cyrilzakka/clinical-trials huggingface dataset:
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia

It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed meal.

Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal challenge and prevent post-prandial hypoglycemia.

PPH is a frequent complication of fundoplication in children. The mechanism responsible for the PPH is poorly understood, but involves an exaggerated insulin response to a meal and subsequent hypoglycemia. We have shown that children with PPH after Nissen fundoplication have abnormally exaggerated secretion of GLP-1, an incretin hormone with multiple glucose lowering effects including stimulation of insulin secretion and suppression of glucagon secretion. In this study we seek to examine the causal role of endogenous GLP-1 in PPH after fundoplication by evaluating the effects of antagonizing the GLP-1 receptor with exendin-(9-39) on key metabolic features of PPH.

Eligibility Criteria:
Inclusion Criteria:

* Children (6 months-18 years) who have had fundoplication or other gastric surgeries, irrespective of duration of postoperative period
* Weight \> 6.5 Kg
* Signs and/or symptoms of PPH: post-prandial blood glucose levels of \< 70 mg/dL ; symptoms including but not limited to feeding difficulties, irritability, nausea, diarrhea, pallor, diaphoresis, weakness, and lethargy after meals

Exclusion Criteria:

* Evidence of a medical condition that might alter results or compromise the elimination of the peptide, including, but not limited to: active infection, kidney failure (creatinine ≥ 2x above upper limit for age), severe liver dysfunction (AST or ALT ≥ 5x upper limit of normal for AST or ALT), severe respiratory or cardiac failure
* Other disorders of glucose regulation such as diabetes mellitus, congenital hyperinsulinism, glycogen storage disease
* Current use (within 1 week) of medications that may alter glucose homeostasis such as glucocorticoids, diazoxide, octreotide
* Use of antihistaminics within 10 days prior to the study
* Moderate and severe anemia defined as a hemoglobin \< 10g/dL
* Pregnancy
* Milk and soy protein allergy
Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome

The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).

This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).

If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.

Eligibility Criteria:
Healthy volunteers

Inclusion Criteria:

* Age ≥18 years
* Healthy with no medication except hormonal contraception

Exclusion Criteria:

* Participation in a trial with investigational drugs within 30 days
* Evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h
* Known allergy towards components of the study drink
* Pregnancy and breastfeeding
* Intention to become pregnant during the study
* Evidence of acute illness

Patients

Inclusion Criteria:

* Age ≥ 18 years
* Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h or must be on regular daily desmopressin medication

Exclusion Criteria:

* Participation in a trial with investigational drugs within 30 days
* Known allergy towards components of the study drink
* Pregnancy and breastfeeding
* Evidence of acute illness
A Safety Study of NNZ-2566 in Pediatric Rett Syndrome

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett syndrome in children and adolescents.

Rett syndrome is a neurodevelopmental disorder primarily affecting females. The disorder is characterized by apparent normal development in early infancy (6-18 months), followed by a period of regression with onset of systemic and neurological signs. The CNS symptoms of Rett syndrome include learning disability, autism symptomatology and epilepsy and these can be severe and highly debilitating. Affected individuals also show signs of autonomic dysfunction, reflected in cardiovascular and respiratory abnormalities. There is no currently effective treatment for Rett syndrome.

This study will investigate the safety, tolerability and blood pharmacokinetics of treatment with oral administration of NNZ-2566 at 50 mg/kg, 100 mg/kg, 200 mg/kg BID, or placebo BID, in children and adolescent females with Rett syndrome. The study also will also investigate measures of efficacy and biomarkers during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of classic/typical Rett syndrome with a documented mutation of the MeCP2 gene.
* Age 5 - 15 years.
* Weight at Screening and Baseline between 15.0 kg-100.0 kg (at least 15.0 kg and no greater than 100.0 kg).
* Each subject must be able to swallow the study medication provided as a liquid solution, or via gastrostomy tube.

Exclusion Criteria:

* Actively undergoing neurological regression
* Abnormal QT interval, prolongation or significant cardiovascular history.
* Current treatment with insulin.
* Anti-convulsants with liver enzyme inducing effects.
* Unstable seizure profile.
* Excluded concomitant medications.
* Current clinically significant (as determined by the investigator). cardiovascular, renal, hepatic, or respiratory disease.
* Gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
* History of, or current cerebrovascular disease or brain trauma.
* History of, or current clinically significant endocrine disorder, e.g. hypo- or hyperthyroidism, or diabetes mellitus.
* History of, or current, malignancy.
* Significant hearing and/or visual impairments that may affect ability to complete the test procedures.
* Allergy to strawberry.
Fluid Management Strategies on Blood Loss in Liver Transplantation

During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.

The investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* end stage liver disease
* age between 18y/o to 75 y/o
* expected to recieve to receive liver transplantation

Exclusion Criteria:

* arrythmia
Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease

This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.

Crohn's disease (CD) is characterized by periods of remission and relapse, with symptoms ranging from abdominal pain and diarrhea to severe complications such as fistulas and intestinal obstruction.

Interleukins (ILs) are known clusters of cytokines that regulate the proliferation, development, and activation of immune cells. IL-12 is predominantly a pro-inflammatory cytokine secreted by antigen-presenting cells (APC) in response to sensing of microbial components by Toll-like receptors. Another member of this family, IL-23 is also produced by DCs and macrophages after toll-like receptors (TLRs) engagement.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
* Non-specific ileitis by histopathology.

Exclusion Criteria:

* Patients with no pathological samples through colonoscopy.
* History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
* Immunosuppressive therapy or biologic agents at the time of study.
* Previous abdominal surgeries.
Psychoeducation for Uveal Melanoma

This clinical trial evaluates a video-based psychoeducational intervention for patients with uveal melanoma. Uveal melanoma (UM) is a rare intraocular cancer. UM patients face an uncertain course of survivorship in terms of their visual acuity, treatment-related side effects, and risk for eventual metastasis of the cancer. Learning about patients' thoughts and reactions to informational resources may better support patients during ocular melanoma survivorship.

PRIMARY OBJECTIVE:

I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in modifying illness perceptions of disease control, chronicity, and coherence (i.e., to become less threatening) over the course of the follow-up period.

SECONDARY OBJECTIVE:

I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in reducing the degree of participant's depressive and anxiety symptoms over the course of the follow-up period.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.

ARM II: Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18 years and older at visit 1)
* History of uveal melanoma as documented in their University of California, Los Angeles (UCLA) medical record
* Receipt of uveal melanoma treatment and/or ongoing follow-up care at the UCLA Jules Stein Eye Institute, as documented in their UCLA medical record
* Ability to read, write, and converse in English
* Access to the internet via a computer or cell phone
* Access to a personal email address
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

-
Effects of Oxytocin and Carbetocin on Renal System in Cesarean Sections

The aim of this study is to evaluate the renal outcome of patients undergoing elective C/S where oxytocin or carbetocin is used for postpartum hemorrhage prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Term (\>37 weeks of gestation) uncomplicated pregnant women undergoing elective cesarean section

Exclusion Criteria:

* Patients refusing to participate in the study
* Complicated pregnancies
* Patients with risk factors for postpartum hemorrhage
* Contraindications for oxytocin or carbetocin usage
* Patients with known renal diseases
* Preterm births (\<37 weeks of gestation)
Expanded Access Protocol Thymus Transplantation

The primary purpose is to provide access for patients who have immunodeficiency or severe autoimmune disease related to poor thymic function to cultured thymus tissue for implantation. With no thymus function, bone marrow stem cells do not develop into educated T cells, which fight infection.

Eligible participants receive cultured thymus tissue for implantation and may undergo biopsy. Immune suppression may be given depending on the immune status and clinical condition of the participant. Immune function testing is continued for one year post-implantation.

The patients enrolled have a high likelihood of death if they do not receive culture thymus tissue because of lack of thymus function. As there are many types of patients who may be enrolled, study results will not have statistical significance.

The study objective is to make cultured thymus tissue available for implantation on an expanded access basis. Data will be collected on survival, naïve T cell development, T cell chimerism, and implant related toxicities, as well as any unexpected study-related serious adverse events.

Eligible subjects receive cultured thymus tissue and may undergo allograft biopsy. Immune suppression may be given depending on the subject's immune status and clinical condition.

Protocol specified studies continue until approximately one year post-implantation. Study participation lasts approximately two years.

Eligibility Criteria:
Cultured Thymus Tissue Inclusion Criteria for Implantation:

* an immunodeficiency or severe autoimmunity for which development of naïve T cells would be expected to lead to lead to clinical improvement.
* written consent (or consent of parent/legal guardian as applicable), review of medical testing, laboratory studies, and physical examinations are used to determine whether the patient is clinically stable and will potentially benefit from receiving cultured thymus tissue. Each participant is reviewed with the Data Safety and Monitoring Board (DSMB).

Cultured Thymus Tissue Exclusion Criteria for Implantation:

* Unrepaired cyanotic congenital heart disease
* Uncontrolled infections. "Uncontrolled" is defined as requiring a ventilator, dialysis, or vasopressor support or anticipated as requiring such support within 6 months.
* Pregnancy

  * For females of child-bearing potential, a serum pregnancy test is done after consent, at the same time another blood draw is done if possible.
  * Females of child-bearing potential must agree to contraceptive measures as indicated in the consent form.
  * A second serum pregnancy test is done within 48 hours prior to administration of study interventions involving FDA pregnancy class D drugs, chemotherapy drugs, or other drugs or interventions known to pose risks to a potential fetus.
* HIV Positive
* History of malignancy
* CMV Infection

  * For subjects receiving immunosuppression as part of the implantation protocol, CMV infection as documented by \>500 copies/ml in blood by PCR on two consecutive assays is an exclusion.
Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery

High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center

Exclusion Criteria:

* patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output.
Digital Cognitive Behavior Therapy Program for Suicide Prevention

This study evaluates the efficacy of Thrive, a computerized cognitive behavior therapy program, to reduce depression and anxiety symptoms and to reduce suicidal thinking among adults. The first 450 participants will participate in a randomized waitlist controlled trial. The remaining 550 participants will be provided the program immediately upon enrolling

The efficacy of Thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline.

This study will examine whether Thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. The first phase of the study will implement a randomized waitlist controlled trial. The second phase of the study will examine the effects in a open trial. Outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.

Eligibility Criteria:
Inclusion Criteria:

* Montana resident
* 18+ years old
* Have regular access to broadband internet
* PHQ-9 score greater than 4

Exclusion Criteria:

* No Montana residency
* \< 18 years old
* No broadband internet access
* PHQ-9 score less than 5
Nutritional Problems After Lung and Heart Transplantation

Part 1) Bone health after transplantation - possible influence of vitamin K

Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of overweight after transplantation


Eligibility Criteria:
Inclusion Criteria:

* accepted for transplantation

Exclusion Criteria:

* not accepted for transplantation
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)

The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.


Eligibility Criteria:
Inclusion Criteria:

* Glucocorticosteroid refractory acute GVHD Grade 2-4
* Prior corticosteroid therapy at \> 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
* Karnofsky Performance Satus Scale ≥ 50%
* Adequate laboratory testing at screening

Exclusion Criteria:

* Subjects having Stage 1 skin acute GVHD
* Subjects with Stage 3 or 4 liver GVHD
* Prior EBV associated malignancy
* Prior or current Hepatitis B or C
* Prior or active tuberculosis
"Clinical Trial to Determine the Efficacy of Vitamin D for Acne Therapy"

The purpose of this study is to study the effects of topical Vitamin D cream (Calcipotriene, also known as Dovonex) on acne. The information gained from this study may lead to new treatments for acne. In this study, Calcipotriene will be compared with a placebo, a cream that looks like Calcipotriene, but contains no active ingredients.

This study will be a randomized, double-blinded, parallel group comparison of calcipotriene vs. placebo cream. Patients with acne will use calcipotriene or placebo cream 2x/day for 12 weeks and will be assessed at weeks 0, 2, 4, 8 and 12. Each group will have 24 subjects as calculated by power analysis. Three additional subjects for each group will be recruited for possible dropouts and total of 27 subjects will be recruited for each group. Primary endpoint (lesion count) and secondary endpoint (IGA- Investigator's Global Assessment) will be determined. Lesion counts will be assessed by one of the investigator physicians or nurse practitioner. Adverse effects including irritation, dry skin, inflammation and worsening of the lesions will be noted at each visit. Photographs will be taken to aid in assessing the clinical changes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, of either gender and any racial/ethnic group
2. Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
3. Subjects must understand and sign the informed consent prior to participation
4. Subjects must be in generally good health
5. Subjects must be able and willing to comply with the requirements of the protocol

Exclusion Criteria:

1. Oral retinoid use within twelve months of entry into the study
2. Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
3. Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
4. Non-compliant patients
5. Pregnant or nursing women
6. Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
7. Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
8. Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Head and Neck Cancer patients with planned Radiation therapy
* Have at least one of 10 pre-defined anatomic mucosal subsites on view
* Age \>/= 18 years
* Life expectancy \>/= 6 months
* Planned RT to the head/neck
* Must be able to perform oral rinse

Exclusion Criteria:

* Active infections of oral cavity
* physiologic condition that precludes the use of an oral rinse
* Hypersensitivity to Caphosol ingredients
* Presence of mucosal ulceration at baseline
* Poorly controlled hypertension, DM or other serious medical/psychiatric illness