cyrilzakka/clinical-trials huggingface dataset:
Teneligliptin and Atorvastatin DDI Study

A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adult 19 to 45 years
2. Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening
3. Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
4. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.
Turkish Version of the "Children's Assessment of Participation With Hands Scale

To the best of our knowledge, there is no Turkish validity and reliability scale that can reveal children's hand involvement. In the study in which the CAP-H was developed, it was stated that this scale could be used in population-level research studies to examine the similarities and differences in children's manual life participation among different diagnosis groups. It is very important to adapt translated assessment tools to different cultures and languages and to verify their reliability and validity. Moreover, self-report questionnaires are advantageous in that they can be used for large-scale testing. The aim of this study was to examine the convergent validity and reliability of a Turkish version of the "Children's Assessment of Participation with Hands (CAP-H)" scale in order to evaluate the hand participation of physically disabled children.

The CAP-H scale was used to evaluate children's hand participation and to examine the validity and reliability of the Turkish version. The original scale was developed by Chien et al. in Australia in 2015 to evaluate the difficulties experienced by children aged 2-12 years in using the hands in daily living activities that require hand participation. In the adaptation of the CAP-H to Turkish, the standard protocol of the WHO for the adaptation of the scales to different languages was applied:

1. Translation of the scale into the target language (forward translation)
2. Review of the scale translated into the target language by an expert panel of 2 pediatric rehabilitation physiotherapists, who can speak both languages.
3. Translation of the scale from the target language to the original language (back translation)
4. Testing the translated scale and discussing its conceptual integrity
5. Final version of the adapted scale (final version)

For validity of CAP-H, Gross Motor Function Classification System and Manual Assesment Classification System scales used.

Eligibility Criteria:
Inclusion Criteria:

* voluntary participation in the study,
* having a physical disability report,
* the evaluated child in the age range of 2-12 years, and
* the respondent (child or parent) to be Turkish literate

Exclusion Criteria:

* Do not want to participate in the study
* Not completing surveys
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project

The aim of the MoDiet study is to evaluate the usefulness of the GourMed© prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

The objective of the MoDiet study is to evaluate the usefulness of the GourMed© (MedicAir Food srl, Milano, Italy) prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Eligibility Criteria:
Inclusion Criteria:

* age 65 years and over
* Gugging Swallowing Screen ranging 10-20;

Exclusion Criteria:

* known or suspected intolerance to any ingredient
* taking other prepackaged products for dysphagia
* creatinine ≥1,5 mg/dl
A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM. The study will evaluate increasing doses of OPD5 to find the best dose and to assess any side effects. Each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of OPD5. Each patient will be hospitalized for about 14 days from the OPD5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, between the ages of 18 years and 70 years at the planned time of study treatment; patients greater than 70 years of age may qualify on a case by case basis
* Diagnosis of multiple myeloma
* Received a previous Autologous Stem Cell Transplantation ( ASCT) (single or tandem) that resulted in disease progression within 24 months
* Received at least 2 prior lines of therapy
* Refractory to previous treatment with a Proteasome Inhibitor (PI), an immunomodulatory drug (IMiD) and an anti-Cluster of Differentiation 38 monoclonal antibody (anti-CD38 mAb)
* Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose

Exclusion Criteria:

* Prior treatment with melphalan flufenamide (melflufen) or OPD5
* Any medical condition that may interfere with safety or participation in this study
* Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance
* Prior allogeneic stem cell transplantation or prior salvage ASCT
A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older at the time of the procedure.
* Dye marking attempted/performed using the Ion Endoluminal Platform

Exclusion Criteria:

* Resection not performed following dye marking procedure
Subcutaneous Amifostine Safety Study

Amifostine is a radioprotective drug which is approved by the US FDA for administration prior to each radiation treatment using the intravenous route. The study evaluated the safety of amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting, hypotension, generalized skin rash, and injection-site skin reactions.


Eligibility Criteria:
Inclusion Criteria:

* Institutional criteria for administration of amifostine
* Radiation therapy
* ECOG PS of at least 2
* No distant mets
* Granulocyte count greater than 2000
* Platelet count greater than 100,000
* Creatinine less than 2.0

Exclusion Criteria:

* Allergy to amifostine
* Life expectancy less than 6 mos
* Investigational drug within last 4 weeks
Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil

The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* nulliparous

  _ one fetus
* head first
* spontaneous labor
* epidural analgesia
* no fetal cardiac rhythm abnormalies before the epidural analgesia
* no active management of labor during 30 minutes after the epidural analgesia induction
* at term
* signature of the consent form

Exclusion Criteria:

* pathological pregnancy
* low maternal blood pressure during the 30 minutes after the epidural analgesia
* uterin contraction which last for 5 minutes or more
* more than 6 uterin contractions during a 10 minutes period
* Ropivacaine contraindication
* sufentanil contraindication
Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

This is a single arm, open-labelled study to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. Patients will be started on PO Cinacalcet 25mg OD + PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.

Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months will be determined

Many patients on haemodialysis will develop secondary hyperparathyroidism. Vitamin D analogues such as alphacalcidol are needed to bring their iPTH levels down to normal. However, these analogues can cause hypercalcaemia, thus its doses are limited by this effect. Cinacalcet, which is currently not widely available to patients in hospitals, is a calcimimetic that can reduce both iPTH and serum calcium levels. No studies have yet to be carried out investigating the outcome of using low doses of Cinacalcet as a means of optimizing doses of vitamin D analogues by keeping calcium levels from going over the upper limit. So a single arm, open-labelled study has been designed to determine the effectiveness of combination Cinacalcet with Vitamin D analogue in the treatment of severe hyperparathyroidism in patients with ESRF on haemodialysis. No formal sample size calculation was done as this is a proof of concept study. Power calculation will be done at the end based on the primary outcome of the study.

Methodology: Patients will be started on PO Cinacalcet 25mg OD + PO/IV active Vitamin D analogues adjusted by increments/decrements in steps of 1 mcg 3x per week every 1-4 weeks until the corrected calcium level is within 2.4-2.54 mmol/L. After iPTH has reached 2-9x ULN, patient enters maintenance phase. If serum calcium falls below 2.1mmol/L, active Vit D dose will be increased and if it is above 2.54 mmol/L, the dose will be decreased.

Percentage reduction of iPTH levels from baseline at 6,12 and 24 months treatment and Percentage of patients achieving iPTH levels within the target range of 2-9x upper limit normal at 6, 12 and 24 months will be determined.

Eligibility Criteria:
Inclusion Criteria:1. End Stage Renal Failure (ESRF) patients on haemodialysis with iPTH levels more than 9x upper limit normal 2. Patients who has history of active Vitamin D analogue doses limited by hypercalcaemia (\>2.54 mmol/L)

Exclusion Criteria:

1. Pregnant or breastfeeding or planning to become pregnant
2. Life expectancy of 6 months or less
3. History of decompensated liver disease
Comparison of the Efficacy and Safety Between Pioglitazone and Placebo Added to Combination Therapy in Type 2 Diabetes

The purpose of this trial is to study the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with placebo in patients with type 2 diabetes.

Pioglitazone hydrochloride, a thiazolidinedione compound, is a new therapeutic agent for the treatment of type 2 diabetes that reduces insulin resistance by enhancing insulin action in skeletal muscle, liver, and adipose tissue. In the study of diabetes, pioglitazone reduced the hyperglycemia, hyperinsulinemia, and hypertriglyceridemia characteristic of insulin-resistant states. The metabolic changes induced by pioglitazone result in increased responsiveness of insulin-dependent tissues and are observed in numerous models of insulin resistance.

In the present randomized, double-blind, parallel study, we aim to compare the efficacy and safety of pioglitazone added to combination therapy of sulfonylurea plus metformin with those of sulfonylurea plus metformin for the treatment of type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, Aged \> 25 years and had been diagnosed as type 2 diabetes for at least 3 months before study entry.
2. Subjects have taken sulfonylurea plus metformin therapy for at least 3 months before study entry.
3. Subjects have to take daily Metformin 500\~2000mg tolerable dosages and sulfonylurea (such as the usage dose of glimepiride ≧4mg; dose of Gliclazide≧160mg; dose of Glipizide ≧20mg; dose of glyburide≧4mg) for at least 1 months.
4. Those subjects with HbA1C historical levels between 7.0% and 11.0% within 3 month prior to study entry.
5. BMI between 20-35 kg /m2.
6. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document.
7. Subjects have been under stable diet control for at least 1 month before study entry.
8. Subjects are willing to stick to current diet and sulfonylurea plus metformin treatment plan during this trial.

Exclusion Criteria:

1. Pregnant women or lactating mothers.
2. Type 1 DM(IDDM), or diabetes caused by pancreas damage、secondary forms of diabetes, i.e., Cushing's syndrome or acromegaly.
3. A history of acute metabolic complication within 3 months before study entry, i.e., ketoacidosis or hyperosmolar state (coma).
4. There are significant macrovascular complications (i.e. unstable angina or acute myocardial infarction) or renal impairment (serum creatinine higher than 1.5 mg/dL).
5. Have a known allergy to pioglitazone.
6. Other medications can be taken if their use had been instituted before study entry, but agents that can interfere with study evaluations, including other oral antidiabetic agents and corticosteroids, were not allowed.
Effects of Chronic Right Ventricular Pacing in Children With Advanced Atrioventricular Block

Recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. The occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (AVB) are still unknown.

Thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced AVB and its impact on clinical, functional and echocardiographic parameters.

This is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced AVB.

The design of the study will involve the following stages:

1. Screening and enrollment: patients will be selected consecutively during ambulatory care at our Institution or by the database of the Surgical Unity of Cardiac Pacing;
2. Clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (SF-36, CHQ-PF50) and six-minute walk test;
3. Evaluation of ventricular function and cardiac synchronicity: Tissue Doppler (TDI) and real-time three-dimensional echocardiography (RT3DE);
4. Follow-up: patients will be monitored during 24 months.

The main end-points are:

* Clinical and functional changes (NYHA functional class)
* Heart failure hospitalization
* Quality of life
* Overall and cardiac mortality
* Cardiac resynchronization therapy and heart transplantation

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years at initial pacemaker implantation
* Advanced AV block with /without congenital heart defects
* Time under cardiac pacing superior than one year
* Unicameral or atrioventricular pacing in single right ventricle site
* Informed consent of the patient or responsible

Exclusion Criteria:

* Bifocal or biventricular pacing
* Discontinuing use of the device for recovery of atrioventricular conduction
* Cardiac transplantation
* Inability to participate in the study procedures
Effects of Caffeine on Sleep-wake Regulation in Teenagers

The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported habitual caffeine consumption: min. 80 mg per month until max 300 mg per week as estimated from mean caffeine content per serving of caffeine containing beverages and food
* Body-Mass-Index: 16.2-25.4
* Informed Consent as documented by signature of participant
* Informed Consent as documented by signature of legal representative

Exclusion Criteria:

* Previous enrollment into the current study
* Investigators' family members, employees or other dependent persons
* Left-handedness
* No normal current health as based on questionnaires, screenings of urine, and examination by the physician in charge
* Drug use: Volunteers must be drug-free for the entire duration of the study, with no history of drug or alcohol dependency.
* Participation in other clinical trials \<3 months prior to study begin
* Shift work \<3 months prior to study begin
* Transmeridian travel (\>2 time zones) \<1 month prior to study begin
* Extreme Chronotype (Munich Chronotype Questionnaire \[17\], MCTQ \<2 or \>7)
* Short or long sleep duration: subjective sleep duration during schooldays not between 6-10 h (based on MCTQ)
* Inability to follow procedures
* Insufficient knowledge of project language (German)
* Circumstances endangering MRI safety
* Non-compliance with sleep/wake times during ambulatory part (deviation of more than ±1.5 hour from scheduled times)
Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.

At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.

Eligibility Criteria:
Inclusion Criteria:

* Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
* Age: 18\~90 years old;
* Underwent diagnostic and therapeutic ERCP;

Exclusion Criteria:

* Coagulation dysfunction(INR\>1.3) or/and low peripheral blood platelet count （PLT \<50x10\^9/L）;
* Preoperative acute cholangitis;
* Preoperative acute pancreatitis;
* Preoperative hemobilia or hemorrhage of digestive tract;
* Preoperative liver failure;
* Combined with Mirizzi syndrome and intrahepatic bile duct stones;
* Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma;
* Biliary-duodenal fistula confirmed during ERCP;
* A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;
* Previous ERCP;
* Pregnant women
Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery

The purpose of this study is to determine the validity of the Human Activity Profile and Godin self-report questionnaires of physical activity in persons seeking metabolic surgery.

This cross-sectional study will collect subject's medical history, anthropometric measurements, physical activity data through an accelerometer worn on the wrist and indirect physical activity measures via the Human Activity Profile and Godin self-report questionnaires. We will collect clinical information from the medical record including predictors of physical activity level in obesity such as nutritional lab and co-morbid conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age \>19
* BMI \> 30
* Able to speak and understand English
* Consent to provide access to medical records for medical history
* Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine
* Consent to wear an activity tracker device for 7 days after designated visits.

Exclusion Criteria:

• Age \< 19
A Predictive Model for Recurrent Acute Pancreatitis

The goal of this observational study is to learn about recurrent acute pancreatitis (RAP) .The main questions it aims to answer are:

1. What are the risk factors for RAP?
2. How to predict RAP?

All patients with acute pancreatitis will be given standardized treatment for the condition.

The researchers will compare the RAP group with the non-RAP group to find the risk factors for RAP.

Investigators retrospectively collected data from the Medical Information Mart for Intensive Care-IV (MIMIC-IV) database and from patients with acute pancreatitis (AP) in the Department of Gastroenterology of Clinical Medical College of Yangzhou University between January 2016 and December 2017, forming the primary and validation cohort, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria of acute pancreatitis (AP)
* Age ≥18 years
* Systematic examination and diagnostic information were available after admission

Exclusion Criteria:

* Not the first episode of AP
* The duration of hospital stay was less than 24 hours
* Died within the first episode of AP
* A history of chronic pancreatitis or tumor
* Pregnancy