bioihbjkbjnl/mcl2 huggingface dataset:
Cefazolin PK Study 3g vs 2g
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study is to characterize the safety and tolerability of cefazolin after a single IV
      administration in healthy subjects in a 3 g/150 mL presentation to meet the increasing
      clinical need for the indication of perioperative prophylaxis in this patient population
      weighing greater than or equal to (≥) 120 kg.
    


Intervention name(s): Cefazolin
Intervention type(s): Drug
Intervention description(s): Cefazolin Injection - 2 g/100 mL or 3 g/150 mL
Intervention MeSH terms: Cefazolin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1
Condition: Human Immunodeficiency Virus (HIV); HIV Infection; HIV-1
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in two stages and will test the safety/tolerability,
      pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the
      immune system and the virus) of the study drug ABBV-181 in Human immunodeficiency virus
      (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.
    


Intervention name(s): ABBV-181; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) Infusion; Intravenous (IV) infusion
Other intervention name(s): Budigalimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus (HIV); HIV Infection; HIV-1; ABBV-181; Analytical Treatment Interruption; Budigalimab; Programmed cell death protein-1 (PD-1); Anti-PD-1 Antibody
Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      This will be a single center, 7-day, examiner blind, two treatment-arm, randomized,
      stratified (Sjogren's Syndrome status [Y/N]), parallel group study conducted in participants
      experiencing dry mouth symptoms. This study is designed to investigate the effect of an
      experimental mouthwash formulation in providing relief of dry mouth symptoms.
    


Intervention name(s): Biotene mouthwash; Mineral Water
Intervention type(s): Other; Other
Intervention description(s): During supervised product use: Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage is permitted. At Home use:Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. A maximum of two doses can be used per day.; During supervised product use:Participants will take a dose (drink) of one measured sip of 15mls of water.
At Home use: Participants can sip (drink) water as often as required. Participants will be consuming their own water for home use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
Condition: Environmental and Genetic Factors on Lung Function
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study to understand how environmental and genetic factors may be
      involved in lung function. Study participants will undergo a 1-day screening that includes a
      blood draw and breathing testing, return for a two-day series of testing to include blood
      draw, and brief breathing test before and after an inhaled challenge with either filtered air
      (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw
      and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants
      then return 18 - 20 days later to repeat the two-day series of testing to be challenged with
      the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5
      hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test
      series. Total study duration is about one to one-and a half months.
    


Intervention name(s): Ozone; Filtered Air
Intervention type(s): Drug; Other
Intervention description(s): Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).; Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: genetic: CXCR3 polymorphism rs2280964
A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.)
      and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.
    

Detailed description: 
      A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing
      Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and
      Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris
    

Intervention name(s): Tretinoin Cream 0.025%
Intervention type(s): Drug
Intervention description(s): The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
Other intervention name(s): Tretinoin
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergic rhinitis is a common condition characterize by inflammation of the upper airways.
      Third generation antihistamines have been demonstrated effective in the treatment of this
      condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis,
      adenosine monophosphate may also be used as a means to investigate these effects but as yet
      its effects have yet to be compared to allergen challenge. We intend to compare the effects
      of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo
      in a double blind cross-over study. The study will include 20 patients with allergic
      rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment.
      The primary outcome variable will be the change in concentration of AMP/Allergen required to
      produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling
      dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be
      deemed significant. We will also measure time to recovery after both challenges. AMP
      challenge is a safe alternative to allergen challenge and does not have the risk of
      anaphylaxis.
    


Intervention name(s): levocetirizine; placebo to levocetirizine
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg once nightly before visit; 1 tablet once nightly before visit
Intervention MeSH terms: Cetirizine; Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; levocetirizine; nasal provocation testing; nasal allergen challenge; nasal adenosine monophosphate challenge
Caregiver Training to Prevent Konzo Disease in Children in Democratic Republic of Congo
Condition: Malnutrition; Manihot Species Poisoning
MeSH terms: Malnutrition; Poisoning
Study type: Interventional

Summary: 
      The proposed research will adapt the caregiver training and child neurodevelopmental
      assessment capacity that the PI previously built in Uganda beginning in 2008, to a
      community-based intervention model for the prevention of konzo in the Democratic Republic of
      Congo.
    

Detailed description: 
      Early childhood (1 through 4 yrs) is a period of dramatic developmental change that can be
      seriously compromised by exposure to toxic cyanogenic cassava (konzo disease), with
      potentially great impact throughout central and western sub-Sahara Africa in regions
      dependent on this food staple. In the face of ongoing economic instability and nutritional,
      medical and educational deprivation affecting konzo at-risk communities in the Democratic
      Republic of Congo, no programs exist for sustaining a favorable developmental milieu for
      these children. By establishing the viability of caregiver training interventions to enhance
      functionality among caregivers and improve caregiving quality while preventing konzo, the
      present R21 proposal can benefit tens of millions of children at-risk neurodevelopmentally;
      not only from poorly processed cyanogenic cassava, but also from a myriad of other
      non-infectious and infectious diseases.
    

