bioihbjkbjnl/mcl2 huggingface dataset:
3D-printed Implant Overdentures
Condition: Edentulous Mouth
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      A randomized clinical trial (RCT) was designed. Fourteen completely edentulous participants
      were randomly allocated into two equal groups. All participants received two implants in the
      inter-foraminal area with ball attachments. Participants in the control group were
      rehabilitated with conventionally manufactured Polymethyl Methacrylate (PMMA) maxillary
      complete denture and mandibular implant overdentures while participants in intervention group
      received digital light processed (DLP)-printed photo-polymerizable PMMA Nextdent maxillary
      complete denture and mandibular implant overdentures. Follow-up appointments were scheduled
      at 3,6, and 12 months where data of Oral Health Impact Profile 19(OHIPEDENT19) was used to
      assess the OHRQoL (oral health related quality of life). In addition, denture retention was
      measured using digital force gauge device. Data were collected and statistically analyzed.
    


Intervention name(s): (DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture
Intervention type(s): Other
Intervention description(s): The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Undiagnosed Chronic Obstructive Pulmonary Disease Sufferers in the Region of Murcia
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is determine the prevalence of undiagnosed Chronic Obstructive
      Pulmonary Disease (COPD) in population served and with exposure to cigarettes in the Region
      of Murcia
    

Detailed description: 
      COPD is a serious, chronic and very disabling, associated with smoking and aging. Therefore
      it is a preventable and treatable process. It is know to be a pathology under diagnosed and
      when diagnosis, this is done in advanced stage, resulting to rise to more complication and
      more severe, in a addition to a high social and economic cost.

      Therefore, take out an epidemiological study, observational, multicentre, whose main
      objective is estimate the prevalence of undiagnosed COPD in population served between 40 and
      70 years and exposure to cigarettes in the Region of Murcia.

      Other objectives are estimate the proportion of patients already diagnosed, identifying risk
      factors associated with not previous diagnosis of COPD and describe the history of symptoms
      in them. Description of therapeutic manage and motivation to give up smoking.

      The study was carried out with 120 researcher doctors and 120 researcher nurses from 40
      health centers in the Region of Murcia.

      Each researcher will select 10 patients for the main objective and 10 for objectives related
      to manage of COPD.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Group of patients seen in consultation not previously diagnosed with COPD, both sexes, aged
        between 40 and 70 years.
      
Keywords: Chronic Obstructive Pulmonary Disease; Diagnosis differential; Dyspnea/classification; Dyspnea/etiology
Effects of Serotonin Inhibitors on Patient-controlled Analgesia Related Nausea and Vomiting
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      ED50 of dexmedetomidine for prevention of emergence agitation after tonsillectomy or
      adenoidectomy in children
    


Intervention name(s): agitation
Intervention type(s): Behavioral
Intervention description(s): agitation score after desflurane anesthesia
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: agitation, desflurane, children
Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 study to examine how the study drug works and its side effects in subjects with
      toenail fungus.
    

Detailed description: 
      A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study
      to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects
      with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks
      and then will be followed for an additional 16 weeks to determine if the study drug was
      efficacious. Subjects will have routine blood draws and other safety assessments during the
      study, as well as regular assessments of their toenail fungus
    

Intervention name(s): Albaconazole 100mg; Albaconazole 200mg; Albaconazole 400mg; Albaconazole 400mg; Placebo 400 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Albaconazole for 36 weeks; Albaconazole for 36 weeks; Albaconazole for 36 weeks; Albaconazole for 24 weeks, Placebo for 12 weeks; Placebo for 36 weeks
Intervention MeSH terms: Albaconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Distal, Subungual onychomycosis; onychomycosis; nail fungus; Toenail fungus
Study Of Nifurtimox Transfer Into Breastmilk In Lactating Women With Chagas Disease
Condition: Chagas Disease; Lactation
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      The investigators propose to study the transfer of nifurtimox into breastmilk of lactating
      women who receive the drug for the treatment of Chagas disease.

