cyrilzakka/clinical-trials huggingface dataset:
Updating Preventive and Treatment Guidelines for Hypoglycemia in Individuals Living with Type 1 Diabetes

The REMODAL trial is a randomized crossover study aiming to update treatment guidelines for mild hypoglycemia in people with Type 1 diabetes using continuous glucose monitoring (CGM) technology. The study will assess whether treating mild hypoglycemia proactively (at a glucose threshold of 5.0 mmol/L) with lower doses of carbohydrate (CHO) is more effective than the traditional reactive approach (treatment at \< 4.0 mmol/L). The goal is to reduce hypoglycemia frequency and improve quality of life, while minimizing caloric intake and rebound hyperglycemia.

The REMODAL trial explores an individualized, proactive approach to treat mild hypoglycemia in individuals with Type 1 diabetes (T1D) who use CGM. Traditional guidelines, established in the 1980s, recommend the "15g/15min rule" - consuming 15g of CHO every 15 minutes for glucose levels below 4.0 mmol/L. However, these guidelines may no longer be optimal with the advancements in insulin therapies and CGM, which provide real-time glucose data and predict glucose trends.

In this study, 32 adult participants with T1D will receive three interventions to test different amounts and timing of CHO intake under real-life conditions. These are as follows:

1. 8g of CHO at a threshold of 5.0 mmol/L (proactive approach).
2. 16g of CHO at a threshold of 5.0 mmol/L (proactive approach).
3. 16g of CHO at a threshold of \< 4.0 mmol/L (traditional reactive approach).

The primary outcome is the prevention rate of hypoglycemic episodes under each intervention, with additional measures on glucose levels, time spent in hypoglycemia, and rebound hyperglycemia. The study also considers differences in glucose management between multiple daily injections, continuous subcutaneous insulin infusion, and automated insulin delivery systems, which may affect CHO needs. This study hopes to redefine effective hypoglycemia management in the modern era of diabetes care, providing personalized recommendations to improve glycemic control and overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older
* Clinical diagnosis of Type 1 diabetes for at least 1 year
* Currently treated with multiple daily insulin injections (MDI), continuous subcutaneous insulin infusion (CSII), or automated insulin delivery (AID) systems
* HbA1c level below 9.0%
* Equal distribution of male and female participants, as well as MDI/CSII and AID users

Exclusion Criteria:

* Gastroparesis
* Significant cardiac rhythm abnormalities
* Clinically significant microvascular complications such as nephropathy (eGFR \< 40 ml/min) or severe proliferative retinopathy
* Diagnosis of epilepsy
* Pregnancy or currently breastfeeding
* Severe hypoglycemic episode within 1 month prior to inclusion
* Macrovascular events or uncorrected hypokalemia (K+ \< 3.5 mmol/L) within 3 months prior to inclusion
* Anticipated treatment changes during the trial period
* Inability to provide informed consent
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 to 89 years)
* All race and ethnicities
* Presenting to the emergency department with suspicion of infection
* Whose assessment includes a CBC with differential
* Meets EMR Sepsis Definition

Exclusion Criteria:

* Pregnancy
* Prisoners
* Transfers from other ED
* Previously enrolled
A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity

The purposes of this study are to compare the effects of Topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12 months of continued treatment in male patients with abdominal obesity.

Topiramate is not approved for the treatment of obesity. This study is a 6-month randomized, double-blind placebo-controlled study, followed by a 6-month open-label extension study to evaluate the effect of Topiramate on abdominal visceral fat accumulation, a clinical surrogate known to be associated with the complications of obesity such as increased incidence of Type 2 diabetes mellitus, hypertension, and dyslipidemia, and their associated morbidities. Patients will be randomized to receive either daily Topiramate or placebo. Effectiveness will be measured by multiple parameters such as abdominal visceral fat (assessed by computed tomography), total and subcutaneous abdominal fat, body composition, body weight, body mass index, glucose tolerance, lipid profile, blood pressure, Topiramate plasma concentration, or 24 hours energy expenditure (selected patients). Safety evaluation (adverse events, vital signs, 12-lead ECG, clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that Topiramate is effective in reducing abdominal visceral fat in male patients and well tolerated. After the initial 12-week titration phase, patients will receive either Topiramate (200mg twice daily or the maximum dose tolerated) or placebo by mouth for 6-months. Then, patients will receive Topiramate (200mg twice daily or the maximum tolerated dose) for 6-months during the open-label phase.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>= 27 and =\< 40
* a waist circumference \>= 100 cm (39.4 inches)
* Baseline weight must be stable (varying no more than 4 kg (8.8 lbs)) for at least two months prior to enrollment
* Must be sedentary (less than one session of continuous moderate physical activity of 30 min/week)
* Must have blood lipid disorder
* Must be non-smokers

Exclusion Criteria:

* Patients with endocrine disease or other physical causes of obesity
* Patients with significantly abnormal hepatic liver function tests or renal disease
* History of schizophrenia, psychotic, or major affective disorder
* History of epilepsy
* History of eating disorders
* History of any other significant medical conditions
Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.

Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis.

The total number of patients enrolled in this study will be approximately 201. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to registration of any patient data
* Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.

Exclusion Criteria:

* Patients with exogenous CS
* Patients with Pseudo CS
* Patients participating in an interventional clinical trial with an investigational drug.
Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate

Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.

Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them.

The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.


Eligibility Criteria:
Inclusion Criteria:

* Men and women at least 18 years of age
* No clinically significant abnormal findings on clinical laboratory evaluation and medical history
* Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
* Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
* Women who are sexually active must be using effective means of contraception

Exclusion Criteria:

* History of dysphagia or swallowing disorders
* Clinically significant illness within 3 months of study enrollment
* Concomitant use of medication that might interact with lanthanum carbonate
* Pregnant or intends to become pregnant within 30 days of completing the study
* Breast feeding
* Alcohol or controlled substance abuse
* Use of an investigational agent within 30 days of study entry
Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols

The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.


Eligibility Criteria:
Inclusion Criteria:

* male and post-menopausal female aged 40-80 years;
* BMI between 22 and 32 kg/m2,
* Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
* Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
* Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
* Have to give written consent to take part in the study

Exclusion Criteria:

* Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95\<SBP\>140 mmHg and/or 45\<DBP\>90 mmHg),
* Previous history of symptomatic vascular disease, TG level \> 2,8 g/l,
* History of metabolic or gastrointestinal disease with the exception of appendicectomy,
* Consumption of large amounts of alcohol,
* Having undergone general anesthesia in the month prior to pre-selection,
* Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* Having serious or acute disease likely to influence study results or involved in life time,
* Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
* Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
* In a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* For female subjects: likely to change her hormonal substitutive treatment,
* Currently in an exclusion period following participation in another clinical trial.
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds

The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.

This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.

Eligibility Criteria:
Inclusion Criteria:

* Subject has Venous Ulcer or Diabetic Ulcer with a surface area \< 100 sq. cm and \< 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
* Subject has wound present for \>30 days despite appropriate wound care
* Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot \>30 mmHg or 0.7 \< ABI \<1.2)
* Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
* Subject is able to understand and provide written consent
* Subject able to understand and provide written consent
* Male or non-pregnant female willing to have urine pregnancy test

Exclusion Criteria:

* Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
* Subject has Untreated Osteomyelitis
* Subject has Allergy to Wound Care Products used in the study
* Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
* Subject has Active Charcot Arthropathy of the Foot
* Subject has study wound location on toes or plantar surface of foot
* Subject has uncontrolled hyperglycemia (HbA1C \>12%)
* Subject has end stage renal disease requiring dialysis
* Subject is undergoing active chemotherapy treatment that inhibits wound healing
* Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment
* Subject has a \>30% wound surface area reduction in size at 1 week after screening visit
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
* Subject is unwilling or unable to comply with protocol requirements
* Subject is pregnant
Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-18 years
* treatment with recombinant growth hormone

Exclusion Criteria:

* Underlying Chronic diseases
* Family history of eye diseases
* elevated occular pressure prior to starting treatment
Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT)

Randomized-controlled trial and microbiome assessment to understand the risk-to-benefit ratio of prophylactic antibiotics (Ceftriaxone) vs placebo in patients with pneumonia and inflammation after cardiac arrest outside the hospital.

Pneumonia is an infection of the lungs resulting in alveolar inflammation and fluid or purulent material accumulation. It is the most common infection after cardiac arrest occurring in up to 65% of patients treated with targeted temperature management. Pneumonia may result from aspiration during cardiopulmonary resuscitation (CPR), or by introduction of oropharyngeal flora into the lungs during airway management. Preventing infection after OHCA may: 1) reduce exposure to broad-spectrum antibiotics and subsequent collateral damage, 2) prevent hemodynamic derangements due to local and systemic inflammation, and 3) prevent an association between infection and morbidity and mortality. These benefits must be balanced with the risk for altering bacterial resistomes in the absence clinical infection. Accordingly, further study is warranted to understand the risk-to-benefit ratio of prophylactic antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Comatose (do not follow simple verbal commands)
* Have any initial heart rhythm (shockable or non-shockable)
* OHCA including the emergency department

Exclusion Criteria:

* Name on opt-out list
* In-hospital cardiac arrest
* Interval \>6 hours from ICU admission to study drug receipt
* Preexisting terminal disease making 180-day survival unlikely
* Refused informed consent
* Emergent coronary artery bypass grafting
* Anaphylaxis or angioedema to beta-lactam antibiotics (i.e., cephalosporins or penicillins)
* Under legal guardianship or prisoner
* Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE)
* Clinical bacterial infection prior to hospital admission defined as any one of the following:

  * Infectious prodrome preceding OHCA
  * Active course of antibiotics for infection prior to admission
  * Active infection documented in the electronic medical record
  * Family or surrogate endorsement of an active infection
Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.

Chronic hepatitis C is a long-lasting infectious disease caused by hepatitis C virus (HCV). According to statistics by the World Health Organization (WHO), the global HCV prevalence is estimated at 2.8%, equating to approximately 185 million. Chronic HCV infection can lead to chronic inflammatory necrosis and fibrosis in the liver, and in some patients can develop into hepatic cirrhosis and even hepatocellular carcinoma (HCC), endangering the health and life of patients.

The development of direct-acting antiviral agents (DAAs) since 2011 markedly improved antiviral efficacy and significantly shortened treatment cycle, making the drugs convenient for clinical use. Small molecule DAAs exert target-specific effects on proteins involved in the HCV life cycle and have been included in the treatment guidelines by leading associations for the study of liver diseases worldwide.

Treatment regimen for hepatitis C - coblopasvir hydrochloride capsules combined with sofosbuvir tablets:

Coblopasvir hydrochloride capsule is an NS5A inhibitor that inhibits the replication and assembly of HCV, and sofosbuvir tablet is a NS5B polymerase inhibitor. The primary efficacy results (sustained virologic response 12 weeks post-treatment, SVR12) were comparable between the phase II and III clinical studies: the overall SVR12 in subjects was 97%. The SVR12 after coblopasvir hydrochloride capsules combined with sofosbuvir tablets in genotype 3 infection with cirrhosis and genotype 3b infection with cirrhosis were superior to the results of sofosbuvir and velpatasvir tablets obtained in clinical studies in Asia (83% vs. 72%; 67% vs. 50%).

Coblopasvir hydrochloride capsule and sofosbuvir tablet were approved for marketing by National Medical Products Administration of China in Feb. 2020 and Mar. 2020, respectively. This study is designed to evaluate the safety and efficacy of coblopasvir hydrochloride capsules combined with sofosbuvir tablets in clinical practice after marketing.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic hepatitis C infection
2. Age 18 years and over
3. Patients who treated with coblopasvir hydrochloride capsules/sofosbuvir tablets;

Exclusion Criteria:

1. Patients who are receiving other DAAs drugs at the same time;
2. Subjects with poor compliance who are unable to complete treatment or follow-up.
Ridge Augmentation Using Allograft Particles Hydrated with or Without Recombinant Human Platelet-Derived Growth Factor

This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

This is a prospective, randomized, and examiner-only-masked study. It is designed to clinically compare the use of bone particulate allograft hydrated with rhPDGF vs bone particulate allograft hydrated with saline, for patients who were planned to receive dental implants but presented with deficient bone ridges. This investigation of two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

In two arms, bone core biopsies will be harvested at time of implant placement 4 months following ridge augmentation grafting. These 2x8mm bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between in both study arms.

Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.

Cone beam computed tomography (CBCT) initial scans are conducted immediately following prior to ridge augmentation and second scans obtained prior to implant placement both arms. These types of Cone Beam CT scans as well as conventional dental x-rays are valuable treatment planning tools that are commonly used in modern-day implant dentistry. The scans and the x-ray images are also used to monitor the health of tissues surrounding implants and to make sure that the implant remains securely implanted into the jawbone over time.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* At least 18 years old
* Must be a patient of the UAB Dental School
* Able to read and understand informed consent document
* Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.
* Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.

Exclusion Criteria:

* Non-English speaking
* Less than 18 years old
* Smokers/tobacco users (\>10 cigarettes/day)
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
* Vertical loss of bone at edentulous ridge.