bioihbjkbjnl/mcl2 huggingface dataset:
Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
Condition: Childhood Mortality
Study type: Interventional
Phase: Phase 4

Summary: 
      MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass
      azithromycin distributions for the prevention of childhood mortality. All communities were
      subsequently treated with mass azithromycin for one year. The present trial re-randomized
      communities to azithromycin or placebo for the fourth and fifth year of the study.
    

Detailed description: 
      Pre-trial treatments: in the original MORDOR trial, communities were randomized to 4 rounds
      of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of
      the trial). All communities were subsequently treated with 2 rounds of biannual mass
      azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial).

      Present trial design: The present trial enrolls all communities previously enrolled in the
      Niger site of MORDOR, and re-randomizes communities to biannual mass distributions of either
      azithromycin or placebo (i.e., the seventh, eighth, ninth and tenth rounds of mass drug
      administration since randomization for the original MORDOR trial, occurring in the fourth and
      fifth year since randomization). This results in four patterns of community-based treatment:
      four years of azithromycin (AAAAA), three years of azithromycin followed by one year of
      placebo (AAAPP), two years of placebo followed by two years of azithromycin (PPAAA), and two
      years of placebo followed by one year of azithromycin and then one year of placebo (PPAPP).
      The primary outcome will be all-cause mortality in children aged 1-59 months,as determined by
      biannual census. The mortality rate following re-randomization (i.e., the seventh, eighth,
      ninth and tenth rounds of mass drug administration) will be compared between the two
      re-randomized groups.
    

Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months; Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
Other intervention name(s): Zithromax
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood mortality; Mass treatment; Azithromycin; Infection
Use and Harm Exposure in New Low Nicotine Cigarettes
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      The proposed research extends previous research on Quest® cigarette smoking behavior by
      testing whether compensatory smoking occurs as cigarette nicotine level decreases, and
      whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in
      210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at
      least five years and are not currently interested in quitting, but interested in trying a new
      cigarette product. Participants will be randomized to one of three conditions: 1) smoke their
      own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing
      cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where
      they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages
      beginning with a 5-day preferred own brand cigarette smoking phase for all participants,
      followed by one of the three cigarette conditions. For those smoking Quest® cigarettes,
      cigarette nicotine level will change every 10 days, either in a step-down or random fashion.
      The primary behavioral outcome is smoking topography, a quantitative measurement of smoke
      exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine
      samples to assess carcinogen exposure, specifically NNAL
      (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled
      breath condensate will also be collected at the laboratory visits. At the initiation of the
      study, participants will view the Quest® print advertisement and complete a survey related to
      product expectations in order to determine the impact marketing and advertisement has on
      beliefs, attitudes and behaviors related to Quest® cigarettes.
    


Intervention name(s): Quest
Intervention type(s): Other
Intervention description(s): Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Condition: Tibial Fracture
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into
      different tissue types. The primary objective of the study is to examine the safety of using
      such cells to treat patients suffering from distal tibial shaft fractures. The cells will be
      isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the
      fracture site.
    


Intervention name(s): autologous mesenchymal stem cells implantation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of
      cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram
      (mg) and a 900 mg intramuscular (IM) injection respectively, to separate vastus lateralis
      muscles on each leg. Cabotegravir is an integrase inhibitor being developed in combination
      with rilpivirine, a non-nucleoside reverse transcriptase inhibitor, for the treatment of
      human immunodeficiency virus (HIV). The objective is to evaluate pharmacokinetics,
      tolerability, and safety of cabotegravir long acting plus rilpivirine long acting
      administered concomitantly as two separate IM injections in the vastus lateralis muscle of
      adult healthy participants. The screening phase will be of 30 days, oral lead-in (OLI) phase
      of 28 days, there will be washout period of 10-14 days, followed by an injection phase and
      follow-up period will be up to 52-weeks. Approximately 15 adult healthy participants will be
      enrolled.
    


Intervention name(s): Cabotegravir Tablets; Rilpivirine Tablets; Cabotegravir extended release suspension for injection (long-acting); Rilpivirine extended release suspension for injection (long-acting)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cabotegravir tablets will be white to almost white oval shaped film coated tablets with a unit dose of 30 mg and will be administered orally.; Rilpivirine tablets will be off-white, round, biconvex film coated tablets with a unit dose of 25 mg and will be administered orally.; Cabotegravir long-acting will be a sterile white to slightly pink suspension containing 200 mg per mL of GSK1265744 as free acid for administration by intramuscular injection.; Rilpivirine long-acting will be a sterile white suspension containing 300 mg per mL of rilpivirine as the free base for administration by intramuscular injection.
Intervention MeSH terms: Rilpivirine; Cabotegravir
Intervention model: Single Group Assignment
Intervention model description: Eligible participants will receive orally, tablets of cabotegravir plus rilpivirine for 28 days. There will be 10 to 14 days wash out period followed by an IM injection of cabotegravir long-acting plus rilpivirine long-acting.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cabotegravir; rilpivirine; HIV; Pharmacokinetics; intramuscular injection
Dendritic Cell Vaccination in Melanoma Patients Scheduled for Regional Lymph Node Dissection
Condition: Melanoma Stage III or IV
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As
      such they are currently used in clinical vaccination protocols in cancer patients, and both
      immunological and clinical responses have been observed. For these therapies accurate
      delivery to target organs is essential. Correct delivery and subsequent migration of
      vaccinated DCs to regional lymph nodes is of paramount importance for effective stimulation
      of the immune system. Currently it is not known what the best route of administration is for
      DC vaccines.

      Using magnetically labeled DCs, we investigate the potential of MRI cell tracking to monitor
      DC therapy. This is investigated in stage III/IV melanoma patients in whom a regional lymph
      node dissection is scheduled. Autologous monocyte-derived DCs are labeled with the clinically
      approved superparamagnetic iron oxide (SPIO) formulation Endorem and 111In-oxine and injected
      either in the skin or directly in lymph nodes under ultrasound guidance. Two days after
      vaccination patients are monitored with scintigraphy and MR imaging. Lymph nodes are then
      resected. Subsequently patients receive 3 more vaccination with DCs. During and after therapy
      immune responses against the used melanoma peptides are monitored.
    


Intervention name(s): Peptide-pulsed dendritic cells
Intervention type(s): Biological
Intervention description(s): peptide-pulsed dendritic cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic cells; Immunotherapy; Vaccination; Melanoma; Peptides; MRI; Scintigraphy; Immune response
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir
      in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir
      (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive
      multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess
      safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
    


Intervention name(s): Famciclovir
Intervention type(s): Drug
Intervention description(s): Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
Intervention MeSH terms: Famciclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: herpes simplex; cold sores; fever blisters; children; Famvir; famciclovir
Bioavailability, Pharmacokinetics and Tissue Distribution of R-flurbiprofen Capsules in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      For previous clinical trials, R-flurbiprofen has been prepared in tablet form. In this study
      R-flurbiprofen, will be available as gelatine capsules.

      This study aims to show the bioavailability of R-flurbiprofen when administered in gelatine
      capsules. The serum availability will be determined by analysis of pharmakokinetic (pK)-blood
      samples at different time points. To assess the safety of the administered capsules adverse
      events will be documented.

      Analysis of lipid signaling molecules in plasma will be done to assess the role of this
      molecules as variable for therapeutic effects.
    


Intervention name(s): R-flurbiprofen
Intervention type(s): Drug
Intervention description(s): 200 mg gelatine capsule once orally
Other intervention name(s): Tarenflurbil
Intervention MeSH terms: Flurbiprofen; Tarenflurbil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pharmakokinetic; capsules; R-Flurbiprofen
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a dose-finding study that evaluated the change in weight after 24 weeks treatment
      with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed
      by 24 weeks treatment with 2 doses of LIK066 and placebo.
    


Intervention name(s): LIK066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LIK066 will be supplied in different doses as tablets to be taken orally.; Placebo
Intervention MeSH terms: Licogliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; Overweight
A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants
      with schizophrenia.

      Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with
      schizophrenia as measured by cognitive function and neurophysiological biomarkers.

      The secondary purpose of this study is to evaluate the pharmacokinetics of ASP6981 in
      participants with schizophrenia.
    

Detailed description: 
      This study will evaluate ASP6981 in stable participants with schizophrenia on stable doses of
      up to 2 second generation antipsychotic drugs for at least 2 months prior to screening.
      Participants will be enrolled and randomized into 1 of 4 treatment sequences: AB, BA, CD, DC.

      Screening period: After a screening period of up to 29 days prior to study drug
      administration, eligible participants will be admitted to the clinical unit on day -3.

      Investigational period: Enrolled participants will be randomized to receive either ASP6981 or
      Placebo first and then will be crossed over to receive the opposite intervention. The study
      will consist of two treatment periods of 14 days separated by a washout period of 14 days.
      Participants will be discharged from the clinical unit on day 15 for the washout period.
      Washout may be extended up to a maximum of 21 days depending on the participant's
      availability.

      Follow up: Participants will return to the clinical unit for an End of Study Visit (ESV) on
      day 28 of period 2 or, if the participant terminated early from the study, 14 days after the
      last dose of study drug.
    

Intervention name(s): ASP6981; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; ASP6981; Safety; Phase 1
Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study in sickle cell disease
      participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants
      with sickle cell disease will be enrolled and randomized: 12 participants in each of four
      active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.
    


Intervention name(s): Low Dose Rifaximin ER; Low Dose Rifaximin DER; High Dose Rifaximin ER; High Dose Rifaximin DER; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Low Dose Rifaximin Extended Release Twice Daily; Low Dose Rifaximin Delayed Extended Release Twice Daily; High Dose Rifaximin Extended Release Twice Daily; High Dose Rifaximin Delayed Extended Release Twice Daily; Placebo Twice Daily
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Growth Hormone on Bone Metabolism in Anorexia Nervosa
Condition: Anorexia Nervosa; Osteopenia; Osteoporosis; Eating Disorders
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      Decreased bone strength is a serious medical problem present in many women with Anorexia
      Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones
      than women with normal bone strength.

      We are investigating whether a hormone that is naturally produced by the human body, called
      growth hormone, can help strengthen the bones of women with this type of disordered eating.
    

Detailed description: 
      -  Twelve week study

        -  Eight visits, six of which can be conducted at your home physician's office

        -  Two bone density scans

        -  Hormonal and nutritional evaluations
    

Intervention name(s): Recombinant Human Growth Hormone; Placebo for Recombinant Human Growth Hormone
Intervention type(s): Drug; Drug
Intervention description(s): Dosage increased in steps for first four weeks. Self injection qd x 12 weeks; Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
Other intervention name(s): Nutropin AQ; Placebo for Nutropin AQ
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anorexia Nervosa; Eating disorder; Bone; Growth hormone; Osteopenia; Osteoporosis
To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Depression
Study type: Observational

Summary: 
      This is an observational, non controlled, multicentric, prospective study planned to be
      conducted in 350 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina
      to identify the predictive factors leading to depression. The incidence of depression
      symptoms and its influence in the evolution of the disease are unknown in the Argentinean
      population. Early diagnosis of depression symptoms allows the specific treatment of them and
      can also delay the rich apparition of the disease. This study intends to quantify the
      incidence of these symptoms and also aims to evaluate which are the predictive factors of the
      apparition of the depression.
    

Detailed description: 
      Multiple sclerosis is a chronic, demyelinating disease of the central nervous system and is
      considered to be one of the most common cause of neurological disability in young adults. The
      clinical and pathophysiological characteristics of the disease lead to the association of
      several conditions over time, among which the depression and/or the depression symptoms are
      one of the most important ones. The underlying mechanism of depression is not clear and the
      etiology of depression is considered to be multifactorial and especially associated to the
      psychosocial stress, to the presence of focal demyelinating lesions and to the immune
      malfunction. Several scales like Beck Depression Inventory Fast Screen (BDI FS), Mini Mental
      State Examination (MMSE), Hamilton Depression Rating Scale (HDRS) have been used to objectify
      the presence of depression symptoms in subjects with MS.

      OBJECTIVES

      Primary objective:

        -  Identification of the predictive factors for the development of depression symptoms in
           subjects with MS in Argentina

      Secondary objective:

        -  Evaluation of the proportion of subjects that develop depression symptoms during the
           follow up

      The subjects will be managed with the clinical and therapeutic elements that the treating
      doctors considered appropriate, without modifying their decisions due to the subjects'
      inclusion into the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with diagnosed MS in Argentinean population.
      
Keywords: Multiple sclerosis; Depression
Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      single rising oral doses and multiple oral doses of TR-701
    

Detailed description: 
      This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single
      (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as
      a capsule in normal, healthy adult volunteers. The study will be sequential between Part A
      and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in
      Part A and first cohort in Part B.
    

Intervention name(s): TR-701; linezolid; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.; Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.; Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: antibiotic