cyrilzakka/clinical-trials huggingface dataset:
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

The purpose of this study is to see if giving study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.

A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.

In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.

There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.

Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.

Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Children with Type 2 Diabetes,
* Between the ages of 12-21 years,
* Tanner stage 4-5 for pubertal development,
* Menstruating females must have a negative urine pregnancy test for inclusion,
* Must have T2DM for at least 6 months,
* History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies,
* HbA1c \< 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet.

Exclusion Criteria:

* A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc),
* BMI\> 40 kg/m2,
* Weight of \< 60 kg,
* Female with menstrual irregularities,
* Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride),
* Evidence or history of chemical abuse,
* Anemia (age specific normal range for hemoglobin will be used),
* Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age),
* Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age),
* Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months.
* Must be taking MTX consecutively for \>/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening

Exclusion Criteria:

* Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease
* Presence of serious infection
* Class IV rheumatoid arthritis
* Prior or current history of tuberculosis infection or exposure
* Any other DMARDs other than methotrexate within 6 weeks of screening
* Pregnant or nursing
* Receipt of live vaccines within 3 months
* Felty's syndrome
Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by 1 x 12 weeks treatment period.

Study design: Randomized, double-blinded, placebo-controlled, parallel, multi-center study of ultramicronized PEA (Normast)with a week of baseline period followed by 1 x 12 weeks treatment period.

Methodology: Given Normast 600mg x 2 daily or corresponding placebo and kept on that dose for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more with at- and/or below-level neuropathic pain for at least 3 months due to trauma or disease of the spinal cord or cauda equina (of at least 6 months old) with a mean pain intensity from 4 to 9 on a 0-10 point numeric rating scale (NRS) during a one-week baseline period will be eligible for the study

Exclusion Criteria:

* known concomitant severe cerebral damage, terminal illness, planned surgery, pregnancy or lactation, alcohol or substance abuse, hypersensitivity to PEA or carrier, and psychiatric disease except depression.
Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population

The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients.

In earlier studies the median VAS during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.


Eligibility Criteria:
Inclusion Criteria:

* Patient age between ages 1year to 18 years
* A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist

Exclusion Criteria:

* Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
Sleep Quality and Presence of Sleep Disordered Breathing

The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older.

Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

The purpose of our study is to survey the quality of sleep and sleep disordered breathing in a HIV infected inner city ambulatory African-American Population aged 50 years and older. A secondary objective is to investigate possible relationships between sleep quality and aspects of a patient's medical history including BMI, CD4 count, HIV viral load, history of substance abuse, psychiatric disorders, concurrent medical conditions, current HIV medications and HIV medication compliance.

Hypothesis: African-American HIV infected individuals aged 50 years and older have a high prevalence of sleep disorders and lower quality of sleep.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Aged 50 years and older
* HIV infected
* Receiving HIV care at the Boulevard Comprehensive Care Clinic, Duval County Health Department

Exclusion Criteria:

* Patients refusing to fill out the questionnaires
* Patients less than 50 years old
* Non-African Americans
* Persons not receiving care at the Boulevard Comprehensive Care Clinic
Laser Acupuncture for Traumatic Facial Paralysis

Objective:

The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with traumatic facial paralysis.

Methods:

This study was retrospective study including 174 patients that undergoing traumatic facial paralysis. All the patients received laser acupuncture (LA).

Patients were assigned to the LA 1 month group, LA 3 month group and LA 6 month group, with 58 patients in each group.

Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI), electroneuronography (ENoG), electromyography (EMG) and Blink reflex


Eligibility Criteria:
Inclusion Criteria:

* 1, Patients diagnosed with traumatic facial paralysis 2, Patients were eligible if they were graded at House-Brackmann grade (HB) 3 or higher.

Exclusion Criteria:

- 1.Serious mental illness or social problems, and neurological disorders, and systemic diseases, such as malignant tumors, and other serious consumptive diseases.

2. Planning for pregnancy, those in pregnancy, or those who were lactating. 3. Neurotmesis by trauma.
Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome

role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative.

For more diffuse invasive gliomas (Grade II or higher), initial management typically includes maximal safe resection when possible.

Increasing evidence supports an association between extent of resection and prolonged progression-free and overall survival for patients with diffuse gliomas of all types and grades Many studies reported that more that 90%of patients with glioma showed recurrence at the orginal tumor location.

Review the outcomes of re-operation in treatment of recurrent brain gliomas To determine the prognostic factors which can predict which patient would benefit from multiple surgery .

Trail to Improve the outcome of these patients and decrease rate of complications


Eligibility Criteria:
Inclusion Criteria:

- Patient previously operated and documented as a glioma with clinical and neuroimaging and pathological evidences.

Patients who will undergo re-operation for treatment of a recurrent brain glioma at the time of study(one year) Histological types : Different histological types of glioma.

Exclusion Criteria:

* patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2

This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB) Infection.

Currently, there is no etiological treatment of STPB-induced HUS. Ideally, such treatment would be started in the early phase of the infection and would protect against both types of toxins and all of their variants. The chimeric anti-Shiga toxins 1 (cαStx1) and 2 (cαStx2) antibodies are intended to be administered as a single infusion and provide simultaneous protection against the two Shiga toxins (Stx1 and Stx2) by decreasing the incidence and severity of Shiga toxin-mediated clinical events including bloody diarrhea/hemorrhagic colitis and Hemolytic Uremic Syndrome (HUS) and associated sequelae.

Eligibility Criteria:
Inclusion Criteria:

1. Bloody diarrhea (by visual inspection) for no more than 36 hours prior to screening (signature of the informed consent).
2. Detection of Shiga toxin (Stx1 and/or Stx2) in stool

Exclusion Criteria:

1. Laboratory findings compatible with development of at least two out of three following criteria that define Hemolytic Uremic Syndrome (HUS):

   Hemolytic Anemia: hematocrit \< 30% with evidence of hemolysis (as indicated by Lactate Dehydrogenase (LDH) above the upper limit of normal for age or the finding of schistocytes on peripheral smear); Thrombocytopenia: platelet count \<150 x 103/uL; Nephropathy: serum creatinine \> Upper Limit Normal (ULN) adjusted for age and gender.
2. Bloody-diarrhea suspected not to be caused by Shiga Toxin-Producing Bacteria (STPB) but by other organisms or preexisting diseases.
3. Family history of proven or suspected hereditary Hemolytic Uremic Syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP).
4. History of chronic/recurrent hemolytic anemia or thrombocytopenia.
Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function

Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
* 18 years old and older
* Creatinine clearance of more than 2 ml/min
* Agreement to participate in the clinical study
* Vascular access by arteriovenous fistula/graft

Exclusion Criteria:

* Plan for kidney transplantation within 6 months
* Severe volume overloading state
* Dialysis through permanent catheter
* Any hematologic malignancy or monoclonal gammopathy
* Any malignancy
* Active infectious disease
* HIV infection
* Patient enrolled to another study within 3 month from starting the present study
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and related system components.

This is a prospective, open label, non-randomized study. The study will evaluate the clinical outcome and possible adverse effects of the directional DBS treatment. The following data will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Age at the time of enrollment: 18 \~ 75;
2. Idiopathic Parkinson's disease;
3. Patient whose symptoms are not adequately controlled by best medical therapy;
4. Hoehn and Yahr stage≥2.5;
5. Patient whose symptoms are improved by at least 30% with levodopa challenge test;
6. Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
7. Is willing and able to comply with all visits and study related procedures;
8. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. Had received lesioning surgical treatment;
2. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
3. Any current drug or alcohol abuse;
4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
5. Any significant psychiatric problems, including unrelated clinically significant depression;
6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
7. Severe brain atrophy (confirmed by CT or MRI);
8. A condition requiring or likely to require the use of diathermy;
9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
10. Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
11. Long-term of immunosuppressive or hormone therapy;
12. Other diseases requiring the stimulators;
13. A condition requiring or likely to require the use of MRI;
14. Participated in any other clinical trials within the preceding 3 months;
15. Unwilling or unable to cooperate with the implantation of DBS system;
16. Unwilling or unable to cooperate with postoperative follow-up;
17. Not considered to be applicable by the investigator.
H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy

The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.

Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
Surgical Extrusion: Volumetric and Insertion Analysis at 6 Months.

The aim is to clinically evaluate the changes that occur in teeth that have undergone surgical extrusion treatment. Three parameters will be recorded before and 6 months after treatment: the position and the volume of the soft tissue, and the level of periodontal attachment.

After informing the patient and obtaining his or her consent to surgical extrusion treatment, a model of the pre-treatment situation will be obtained by intraoral scanning and the attachment levels will be recorded by periodontal probing at 6 points around the tooth.

The dimensional and positional changes of the soft tissue will be analyzed by superimposing both digital impressions in each patient.

In the same way, periodontal attachment levels before and 6 months after treatment will be compared.

The data will be analyzed statistically and conclusions will be drawn regarding the surgical extrusion treatment.

Eligibility Criteria:
Inclusion Criteria:

* Tooth with a subgingival residual dentine margin.
* Patients refusing tooth extraction and dental implant placement as first choice.

Exclusion Criteria:

* Patients in whom surgical intervention is contraindicated.
* Teeth with vertical fractures up to the apex.
* Teeth with pocket depth \>4 mm in any of their walls.
* Failure of the treatment leading to the loss of the extruded tooth.
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)

This is a one-year multi-centre, double blind, placebo controlled, randomized trial investigating oral vitamin D3 (Colecalciferol) as an add-on treatment to interferon-beta-1b for Multiple Sclerosis (MS). Not less than one month after initiation of therapy with interferon beta 1b, MS patients will be randomised to once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 0.5 mg of vitamin D3, or to once weekly peroral treatment with matching placebo. The hypothesis is that vitamin D suppresses clinical and MRI activity of MS.

The patients will be examined clinically at baseline and at 6, and 12 months. Laboratory assessments will be performed at screening and 1, 2, 3, 6, 9 and 12 months after baseline. MRI will be performed (T1-weighted and T2-weighted) at randomization and 12 months thereafter. Sample size is 80 patients: two groups with 40 patients in each group. The primary statistical analyses will be based on the intent-to-treat (ITT) population which consist of all randomized patients who have started study medication. The primary efficacy variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate. The incidence (with corresponding 95% confidence interval) of hypercalcaemia (mild, moderate and severe), laboratory abnormalities, dose adjustments, and significant adverse events will be calculated. The vitamin D status (proportion of patients with P-PTH \<20 ng/l and S-OH(D)2 \>85 nmol/l) at 6 and 12 months will be analyzed using logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* RRMS EDSS 0-5
* Betaferon used for at lest one month with positive MxA-response

Exclusion Criteria:

* hypercalcaemia
* kidney stones
* uncontrolled hypertension
* hypothyreosis
* peanut allergy
* severe depression
* sarcoidosis
* use of other IMD than interferon-beta
Balloon Catheter vs. Basket Catheter for Endoscopic Bile Duct Stone Extraction

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.

A prospective, multi-center, investigator sponsored, randomized controlled trial, 80 subjects will be randomly assigned to groups that were treated with basket or balloon catheters.

A descriptive analysis will be performed on primary endpoint, containing frequency of number and percentage of patients. A two proportion equality test will be conducted to explore whether incidence rates are different.Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, age \> 18 years.
2. BDSs of diameter ≤10mm, which could be extracted using a standard balloon or basket catheter without mechanical lithotripsy, and a common bile duct (CBD) diameter ≤15mm.
3. Signed inform consent form and agreed to follow-up on time

Exclusion Criteria:

1. Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
2. Patients involved in other study within 60 days.
3. biliary stricture
4. Billroth II or Roux-en-Y anatomy
5. Acute pancreatitis.
6. a history of previous ERCP
7. pregnant or breastfeeding women