home-based iymphedema treatment and the differences between the home-based and outpatient treatment. The main question is to verify that home-based treatment is as effective as outpatient treatment. We set two groups in this study, comparing the volume of affected upper limb to see if home-based iymphedema treatment is valuable method.

Secondary outcome measures:

1. Core Quality of Life Questionnaire (EORTC QLQ-C30), It included five functional measures (somatic function, role function, cognitive function, emotional function, social function), three symptom measures (fatigue, pain, nausea and vomiting), six individual measures (dysphagia, loss of appetite, sleep disturbance, constipation, diarrhea, financial hardship), and one patient self-assessment item (total health status).
2. Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI).

Eligibility Criteria:
Inclusion Criteria:

1. Lymphedema appeared in the upper limb after breast cancer-related treatment, and compared with the healthy side, the edema dimension was more than 2cm.
2. Age 18-75 years old;
3. Edema stage Ⅰ to Ⅱ;

Exclusion Criteria:

1. People with severe cognitive impairment;
2. Bilateral lymphedema;
3. Patients undergoing radiotherapy；
4. Patients with uncontrolled tumors;
5. Congestive heart failure and other comprehensive detumescence treatment contraindicated patients.
3D Imaging of Neonatal Faces

Facial scans of newborns will be performed before and after implementation of respiratory support devices such as nasal CPAP. 3D scanned images will be processed by Fisher \& Paykel Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.

Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D scanned image will be obtained prior to implementation of nasal support devices and after nasal support devices. Fisher \& Paykel Healthcare Limited will analyze the 3D images and observations will be made for changes in nasal structure or distortion.

Eligibility Criteria:
Inclusion Criteria:

* Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
* Signed informed consent form

Exclusion Criteria:

* Nasally intubated infants
* Infants with craniofacial abnormalities
Effects of Kendall Exercises Versus Kabat Exercises in Patients With Chronic Low Back Pain

Low back pain (LBP) is pain, muscle tension, or stiffness under the costal border and above the inferior gluteal folds, with or without leg pain.


Eligibility Criteria:
Inclusion Criteria:

* Both Genders
* Adults Aged Between 30-65
* Low Back pain should be Persistent for more than 12 weeks
* Visual Analogue scale or VAS of 3 or higher
* Idiopathic pain
* Ability to engage in physical activity and participate in the intervention program
* Willingness and ability to provide informed consent to participate in the study

Exclusion Criteria:

* Low back pain due to other causes

  1. Fibromyalgia
  2. Previous spine surgery
  3. Spondylolisthesis
  4. Spondylolysis
  5. Rheumatoid arthritis or Ankylosing spondylitis
  6. Spinal inflammation or tumor
  7. Spinal or pelvis fracture
  8. Osteoporosis
  9. Respiratory or heart diseases
  10. Stroke
  11. Pregnancy
* Persistent use of pain medication
* Patients who had undergone any other treatments, such as acupuncture or physical therapy, in the last 3 months
* Anticipated inability to comply with study protocols or attend scheduled."
Can Blood Flow Restriction Therapy Improve Strength for Shoulder External Rotators Better Than Exercise Alone

The purpose of this study is to evaluate the ability of blood flow restriction therapy to improve strength of shoulder muscles during the sidelying external rotation (ER) exercise versus a control group who only performs the sidelying ER exercise.

The purpose of this study is to determine if blood flow restriction (BFR) therapy is superior at increasing strength of the shoulder (supraspinatus, infraspinatus, posterior deltoid, and middle deltoid) and increasing tendon size of the supraspinatus and infraspinatus (as determined by diagnostic ultrasound) while performing the sidelying external rotation exercise compared to those who only perform the sideyling external rotation exercise without BFR.

Subjects will be randomized to one of two treatment groups: exercise with BFR or exercise alone. Recruitment will be a sample of convenience consisting of healthy adults (age range 22 to 45). Subjects will perform the sidelying external rotation exercise 2 times a week for an 8 week period.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult (age 18 and older) with no current shoulder pathology

Exclusion Criteria:

1. Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology
2. Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period
3. Cervical/thoracic spine surgery during the prior 1 year
4. Subject having one or more contraindications for BFR training.
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases

This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.

A phase II, randomized, controlled, double blinded and multicenter study with 2 arms, administering the study drug during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Randomization will be done 2:1 (experimental:control). Chemotherapy can be added before documented disease progression at the discretion of the physician.

The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The primary endpoint is intracranial disease progression over 6 months.

The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.

Tissue samples and serum will be collected for future correlative studies.

All the images will be centrally reviewed at the end of study.

Eligibility Criteria:
Inclusion Criteria:

* Providing a written informed consent (see Appendix A);
* Age ≥18 years;
* Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);
* At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;
* Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
* KPS ≥70;
* Absolute neutrophil count ≥ 1500/mm³;
* Platelet count ≥ 50,000/mm³;
* Serum creatinine ≤2.0 mg/dL;
* Serum transaminases ≤2 x the upper limit of normal (ULN);
* Total serum bilirubin ≤2 x ULN;
* And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.

Exclusion Criteria:

* Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);
* Prior WBRT, brain metastases resection with no other measurable lesion remaining;
* Extracranial metastases in two or more organs;
* Known leptomeningeal or subarachnoid tumor spread;
* Plan to use radiosurgery or radiation boost after completion of WBRT;
* Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;
* Previous use of an anti-EGFR drug;
* Participation in another ongoing therapeutic trial;
* Presence of known HIV seropositivity, severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix);
* Hypersensitivity or allergy to any of the drugs to be administered in this study;
* Inability or unwillingness to complete the required assessments;
* Geographic inaccessibility for treatment or follow-up evaluations.
Effects of a Late Phase Exercise Program Following Total Hip Arthroplasty

A group of orthopedic physiotherapists have developed a late phase program to educate and instruct total hip replacement patients in progressive exercises appropriate for their level of recovery. The components of this program include an educational presentation, individual assessment and exercise prescription. The investigators' intent is to pilot the program using a sample of patients. The objective of this pilot project:

To examine the effects of the late phase education session and home-based exercise program in restoring hip muscle strength, gait and function


Eligibility Criteria:
Inclusion Criteria:

* unilateral primary total hip arthroplasty (THA)
* 8-12 weeks post THA
* over the age of 18
* able to walk 15m without a walking aid
* able to participate in an exercise program without physical assistance
* available for follow up as per the study protocol
* able to read and understand English and follow verbal and visual instructions

Exclusion Criteria:

* medically unstable
* have central or peripheral nervous system deficits
* have an underlying terminal disease (cancer)
* have suspicion of infection following joint replacement