cyrilzakka/clinical-trials huggingface dataset:
Safety, Pharmacokinetics and Efficacy Study of MP-214 in Patients With Schizophrenia

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of 3 fixed doses of MP-214 orally administered once daily to patients with schizophrenia. MP-214 tablets will be administered to patients starting at an initial dose, followed by up-titration to a fixed dose (low, medium or high) for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Patients meeting DSM-IV-TR criteria for schizophrenia
* PANSS total score \<= 120 during the observation period
* Patients who have been treated with oral antipsychotics within 4 weeks before informed consent
* Patients whose consent is obtained from themselves in written form

Exclusion Criteria:

* Patients who have defined as any mental disorder other than "Schizophrenia" based on the criteria of DSM-IV-TR
* History of drug or alcohol abuse
* Concurrent Parkinson's disease
* History of, or concurrent spastic disorders like epilepsy, cerebrovascular disease, anuresis or adynamic(= paralytic) ileus, malignant syndrome, diabetes, hepatic disorder
* Patients who exhibit abnormalities on Physical Examination, have abnormal vital signs, ECG, or clinical laboratory values
* Current cataract during the observation period
* History of shock or anaphylactoid symptoms to drugs

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms

Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo.

Internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. Four rings that were prepared from each specimen were allowed to reach equilibrium with physiological Krebs solution prior to precontraction with U46619. Using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean EC50 calculated for each patient.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo coronary artery bypass graft operation

Exclusion Criteria:

* Chronic treatment with corticosteroids
The Efficacy of Symbiotic on Cytokines

The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.

Inclusion criteria:

1. Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
2. Neonates who tolerated minimal enteral feeding within postnatal first week

Exclusion criteria:

1. PROM\> 24 hours and/or chorioamnionitis
2. Mechanic ventilation supply more than 7 days
3. Culture proven sepsis
4. Major congenital anomaly
5. Patients undergoing surgery

Intervention:

The allocations will contain in opaque, sequentially numbered sealed envelopes. The study group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will be analysed by ELISA multiplex method.

Eligibility Criteria:
Inclusion Criteria:

1. Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
2. Neonates who tolerated minimal enteral feeding during first week of life

Exclusion Criteria:

1. PROM\> 24 hour and/or chorioamnionitis
2. Mechanical ventilation supply more than 7 days
3. Culture proven sepsis
4. Major congenital anomaly
5. Neonates undergoing surgery
The Role of Perirenal Fat As Predictor in Diabetic Nephropathy

1 detect the relationship between perirenal fat thickness (PrFT) and estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes (T2DM).

2)Explored the relationship between PRF thickness and the onset and progression of albuminuria in patients with diabetes 3)Evaluate associations between obesity-related markers with albuminuria and advanced kidney disease in patients with type 2 diabetes mellitus (DM)

Diabetic kidney disease (DKD) is the most frequent and severe complication of diabetes mellitus (DM). Approximately 40% of patients with diabetes present with proteinuria and renal dysfunction and DKD reportedly account for 50% of newly diagnosed end-stage renal disease (ESRD) . Metabolic disorders caused by hyperglycemia in DKD can lead to both glucose and lipid metabolism disorders. Not only hyperglycemia, many factors including obesity have been reported to be risk factors for diabetic kidney disease .

Body mass index (BMI) and waist circumference (WC), widely used as obesity indexes, have been proved to aggravate the development of CKD in different subsets of patients , but BMI and WC lack detailed information about the distribution of body fat. Body fat is now usually divided into subcutaneous fat and visceral fat according to the anatomical and physiological functions of fat deposition . Visceral fat has been thought to be associated with the progression of CKD .

Recently, new anthropometric and imaging methods have been used to assess visceral fat in clinical practice and research. Perirenal fat is a fat pad surrounding the kidneys, located between the renal fibrous membrane and the renal fascia in the retroperitoneal space .PRF has been reported to be associated with renal disease in various ways.Additionally, it has been proved that renal sinus fat was associated with an increased risk of CKD in general subjects through inflammatory signaling

Eligibility Criteria:
Inclusion Criteria:

- Patients with T2DM aged 18-70 were included in this study. T2DM was diagnosed according to American Diabetes Association (ADA) ,Data collection will obtained over one year from October 2024 to October 2025.

Clinical diagnosis of Alzheimer's Disease Must be able to swallow tablets

Exclusion Criteria:

* b. Exclusion criteria:

  1. patients with a history of malignancy and surgical trauma.
  2. patients diagnosed with nondiabetic renal diseases
  3. Patients with renal replacement therapy (renal transplant or dialysis patients), renal morphological abnormalities (difference in kidney length between the two cm, solitary kidney or multiple kidneys, congenital kidney abnormalities, polycystic kidney, and hydronephrosis), liver cirrhosis.
  4. Insulin dependent diabetes
  5. Thyroid disease
Cannabidiol: a Novel Intervention for Cannabis Use Problems?

The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 16 and 60 years old.
* Meet DSM-5 criteria for moderate cannabis use disorder (≥4 DSM-5 criteria)
* Express desire to quit using cannabis within the next four weeks,
* Have ≥1 previous failed quit attempt.
* Smoke tobacco with cannabis,
* Test positive for recent cannabis use according to urine analysis,
* Vital signs within healthy limits and have capacity to give consent

Exclusion Criteria:

* Not willing to use effective contraception from when consent is taken to 6 weeks after treatment has stopped
* Positive pregnancy test or breastfeeding
* Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients
* \>twice/month use of other illicit drugs
* Outside normal Body Mass Index (BMI)
* A physical health problem deemed clinically significant
* The use of current prescribed psychotropic drugs
* Current or prior self-reported diagnosis of a psychotic disorder
* Non-English speakers due to verbal assessments.
Child Healthcare at MATER - Pediatric Study

The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

This is a single-site cluster randomized controlled trial. Over an 18-month period, 108 pregnant women receiving treatment for opioid use disorder will be identified, screened, and enrolled into the study. Beginning with the birthdate of the first infant born in the study, 18 consecutive 1-month birth intervals will be randomized in a 1:1 ratio to one of two study arms: (1) group well child care or (2) individual well child care. Nine birth clusters will be randomized to individual well child care(control arm) and nine birth clusters will be randomized to group well child care(intervention arm), with concealment of randomization from enrolled participants until they give birth. All study participants will be included in the study until their child is approximately 18 months of age. All study participants will have a total of 5 assessment visits with research personnel; visits will occur immediately following enrollment into the study (baseline), prior to the participant's child turning 1 month of age, and within 4 weeks of the participant's child turning 6, 12, and 18 months of age. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* at least 28 weeks pregnant or less than 2 weeks postpartum
* receiving treatment for opioid use disorder
* ability to read and speak English
* plans to parent infant after delivery
* intent to seek pediatric care within Nemours/Thomas Jefferson University system
* intent to remain in the Philadelphia area for the next 2 years

Exclusion Criteria:

* inability to speak English
* plans to move outside of the Philadelphia area in the next 2 years
* plans to not parent infant after delivery
* plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System

Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.
Efficacy and Safety Between Different Dilution of Insulin

Hyperglycemia associated with insulin resistance is common in critically ill patients, even in those nondiabetic patients. Hyperglycaemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death. Tight glycaemic control in adult long-stay critically ill patients using intensive insulin therapy reduces absolute mortality. It has been reported that pronounced hyperglycemia may lead to complications in such patients, although data from controlled trials are lacking. However, target glycaemia may be difficult to achieve in clinical practice. Insulin adsorption onto infusion equipment (e.g., infusion tubing) may affect glucose control, possibly leading to hyperglycemia. In the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80% of insulin in dilute physiological saline solution.

Problem statement \& Study rationale

Up to my knowledge, there is no study that demonstrate differences between types of dilution for insulin infusion in ICU patient in Malaysia; thus, this study is aimed to evaluate it. In 2001 it has been reported that intensive insulin therapy (IIT) in surgical intensive care unit (ICU) patients was associated with reduction in mortality and morbidity as well as other associated factors. There is limited study in comparing dilution of insulin in normal saline and other types of diluents.

Other than that, it is important to know which diluent the best is to choose for the management of hyperglycaemia in ICU patient.


Eligibility Criteria:
Inclusion Criteria:

1. Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.
2. Adult patient 18 years old and above.
3. 2 consecutive blood sugar more than 10 mmol/L including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state.
4. Within 12 hours from admission.
5. Patient not in high inotropic support and with APACHE II score less than 17.

Exclusion Criteria:

1. Pregnancy.
2. History of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives)
3. Post cardiac arrest or prolonged resuscitation.
4. Patient with cardiogenic shock.
Metabolic and Infectious Complications Post Belatacept Conversion

The BELASWITCH study is a prospective single-centre study including all kidney transplant patients for whom a conversion from Tacrolimus to Belatacept has been decided by the transplant clinicians of the Grenoble Alpes University Hospital.

Each patient will be included at the time of conversion (patients stable on Tacrolimus for at least 6 months) and will be their own control 1 year after conversion to Belatacept.

The study has two components:

* A "Metabolic" benefit arm: the investigators assume that conversion from Tacrolimus to Belatacept reduces the risk of diabetes by reducing the level of insulin resistance.
* An "Infectious" risk arm: measurement of the viral load of Torque Teno Virus to assess the state of immunosuppression of patients. In this sense, the investigators hypothesise that it could serve as a biomarker of immunodepression in this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have had a kidney transplant more than 6 months ago.
* Whose immunosuppression includes stable Tacrolimus (change in dose or dosage form allowed) for at least 3 months.
* Therapeutic plan to change Tacrolimus-based immunosuppression to Belatacept
* Having signed the consent of collection CRB04 - Nephrology Collection (last authorization number: AC-2019-3627) and the BELASWITCH protocol consent.

Exclusion Criteria:

* Subjects under guardianship or deprived of liberty
* Patients who object to the use of their data and/or samples in the research
* Patients having received an immunosuppressive treatment different from the standard one (Tacrolimus, mycophenolate mofetil or Everolimus, corticosteroids)
* ABO and/or HLA incompatible kidney transplantation
Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers

In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure environments. They have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders.

Throughout the SARS-CoV-2 pandemic, many HCWs have worked in high-pressure environments. Moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to challenges in the delivery of high-quality care, possibly due to a lack of experience or equipment, or as a result of low staffing levels. These unfavorable circumstances and exposure risk to infection are likely to increase the risk of mental health disorders such as post-traumatic stress disorder (PTSD) or depression, other anxiety disorders, substance misuse and suicide In the present study, This study aimed to assess the psychological state of HCWs who were facing challenges of SARS-CoV-2pandemic comparing them to non medical staff group based on use of the Hamilton Anxiety and Depression Rating Scale.

Eligibility Criteria:
Inclusion Criteria:

* All health workers team

Exclusion Criteria:

* no exclusion criteria
Three Different Oral Hygiene Regimes on Three Volatile Sulfur Compounds

The purpose of the study is to evaluate the effect of various oral hygiene regimes on three volatile sulfur compounds.

Thirty male monk volunteers who matched with the including criteria were divided randomly into two groups. Both groups were practiced to brush their teeth with scrubbing method for one week. Then, each group were instructed to do different additional protocol regimen- group A have to do mouth washing and tooth brushing and group B have to practice tongue cleaning addition to tooth brushing for three weeks. At the fifth week, both groups were instructed to practice tooth brushing, mouth washing and tongue cleaning. Three different volatile sulfur compounds were measured by oral chroma. Tongue characteristics, oral examination were checked as the outcomes of this study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral malodor
* No systemic diseases and no severe dental diseases
* At least 20 functional teeth

Exclusion Criteria:

* Risky oral habit (smoking and betel quid chewing)
* Current use of antibiotics or any drugs
* Current use of any kind of mouthwash
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications

Exclusion Criteria:

Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants
Early Response Evaluation in NSCLC Patients Treated With Immunotherapy

A pilot study with biomarker exploration.50 patients with stage IV non-small cell lung cancer (NSCLC) that are eligible for treatment with nivolumab. Patients will undergo a 18F-FDG-PET/CT and EBUS-FNA of the lymph nodes and have blood drawn before and after immune checkpoint inhibitor treatment to compare tumor FDG uptake and to identify changes in the immune effector cell subsets in TDLNs. Blood will be drawn in parallel to compare the distribution of immune effector cell subsets before and after treatment initiation. Because of the possible burden for patients, the EBUS-FNA is not mandatory to complete the study and is there for an exploratory objective. Also blood will be drawn for a tumor mutational burden at baseline. The first six patients will undergo a dynamic PET-CT scan in addition to a static scan to study the influence of possible immunotherapy induced changes to the body distribution and kinetics of FDG..

Early response evaluation with 18F-FDG PET/CT and immunological profiling of circulating immune cells and tumor-draining lymph nodes in non-small cell lung cancer patients treated with immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* willing and able to provide written informed consent for the study.
* ≥ 18 years of age on day of signing informed consent.
* confirmed diagnosis of NSCLC.
* Histological tumor biopsy for PD-L1 IHC assessment (DAKO assay) available.
* Ipsilateral hilar or mediastinal lymph node with a short axis diameter ≥1 cm.
* Eligible and planned to receive nivolumab according to EMA label and national guidelines.
* Measurable disease according to RECIST v1.1.
* WHO performance status of 0-2.

Exclusion Criteria:

* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to baseline PET-scan.
* Has an active infection or had an active infection within 2 weeks prior to baseline PET-scan.
* Has a known history of hypersensitivity to contrast material.
* Isolated distant relapse after curative intent treatment for stage I-III NSCLC.