bioihbjkbjnl/mcl2 huggingface dataset:
Reduced Visit Frequency in the Treatment of Uncomplicated Severe Acute Malnutrition: Evaluation of Operational Feasibility and Safety
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      Community-based management of severe acute malnutrition (SAM) has been shown to be safe and
      cost-effective, but program coverage remains low. New treatment models that maintain high
      levels of clinical effectiveness but allow for increased coverage are still needed. A reduced
      schedule of follow-up, in which children receive clinical follow-up and therapeutic foods on
      a monthly rather than weekly or biweekly basis, may be one alternative. This study aims to
      describe the safety and feasibility of a monthly distribution of ready-to-use therapeutic
      food in the treatment of uncomplicated SAM, in terms of clinical response to treatment and
      household ready-to-use therapeutic food (RUTF) utilization. This is a non-randomized pilot
      intervention study in which 115 children eligible for the outpatient treatment of SAM were
      provided a monthly ration of RUTF. Anthropometric measurements were taken on a weekly basis
      for 4 weeks to monitor treatment response defined as weight gain, (mid-upper arm
      circumference) MUAC gain, weight loss > 5%, and the development of edema. Unannounced
      household spot checks were conducted over 4 weeks to assess household utilization of RUTF and
      storage practices.
    


Intervention name(s): Monthly distribution of RUTF
Intervention type(s): Dietary Supplement
Intervention description(s): 115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Condition: Bipolar I Disorder; Mania; Depression
MeSH terms: Recurrence; Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      1) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared
      with placebo in prevention of relapse in patients with bipolar I disorder whose current
      episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To
      evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with
      placebo in prevention of relapse in patients with bipolar I disorder whose current episode
      (i.e. index episode) is manic or depressive, with or without mixed features who were
      initially stabilized on a target dose of 3.0 mg/day
    


Intervention name(s): Cariprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cariprazine capsules, oral administration, once daily; Matching placebo capsules, oral administration, once daily
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma
Condition: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the
      efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX)
      chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric
      adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.
    


Intervention name(s): CS1001 monoclonal antibody; CS1001 placebo; Oxaliplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months; Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months; Administered as an IV infusion on Day 1 Q3W; Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
Intervention MeSH terms: Capecitabine; Oxaliplatin; Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tacrobell tab_Phase1_PK
Condition: Immunosuppressant(Organ Transplantation, RA)
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, two-way crossover study to assess the tolerability and
      pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy
      male volunteers.
    


Intervention name(s): Tacrobell tab. 2mg; Prograf cap. 2mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics
Antiplaque/Antigingivitis Effect of Lacer Oros Integral
Condition: Periodontitis; Dental Plaque; Gingival Inflammation
MeSH terms: Gingivitis; Periodontitis; Dental Plaque; Inflammation
Study type: Interventional

Summary: 
      Background; A new mouth rinse formulation ("Lacer Oros Acción Integral", Lacer SA, Barcelona,
      Spain) has been recently proposed, including O-Cymen-5-ol, potassium nitrate, zinc chloride,
      dipotassium glycyrrhizate, sodium fluoride, panthenol and xylitol, within its ingredients.
      Thus, it may be relevant to test the efficacy of this new "Lacer Oros Acción Integral" mouth
      rinse formulation in a RCT.

      Primary Objective: The primary objective of this RCT will be to evaluate the
      antiplaque/antigingivitis effects of the test mouth rinse.

      Population: Consecutive subjects in supportive periodontal therapy (SPT) will be screened at
      the Post-Graduate Periodontal Clinic in the University Complutense, Madrid, and enrolled in
      the clinical trial if they are periodontitis patients, already enrolled in a SPT, for at
      least 6 months, systemically healthy, with moderate gingival inflammation and complains of
      dentin hypersensitivity.

      Study design: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week,
      clinical trial

      Intervention: The experimental group will use three times daily a provided manual toothbrush
      with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros
      Acción Integral - new formula, Barcelona, Spain). The control group will use three times
      daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of
      the control mouth rinse (Lacer Oros Acción Integral - new formula, without active
      ingredients, Barcelona, Spain).

      Visits: Screening, baseline, 2 and 12 weeks.

      Outcomes: Periodontal clinical outcomes (plaque levels, gingival condition, probing pocket
      depth), Stainign, Microbiological outcomes (culture and qPCR). Patient reported outcomes,
      compliance, adverse effects.
    


Intervention name(s): test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).; control group
Intervention type(s): Other; Other
Intervention description(s): The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).; The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pilot, parallel, double-blind, randomized, placebo-controlled, 12-week, clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Pregnancy Regulation of Insulin and Glucose
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      It is unknown whether beta cell dysfunction and insulin resistance in Gestational Diabetes
      Mellitus (GDM) is representative of a chronic maternal defect, unmasked by pregnancy, or
      whether it is the result of an imbalance of a placental hormones. Undiscovered placental
      factors which vary between pregnancies likely contribute to the pathogenesis of GDM. To
      elucidate the pathophysiology underlying GDM, the investigators will attempt to discover
      these factors and characterize pregnancy-associated changes in insulin secretion and
      sensitivity in women with and without GDM.
    

Detailed description: 
      Gestational diabetes mellitus (GDM) complicates 3-7% of pregnancies in the United States and
      is associated with perinatal morbidity and a high risk of future maternal type 2 diabetes.
      Current prevention and treatment of GDM relies on techniques developed in the type 2 diabetes
      population, without regard to unique physiology in pregnancy. GDM occurs in the setting of
      profound pregnancy changes in glucose metabolism: late pregnancy is normally characterized by
      marked insulin resistance. In order to maintain normal glucose levels and avoid GDM,
      pancreatic beta cells must augment insulin secretion to compensate. Women with GDM have
      inadequate beta-cell compensation for pregnancy-induced insulin resistance, resulting in
      hyperglycemia. It is unknown whether beta cell dysfunction and insulin resistance in GDM is
      representative of a chronic maternal defect, unmasked by pregnancy, or whether it is the
      result of an imbalance of a placental hormones. Undiscovered placental factors which vary
      between pregnancies likely contribute to the pathogenesis of GDM. Discovery of these factors
      and elucidation of the pathophysiology underlying GDM will allow for the development better
      GDM-specific prevention and treatment strategies.
    

Intervention name(s): Oral glucose tolerance test
Intervention type(s): Other
Intervention description(s): 75 gram oral glucose tolerance test (fasting) at: Visit 1 (pregnant [4-14 weeks gestation] and nonpregnant women); Visit 2 (pregnant subjects only at 24-28 weeks gestation); Visit 3 (pregnant subjects only at 6-12 weeks postpartum)
Other intervention name(s): OGTT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        150 Pregnant Women with history of GDM or at risk for diabetes mellitus and 200 Nonpregnant
        Women with history of GDM
      
Biospecimen description: 
      Blood, urine, DNA, plasma, serum. With subject consent: maternal cord blood, urine, DNA,
      fetal cord blood, neonatal DNA, placental tissue, RNA
    
Keywords: Insulin sensitivity; Insulin secretion; Pregnancy; Placental proteins
Physics Forceps vs Conventional Forceps in Extraction of Mandibular Molars
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      Our study compared two different forceps for extraction of mandibular molars, the
      conventional extraction forceps and the Physics forceps. We assesed the relative pain score,
      patient satisfaction, success of extraction, incidence of alveolar plate fracture and soft
      tissue healing; post extraction. Our results found statistical significance in comparison of
      both forceps under relative pain score, patient satisfaction and soft tissue healing post
      extraction.
    

Detailed description: 
      Abstract

        -  INTRODUCTION/ BACKGROUND Tooth extractions are commonly done with conventional forceps.
           Recent advances like physics forceps help in atraumatic extractions by preserving the
           buccal plate, having less pain and better gingival healing. The buccal portion of the
           forceps is a plastic covered bumper which prevents reflection of buccal gingiva and
           buccal plate fracture. This is the first such comparison study to measure gingival
           healing in mandibular molar region with D2 bone quality.

        -  OBJECTIVE To compare the efficacy of Physics Forceps and Conventional Forceps in
           extraction of mandibular molars by randomly dividing the patients in two groups. The
           efficacy is determined by comparing the success of extraction, relative pain score,
           incidence of alveolar fracture, patient satisfaction and soft tissue healing on 3rd
           post-operative day.

        -  METHODOLOGY Patients who were indicated for extraction were included in the study. They
           were divided into two groups of 10 by double blinded randomization. Local Anesthesia was
           administered and the extraction was carried out using either Physics or Conventional
           forceps. Post extraction, the pain score was assessed using the VAS. Along with these,
           the gingival healing, success of extraction and alveolar plate fracture was assessed by
           the subject expert on the 3rd day post-operative day.
    

Intervention name(s): Extraction of Mandibular Molar using Physics Forceps; Extraction of Mandibular Molar using Conventional Forceps
Intervention type(s): Procedure; Procedure
Intervention description(s): Extraction of mandibular molars using physics forceps; Extraction of mandibular molars using conventional forceps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
Condition: MS (Multiple Sclerosis)
MeSH terms: Multiple Sclerosis; Peroneal Neuropathies; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary aim of this study is to:

        1. Collect pilot data on the effect of task-specific lower extremity training using the
           Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;

        2. Collect pilot data on the use of combination therapy on improving gait in subjects with
           MS. This therapy will use both Anklebot training and robot-assisted gait training.

      Hypothesis: Both trainings will result in improved walking performance, but the combination
      therapy will result in greater gains than ankle training alone.
    


Intervention name(s): Anklebot; Lokomat
Intervention type(s): Device; Device
Intervention description(s): The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.; The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: robot; treadmill; foot drop; rehabilitation; gait
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
Condition: Cochlear Nerve Deafness; Cochlear Diseases; Cochlear Hearing Loss; Hearing Loss; Deafness
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Cochlear Diseases
Study type: Interventional

Summary: 
      We recently developed a new Neuro-immersion system based on virtual reality and 3D
      (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial
      localization performance of sounds and to highlight localization deficits in the three
      dimensions of space in deaf patients. Unfortunately, there is currently no suitable support
      to compensate for these localization deficits. However, the discomfort felt by the patients
      is clearly verbalized.

      Thanks to the new virtual reality system, we are now able to develop a training protocol
      based on spatial sound localization tasks.
    


Intervention name(s): Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2; Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During Protocol 1 (visit 1), participants of Group A will perform auditory spatial localization tasks with sensory feedback and during Protocol 2 (visit 2), they will perform auditory tasks without any notion of spatial localization. The 2 visits will be spaced at least 2 weeks (Wash-out).
The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.; During Protocol 2 (visit 1), participants of Group B will perform auditory tasks without any notion of spatial localization and during Protocol 1 (visit 2), they will perform auditory spatial localization tasks with sensory feedback. The 2 visits will be spaced at least 2 weeks (Wash-out).
The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects of Cranial Electrotherapy Stimulation (CES) on Brain Function, Brain Chemistry and Mood
Condition: Mood
Study type: Interventional

Summary: 
      Document whether the Fischer Wallace Cranial Stimulator produces any measurable changes in
      brain activity.
    

Detailed description: 
      The advent of an appreciation that alternative and complementary practices can have some
      beneficial effect on health has prompted the question of whether there are empirical measures
      of improvement that do not rely solely on subjective reports. The present study proposes to
      explore whether transcranial stimulation (or cranial electrotherapy stimulation; CES) using
      an FDA-approved device can alter brain function, mood and responses to cognitive tasks.
    

Intervention name(s): Fisher Wallace Cranial Stimulator
Intervention type(s): Device
Intervention description(s): The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cranial stimulation; BOLD (Blood Oxygenation Level Dependent); fMRI (Functional Magnetic Resonance Imaging); spectroscopy
mDixon TSE MRI Sequence And Conventional MRI Sequences In Dysimmune Orbitopathies (DDX)
Condition: Dysthyroid Ophthalmopathies
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Study type: Observational

Summary: 
      The dysthyroid orbitopathy (DO) is a chronic disease, evolving during 2 to 3 years, with a
      hypertrophy and a variable degree of inflammation of the eyelid muscles, the oculomotor
      muscles and the orbital fat.

      If the diagnosis of OD is primarily clinical and laboratory, MRI is an additional
      contribution to the clinic, guiding the therapeutic management by detecting inflammatory
      lesions not found on clinical examination in 1/3 of cases.

      The three MRI sequences conventionally practiced ((T2, T2-fat-sat, T1) allow muscles signal
      analysis oculomotor abnormalities as well as the orbital fat.

      Compared to these sequences, the main advantage sequences DIXON is a faster acquisition. In
      addition, DIXON type of imaging overcomes most of these artifacts and to obtain a homogeneous
      fat removal.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with a dysthyroid orbitopathy undergoing a MRI
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a
      multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study with a 4 week treatment period in hypertensive pediatric subjects.

      Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after
      which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil
      or placebo. The study includes 2 panels based on subject weight.

      The primary efficacy analysis is based on the intent-to-treat population and tests for slope
      = 0 in a linear regression model with change in sitting systolic blood pressure as the
      dependent and non-zero dose pooled across weight panels as the independent variable. For
      subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value
      forward assigns the value.

      Additional analyses will include data pooled from a similar dose ranging study conducted in
      children 1 to < 6 years of age.
    


Intervention name(s): candsartan cilexetil
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the cognitive effects associated with administration
      of intranasal esketamine 84 mg.
    

Detailed description: 
      This is a randomized (participants assigned to 1 of 2 treatment sequences by chance),
      double-blind (identity of study drugs will not be known to participant or members of study
      staff), placebo-controlled (a substance without active drug identical in appearance to
      esketamine), 2-period crossover study (participants assigned to each treatment sequence will
      receive 1 dose of esketamine and 1 dose of placebo administered intranasally [through the
      nose]) conducted in healthy adult participants at a single center. Participants will complete
      3 study phases: A screening phase of up to 3 weeks; a 2-week double-blind treatment phase,
      which includes 2 treatment periods (Periods 1 and 2) separated by a washout interval of at
      least 7 days; and, a 1-week posttreatment (follow up) phase, if applicable. The duration of
      the study for each participant will be approximately 6 weeks. Blood and urine samples will be
      collected during the study for laboratory assessments. Participants will be monitored for
      safety from the time of signing the informed consent form up until 1 week after the last dose
      of study drug (or end of treatment).
    

Intervention name(s): Esketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 84 mg esketamine administered intranasally; Placebo administered intranasally
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Esketamine; Cognitive functioning