bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of SHR-1819 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, single dose escalation
      phase 1 study.
    

Detailed description: 
      This is a single center, randomized, double-blind, placebo-controlled, single dose escalation
      phase 1 study. The objective of this study is to evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy
      subjects.
    

Intervention name(s): SHR-1819; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1819 will be subcutaneously administered with different dose levels; Placebo will be subcutaneously administered with different dose levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Analysis of Two Toric Intraocular Lenses
Condition: Cataract; IOL
MeSH terms: Cataract
Study type: Observational

Summary: 
      Purpose: Comparison of two torical intraocular lenses with differents haptic design in
      patients with cataract.

      Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent
      phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the
      AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after
      surgery visual acuity, rotation stability and astigmatism correction were evaluated.
    


Intervention name(s): intraocular lenses
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with cataract on both eyes.
      
Keywords: toric IOL
Evaluation of Age- and Alzheimer's Disease-Related Memory Disorder
Condition: Alzheimer Disease; Dementia; Memory Disorder; Healthy
MeSH terms: Alzheimer Disease; Dementia; Memory Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine how a part of the brain called the hippocampus
      contributes to memory changes that occur with aging and Alzheimer's disease (AD).

      Memory problems are the most important early symptoms of AD. The hippocampal region of the
      brain may be responsible for many age- and AD-related memory disorders. This study will use
      magnetic resonance imaging (MRI) scans to examine the structure, chemical composition, and
      function of the hippocampus in participants with AD, participants with mild memory problems,
      participants who are healthy but are at risk for AD, and healthy volunteers.

      Participants in this study will undergo MRI scans of the brain. During the MRI, participants
      will perform memory tests to demonstrate hippocampal functioning.
    

Detailed description: 
      The major focus of the Geriatric Psychiatry Branch (GPB) is the study of individuals with
      memory disorders as a result of age or neurodegeneration. In particular, memory is the most
      important earliest clinical symptom of Alzheimer's disease (AD). Although the hippocampus may
      not be a biological determinant of all memories, there is a growing body of evidence
      suggesting that dysfunction of the hippocampus plays an important role in the most common
      forms of memory disorders. This proposal will allow for the application of an array of newly
      developed magnetic resonance imaging and spectroscopy methods to the study of hippocampal
      function in these patients. Most importantly, for the first time, structure, perfusion and
      neurochemical composition of the hippocampus in living individuals can be evaluated at high
      resolution without known risk. The study of longitudinal changes in hippocampal function
      should allow us to understand the contributions that various genotypes, e.g., ApoE4, and
      abnormalities in cerebrospinal fluid, e.g., A-beta42 and tau, play in the development of
      abnormal hippocampal structure and function.
    

Keywords: Alzheimer's Disease; Spectroscopy; Longitudinal; Perfusion; Hippocampus; N-acetylaspartic Acid; Cerebral Blood Flow; Aging; Dementia; Alzheimer's; Memory Disorder; Memory; Healthy Volunteer; HV; Normal Control
The Effects of Vibration and Pressure Interventions
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aimed to evaluate two methods (pressure and vibration intervention) used to reduce
      pain during IM injections in children.
    

Detailed description: 
      Objectives: This study was conducted to evaluate the effects of the Vibration and Pressure
      Intervention for reducing pain during intramuscular (IM) injections in children.

      Design: The study was conducted via a randomized controlled design. Setting: The study
      population consisted of children in the five to 10 age group admitted to the emergency
      department of a public hospital (Samsun Education and Research Hospital) between August 2022
      and October 2022 and who received an IM injection as part of the medical treatment in child
      emergency department.

      Interventions: The study data were collected from the children, who were divided into
      Vibration Intervention group, Pressure Intervention group, and control groups.

      Main outcome measures: The children's pre-procedure fear and anxiety levels were evaluated
      using the Children's Fear Scale (CFS), and Children' Anxiety Meter State. Then, their pain
      levels during the procedure were evaluated using the Wong-Baker FACES Rating Scale.
    

Intervention name(s): The Vibration Intervention; The Pressure Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The vibration frequency of the massager, which accelerates blood circulation, is 6000 / min, it works with a 1.5 volt battery. Can be used easily with one hand. The vibration simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.; Pressure was placed in the ıntramuscular area properly 30 seconds before injection. Then the injection process was completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, and experimental design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: anxiety; fear; pain
Sutured Versus Cyanoacrylate Glue Mesh Fixation for Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Because it avoids direct nerve irritation or entrapment, mesh fixation with tissue adhesive
      glue seems an optimal option to reduce postoperative pain. Indeed, preliminary results
      published with different glues all showed promising results with reduced postoperative pain.

      This randomized controlled study aimed to compare mesh fixation using N-butyl 2-cyanoacrylate
      with classical suture fixation in Lichtenstein hernia repair in terms of chronic groin pain,
      postoperative complications, operative time and recurrence.
    


Intervention name(s): Cyanoacryale; Suture
Intervention type(s): Procedure; Procedure
Intervention description(s): mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue; mesh fixation was done with polypropylene 2/0 sutures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Blood-borne Infection Screening in an Afghan Antenatal Population
Condition: Viral Hepatitis B; Contraception; Breast Feeding, Exclusive; Effects of; Lack of Care of Infants
MeSH terms: Hepatitis B
Study type: Interventional

Summary: 
      Baseline information indicates there are measurable levels of hepatitis B SAg and low
      utilization of postpartum contraception, correct breastfeeding practices, or adherence to
      infant vaccination schedules in Kabul, Afghanistan. This intervention will randomize
      hospitals to assess the following aims:

      Aim 1: To determine whether the re-training and assignment of health care providers dedicated
      to intrapartum rapid testing and post-partum counseling will positively impact maternal and
      neonatal health indicators as compared to utilization of existing health providers for these
      services among women delivering in publish health maternity hospitals in Kabul, Afghanistan.

      Aim 2: To assess whether patients randomized to the intervention and their spouses perceive
      value in concentrated post-partum counseling.

      Aim 3: To investigate whether an intervention providing immediate post-partum provision of a
      long-acting family planning method would be feasible and acceptable to both men and women in
      Kabul, Afghanistan.
    

Detailed description: 
      Outcomes are assessed through questionnaire responses and inspection of vaccination cards at
      six month intervals by trained study staff through one year total study time. Differences
      between groups will be assessed with generalized linear mixed modeling. Information obtained
      to address Aim 3 will be gathered at the 12 month follow-up and analyzed with simple
      proportions and Chi-square test to assess differences between sexes and other socioeconomic
      indicators.
    

Intervention name(s): Concentrated postpartum counseling
Intervention type(s): Behavioral
Intervention description(s): Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Clofarabine and Ara-C for the Treatment of Relapsed AML and Untreated MDS
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndromes; Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to to determine the safety and effectiveness of therapeutic
      combination - Clofarabine and Cytarabine for the treatment of AML and MDS.
    

Detailed description: 
      Previous studies of Clofarabine and Cytarabine combination treatment in adult AML and MDS
      patients showed promising results.

      This study is done to confirm the findings from previous studies. Primary objective is to
      determine the overall response rate (complete response [CR] plus partial response [PR]);
      secondary objective of this study is to characterize and quantify the toxicity profile
      associated with clofarabine plus cytarabine treatment.

      A maximum of 35 patients will be treated on this study. They will receive 5 consecutive days
      of clofarabine intra venous infusion (IVI) followed 4 hours later by cytarabine IVI.Patients
      will receive up to a maximum of 4 cycles of study treatment. Next cycle will start
      approximately 4 weeks after Day 1 of previous cycle.No other investigational or commercial
      agents including chemotherapy, radiotherapy, or immunotherapy may be administered to patients
      enrolled in this study with the intention of treating the underlying malignancy

      Patients will remain on study, and be monitored until 4 months have elapsed from the
      beginning date of their last cycle of treatment.
    

Intervention name(s): Clofarabine and Cytarabine
Intervention type(s): Drug
Intervention description(s): Phase II Trial of Clofarabine and Cytarabine in Relapsed Standard-Risk AML and Untreated High-Risk MDS in Adult Patients, and Untreated AML in selected Elderly Patients at high risk of anthracycline toxicity
Other intervention name(s): Clofarabine: CAFdA; Cl-F-ara-A; Cytarabine: Ara-C
Intervention MeSH terms: Cytarabine; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; MDS; CML; Relapsed; Refractory; Chemo treatment; Clofarabine; Cytarabine; standard or poor cytogenetic risk AML; untreated high-risk (>10% blasts) MDS; CML in accelerated phase or blast crisis; Elderly AML patients with risk of anthracycline toxicity
The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor)
      in the adverse vascular effects demonstrated after exposure to air pollution
    

Detailed description: 
      Air pollution is a major problem, and can be linked to around 5% of all deaths worldwide each
      year. There are strong associations between air pollution exposure and heart disease but we
      do not yet understand how these harmful effects are mediated. Understanding this mechanism is
      likely to have a major impact on the way we treat patients with heart disease and have the
      potential to shape future environmental health policy. The upregulation of Endothelin-1
      provides a plausible mechanism for these harmful effects, and we plan to investigate this in
      more depth in the human forearm following exposure to diesel exhaust.
    

Intervention name(s): Endothelin-1; BQ-123 and BQ-788
Intervention type(s): Drug; Drug
Intervention description(s): Intra-arterial infusion of Endothelin-1 at 5pmol/min for 1 hour during venous occlusion plethysmography; 1 hour intra-arterial infusion of BQ-123 at 10nmol/min followed by co-infusion of BQ-788 at 1nmol/min for a further hour during forearm venous occlusion plethysmography
Other intervention name(s): ET-1; American Peptides - 88-1-10 (ET-1); American Peptides - 88-2-10 (BQ-123); American Peptides - 88-2-55 (BQ-788)
Intervention MeSH terms: cyclo(Trp-Asp-Pro-Val-Leu); BQ 788
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Endothelin; Air pollution; Diesel exhaust; Vascular function; exposure
A Study to Investigate the Effect of Food on the Pharmacokinetics of HSG4112
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Study Objective: The objective of this clinical trial is to investigate the effect of
           food on the pharmacokinetics of HSG4112 after oral administration in healthy male
           subjects.

        2. Study Design and Plan: This study is a randomized, open-label, single dose, 3-way
           crossover clinical trial. A unique randomization number will be assigned to each subject
           deemed eligible to participate in the study based on the inclusion/exclusion criteria. A
           total of 12 subjects will be randomized to 6 different sequence groups. Each subject
           will receive a single dose of HSG4112 480 mg via oral administration under fasted,
           low-fat diet, and high-fat diet conditions, with a washout period of 21 days in between
           each dosing.
    


Intervention name(s): HSG4112
Intervention type(s): Drug
Intervention description(s): Once-daily oral administration
Other intervention name(s): 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics
Condition: Cerebral Blood Flow; Cognitive Function
Study type: Interventional

Summary: 
      DHA has previously been shown to increase regional cerebral blood flow response to tactile
      stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be
      demonstrated. Given that the brain relies on a constant supply of blood-borne metabolic
      substrates (e.g. glucose, oxygen), increasing regional cerebral blood flow may also have an
      impact on cognitive function. The current study aims to investigate the effects of two doses
      of DHA-rich fish oil on task-related cerebral hemodynamic response and cognitive performance
      in healthy adults.
    


Intervention name(s): DHA-rich fish oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Either 1 g or 2 g DHA-rich fish oil taken daily for 12 weeks. Participants in the 1 g group will also consume 1 g olive oil placebo capsules per day to maintain double blind.; 2 g placebo (olive oil) taken daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebral blood flow; NIRS; n-3 PUFAs; fish oil; cognitive function
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the
      Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve
      Subjects with Chronic Hepatitis C Virus Infection.
    


Intervention name(s): GS-6620; GS-6620; GS-6620; GS-6620; GS-6620; GS-6620; GS-6620 tablet, 450 mg BID; GS-6620 tablet; GS-6620 tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GS-6620 tablet, 50 mg QD; GS-6620 tablet, 100 mg QD; GS-6620 tablet, 300 mg QD; GS-6620 tablet, 100 mg QD, Fasted; GS-6620 tablet, 300 mg QD, Fasted; GS-6620 tablet, 900 mg QD, Fasted; GS-6620 tablet, 450 mg BID; GS-6620 tablet, 900mg , BID; GS-6620 tablet, 900 mg
Keywords: Hepatitis C; HCV; HCV RNA; Polymerase inhibitor; Treatment naïve; GS-6620
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will
      enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.
    


Intervention name(s): NBI-98854; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in Healthy Male Volunteers to Look at How the Test Medicine GLPG1690 is Taken up by the Body When Doses of Itraconazole and Voriconazole Are Given to Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The sponsor wants to investigate how well the test medicine is taken up by the body when
      given alongside two other already approved medicines. This kind of study is known as a
      drug-drug interaction study. In this case the other medicines are itraconazole and
      voriconazole.

      The sponsor will also look at the safety and tolerability of the test medicine when taken
      alone, and when taken with the approved medicines.
    


Intervention name(s): GLPG1690; Itraconazole; Voriconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of GLPG1690.; A single oral dose of itraconazole.; A single oral dose of voriconazole.
Intervention MeSH terms: Itraconazole; Voriconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group
      study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with
      infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are
      naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1
      ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once
      every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once
      every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6,
      then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.
    


Intervention name(s): Etrolizumab; Infliximab; Placebo (IV); Placebo (Injection)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.; 5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.; Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.; Administered by SC injection Q4W until Week 52
Other intervention name(s): PRO145223; RO5490261; RG7413
Intervention MeSH terms: Infliximab; Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment