cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Aquatic Specific Physiotherapy on Incomplete Spinal Cord Injuries

Purpose of the study: To analyse the effectiveness of aquatic physiotherapy on spinal cord injuries (LMi) in the improvement of balance and gait, in the inflammatory profile, and the impact on the quality of life.

Main objective: To analyse if there are differences in the recovery of the balance, in incomplete subacute spinal cord injuries, with lesion level T1-L5 and ASIA (American Spinal Injury Association) C and D .

Secondary objectives:

1. functional gait
2. To evaluate if the time from the injury to the start of the aquatic therapy influences the results on balance and functional gait.
3. To study the effect of aquatic therapy on serum markers of systemic inflammation.
4. Quality of life related to health. Design: Crossed, controlled and randomized clinical trial, with blind evaluation of the response variables.

Scope of the study: National Hospital of Paraplegics. Toledo (Spain). Population: Subjects with incomplete spinal cord injury ASIA C and D. n = 50 (25 in each arm randomly).

Intervention:

6 weeks of specific Aquatic Physiotherapy (3 times a week). Group 1 will perform aquatic physiotherapy at the time of entering the study, and group 2 will perform it 6 weeks later.

Outcomes: Static and dynamic balance (Berg test and Time Up and Go). Speed of the gait (test of 10 m.). Gait resistance (6 min. Test). Functional capacity of the gait (WISCI II). Biomechanical analysis (sensorial-dynamic, rhythmic and directional control, and gait test) by posturography. Questionnaires EuroQol-5Dimensions-5Level (EQ-5D-5L) and the Spanish Version of the Quality of Life Index (SV-QLI) in spinal cord injury (SCI).

Biomarkers of inflammation: 20 cytokines. Analysis of results: The main outcome measure will be the percentage of patients who have improved. Considering improvement when the difference between the groups is, at least, a 10% of their score in the Berg test between V0 and V1 (with their corresponding 95% confidence intervals). It will be adjusted for confounding and interaction factors with a multivariate analysis using logistic regression. All analyses will be performed according to the intention to treat principle.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with incomplete spinal cord injury T1-L5 (ASIA C y D).
* Traumatic and not traumatic injuries, with injury date of less than 8 months.
* Able to maintain assisted standing up
* Subjects signing the informed consent form

Exclusion Criteria:

* Subjects with progressive injuries.
* heart or lung disease
Carnosine Supplementation and Cardiovascular Function

Carnosine is a dipeptide synthesized in the body from β-alanine and L-histidine. It was originally discovered in skeletal muscle where it is present in larger amounts than in other tissues, but it is also found in high concentrations in the brain, heart, and gastrointestinal tissues of humans. Although its physiological role has not been completely understood yet, carnosine is a non-enzymatic free-radical scavenger and a natural antioxidant and has anti-inflammatory and neuroprotective properties.

The hypothesis of this research is that the consumption of carnosine supplements in the form of capsules, as well as chicken meat enriched with carnosine (functional food) has a beneficial effect on vascular reactivity measured in different vascular basins, and the lipid profile with a positive effect on the reduction of oxidative stress and inflammatory response in healthy sedentary people. subjects and active athletes measured in different vascular basins.

The main goal of this study is to investigate the influence of carnosine supplement consumption (in the form of capsules and functional food) on vascular and endothelial function in a population of healthy young subjects and active athletes.


Eligibility Criteria:
Inclusion Criteria:

* young healthy sedentary individuals - did not perform regular physical activities for at least 12 months before conducting the study
* young healthy active athletes - have a minimum of 5 training sessions per week (mainly endurance training) for at least 12 months prior to conducting the study

Exclusion Criteria:

* smoking
* hypertension
* coronary disease
* diabetes
* hyperlipidemia
* kidney damage
* cerebrovascular and peripheral artery diseases
* and any other disease that could have an impact on vascular and endothelial function
Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography

Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile couples. However, the long-term effect of ART exposure on cardiovascular development and potential association with ART procedure and parental factors is confused. The aim is to shed more light on the pattern and extent of cardiovascular developmental alteration among ART children and its association with potential confounders.

A historic cohort study was designed with prospective follow-up of ART children conceived in the Clinical Centre of Reproductive Medicine (CCRM) and born in Maternal-Fetal Medicine Unit (MFMU) of First Affiliated Hospital of Nanjing Medical University (FAHNMU) from 1 January 2002 to 31 December 2012.

The present design is a prospective single-center study in FAHNMU. ART group will be recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children conceived in CCRM and born in MFMU.

The controls will be recruited by a non-random, consecutive sample on the basis of the spontaneous conception population attending the MFMU of FAHNMU during the same period as ART group for prenatal screening and subsequent delivery considering their age.

Eligibility Criteria:
Inclusion Criteria:

* the capability of complete examination of transthoracic echocardiography
* the absence of complex cardiac malformations and systematic diseases.

Exclusion Criteria:

* the presence of a history of systemic diseases, frequent arrhythmias, and critical acquired heart diseases,
* the presence of the background of familiar cardiomyopathy in their family,
* limited acquisitions of echocardiographic imaging
* poor image quality for assessment.
Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the better will be the prognosis. In this context, heart rate variability (HRV) stands out, which is a non-invasive tool representing autonomic modulation, with potential prognostic value. The literature showed there are no changes in HRV at rest using linear methods of analysis, but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and provide additional information to the linear. Objective: to analyze autonomic modulation using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in comparison to typical children. In addition, to correlate HRV analysis between them, also between behavior and severity of the disease. Methods: this study involves both typical children and children with ASD. Autonomic modulation will be performed using nonlinear indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to identify differences between moments and protocols two-way analysis of variance will be used along with the Bonferroni post-test or Dunn post-test according to the data distribution. Statistical significance will be set at 5%.


Eligibility Criteria:
Inclusion Criteria:

* Children with autistic disorder or typical development.

Exclusion Criteria:

* Participants that do not participant of all evaluations.
* Participants with an error superior to 5% in the RR intervals series.
Prevention of Diverticulitis by Taking a Daily Probiotic

There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form of Yakult fermented milk supports a healthy balanced population of "friendly" gut bacteria. This, coupled with evidence from four European trials showing probiotic benefit for recurrent diverticulitis and an understanding of how the disease develops, indicates that LcS may also be beneficial. The investigators plan to undertake a pilot study investigating whether consumption of once daily probiotic LcS as Yakult fermented milk would help either prevent attacks of diverticulitis completely or significantly reduce frequency of attacks. Subjects will be recruited from Surrey primary care units and will be closely monitored for 12 months whilst being supplied with a daily dose of for the full 12 months to see if this improves gut health.

Because dietary fibre, obesity and diabetes are all confounding factors that influence the frequency and severity of attacks of diverticulitis, the research project will take account of this by:

1. Monitoring dietary fibre using a diet diary
2. Measurement of height and weight to determine BMI
3. Screening for undiagnosed diabetes and pre-diabetes

As well as keeping a diet diary, subjects will be asked to keep a general health diary, and to complete gut health questionnaires at start, 6 months and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. A history of two episodes of UAD treated with antibiotics in the last five years.
2. Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery.
3. Agreement to consume one bottle of Yakult daily for 12 months
4. Availability of space in the domestic refrigerator for storage of Yakult units
5. Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult
6. Able to cope with keeping a diary etc.
7. Willing to take Yakult supplies and a cold bag on holiday to ensure as near as possible continuous daily doses (certainly never more than one week break as Lactobacilli casei will persist in the human gut for at least one week
8. Capable of giving informed consent
9. Aged ≥ 50 and ≤ 75 years at commencement of trial.

Exclusion Criteria:

1. Recent history of peptic ulcer
2. Chronic renal insufficiency
3. Ongoing or past major diverticulitis complications
4. Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM)
5. Dementias or memory problems
6. Regular probiotic consumption over the past year.
7. Undergoing immunosuppressive therapy or treatment
8. Lactose intolerance or intolerance to dairy products
9. Immunosuppressed patients
Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer

This is a longitudinal, one arm, prospective phase II study, designed to evaluate the efficacy of Olanzapine Netupitant and Palonosetron in the controll of nausea and vomiting induced by highly emetogenic chemotherapy.

The population of the study is women diagnosed with breast cancer, who will start chemotherapy (Doxorubicine and Cyclophosfamide). We will evaluate the control of nausea and vomiting in the first cycle of chemotherapy, utilizing Netupitant (300mg) + palonosetron (0,56mg) in day 1 and Olanzapine 5mg starting on Day 0, given once a day for five days. The primary endpoint of this study is complete response rate (no nausea, no emesis no use of rescue medication).

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer hitologically confirmed
* 18 Years and older (Adult, Older Adult)
* Patients about to start use of Doxorubicine 60mg/m2 + Cyclophosfamide 600mg/m2
* No previous chemotherapy for breast cancer

Exclusion Criteria:

* Patients not capable of completing the questionnaire
* Patients with other condition that could cause nausea and emesis
* Use of opioids
* Use of antipsychotic medications
* Patients not capable of taking medications orally
Sleep Disorders and Psychophysical Well-being in HIV+ Patients

The primary goal of this observational study is to investigate sleep quality in patients living with HIV+. The secondary objective is to measure the influence of sleep quality on indicators of mental health (anxiety, depression and stress) and quality of life.

The main questions it aims to answer are:

* Measuring the effects of poor sleep quality on mental and physical health in HIV+ patients.
* Monitor the sleep pattern in the HIV+ population.

Participants will fill out an online cross-sectional survey.

The online questionnaire survey will collect:

* sociodemographic and clinical data related to HIV infection,
* sleep quality,
* mental health,
* quality of life.


Eligibility Criteria:
Inclusion Criteria:

* HIV diagnosis.
* Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Ongoing antiretroviral therapy.
* Age \> 18 years.
* Native Italian speaker.
* Informed consent to participate in the study

Exclusion Criteria:

* Absence of an HIV diagnosis.
* Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Absence of ongoing antiretroviral therapy.
* Age \> 18 years.
* Not being a native Italian speaker.
* Refusal to sign informed consent
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify or regulate the functioning of the immune system. It is an FDA approved drug for people with multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL), but it does appear effective in CLL when used alone, and is being studied for use in combination with chemotherapy in this and other lymphomas and leukemias.

In this research study we are hoping to learn more about the effects of lenalidomide on CLL when given in combination with bendamustine and rituximab, which is a highly effective regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest dose of lenalidomide that can be given safely, without causing any serious or unmanageable side effects.

Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4 weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on day 1 of each cycle.

Subjects will receive routine blood tests and physical exam during each cycle. Tumor assessments by CT scan will be performed during cycles 2, 4, and 6.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic leukemia)
* Life expectancy \> 3 months
* Organ and marrow function with protocol parameters
* Able to take aspirin daily

Exclusion Criteria:

* Age \>80 years
* Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
* Pregnant or breast-feeding
* Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent
* Known hypersensitivity to thalidomide or lenalidomide
* Prior use of lenalidomide
* Concurrent use of other anti-cancer agents or treatments
* HIV positive
* Prior history of another malignancy unless disease free for at least 2 years
* Uncontrolled intercurrent illness
The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.

Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline and increased mortality.

Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.

To explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (\>26 versus 18-26 versus 10-17).

Eligibility Criteria:
Inclusion Criteria:

1. Written consent given
2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
3. ASA Physical Score I-III

Exclusion Criteria:

1. Patients with a history of neurological disease, such as Alzheimer disease.
2. Patients with a history of psychiatric disease
3. Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.
4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
5. the Montreal Cognitive Assessment (MoCA) scores below 10
6. Patients who have severe intraoperative adverse events, such as cardiac arrest.
7. Patients with contraindication of tropisetron.
Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer

The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis pancreatic cancer
* inoperable stage II or stage III or IV disease(UICC, 1997)
* Age 18 to 75 years
* Karnofsky Performance status \> 50
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy
* Cerebral metastases
* Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
* Leukocytes \< 4000 or neutrophils \< 2000 or platelets \< 100000 or hemoglobin \< 10 g/dl
* Creatinine value \> upper normal limit
* GOT or GPT \> 2.5 times upper normal limit or bilirubin \> 1.5 times upper normal limit in absence of hepatic metastases
* Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
* Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
* Inability to provide informed consent
* Inability to comply with follow-up.
Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins

The aim of this study is to analyze the effect of a sperm selection method by adhesion to partners' zona pellucida proteins on the assisted reproduction treatment (ART) outcome parameters.

The success rate after treatment by in-vitro fertilisation (IVF) depends on the sperm selection process. Classical sperm selection techniques are based on the spermatozoa morphology and motility, therefore are not able to measure the sperm ability to recognise the oocyte. Furthermore it is known that semen samples showing higher adherence rate to zona pellucida have higher fertilisation potential than spermatozoa that fail to bind to zona proteins.

There have been numerous reports on applying partner' native zona pellucida in sperm selection prior ICSI. However, these studies imply the whole native zona pellucida, while this study will focus on the application of acid-solubilized zonae pellucidae.

Here in this study, the aim is to assess the fertilisation rate, the number and quality of the formed embryos, implantation and ongoing pregnancy success after sperm selection for ICSI by their ability to adhere to immobilized zona pellucida proteins.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for primary or secondary infertility
* Healthy females
* Clinical diagnosis for unexplained infertility
* Females between 20 and 45 years old.
* Males between 20 and 50 years old.
* At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage

Exclusion Criteria:

* Presence of low quality oocytes
* Females with endometrial or ovarian infertility factor
Cystic Fibrosis and Cognitive Function

The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function

A growing body of evidence suggests that hyperglycemia in type 1 and type 2 diabetes is associated with alterations in brain structure and cognitive impairment. People with cystic fibrosis related diabetes (CRFD) are exposed to hyperglycemia as seen in other forms of diabetes, and cystic fibrosis is also associated with chronic systemic inflammation. Both hyperglycemia and chronic inflammation have been postulated to affect brain structure and function. Cystic fibrosis trans-membrane conductance regulator (CFTR). protein is widely expressed in the neurons of the brain including in the hippocampus The hippocampus plays an essential role in learning and memory processing and is thought to be particularly vulnerable to effects of metabolic stressors. The expression of CFTR in neurons has several potential implications for central nervous system function, including cognition.

The long-term goal of this project is to examine the effects of cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) on brain structure and function.

Eligibility Criteria:
Inclusion Criteria:

patients with Cystic fibrosis

Exclusion Criteria:

* History of stroke
* History of epilepsy
* History of neurosurgical procedures
* Past or current history of severe psychiatric illness
* Pass or current history of alcohol or substance abuse
* Presence of metallic substances in body or inability to remove before imaging procedure
* History of claustrophobia or known inability to tolerate MRI
* Current pregnancy
* Inability to consent