cyrilzakka/clinical-trials huggingface dataset:
Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics

The purpose of this study is to determine the effect of adding liraglutide to high dose insulin therapy compared to high dose insulin therapy alone in patients with insulin-treated Type 2 diabetes with insulin requirements of \> 100 units of insulin per day.

40 subjects with Type 2 diabetes using \> 100 units of insulin per day with or without metformin with HbA1c \> 6.5% will be randomized into 2 treatment groups: treatment group will have liraglutide added to insulin and control group will have insulin uptitration only for 6 months. Primary endpoint to be compared between groups will be HbA1c at 6 months. Secondary endpoints will include weight, total daily insulin dose, percent time in euglycemic, hyperglycemic, and hypoglycemic ranges by continuous glucose monitor (CGM), and effect on GlycoMark and hs-CRP. Safety endpoints will include incidence of hypoglycemia and incidence of gastrointestinal side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with Type 2 diabetes with HbA1c from 6.5 to 10% treated with intensive insulin therapy (MDI or CSII, including U-500 insulin-treated patients) using \> 100 units of insulin, with or without a stable dose of oral insulin sensitizing medications, for at least three months.
2. Aged 18 to 80 years.
3. Females of child-bearing potential must be using adequate form of contraception.
4. Patient willing to monitor BG four times daily, use CGM, and comply with study-related protocol.

Exclusion Criteria:

1. Type 1 diabetes.
2. Use of any GLP-1 receptor agonist within previous three months.
3. Use of DPP-4 inhibitors or oral insulin secretagogues within the previous three months.
4. Use of glucocorticoids (except inhaled).
5. Use of any experimental drug within previous three months.
6. Known or suspected allergy to liraglutide, Novolog or Levemir.
7. Personal or family history of medullary carcinoma of the thyroid or MEN-2.
8. Concomitant chronic renal disease with creatinine \> 1.5%.
9. Concomitant chronic hepatic, gastrointestinal or other illness (including pancreatitis or active cardiovascular disease except stable exertional angina).
10. Inability or unwillingness to monitor BG, use CGM, or comply with study protocol.
11. Women of child-bearing potential unwilling to use adequate contraception, intending to become pregnant or breast-feeding.
Simultaneous Lengthening of Bilateral Femora and Tibiae in Achondroplastic Patients

The purpose of this study is to determine whether lengthening of both the tibiae and femora in achondroplastic patients is safe and provides reproducible outcome.


Eligibility Criteria:
Inclusion Criteria:

* Achondroplasia, first lengthening period

Exclusion Criteria:

* Previous lengthening
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate to severe chronic posterior blepharitis
* If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* had ocular surface surgery (LASIK, refractive, pterygium) within the past year
* unwilling to discontinue use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of eyelid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Philadelphia Preterm Prevention Project

This is a randomized clinical trial in which all Philadelphia resident women experiencing a pre-term birth (PTB) at \<34 weeks of gestation (GA) over an 18 month period will be approached at the time of the postpartum hospital stay. Consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. Our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat PTB.

This is a randomized clinical trial in which all Philadelphia resident women experiencing a pre-term birth (PTB) at \<34 weeks of gestation (GA) over an 18 month period will be approached at the time of the postpartum hospital stay. Consenting women will be randomized into a usual care group or an interconceptional intervention targeting five risk conditions, all of which increase systemic inflammation. Our primary objective in this study is to assess the efficacy of our interconceptional intervention on the rate of repeat PTB.

Participants will be randomized into one of two groups: usual care of interconceptional intervention. Those who are randomized into the interconceptional intervention group will be targeted for five risk conditions, including smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI. It is hoped that by reducing these seemingly disparate yet well-known risk conditions, we can reduce PTB and the subsequent race/ethnic disparities.

Eligibility Criteria:
Inclusion Criteria:

* delivery of live born infant at \<34 weeks of gestation in one of 18 Philadelphia area hospitals
* English or Spanish speaking
* Philadelphia residency
* not receiving operative sterilization before discharge from the hospital

Exclusion Criteria:

* N/A
Long Term Follow-Up Study for rAAV-GAD Treated Subjects

The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.


Eligibility Criteria:
Inclusion Criteria:

* Participated in a clinical trial where they received AAV-GAD
* Able to give informed consent to participate in the study

Exclusion Criteria:

* Received Deep Brain Stimulation after receiving AAV-GAD
* Received any experimental device in the brain after receiving AAV-GAD
* Had any type of brain surgery after receiving AAV-GAD
* Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD
Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern

The present record represents a secondary data analysis of the Dietary Approaches to Stop Hypertension (DASH) trial. Study data and specimens were accessed through the National Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Coordinating Center (BioLINCC). A global, untargeted, metabolomic profile was used to investigate biomarkers of the DASH dietary pattern as well as blood pressure change.

The present study was conducted in order to: 1) quantify the metabolomic expression of the DASH dietary pattern; and 2) examine the relationship between metabolites that reflect the DASH dietary pattern and blood pressure change. This secondary data analysis leverages the completed DASH trial, a randomized feeding trial (N=459).

Eligibility Criteria:
Inclusion Criteria:

* Men and women with systolic blood pressure \<160 mmHg and diastolic blood pressure 80-95 mmHg

Exclusion Criteria:

* Taking anti-hypertensive medication
* Poorly controlled diabetes mellitus
* Hyperlipidemia
* Cardiovascular event within the past 6 months
* Chronic disease that may interfere with participation
* Pregnancy or lactation
* Body mass index \> 35 kg/m2
* Unwilling to stop taking vitamin or mineral supplements or antacids
* Kidney disease
* Consumption of \>14 alcoholic beverages per week
* Did not consent to the use of biological specimens
* Did not attend the 8 week follow-up visit
* No serum specimen or insufficient volume of serum specimens in repository
EMERGENCE AGITATION After Premedication IN PAEDIATRIC MAGNETIC RESONANCE IMAGING: A RETROSPECTIVE COHORT STUDY

The aim of this study was to assess the anxiolytic and sedative effect of OZALIN® / OZASED® (ADV6209) 0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under inhalational anesthesia. Our hypothesis is that compared to children who do not receive any premedication, palatability of OZALIN® / OZASED® by allowing an easier acceptance of the drug, improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes, including emergence agitation.

Magnetic resonance imaging is considered the primary investigative tool for evaluating a wide range of paediatric medical conditions. Sedatives are often needed in this population to ensure immobilization during the acquisition of the images.

Midazolam has always been the most used anxiolytic-sedative drug in the pediatric population. Over time, the intravenous formulation of midazolam has been used also for oral, nasal or rectal administration but those alternative routes of administration represent an off-label use. Recently, in Europe was licensed ADV6209, a midazolam solution for oral use containing gamma-cyclodextrin (OZALIN® / OZASED®).

The aim of this study was to assess its anxiolytic and sedative effect at a dosage of 0,25mg/Kg in children undergoing magnetic resonance imaging (MRI) under inhalational anesthesia. Our hypothesis is that compared to children who do not receive any premedication, palatability of OZALIN® / OZASED® by allowing an easier acceptance of the drug, improves the quality of anesthesia induction and postoperative behavioral outcome improving sedation and reducing the need for inhalation anesthetic which has been recognized as the main cause of post-procedural behavioral changes, including emergence agitation.

Eligibility Criteria:
Inclusion Criteria:

- We included in the study 100 children (either gender), aged 1-10 years, American Society of Anaesthesiologists (ASA) physical status 1 and 3 who, between March and December 2022, received inhalation anesthesia for brain and spinal cord MRI for diagnostic investigations or postoperative and oncological follow-up

Exclusion Criteria:

* 1) a history of hypersensitivity to midazolam; 2) chronic therapy with benzodiazepines; 3) acute respiratory tract infections; 4) psychiatric and behavioural disorders; 5) ASA physical status \>3.
Music Breathing for Caregivers of Children Newly Diagnosed With Cancer

This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.

Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.

Aims:

* To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
* To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.

Hypotheses:

It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

Parental caregivers (the primary caregiver; either mother or father) who

* has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
* can read and communicate in Chinese (Cantonese or Mandarin)
* has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
* is willing to download and use Zoom as the intervention delivery platform.

Exclusion Criteria:

* has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
* is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
* is currently participating in any interventions or additional counselling services.
* has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications
Local Treatment by Thermic Destruction of Primitive Breast Cancer

Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser


Eligibility Criteria:
Inclusion Criteria:

* Noninflammatory unilateral and unifocal breast cancer
* Size \</= 20mm (ultrasound measure)
* Histological confirmation of cancer by biopsy grade status hormone and HER2.
* Good delineation of the lesion on ultrasound.
* Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
* Age between 18 and 80
* ECOG performance status 0 or 1
Oral Iron Supplementation on Alternate Vs. Consecutive Days for Iron Deficiency Anemia in Pregnancy

This will be a randomized clinical trial. Enrolled subjects will be randomized (1:1) into two study arms to receive either daily (Group 1) or alternate day (Group 2) supplementation with one oral pill containing ferrous sulfate with an equivalent elemental iron dose of 65 mg per pill.

During the enrollment (baseline) visit, subjects will undergo a blood draw to assess hemoglobin, ferritin and soluble transferrin receptor (sTfR) levels to confirm current depleted iron stores and will then be randomly allocated into one of the two study arms. All ferrous sulfate (oral tablets) will be provided to patients by the investigators. All subjects will be instructed to take oral iron on an empty stomach or 1 hour after meals for better absorption, preferably with a vitamin C rich product such as orange juice. To minimize variability introduced by other potential iron sources, prenatal vitamins that have the same amount and form of iron will be provided to both study groups.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients will be enrolled at less than 30 weeks gestational age (GA) with laboratory confirmed IDA (as defined by hemoglobin under 10.5 g/dL, as well as ferritin under 15 mcg/L)

Exclusion Criteria:

* Patients \<18 years old, patients who have severe IDA that requires blood transfusion or IV iron infusion, patients who have other known hemoglobinopathy (such as thalassemia or sickle cell anemia) or anemia of different mechanism (such as vitamin B12 or folate deficiency), patients with ulcerative colitis, Crohn's disease, gastric ulcers, patients who have previously undergone gastric bypass surgery, patients who experience admission for antepartum bleed, have been diagnosed with abnormal placentation (i.e., placenta previa, placenta accreta, placenta increta or percreta)
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* 18 y.o. ≤age≤75 y.o.;
* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection).

Exclusion Criteria:

* age \<18 y.o. or age \> 75 y.o.;
* Never had the variceal bleeding episode before;
* Do not have endoscopic treatment;
* combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);
* Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
* Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
* Acute variceal bleeding within 5 days.
* Use of other antibiotics in the past 2 weeks;
* Refuse to participate
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes

This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months
2. Age ≥18 years
3. Using Novolog or Humalog insulin at time of enrollment
4. For females, not currently known to be pregnant
5. An understanding of and willingness to follow the protocol and sign the informed consent
6. Willing to have photographs taken of their infusion sites
7. Willing to download their 670G pump every week to a research Carelink account
8. Willing to submit a brief online questionnaire at the time of any infusion set failure
9. Able to understand spoken or written English
10. Hemoglobin A1c \<8.5% at the time of enrollment
11. Willing to perform three or more fingerstick glucose measurements each day
12. Willing to sign a consent for release of medical information at the time of enrollment
13. Willing to change their infusion pump insulin reservoirs at least every 6 days

Exclusion Criteria:

1. Hypoglycemic seizure or loss of consciousness in the past 6 months
2. Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
3. A known cardiovascular disease
4. Active proliferative diabetic retinopathy
5. Known tape allergy
6. Current treatment for a seizure disorder
7. Cystic fibrosis
8. Active infection
9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
10. Inpatient psychiatric treatment in the past 6 months
11. Presence of a known adrenal disorder
12. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study
13. Abuse of alcohol
14. History of dialysis, renal failure or known eGFR \<60 ml/min/1.73m2
15. Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment
Attention Training and Cognitive Therapy

The present study aimed to investigate the efficacy and process of change that occurs in Attention Training in comparison to an established treatment for social phobia, Cognitive Therapy. A randomized trial was conducted in which participants were allocated to either six weeks of Attention Training or Cognitive Therapy. It was hypothesized that both treatments would be effective in reducing social phobia symptoms, but that Attention Training would work primarily by reducing levels of self focused attention, while Cognitive Therapy would work through changes to probability and threat appraisals.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age,
* be fluent in English
* have a primary concern of social anxiety that met DSM-IV criteria (APA, 2000) for social phobia. Both subtypes of social phobia, specific and generalized, were accepted into the study.

Exclusion Criteria:

* the presence of comorbid condition(s) that were more severe than the presenting social phobia
CORE: CO Monitoring for Reach and Efficacy in Tobacco Treatment for Cancer Patients

The purpose of this study is to assess the cessation success rates of an intensive tobacco treatment program in a patients undergoing cancer treatment at 30 days, 3 months and 6 months.

This mixed-methods, observational cohort study will assess intensive tobacco treatment with carbon monoxide monitoring offered to all eligible smoking patients presenting for cancer treatment to the NCCC at our main Lebanon campus and our very rural St. Johnsbury campus. Subjects will not be randomized and study will not be blinded. Cessation rates among the intensive tobacco treatment will be compared to usual care, matched historical controls, and to patients who refuse all tobacco treatment program elements.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 and older
* Active Smoker at the time of initial consultation for cancer (defined as any smoking within 2 weeks of consult)

Exclusion Criteria:

* Adults unable to consent
* Prisoners
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.


Eligibility Criteria:
Inclusion Criteria:

* ABO-compatible renal transplant recipients

Exclusion Criteria:

* multi-organ transplant
* HIV(+) donor or recipients
* history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)
* more than three-fold increase in AST or ALT level for 28 days
* pregnancy
* lactation