bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption (relative
      bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b
      tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours
      after meal); to assess the effect of type and timing of the meal on the rate and extent of
      absorption of seltorexant Phase 3 tablet formulation (low dose and high dose strength) in
      healthy male and female participants; and to assess the pharmacokinetic of single-dose
      administration of low dose and high dose of seltorexant in healthy male and female
      participants 3 hours after meal.
    


Intervention name(s): Seltorexant High Dose; Seltorexant Low Dose
Intervention type(s): Drug; Drug
Intervention description(s): In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally.; In Part 3 (3B and 3C), Seltorexant low dose will be administered orally.
Other intervention name(s): MIN-202; JNJ-42847922; MIN-202; JNJ-42847922
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A PET Study With RO5545965 in Healthy Male Volunteers
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, open-label study will evaluate the PK-PDE10A Enzyme Occupancy
      Relationship of RO5545965 after a single dose in healthy male volunteers by positron emission
      tomography (PET).
    


Intervention name(s): RO5545965
Intervention type(s): Drug
Intervention description(s): Single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial
Condition: Exposure to Ionizing Radiation
Study type: Observational

Summary: 
      The study compares radiation exposure parameters between coronary angiography procedures
      performed by left wrist, right wrist or groin (femoral) procedure access site
    

Detailed description: 
      Patients referred for coronary angiography will be randomized to either left radial, right
      radial or femoral arterial access sites, and the coronary angiogram will be performed in a
      standard fashion, including left ventriculography. Radiation exposure parameters including
      Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be
      recorded. Operator experience as well as demographic data will be recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred for diagnostic coronary angiography
Efficacy of RIVAstigmine on Motor, Cognitive and Behavioural Impairment in Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy (PSP)
MeSH terms: Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Phase 3

Summary: 
      Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease from the
      parkinsonian syndrome group. It represents 5 to 10% of all parkinsonian syndromes and affects
      3,000 to 10,000 persons in France. PSP is characterised by a doparesistant parkinsonism with
      axial signs such as early gait instability and falls, oculomotor signs such as a vertical
      gaze palsy, dysphagia and dysarthria, and both cognitive and behavioural disturbances. The
      latter predominantly manifest as psycho-motor slowness, apathy and frontal executive
      deficits. Swallowing impairments and falls may lead to life-threatening situations and death
      occurs 6-9 years after disease onset.

      Apart from L-dopa which may transiently and inconsistently improve motor symptoms no
      effective symptomatic, disease-modifying or neuroprotective therapy is presently available to
      reduce disability in any way. Therefore these patients often receive mostly non-medical care
      such as physiotherapy and speech therapy.

      In addition to dopaminergic degeneration there is evidence of cholinergic deficits in PSP
      correlated with gait and balance impairments . This stands in contrast with the limited
      number of studies of cholinergic augmentation strategies in PSP.

      Trials of cholinesterase inhibitors in PSP have produced rather conflicting results:
      donepezil improves cognition but deteriorates some motor functions whereas a case series of 5
      PSP patients treated with rivastigmine found an improvement in several cognitive aspects and
      no deterioration of motor functions .On the other hand in Parkinson's disease there is
      convincing evidence of a positive effect of rivastigmine on cognition , apathy and falls
      Investigators' hypothesis is that rivastigmine (an acetyl- and butyryl-cholinesterase
      inhibitor) may reduce gait and postural impairment in PSP and may therefore limit the number
      of falls and their consequences both in terms of injuries sustained (fractures etc...) and on
      the patients' autonomy. In addition investigators hypothesise that rivastigmine may also
      reduce the cognitive and behavioural impairment associated with PSP. Taken together these
      improvements are likely to produce a significant effect on the patients' quality of life and
      their caregiver burden.
    


Intervention name(s): Rivastigmine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure
Condition: Survival, Prosthesis; Oxygen Deficiency
MeSH terms: COVID-19; Respiratory Insufficiency; Hypoxia; Prosthesis Failure
Study type: Observational [Patient Registry]

Summary: 
      The objective of our study is to evaluate the effectiveness of prone position in preventing
      intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory
      failure.
    

Detailed description: 
      The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as
      limited ICU capacity is strained by a new high-mortality disease and large numbers of
      patients requiring prolonged periods of hospitalization, as well as respiratory support
      equipment such as ventilators and intensive care unit (ICU) beds.

      If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated
      patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV
      vigil) remains a subject of debate and research.

      This is a retrospective, monocentric, descriptive and analytical cohort conducted over a
      period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized
      in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute
      respiratory failure caused by COVID-19.
    

Intervention name(s): Prone position
Intervention type(s): Other
Intervention description(s): Each prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Each awake prone position session had a minimum duration of one hour and a maximum duration
        of 12 hours for a minimum of 3 hours per day.

        Epidemiological, clinical, paraclinical, therapeutic and evolutionary data were collected
        using a data processing form including the different variables collected in the patients'
        medical records. These data were then computerized and analyzed using IBM SPSS version 21
        software.

        Qualitative variables were described as numbers and/or percentages, and quantitative
        variables as mean ± standard deviation, or as median with interquartile range for variables
        not having a normal distribution.
      
Keywords: acute respiratory distress syndrome; COVID-19; conscious; prone position; survival rate
Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries
Condition: Deep Caries
Study type: Interventional

Summary: 
      The objective of this study is to assess and compare the possible post-operative pulpal
      symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of
      pulp exposure, child acceptance, chair time and radiographic success between two techniques
      for managing dental caries: minimal caries removal and complete caries removal in primary
      molars.
    

Detailed description: 
      Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a
      treatment option for primary molars with deep carious lesions or reversible pulpitis where
      only soft demineralized dentin around the lateral walls of the carious lesion is removed. The
      aim of this study is to assess the success of such a technique in managing primary molars
      with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain,
      pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair
      time and radiographic success.
    

Intervention name(s): Minimal caries removal; Complete caries removal
Intervention type(s): Procedure; Procedure
Intervention description(s): the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.; the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the absorption of 20 mg Lefradafiban in two formulations, each under
      physiological conditions and with 40 mg Pantoprazole
    


Intervention name(s): Lefradafiban tablet; Pantoprazole tablet; Lefradafiban double chamber sachet
Intervention type(s): Drug; Drug; Device
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects
      treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone
      following hematopoietic cell transplantation (HCT). The purpose of this study is to test the
      hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher
      lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1
      year post-HCT than subjects receiving calcium and vitamin D alone (Control Group).
    


Intervention name(s): Pamidronate; Calcium and vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.; All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
Other intervention name(s): Aredia; Bonapam; Cholecalciferol; Ergocalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol; Ergocalciferols; Pamidronate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bone mineral content; bone mineral density; bone formation; bone resorption; pamidronate; children; DXA; bone marrow transplant
Acute Effects of GLP-1 on Renal Hemodynamics
Condition: The GLP-1-mediated Gut-kidney Axis
Study type: Interventional

Summary: 
      This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic
      action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue
      oxygenation.
    

Detailed description: 
      Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the
      extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these
      studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing
      to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In
      the current randomized and controlled study, investigators aim to test the hypothesis that
      GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and
      decrease oxygen consumption, leading to higher tissue oxygenation. Thus, contributing to the
      renoprotective action of GLP-1.

      Under fixed sodium intake for 4 days before each study day, 10 healthy male participants will
      be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with
      an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2*) and
      perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will
      be conducted, using Magnetic Resonance Imaging (MRI).
    

Intervention name(s): Glucagon-Like Peptide 1; saline 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion (1.5 pmol/kg/min) for 60 min.; Intravenous infusion for 60 min.
Other intervention name(s): GLP-1; Placebo for GLP-1
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: glucagon-like peptide-1; kidney; renal hemodynamics; renal blood flow
Hydroxyurea to Prevent Organ Damage in Children With Sickle Cell Anemia
Condition: Hematologic Diseases; Anemia, Sickle Cell
MeSH terms: Anemia; Anemia, Sickle Cell; Hematologic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if hydroxyurea therapy is effective in the
      prevention of chronic end organ damage in pediatric patients with sickle cell anemia.
    

Detailed description: 
      BACKGROUND:

      In 1995, the Multicenter Study of Hydroxyurea (MSH) demonstrated that hydroxyurea is
      effective in decreasing the frequency of painful crises, hospitalizations for crises, acute
      chest syndrome, and blood transfusions by 50%. The recently completed phase II study of
      hydroxyurea in children (PED HUG) demonstrated that children have a response to hydroxyurea
      similar to that seen in adults in terms of increasing fetal hemoglobin levels and total
      hemoglobin, and decreasing complications associated with sickle cell anemia. In addition,
      this study demonstrated that the drug does not adversely affect growth and development
      between the ages of 5 and 15. A recently completed pilot study of hydroxyurea given to
      children between the ages of 6 months and 24 months demonstrated that the drug is tolerated
      well by small infant, and that the fetal hemoglobin switch can be forced to remain in the "on
      position" by hydroxyurea administration.

      A Special Emphasis Panel (SEP) met on April 12, 1996 to review the results of the MSH trial
      and the progress to date of the PED HUG study. The SEP recommended that NHLBI undertake the
      BABY HUG trial.

      DESIGN NARRATIVE:

      BABY HUG is a randomized, double-blind, placebo-controlled study to determine if hydroxyurea
      can prevent the onset of chronic end organ damage in young children with sickle cell anemia.
      Approximately 200 children with sickle cell disease will be recruited to receive either
      hydroxyurea or placebo. The children will be screened at study entry for signs of abnormal
      brain, kidney, pulmonary, and splenic function, and developmental milestones. They will then
      be randomly assigned to receive either hydroxyurea or placebo and followed yearly to assess
      chronic end organ damage of the major organ systems. The primary endpoint will be a 50%
      reduction in rates of damage to the major organs with surrogate markers of organ function
      during follow-up in Phase II of the trial.
    

Intervention name(s): Hydroxyurea; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive hydroxyurea.; Participants will receive placebo.
Intervention MeSH terms: Hydroxyurea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Blood Diseases; Sickle Cell Anemia
Trial of Cocoa-based Food in Children
Condition: Motor Activity
Study type: Interventional

Summary: 
      Today, there is an important lack of knowledge on child metabolism and the effects of
      phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here,
      the investigators will monitor the metabolism of children using minimally invasive techniques
      at rest, and with physical/mental activities and assess the changes associated with the
      intake of cocoa-based food.
    


Intervention name(s): cocoa-based food; cocoa-based food
Intervention type(s): Other; Other
Intervention description(s): single intake of cocoa-based food; Single intake of cocoa-based food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Amisulpride in Schizophrenic Acute Phase Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      To collect the safety and response of using Amisulpride in acute schizophrenic patients
    


Intervention name(s): Amisulpride
Intervention type(s): Drug
Intervention description(s): Oral tablets
Intervention MeSH terms: Amisulpride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to
      assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim
      (B12019) and the reference product Neulasta® in healthy subjects
    


Intervention name(s): Neulasta, B12019
Intervention type(s): Biological
Intervention description(s): GCSF, Growth Colony Stimulating Factor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A New Supplement for the Immune Response to HPV Infection
Condition: HPV Infection
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether a supplement in which ellagic acid plus
      annona muricata are combined, may modulate the immune response to high risk HPV infection.
      Sixty women will be enrolled in a randomized, controlled study, having a histological
      diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the
      activation of onco suppressor protein by the supplement and secondary outcome is the
      clearance of HPV infection in the treated group.
    


Intervention name(s): ellagic acid + annona muricata
Intervention type(s): Drug
Intervention description(s): pills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HPV, L-SIL
What the Body Does to Foliglurax in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates how the body takes up and gets rid of foliglurax after swallowing a
      liquid dose.
    

Detailed description: 
      Six healthy men will swallow a liquid dose of 80 mg that is labelled with a small dose of
      radioactive tracer. Blood, urine and faeces will be collected to measure how much of the
      radioactivity gets into the blood stream and ends up in the urine and faeces. It is also
      measured how the body gets rid of the radioactivity and how quickly.
    

Intervention name(s): Foliglurax
Intervention type(s): Drug
Intervention description(s): Single oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Regional anesthesia improves quality of recovery after surgery in many studies.
      Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative
      to current regional anesthetic techniques. This randomized, controlled trial is to examine
      the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast
      tumor resection.
    

Detailed description: 
      A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients
      were allocated to either the general anesthesia group (group control) or SPB (serratus plane
      block) + general anesthesia groups (group SPB) using randomized central computer-generated
      sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group
      assignment was concealed by opaque sticking envelops. The major research content is to
      evaluate the quality of recovery using 40 questionnaire (QoR-40).
    

Intervention name(s): Ropivacaine; 0.9% Nacl
Intervention type(s): Drug; Drug
Intervention description(s): patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.; patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
Other intervention name(s): local anesthetic; Normal saline
Intervention MeSH terms: Ropivacaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound; Serratus Plane Block; Quality of recovery