      Breastmilk and blood samples will be obtained from these patients at pre-specified times
      after they take the clinically indicated medication, and the concentrations in both matrices
      will be compared to estimate degree of transfer. Estimation of nifurtimox transfer into
      breastmilk will allow the evaluation of potential degree of exposure of infants breastfed by
      these women to nifurtimox. This study will help clarify safety of continuing breastfeeding
      while receiving treatment with nifurtimox for Chagas disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population of young women with Chagas disease referred to our center for evaluation and
        treatment
      
Biospecimen description: 
      breastmilk; plasma
    
Keywords: Chagas disease; lactation; breastmilk; postpartum period; infants; pediatric clinical pharmacology; developmental clinical pharmacology; parasitology; trypanosoma cruzi; nifurtimox
A Dietary Supplement for Mood Symptoms in Early Postpartum: A Double Blind Randomized Placebo Controlled Trial
Condition: Postpartum Blues; Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a dietary supplement (DS) is effective in
      protecting against sad mood in postpartum as compared to placebo.
    

Detailed description: 
      This double blind placebo controlled randomized trial will evaluate the effect of
      administration of a dietary supplement (DS) on the intensity of postpartum blues. It is
      expected that the administration will result in less sadness in day-5 postpartum women after
      negative mood induction in those receiving the dietary supplement compared to placebo.
    

Intervention name(s): Motherwell; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.; Matching placebo for appearance, taste
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one arm receives Motherwell and one arm receives placebo; randomized double blind The supplement is expected to prevent depressed mood induction during postpartum blues whereas the placebo is not. The effect of depressed mood induction is strong during postpartum blues in 75% to 95% of mothers (who do not take Motherwell). The supplement is the intervention.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Postpartum; Dietary Supplement; Mood Symptoms
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional

Summary: 
      High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients
      with acute myeloid leukemia. However, most patients receiving this therapy are required to be
      admitted to the hospital during their treatment course.

      The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment
      given in an in-patient setting versus an out-patient setting.
    

Detailed description: 
      The primary objective of this study is to:

      • To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine
      (HiDAC) for AML consolidation administered in an outpatient setting.

      The secondary objectives of this study are to:

        -  To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of
           care inpatient HiDAC consolidation.

        -  Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to
           that with the standard inpatient regimen.
    

Intervention name(s): Cytosine Arabinoside
Intervention type(s): Drug
Other intervention name(s): AraC; Cytosar U; Cytosine aribinoside; Arabinosylcytosine; Cytarabine sterile; 1-B-Arabinoe-furanosyl-cytosine
Intervention MeSH terms: Cytarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myeloid leukemia; outpatient consolidation treatment
Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
    

Detailed description: 
      A Phase I, Open-Label, Single-Dose, Single Period Study to Evaluate the Pharmacokinetics of
      Mucinex® 1200 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects
    

Intervention name(s): Mucinex®
Intervention type(s): Drug
Intervention description(s): Mucinex® 1200 mg ER Bi-Layer tablet
Other intervention name(s): guaifenesin
Intervention MeSH terms: Guaifenesin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the effects of 16-week treatment with DFD-29 40 mg
      QD dose in comparison to Placebo on the skin, intestinal and vaginal microbiota.
    

Detailed description: 
      A multi-center (up to three sites), randomized, double-blind, placebo-controlled, parallel
      group trial with a treatment period of 16 weeks.

      Sixty (60) healthy adult human subjects will be randomized in a 2:1 ratio to receive
      treatment with DFD-29 (Minocycline Hydrochloride Capsules) 40 mg QD orally or matching
      Placebo (for DFD-29 capsules) QD orally for a period of 16 weeks.

      The trial will have a screening period (Day -30 to Day -1) and a trial treatment period (Day
      1 to Day 113). There will be 6 planned visits to the study site for subjects.

      Impact on microbial flora will be assessed from skin swabs, stool samples and vaginal swabs
      (female subjects) taken at multiple timepoints.
    

Intervention name(s): Minocycline hydrochloride capsules; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Minocycline hydrochloride capsules, 40 mg will be administered orally once daily for 16 weeks.; Placebo capsules will be administered orally once daily for 16 weeks.
Other intervention name(s): DFD-29; Placebo comparator
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multi-center, randomized, double-blind, placebo-controlled, parallel group trial with a treatment period of 16 weeks.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Use of Clobazam for Epilepsy and Anxiety
Condition: Epilepsy; Anxiety
MeSH terms: Epilepsy; Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric
      patients with epilepsy and clinically significant anxiety will be recruited and if enrolled
      will receive active treatment, involving flexible dose titration of clobazam and will be
      monitored for a period of four months. The study will be monitored and overseen by the Johns
      Hopkins Hospital Institutional Review Board.
    


Intervention name(s): Clobazam
Intervention type(s): Drug
Intervention description(s): Clobazam is used as an adjunct medicine for all participants.
Other intervention name(s): Onfi
Intervention MeSH terms: Clobazam
Intervention model: Single Group Assignment
Intervention model description: All participants receive treatment and outcome is assessed; there is no control group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics
Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER
      Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in
      healthy, adult, human subjects, under fed conditions and to monitor adverse events and ensure
      the safety of subjects.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,
      crossover oral bioequivalence study of Divalproex Sodium Extended Release Tablets 500 mg of
      Dr. Reddy's Laboratories Limited, and Depakote ER 500 mg mg Tablets of Abbott Laboratories in
      healthy, adult, human subjects, under fed conditions.
    

Intervention name(s): Divalproex Sodium
Intervention type(s): Drug
Intervention description(s): Divalproex Sodium ER Tablets, 500 mg
Other intervention name(s): Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Divalproex Sodium; Crossover
Paracervical Block for Pain Control in First Trimester Abortion
Condition: Legal Abortion With Complication; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Many woman undergoing a surgical abortion receive a paracervical nerve block for pain
      reduction, in which lidocaine (a numbing medication) is injected around the cervix. These
      injections numb the cervix and possibly the lower part of the uterus. However, the injection
      can be uncomfortable and it is not well known whether it is effective in reducing pain. The
      purpose of this study is to determine the level of pain women experience with a surgical
      abortion and the effect that paracervical block might have on that pain.
    

Detailed description: 
      The investigators expect to have 120 women complete this study, between study sites at OHSU's
      Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every
      participant will still receive the standard oral medication for pain (ibuprofen) and anxiety
      (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant
      and have already decided to have a surgical abortion.

      The primary outcome evaluated will be pain reported at time of cervical dilation. The
      investigators will assess pain at various time points (including secondary outcomes)
      immediately upon completion of the respective step and pain and satisfaction 30 minutes
      postoperatively.
    

Intervention name(s): Paracervical Block; Sham Paracervical Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.; In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Paracervical Block; pain control; abortion
High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional

Summary: 
      Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to
      recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective
      in decreasing amount of protein in urine in patients with diabetic kidney disease than high
      doses of trandolapril.
    


Intervention name(s): High dose ACE-I vs ARB
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Diabetes; Proteinuria; Angiotensin converting enzyme inhibitors; Angiotensin receptor antagonists
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior
Condition: Addiction; Risk Reduction Behaviour
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk
      behavior
    


Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Addiction; Psychoeducation; Risk reduction behaviour; Drop in center (DIC)
A Pharmacokinetics Study of Aleglitazar in Combination With Digoxin in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and
      safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In
      period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will
      receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on
      study treatment is one month.
    


Intervention name(s): aleglitazar; digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of aleglitazar; Single dose of digoxin
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Early Childhood Prevention of Childhood Overweight
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      You are invited to participate in a research study to understand more about childhood obesity
      and how to prevent it. We hope to learn how families influence each others eating habits.
    

Detailed description: 
      This study aims to understand more about childhood obesity and how to prevent it. Two
      different methods of prevention will be tested and participants will be allocated at random
      to one of these methods. The investigators hope to learn how families influence each others
      eating habits.

      Participants in this study will attend a series of five classes, once a week for five weeks,
      on the topic of child feeding. The aim of the classes is to learn how to feed your child so
      as to prevent future eating and weight problems. The research component includes filling out
      some surveys before classes begin and at the end of the last class. Classes are small and
      interactive so that parents have a chance to voice concerns and get feedback.
    

Intervention name(s): 5-keys counseling; Lifestyle counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5-session small group intervention; 5-session small group behavioral intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced
      malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese
      studies.
    


Intervention name(s): PF-00299804
Intervention type(s): Drug
Intervention description(s): Dosage form: 5 mg and 20 mg tablet Dosage: 15 mg, 30 mg and 45 mg, orally, once daily Number of Cycles: until progression or unacceptable toxicity develops.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumor