bioihbjkbjnl/mcl2 huggingface dataset:
Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
Condition: Chronic Hepatitis D Infection
MeSH terms: Infections; Hepatitis A; Hepatitis D; Hepatitis D, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a
      (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus
      (HBV) co-infected with hepatitis delta virus (HDV).
    

Detailed description: 
      The study is designed to evaluate safety and efficacy of MXB in a subset of HBV infected
      patients who are co-infected with HDV. Hepatitis delta represents the most severe form of
      chronic viral hepatitis and there is no approved treatment option available for patients
      infected with both HBV and HDV.

      24 patients will be randomised into 3 arms: pre-treatment with MXB followed by PEG-INF-a
      treatment versus a combination of both drugs versus PEG-INF-a.

      Prolonged blockade of HBV entry into hepatocytes should also block infection with HDV
      particles (which uses hepatitis B surface antigen (HBsAg) as its envelope) and thus provide a
      therapeutic option for this otherwise hardly treatable disease. PEG-INF-a is used for the
      treatment of chronic hepatitis delta. The study endpoints are virological response (HBsAg,
      hepatitis delta virus ribonucleic acid (HDV RNA), hepatitis B virus deoxyribonucleic acid
      (HBV DNA)), as well as safety and tolerability and drug immunogenicity.
    

Intervention name(s): PEG IFN alfa-2a; Myrcludex B
Intervention type(s): Drug; Drug
Other intervention name(s): Pegasys; Myrcludex
Intervention MeSH terms: Peginterferon alfa-2a; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Nerve Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate the effects of memantine in ALS patients using
      functional outcome measures.
    


Intervention name(s): Memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; ALS; Motor Neuron Disease; MND; Memantine
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the safety and tolerability of JNJ
      54175446 in participants with Major Depressive Disorder (MDD).
    


Intervention name(s): JNJ-54175446, 600 mg; JNJ-54175446, 150 mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive JNJ-54175446, 600 mg as an oral suspension.; Participants will receive JNJ-54175446, 150 mg as an oral suspension.; Matching placebo to JNJ-54175446
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Pharmacokinetic Study on the Effect of LY2216684 on the Active Metabolite of Clopidogrel
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure how much of the study drugs (clopidogrel and
      LY2216684) reach the blood stream and how long it takes the body to dispose of them and to
      determine how clopidogrel and LY2216684 might affect each other in the body. Information
      about any side effects that may occur will also be collected.
    

Detailed description: 
      Clopidogrel is rapidly converted to R-130964 by the enzyme cytochrome P450 2C19 (CYP2C19).
      Enrollment in the study was limited to participants with specific genotypes of the CYP2C19
      gene, including the *1/*1 genotype (CYP2C19 extensive metabolizers) and the *1/*17 or *17/*17
      genotypes (CYP2C19 ultra-rapid metabolizers). All primary and secondary objectives were
      limited to participants with the CYP2C19*1/*1 genotype.
    

Intervention name(s): Clopidogrel; LY2216684
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment Of Duration Of Action, Safety & Toleration Of UK369,003 and Cialis In Patients With Erectile Dysfunction
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of duration of action, safety & toleration of different formulations and doses of
      UK-369,003 and Cialis in patients with male erectile dysfunction. Patients should have
      previously been on PDE5 inhibitors and have been respondents to the drug. Duration of
      treatment is 4 weeks.
    


Intervention name(s): UK0369,003; Cialis (Tadalafil)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of the Effects of Ziprasidone for the Treatment of Schizophrenia or Schizoaffective Disorder in Patients Who Were Switched From Other Antipsychotic Drugs
Condition: Schizoaffective Disorder; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if differences exist in outcome in patients with
      schizophrenia or schizoaffective disorder who were switched from other antipsychotics to
      ziprasidone.
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): Ziprasidone 40 mg capsules twice daily for the first 7 days followed by flexible dosing between 40 and 80 mg twice daily for the remaining 5 weeks.
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
Condition: Cryotherapy Effect
MeSH terms: Hyperthermia; Fever
Study type: Interventional

Summary: 
      Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military
      soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C
      with the presence of central nervous dysfunction (altered mental status). The gold standard
      method of care for EHS is immediate onsite whole body cooling using cold-water immersion
      (cooling rates >0.15°C•min-1), which is reported to have the highest cooling rate. In the
      treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to
      minimize the time above the critical threshold of body temperature at 40°C to less than 30
      minutes for the best chance of survival and to minimize the severity of prognosis. However,
      in situations where cold water immersion is not feasible (in certain military, firefighter,
      or other remote settings), other cooling modalities must be available that have a cooling
      capacity similar to that of cold-water immersion. In this proposed study, the investigators
      aim to examine the cooling rates of the Polar Breeze® device (developed by Statim
      Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often
      recommended by sports medicine professionals as an alternative to cold-water immersion, and
      passive rest in participants with exercise-induced hyperthermia.
    


Intervention name(s): Thermal Rehab Machine; Forearm Ice Towels
Intervention type(s): Device; Other
Intervention description(s): The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air; Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)
Other intervention name(s): Polar Breeze
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using forearm ice towels, and cooling using the investigational thermal rehab machine.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy
Condition: Adenoma Colon; Colonic Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive
      population undergoing colonoscopy. The main question it aims to answer is the Adenoma
      Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio
      to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy
      (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase
      the ADR significantly.
    


Intervention name(s): ENDO-Aid by Olympus
Intervention type(s): Device
Intervention description(s): Colonoscopy assisted by ENDO-AID device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ADR; CADe; Endo-AID
Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca
Condition: Brain Tumor, Pediatric, Brainstem Glioma; Brain Tumor, Pediatric, Recurrent
MeSH terms: Neoplasms; Glioma; Brain Neoplasms; Recurrence
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This Protocol is a pilot, clinical interventional study to selected patients between five and
      fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade
      recurrent in the central nervous system tumors, in whom there has been no response to
      conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow
      treatment with conventional measures, and that already have an indication for a neurosurgical
      palliative procedure. It will be a close pharmacovigilance on possible adverse effects
      related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum
      derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will
      be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.
    


Intervention name(s): Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
Intervention type(s): Drug
Intervention description(s): Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.
Other intervention name(s): Pt(acac)2/Titanium dioxide (Ti02); Pt(acac)2/F-TiO2; NPt; NPt-Ca
Intervention MeSH terms: Titanium dioxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy and Safety Study of DHA-O in Adults With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of DHA-O to lower
      elevated triglyceride levels in healthy adults with hypertriglyceridemia.
    


Intervention name(s): DHA-O; Fish oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: omega-3; DHA; triglycerides; lipids; cardiovascular; hypertriglyceridemia
Effectiveness of Parenting Intervention for Improving Child Mental Health
Condition: Behavior Problem; Conduct Disorders in Children; Mental Health Wellness 1
MeSH terms: Problem Behavior; Conduct Disorder
Study type: Interventional

Summary: 
      In this study, effectiveness of a group parenting intervention was assessed in a community
      setting, for its impact on child behaviour problems and parental mental health.
    


Intervention name(s): Samarthan
Intervention type(s): Behavioral
Intervention description(s): Samarthan intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on
      pain sensitivity control and color change after home tooth whitening. It also evaluated the
      influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of
      patient satisfaction after bleaching treatment.
    


Intervention name(s): Carbamide Peroxide (PC) 22%) + placebo gel; Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%
Intervention type(s): Other; Other
Intervention description(s): Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them. The volunteers were instructed to apply a small amount of placebo gel, without active ingredient, with color, texture and odor similar to 1.5% oxalate gel (Painless, BM4, SC, Brazil) in the spaces related to the vestibular portions of the teeth trays, which were used for 10 minutes.; Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them with absorbent paper. The volunteers applied a small amount of 1.5% potassium oxalate gel (Painless, BM4, SC, Brazil) in the spaces relative to the vestibular portions of the tray's teeth, which were used for 10 minutes.
Intervention MeSH terms: Carbamide Peroxide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Releasing the Tourniquet in Total Knee Replacement Before Closure on the Blood Loss , Joint Effusion , Hematoma Formation and Wound Complication
Condition: Hematoma; Arthroplasty Complications
MeSH terms: Hydrarthrosis; Hematoma
Study type: Observational [Patient Registry]

Summary: 
      The study , observe the effect of releasing the Tourniquet in total knee replacement surgery
      before closure in comparison with releasing it after wound closure

      The effect was assessed by Hb drop post operative and Hematoma formation ( measured by
      ultrasound ) as well as the wound complication
    

Detailed description: 
      The study is conducted in tertiary university hospital as a referral hospital for joint
      arthroplasty , the patients was informed about the study and consent was taken , the same
      operator , same theater and the same prosthesis company as well as the same radiologist
      during the study period.

      the patient randomly assigned to either group A (Tourniquet release before closure of the
      wound and hemostasis ensured ) , or a group B ( Tourniquet release after wound closure )

      post operative Hb drop was studied between the groups , and each patient underwent ultrasound
      measurement of the intraarticular hematoma . The wound complication between the groups was
      also studied .
    

Intervention name(s): tourniquet
Intervention type(s): Device
Intervention description(s): Tourniquet release before/after wound closure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the study was conducted in University hospital in the Capital city , the patients were from
        all around the country - Jordan - , as the hospital is as tertiary hospital most of the
        patients were above 60 , mostly female
      
Keywords: Tourniquet; Intra articular Hematoma; Total Knee Replacement
Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds
Condition: Inflammation
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine if there are signs of inflammation in one's blood
      and urine and to find out if one's body size or ethnicity has an effect on these substances.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        pediatric out-patient at UCDavis Medical Center clinic
      
Biospecimen description: 
      Aliquots from the citrate vial & Serum seperator vial are being retained
    
Keywords: Inflammation; Oxidative Stress; Microalbuminuria
Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Condition: Pain, Postoperative; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in
      children from 3 months to 16 years submitted unilateral limb surgery.
    

Detailed description: 
      This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in
      children from 3 months to 16 years submitted unilateral limb surgery. The children were
      divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours
      before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours
      before surgery (N-44). Both groups were subjected to the same general anesthesia protocol,
      opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received
      dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age,
      gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Orthopedic Surgery was applied for the treatment of osseous disorders; Orthopedic Surgery was applied for the treatment of osseous disorders
Other intervention name(s): Orthopedic Surgery
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: GABAPENTIN POSTOPERATIVE PAIN CHILD
Fiber Blends and Gut Microbiota (FB)
Condition: Gut Microbiome
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether consuming snacks containing
      different blends of dietary fibers alters the type and number of bacteria found in your gut
      and improves markers of overall health.
    

Detailed description: 
      All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two
      snack prototypes containing two different fiber blends on gut community structure and
      features of host biological state (plasma proteome/ metabolome). The information gained from
      this work will increase our understanding of the importance of specific dietary fibers in
      manipulating the composition of the gut microbiota in ways that may improve our metabolic
      health.
    

Intervention name(s): Two fiber-blend snack and four fiber-blend snack
Intervention type(s): Other
Intervention description(s): All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Certification Standards and Diagnostic Accuracy for Surgeon-performed Ultrasonography
Condition: Ultrasonography Skills
Study type: Interventional

Summary: 
      Ultrasonography (US) is an operator depended image modality that is difficult to reproduce
      and interpret by others. Competence of the US operator is crucial for reliable diagnostics
      but no evidence-based certification of head and neck US skills has been developed.
      Investigators conducted an experimental study aimed to explore diagnostic accuracy and
      establish validity evidence for certification standards in surgeon-performed ultrasonography.
    


Intervention name(s): Measurement of competence
Intervention type(s): Other
Intervention description(s): This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic