bioihbjkbjnl/mcl2 huggingface dataset:
Oxidative Stress and L-CBMN Cytome Assay in Obese After 3 Weeks VLCD
Condition: Obesity; Weight Loss; DNA Damage
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      Obesity leads to physiological imbalance resulting in hyperglycemia, dyslipidaemia and
      inflammation and can generate systematic oxidative stress through multiple biochemical
      mechanisms. Oxidative stress (OS) can induce DNA damage and inhibit DNA repair mechanisms.
      Very low calorie diet (VLCD) have rapid positive effect on weight loss, glucose homeostasis,
      insulin resistance, inflammation and OS. The aim of this study is to determine the effect of
      a three-week VLCD on anthropometric, biochemical and genomic parameters in individuals with
      BMI ≥ 35kg/m2.
    

Detailed description: 
      Obesity is a complex chronic multifactorial disease associated with concomitant or increased
      risk for chronic inflammation, insulin resistance, dyslipidemia, oxidative stress, type 2
      diabetes, cardiovascular disease, stroke and multiple cancer types. Oxidative stress (OS) can
      cause permanent DNA damage which could be detected with lymphocytes cytokinesis-block
      micronucleus (L-CBMN) cytome assay. Weight loss and improvement of dietary habits in people
      with obesity can affect genome stability and have beneficial effects on insulin sensitivity,
      inflammation and OS. Effects of very low calorie diet (VLCD) on DNA damage are scarce. The
      aim of this study is to determine the effect of a three-week VLCD used in Special Hospital
      for extended treatment of Duga Resa in patients with BMI ≥ 35kg/m2 on permanent DNA damage,
      lipid profile, insulin resistance, inflammation and anthropometric parameters.
    

Intervention name(s): Very low calorie diet
Intervention type(s): Device
Intervention description(s): In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Very low calorie diet; Oxidative stress; Micronuclei; apoptosis
Decision-aid on Breast Cancer Screening
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The present study aim to assess the effect of an interactive web decision aid on informed
      choice - measured via knowledge, attitudes and intentions concerning breast cancer screening
      - comparing the decision aid with a standard information provided via web.
    

Detailed description: 
      Breast cancer is the most common cancer in women. In Italy, women are invited to a
      population-based mammography screening programme for the first time at the age of 45 or 50
      years. Results from randomised controlled trials, observational studies, and systematic
      reviews continuously fuel the debate on the balance on benefits (reducing breast cancer
      mortality) and harms (overdiagnosis, overtreatment) of mammography screening. Physicians,
      policy makers, as well as laypeople or patient associations agree on the need to inform women
      about the potential benefits and harms in order to allow an aware decision process. Decision
      aids are an effective way to support lay people in their decisions about health.
    

Intervention name(s): Decision-aid; Standard information
Intervention type(s): Other; Other
Intervention description(s): Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.; Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: breast cancer screening; mammography; decision-aid; informed choice; National Cancer Screening Program
A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma
Condition: Glioblastoma Multiforme; Anaplastic Oligoastrocytoma
MeSH terms: Glioblastoma; Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex
      for production of human IL-12. IL-12 is a protein that can improve the body's natural
      response to disease by enhancing the ability of the immune system to kill tumor cells and may
      interfere with blood flow to the tumor.

      The main purpose of this study is to evaluate the safety and tolerability of a single tumor
      injection of Ad-RTS-hIL-12 given with oral veledimex.
    

Detailed description: 
      Eligible patients will be stratified to one of two groups, according to clinical indication
      for tumor resection. Patients who are scheduled for a standard of care craniotomy and tumor
      resection will receive one dose of veledimex before the resection procedure. Ad-RTS-hIL-12
      will be administered by free-hand injection. Patients will continue on oral veledimex for 14
      days.

      Patients not scheduled for tumor resection will receive Ad-RTS-hIL-12 by stereotactic
      injection and then will continue on oral veledimex for 14 days.

      The study is divided into three periods: the screening period, the treatment period and the
      follow-up period.
    

Intervention name(s): Ad-RTS-hIL-12; veledimex
Intervention type(s): Biological; Drug
Intervention description(s): 2.0 x 10^11 viral particles (vp) per injection or 1.0 x 10^12 viral particles (vp) per injection
one intratumoral injection of Ad-RTS-hIL-12; 4 doses (20mg/day, 40mg/day, 80mg/day, and 120mg/day)
14 oral daily doses of veledimex
1 Expansion cohort at a single dose level at or below MTD
Other intervention name(s): INXN-2001; INXN-1001; Activator Ligand
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine brain penetration of single oral doses of TAK-041
      and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).
    

Detailed description: 
      The drug being tested in this study is called TAK-041. This study will look at brain
      penetration of single oral doses of TAK-041 and its effects on amphetamine-induced dopamine
      release in the CNS.

      The study will enroll participants until 12 evaluable participants complete all study
      procedures. The first 4 participants enrolled in this study will receive a dose of 20 mg
      TAK-041 and 0.50 milligram per kilogram (mg/kg) dose of amphetamine. The dose for subsequent
      participants will be determined based on the results of amphetamine-induced dopamine release
      in the first 4 participants (5 to 40 for TAK-041 and 0.25 or 0.50 mg/kg for the amphetamine).

      This single-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is approximately 92 days. Participants will remain confined to the
      clinic for 3 to 4 days during 2 confinement periods. Participants will make monthly visits
      during Days 8-64 and a final visit 30 days later.
    

Intervention name(s): Amphetamine; TAK -041; [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Amphetamine tablets.; TAK-041 oral suspension.; [11C]PHNO injection.
Intervention MeSH terms: Amphetamine; Naxagolide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Comparing Hall vs Conventional Technique in Placing Preformed Metal Crowns From Sudan
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Preformed metal crowns (PMCs) have high success rates in restoring primary molars in children
      but they were not generally used by dentists, especially in developing countries due to its
      demand of high clinical skills with the conventional technique (CT). The biological approach,
      Hall technique (HT), requires less training and can be placed by less experienced dental
      operators including therapists. Previous studies were mainly carried out in developed
      countries. The aims were to investigate and compare the efficacies and cost-effectiveness of
      PMCs placed by these two techniques.
    

Detailed description: 
      A prospective randomised control trial design was used. The study was carried out in a dental
      practice in Sudan, an under-developed country with lower social economic group. Children
      between 5-8 years were invited and selected if they met the inclusion criteria. Only those
      who had 1-2 carious primary molars needing PMCs were randomised. The PMCs were placed by a
      dentist in the CT arm and by a therapist in the HT arm. The children were follow up every 6
      months up to 2 years. The demographic details, periodontal health, occlusion, children
      anxieties, and procedure time were recorded. The Kaplan-Meier survival rates for each arm
      were calculated. The incremental cost effectiveness ratio (ICER) was calculated using the
      results and the local salaries
    

Intervention name(s): Hall Technique PMC
Intervention type(s): Procedure
Intervention description(s): Hall Technique primary fitted crowns to restore carious primary molars
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Controlled randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics of Levobupivacaine During Continuous Caudal Epidural Analgesia in Newborns
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in
      newborns during the continus caudal epidural analgesia. This type of analgesia is used for
      severly ill newborns. There is a need to lower the opioid doses for this population who is
      undergoing the surgery due to the life threading indication. In some cases it is considered
      to use the epidural analgesia for the sake of the patient.

      The main question is:

      Is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing
      for these patients?

      Is this type of dosing of epidural analgesia safe and effective for newborns?
    


Intervention name(s): Blood draw
Intervention type(s): Diagnostic Test
Intervention description(s): The blood draws in specified time points
Intervention model: Single Group Assignment
Intervention model description: PK study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: C-CELA; newborn; analgesia; epidural; pain
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the effect of
      abnormal liver (hepatic) function on the amount of trial drug getting into the body and
      removal of the drug from the body (this is called pharmacokinetics).

      In this trial the participants will receive three subcutaneous (under the skin) injections of
      the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug
      similar to human growth hormone) intended for once-weekly subcutaneous administration.
    


Intervention name(s): Somapacitan
Intervention type(s): Drug
Intervention description(s): 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the combination of naltrexone SR and
      bupropion SR is safe and effective in the treatment of obesity.
    

Detailed description: 
      Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone
      is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo
      in subjects with uncomplicated obesity. The current study investigated the safety and
      efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese
      subjects with uncomplicated obesity and in those with overweight/obesity and hypertension
      and/or dyslipidemia.
    

Intervention name(s): Naltrexone SR 32 mg/bupropion SR 360 mg/day; Placebo; Ancillary therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
Other intervention name(s): NB32
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity
A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body
Condition: Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer)
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, fixed sequence study in healthy subjects (vasectomized
      males and females of non-childbearing potential), performed at a single study centre.
    

Detailed description: 
      The study will comprise:

        -  A screening period of maximum 21 days;

        -  A fixed sequence of 3 treatment periods: Treatment Period 1: Capivasertib only,
           Treatment Period 2: Itraconazole pre-treatment (run-in) period, and Treatment Period 3:
           Capivasertib and itraconazole in combination.

        -  A Follow-up Visit at 7 to 14 days after the last capivasertib PK sample in Treatment
           Period 3.

      There will be no washout between Treatment Period 2 and Treatment Period 3. Each subject will
      be involved in the study for up to 7 weeks.
    

Intervention name(s): Capivasertib; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subects will be administered single doses of capiversatib on Day 1 and Day 6.; Subjects will be administered itraconazole twice daily on Day 3, followed by once daily doses in the morning for 4 days.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-Drug Interaction; Protein kinase inhibitor; Capivasertib; Itraconazole
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of varying degrees of impaired
      hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after
      a single oral dose.
    


Intervention name(s): ABL001
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; ABL001; Child-Pugh; healthy subjects with normal hepatic function
Bioequivalence Study of Dexlansoprazole Capsules From Two Manufacturing Plants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of dexlansoprazole from a 30
      milligram (mg) or 60 mg delayed-release capsule manufactured at Takeda GmbH Plant
      Oranienburg, Germany (TOB) relative to that of dexlansoprazole from a 30 mg or 60 mg capsule
      manufactured at Takeda Pharmaceutical Company Ltd. (Osaka, Japan) (TPC).
    

Detailed description: 
      The drug being tested in this study is called dexlansoprazole. This study will compare
      bioavailability of dexlansoprazole from 30 mg and 60 mg dexlansoprazole delayed release
      capsules manufactured at TOB relative to the corresponding 30 mg and 60 mg dexlansoprazole
      delayed release capsules manufactured at TPC. The study will enroll approximately 104
      participants. Participants will be randomly assigned (by chance, like flipping a coin) to 1
      of the 4 treatment sequences:

        -  Dexlansoprazole 30 mg TOB followed by Dexlansoprazole 30 mg TPC

        -  Dexlansoprazole 30 mg TPC followed by Dexlansoprazole 30 mg TOB

        -  Dexlansoprazole 60 mg TOB followed by Dexlansoprazole 60 mg TPC

        -  Dexlansoprazole 60 mg TPC followed by Dexlansoprazole 60 mg TOB

      All participants will be asked to take single oral dose of dexlansoprazole at the same time
      on Day 1 of each Period. This single center trial will be conducted in the United States. The
      overall time to participate in this study is 18 days. Participants will visit the clinic on
      Day -1 and remained confined until Day 2 of Period 1 and 2. A washout period of minimum 5
      days will be maintained between the doses in each Period. Participants will be contacted by
      telephone 10 (+/-2) days after the last dose of study drug for a follow-up assessment.
    

Intervention name(s): 30 mg dexlansoprazole capsules manufactured at TOB; 30 mg dexlansoprazole capsules manufactured at TPC; 60 mg dexlansoprazole capsules manufactured at TOB; 60 mg dexlansoprazole capsules manufactured at TPC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.; Dexlansoprazole delayed-release.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
Optical Frequency Domain Imaging (OFDI) for Biliary Stricture Imaging
Condition: Biliary Stricture
MeSH terms: Cholestasis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the potential of comprehensive biliary Optical
      Frequency Domain Imaging (OFDI) for assessing common bile duct or common hepatic duct
      strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing
      cholangitis (PSC).
    

Detailed description: 
      The study will be conducted in approximately 20 patients with known or suspected common bile
      duct or common hepatic duct stricture scheduled for endoscopic retrograde
      cholangiopancreatography (ERCP) with duodenoscope-assisted cholangiopancreatoscopy (DACP) and
      biopsy.

      Following initial fluoroscopic evaluation, the study experimental procedure will begin. The
      catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla
      and into the common bile duct. The extra-biliary portion of the catheter will be visible by
      the duodenoscope at all times. The intrabiliary portion of the catheter will be visible by
      fluoroscopy, and will be positioned across the biliary stricture. Rotational cross-sectional
      images of the bile duct will be obtained using the OFDI imaging catheter while pulling back
      the internal optical components over a pre-determined length. OFDI imaging will be conducted
      approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by
      fluoroscopy.
    

Intervention name(s): MGH Optical Frequency Domain Imaging (OFDI)
Intervention type(s): Device
Intervention description(s): Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Biliary Stricture; OCT; Imaging
Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      It has been shown that patients complaining of gas-related symptoms significantly improve on
      a diet low in fermentable residues. However, other studies suggest that some non-absorbable,
      fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce
      beneficial effects to the host, including improvement of abdominal symptoms. The aim of the
      study is to compare the effects of a diet low in fermentable residues versus a diet
      suplemented with prebiotics on intestinal microbiota composition, microbiota activity
      (intestinal gas production) and digestive symptoms.
    


Intervention name(s): Bimuno Galacto-oligosaccharide 1.37 g/d; Low- FODMAPs diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotic versus low-FODMAPs diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intestinal microbiota; Intestinal gas; Dietary intervention; Low-FODMAPs diet; Prebiotics