Intervention name(s): Wetting method (WTM); Mediational Intervention for Sensitizing Caregivers (MISC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The wetting method is an evidence-based, simple process to remove cyanogens from cassava flour. It involves teaching women to add water to cassava flour and allow it to stand for 2 h in the sun or 5 h in the shade for the hydrogen cyanide gas to escape. Colorfully illustrated and durable laminated posters depicting the WTM will be distributed to participating households. Women will receive this training bi-weekly for 12 months; The study team will use MISC to train DRC mothers in practical day-to-day activities with their children to enhance 5 key mediational processes: 1) focusing (getting the child's attention and engaging directing them to learning experiences); 2) exciting (communicating excitement, appreciation, and affection with the learning experience); 3) expanding (making the child aware of how the learning experience transcends the present situation and can include past and future issues beyond the immediate need of the moment); 4) encouraging (emotional support to foster the child's sense of security and competence); and 5) regulating (helping to direct the child's behavior in constructive ways with a goal towards self-regulation).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Psychological Impact of the Health Measures Generated by the COVID19 in Adolescents
Condition: Psychological Adaptation; Psychology, Social
Study type: Observational

Summary: 
      The lockdown of the French population is a health measure put in place in response to the
      pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to
      recommend hygienic "barrier gestures" and social distancing, the decision to confine the
      population at the national level was decided by the executive from Monday 16 March to Monday
      11 May 2020. The national confinement implies the restriction of movement to the strict
      necessary, outings near the home and the closure of schools and communities. These decisions
      have led to an unprecedented state of stress for the entire French population, the
      consequences of which are unknown in the short, medium or long term. The objectives of this
      study are to evaluate the psychological impact of the confinement on adolescents with or
      without chronic disease and also the difficulties and fears engendered by deconfinement .
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.
Other intervention name(s): Interview
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be proposed to all the adolescents followed in the Centre hospitalier
        Intercommunal de Creteil for a chronic disease or not.
Oral Health Among Adolescents.
Condition: Dental Consultation
Study type: Observational

Summary: 
      The aim of this study is to identify the knowledge and behavior on dental health and hygiene
      among adolescents. In most cases, the investigators know tooth decay can be prevented and
      reversed at an early stage by observing good oral hygiene. Few studies have been done among
      adolescents.

      This study could justify the implementation of public health actions in terms of prevention.
    


Intervention name(s): Questionnaire on practices and knowledge in terms of oral hygiene
Intervention type(s): Other
Intervention description(s): Questionnaire on practices and knowledge in terms of oral hygiene during a dental consultation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        15 - 17 year old adolescents
Effectiveness of Nebulized Hypertonic Saline and Epinephrine in Hospitalized Infants With Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute bronchiolitis is the main cause for respiratory illness that requires hospitalization
      in children younger than 2 years. In the United States it has been shown that the burden of
      the disease is considerable, having an annual cost of more than $ 500 million and being
      responsible for the 17% of all infant hospitalizations . Aim of the present study was to
      verify the effects of nebulized 3% saline solution in comparison to normal saline in
      addiction to epinephrine in a large population of RSV positive cases of bronchiolitis; all
      patients presented a disease as much as severe to require hospitalization.The main study
      endpoints were the length of stay in hospital and the clinical response.
    

Detailed description: 
      Among 136 patients assessed within 12 hours for entry into the study, 109 (69 males) accepted
      to participate, gave an informed consent and were randomly assigned either to receive every 6
      hours the nebulized 0.9% saline (NS) (group I) or the 3% HS (group II) in addition to
      aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids). Patients
      were randomized to receive different saline treatments using a computer-based randomization
      program. Study solutions, prepared by the local hospital pharmacy, were blinded to
      participants and investigators. Each treatment was delivered by a nebulizer with continuous
      flow of oxygen at 6 L/min through a tight-fitting facemask.

      The main study endpoints were the length of stay (LOS) in hospital and the clinical response.
      LOS in hospital was defined as the time between study entry (within 12 hours of admission to
      the hospital) and the time at which the infant was discharged on the basis of the clinical
      grounds by the attending physician. Clinical response was determined using daily CSS
      evaluation; furthermore, the CSS was evaluated every day before and 30 minutes after
      nebulisation.
    

Intervention name(s): 3% hypertonic saline solution
Intervention type(s): Other
Intervention description(s): Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bronchiolitis, 3% Hypertonic Saline Solution
Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study design of this trial is open-label, randomized, multi-center, parallel-group study.
    

Detailed description: 
      The effectiveness of treatment of a disease depends mainly on two factors: the efficacy of
      the treatment and the compliance of the patient with this treatment. Polymedication is one of
      the predisposing factors to low compliance in type 2 DM. It can be expected that a simple
      regimen may improve compliance. Amaryl Mex phase III trial was not designed to compare the
      compliance of patients with different dosing regimens of oral antidiabetic drugs. However, it
      was found that patients' compliance in the morning was better than in the evening, suggesting
      that Amaryl Mex once daily regimen may improve compliance. Pill count is the gold standard
      for measuring compliance, but this method provides incomplete and unreliable results.
      Advanced electronic monitoring device obtains details of patients' behavior during the day
      and over long periods.
    

Intervention name(s): Glimepiride/ Metformin; Glimepiride/ Metformin
Intervention type(s): Drug; Drug
Intervention description(s): 4/1000mg once daily; 4/1000mg bid
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amaryl MEX
A Blood Test to Look at Cells of the Immune System in Healthy Children
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to learn more about some of the immune cells in the blood (CD4
      cells, for example) of healthy children in order to better understand the differences in the
      blood cells of children infected with HIV.

      Because children's bodies are still developing, their cells are different from those of
      adults, and their bodies respond differently to infections such as HIV. In order to
      understand how immune cells grow and mature so that they can fight HIV, it is important to
      see how these cells behave in normal children.
    

Detailed description: 
      Early in life, the cells involved in immune selection differentiate into CD4+ and CD8+ cells.
      Currently there is insufficient information on the cell maturation and activation of these
      peripheral blood mononuclear cell (PBMC) subsets in normal children. The critical need for
      this information has been brought about by the pediatric HIV/AIDS epidemic, which requires
      the measurement of peripheral blood CD4+ T cells and other cells types for interpretation of
      HIV disease progression. The immunopathogenesis of pediatric HIV infection differs from that
      in adults but is not well understood. In order to better understand HIV disease progression
      in HIV-infected children, these PBMC subsets must be studied in normal children so that
      control values can be established.

      Healthy infants, children, and adolescents presenting for routine care or elective surgery
      have a single blood sample obtained. Blood is used for complete blood count, peripheral blood
      mononuclear cell flow analysis for surface markers, and plasma and cell storage. Demographic
      information including age, sex, race, and ethnicity is obtained at the time of the blood
      draw. The reason for the patient's visit is also documented. No study drugs are administered
      or supplied as part of this study. Statistical analysis is used to estimate the median
      distribution of each CD4 and CD8 subset.
    

Keywords: Monocytes; Flow Cytometry; HIV Seronegativity; Phenotype; Lymphocyte Subsets
The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation
Condition: Brain Tumor; AVM; ICH
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic
      changes to head fixation in the patients undergoing neurosurgery.
    


Intervention name(s): remifentanil
Intervention type(s): Drug
Intervention description(s): According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during head fixation. And, For this allocation of dose of remifentanil the investigators use biased coin design up-and-down method.
For the first patient, the dose of remifentanil would be fixed at 5.5ng/ml which we predict as EC90. And, step size of dose is 0.5ng/ml.
Other intervention name(s): Biased coin design up-and-down method.
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The creole study is a A Multi-centre, multinational, randomised single-blind, parallel group,
      three-armed superiority trial which is aimed at comparing the efficacy of three "free"
      combinations of two anti-hypertensive agents on 24 hour ambulatory systolic blood pressure
      (ASBP) in black African hypertensive patients.
    

Detailed description: 
      The CREOLE trial will be performed at ten investigational sites in six countries in
      Sub-Saharan Africa which include Cameroun, Kenya, Mozambique, Nigeria, South Africa and
      Uganda. Subjects will be randomised to one of three treatments which are Perindopril plus
      Amlodipine or Perindopril plus Hydrochlorothiazide or Amlodipine plus
      Hydrochlorothiazide.Patients will commence treatment at a starting dose of Amlodipine plus
      Hydrochlorothiazide 5/12.5 mg or Amlodipine plus Perindopril 5/4 mg or
      Perindopril/Hydrochlorothiazide 4/12.5 mg. These doses will increase at the two months visit,
      to Amlodipine/Hydrochlorothiazide 10/25 mg or AmlodipinePperindopril 10/8mg or
      Perindopril/Hydrochlorothiazide 8/25 mg.

      The patients will have ambulatory blood pressure monitoring at randomization and at six
      months and office blood pressure measurements at randomization and at two-month, 4-month and
      six-month visits.The overall aim is to discover the best combination of front-line
      anti-hypertensive medications for black patients residing in sub-Saharan Africa.
    

Intervention name(s): Perindopril plus Amlodipine; Perindopril plus Hydrochlorothiazide; Amlodipine plus Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Group 1; Group 2; Group 3
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment