bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study carried out at a single site in 88 healthy male subjects and healthy
      female subjects of non childbearing potential to investigate the safety, tolerability,
      pharmacokinetics (PK) and pharmacodynamics (PD) of DNL343.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): DNL343; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single and repeating oral dose(s); Single and repeating oral dose(s)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This study serves to compare the effectiveness of treating cutaneous leishmaniasis with
      either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM
      device.
    

Detailed description: 
      A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and
      diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous
      sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery
      Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care
      for this disease, but the i.v. administration and the many known side effects prompt the
      search for an improved method of treating this disease, especially for milder cases. This
      study compares the safety and efficacy of these two treatment approached.
    

Intervention name(s): Sodium stibogluconate (Pentostam); ThermoMed
Intervention type(s): Drug; Device
Intervention description(s): intravenous 20 mg/kg/day for 10 days; ThermoMed heat treatment device, one treatment
Other intervention name(s): Pentostam; WR 229,870
Intervention MeSH terms: Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Effects of Silymarin on Cisplatin Induced Nephrotoxicity in Upper Gastrointestinal Adenocarcinoma
Condition: Upper GI Cancer; Cisplatin Adverse Reaction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid
      tumours. acute renal failure, despite conservative fluid and electrolyte management,
      frequently reported adverse event and limiting cisplatin use. Silymarin, a flavonolignan
      complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective,
      anticancer and in animal model nephroprotective properties. Neutrophil gelatinase-associated
      lipocalin (NGAL) protein is a promising biomarker to detect acute kidney injury due to
      cisplatin. Milk thistle extract inhibitory effects on epidermal growth factor receptor,
      vascular endothelial growth factor and insulin-like growth factor-I have shown in the
      previous in-vitro studies.The aim of present study,a randomized double-blind placebo-
      controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin
      induced nephrotoxicity and it's impact on chemotherapy. Fifty-eight patients with diagnosed
      upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus
      chemotherapy [cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21
      days] for 63 day after inclusion. serum creatinin, blood urea nitrogen (BUN), serum and urine
      electrolyte will be measured daily during chemotherapy.

      changes in urine NGAL, serum vascular endothelial growth factor (VEGF)and caspase activity
      assessed up to 64 days.
    

Detailed description: 
      This study will look for possible protective effects silymarin on kidney injury in patients
      receiving cisplatin.
    

Intervention name(s): Silymarin; Placebo; chemotherapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Silymarin 420 mg in 3 divided dose plus standard chemotherapy; placebo tablets: 420 mg in 3 divided dose; All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2
Other intervention name(s): Milk thistle; Identical inert tablet to mimic silymarin (140 mg); Cisplatin; fluorouracil; Docetaxel
Intervention MeSH terms: Cisplatin; Docetaxel; Fluorouracil; Silymarin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: cisplatin; nephrotoxicity; antioxidant; urine neutrophil gelatinase-associated lipocalin (NGAL)
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
Condition: Effects of Recruitment Maneuver During Intraoperative and Postoperative Period
Study type: Interventional

Summary: 
      This study is to evaluate effects of recruitment maneuver in patients undergoing robotic
      assisted radical prostatectomy.
    


Intervention name(s): recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only
Intervention type(s): Procedure
Intervention description(s): application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Removing anti nutrient factors using simple cost-effective and sustainable household methods
      to improve nutritional status of children in communities were plant based complementary foods
      are the main source of Nutrients is highly recommended. Therefore, the aim of this study is
      to determine effect of soaking complementary foods on hemoglobin, nutritional and health
      status of children 6-23 months in agrarian community of bale zone.
    

Detailed description: 
      Objectives of the intervention

        -  To determine prevalence and associated factors of nutritional status and anemia among
           children aged 6-23 months in agrarian community of Bale zone

        -  To Explore the complementary feeding practice knowledge perception of mother with
           children aged 6-23 months in agrarian community of Bale zone

        -  To determine effect of soaking complementary foods flour on nutritional status of
           children aged 6-23 months in agrarian community of Bale Zone

        -  To determine effect of soaking complementary foods flour on hemoglobin level of children
           aged 6-23 months in agrarian community of Bale Zone

        -  To determine effect of soaking complementary foods flour on frequency of morbidity of
           children aged 6-23 months in agrarian community of Bale Zone

      Target groups The target groups for the intervention will be mothers with their children aged
      6-23 months in selected Districts of Bale zone and participated in the baseline study.

      Following baseline study, the two districts were assigned to be either an intervention or
      comparison group randomly. While the intervention community received the Nutrition
      counselling on promotion of complementary flour soaking, the comparison community was
      monitored for presence of any other intervention that might have a potential to mask the
      effect of the current intervention in the target. The intervention will be carried out for a
      period of six months.

      End-line data collection included the following major components:

        -  Dietary Diversity practice

        -  Anthropometric measurements

        -  Hemoglobin test
    

Intervention name(s): counselling
Intervention type(s): Other
Intervention description(s): intervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Complementary feeding; soaking Flours; Undernutrition; Anemia
Bioavailability of Blackberry Juice Anthocyanins
Condition: Overweight and Obesity; Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of this study is to evaluate the bioavailability of blackberry juice
      anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.
    

Detailed description: 
      Anthocyanins (ANT), a particular class of flavonoids that can be found in red wine and red
      fruits, have been associated with relevant health benefits. It has become clear that the
      flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but
      metabolites arising from them after absorption. Therefore, it is important to identify which
      ANT metabolites are responsible for their health benefits. Since ANT can prevent/treat some
      of the metabolic features of obesity it is also crucial to study whether ANT bioavailability
      is not compromised in obesity.

      An anthropometric evaluation will allow the classification of subjects according to their
      body mass index (BMI). A complete medical examination including the assessment of clinical
      laboratory parameters will also be performed to characterize the health status of recruited
      subjects.

      Before the beginning of the study, the last fecal sample obtained will be collected. Urine
      samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects.
      Afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol
      (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice
      ingestion. Another urine sample will be collected at 120 min. The first fecal sample obtained
      at least 6 h after juice ingestion will be collected. Blood pressure (0 and 120 min) and
      glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit.

      Ethanol was added to the blackberry juice to mimic the concentration presented in red wine
      (12%).

      A thorough screening analysis for ANT will be performed in plasma and urine samples collected
      from the volunteers at different time points. Fecal samples will also be collected to
      evaluate the relationship between the presence of ANT metabolites and the gut microbiota
      composition.
    

Intervention name(s): Blackberry juice with 12% ethanol; Blackberry juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Flavonoids; Anthocyanins; Blackberry Juice; Bioavailability; Obesity
Study to Assess the Safety and Tolerability of MBF-015 in Healthy Young Volunteers
Condition: Safety and Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomised, double blind, placebo controlled clinical study to
      assess the safety and tolerability of MBF-015 in healthy volunteers.This clinical phase I
      trial is divided in two stages and involves, first, a single ascending dose (SAD) study in
      healthy young male volunteers and then a multiple ascending dose (MAD) study in healthy young
      men and woman. MBF-118 is developed for the treatment of multiple sclerosis.
    

Detailed description: 
      This clinical phase I trial is divided in two stages. The first stage will be a dose
      escalation study without therapeutic benefit, in which MBF-015 will be administered as single
      oral ascending dose to healthy young male volunteers. Up to four different rising doses will
      be tested (4 mg, 8 mg, 16 mg, 32 mg, 64 mg) in groups/cohorts of 8 participants. Thus, five
      groups/cohorts will participate. For each dose level/group, the participants will be
      randomized to active or placebo with 2 participants being randomly assigned to placebo and 6
      to the active drug. First, one volunteer will receive active drug and another one will
      receive placebo (subgroup 1); after at least 72h of safety and tolerability assessment a
      second subgroup of 3 volunteers will receive 2 active drug and 1 placebo; after at least
      another 72h of safety and tolerability parameters assessment, a third subgroup of 3
      volunteers will receive the active drug. After evaluation of safety parameters of
      corresponding dose level, the process will replicate one week afterwards in the following
      dosages.

      The second stage will be a dose escalation study without therapeutic benefit, in which
      MBF-015 will be administered as single oral daily dose, during 5 days to young male and
      female healthy volunteers. Up to four different rising dose levels will be tested (8 mg, 16
      mg, 32 mg, and 64 mg) in cohorts of 8 subjects that are randomised to active treatment and
      placebo (6:2) and divided into three subsequent treatment blocks, as described above in the
      first stage.

      The pharmacokinetics profile of MBF-015 will be also assessed at each dose level tested of
      the Single ascending dose study and the multiple ascending dose study. The 64 mg SAD part
      will also be used to measure the product concentration in cerebrospinal fluid (CSF).
    

Intervention name(s): MBF-015 4 mg oral capsule; MBF-015 16 mg oral capsule; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MBF-015 oral capsules Histone deacetylase inhibitor; MBF-015 oral capsules Histone deacetylase inhibitor; Hard gelatin capsules filled with cellulose microcrystalline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Histone deacetylase inhibitor
The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity
Condition: Gastrointestinal Motility Disorder; Dyspepsia
MeSH terms: Hypersensitivity; Dyspepsia
Study type: Interventional

Summary: 
      Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by
      meal-related symptoms such as early satiation and postprandial fullness. Disturbances of
      gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence,
      motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a
      highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout
      the GI tract, is currently approved for the treatment of chronic constipation. The objective
      of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in
      healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years)
      underwent a barostat and intragastric pressure (IGP) measurements after treatment with
      placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions
      with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and
      scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric
      compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference
      (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a
      nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP
      from baseline during the intragastric infusion of ND until maximal satiation. During all
      tests, epigastric symptoms were scored every 5 minutes.
    


Intervention name(s): Prucalopride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orally administered; Orally administered
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gastric accommodation; gastric sensitivity; gastric compliance; nutrient tolerance
Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Condition: Postoperative Pain Relief
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective
      laparoscopic cholecystectomy under general anesthesia were included in this randomized
      controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group
      patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h).
      Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP,
      postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis,
      respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12
      hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative
      bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.
    


Intervention name(s): Placebo; transdermal therapeutic system- nicotine.; transdermal therapeutic system- melatonin.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.; Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.; Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
Other intervention name(s): TDN, Nicorette® invisi 15mg /16hr.; TDM, melatonin sleep patch from Respro Labs ™ (7 mg/8hr).
Intervention MeSH terms: Melatonin; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Transdermal nicotine; Transdermal melatonin; Postoperative pain; Laparoscopic cholecystectomy
The Effect of Coronal Restoration Type on Satisfaction Patients.
Condition: Quality of Life
Study type: Interventional

Summary: 
      This study aimed to evaluate the impacts of coronal restorations of endodontic treated
      posterior teeth (ETPT) on the satisfaction and quality of patient's life. The patients who
      were chosen for this purpose were asked to fill in 3 questionnaires.Electronic charts and
      files of patients who received endodontic treatment in our faculty between 2018 and 2020 were
      reviewed and chosen. The patients included in the study had been treated by the same
      endodontist and restorative dental specialist. The coronal restoration of the ETPT had to be
      either direct composite restoration (DCR) or indirect ceramic restoration (ICR). When the
      data of patient files and database systems were combined, 76 patients were deemed fit for
      this study. The patients were contacted by phone to request participation in the study. A
      rendezvous was created for the patients who agreed to get involved in the study, and those
      who came to the appointment filled in the questionnaires. Demographics, the semantic
      differential scale, and the OHIP-14 scores provided data that were entered into Minitab 18
      software.
    

Detailed description: 
      This cross-sectional clinical study was approved by the Ethics Committee of the Istanbul Okan
      University and conducted both at its Endodontics and Restorative Departments of Dentistry
      Faculty. A query of the Nucleus database (a patient management software) was performed to
      identify dental charts of patients who received endodontic treatment between December 2018
      and January 2020. We searched only for primary endodontic treatment of vital tooth codes, and
      then selected the same endodontic specialists' patients. A total of 400 teeth were identified
      for screening. Next, a specified restorative dentistry specialist's patient searched within
      these patients, and 150 patients were obtained. The study was completed with 68 participants
      (n=34 each). Then data and radiographs of patients were checked out for the eligibility
      criteria.
    

Intervention name(s): Coronal restoration
Intervention type(s): Procedure
Intervention description(s): A restorative material like composite resin is condensed into the cavity of teeth.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: OHIP-14; Quality of life; Endodontically treated teeth; Composite resin