bioihbjkbjnl/mcl2 huggingface dataset:
Cellular Dynamics of Subcutaneous Fat Distribution in Obese Women
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The body shape of obese women varies between having the majority of fat either above the
      waist ("apple" shape) or below the waist ("pear" shape). The study will investigate what
      restricts: apple"-shaped women from being "pear"-shaped at the cellular level. Since "pear"
      shaped women tend to have better health, this study will open the door to future research in
      regulating body shape and thus improving health.
    

Detailed description: 
      Adipose tissue expandability and the distribution of stored fat in the body are stronger
      predictors of health risk. A better understanding of the factors that determine regional fat
      mass growth may lead to developing new strategies for prevention or treatment of metabolic
      complications of obesity. The objective of this proposal is to study the responsiveness of
      different fat depots to adipogenic stimulation in upper-body and lower-body obese women.
    

Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30mg per day for four months
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Obesity; Fat distribution; Adipogenesis; Adipocyte; Preadipocyte; Ectopic fat
A Study of Ketamine in Patients With Treatment-resistant Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the optimal dose frequency of ketamine in patients
      with treatment-resistant depression (TRD).
    

Detailed description: 
      This is a double-blind (patients and study personnel do not know the identity of the
      administered treatments), randomized (the drug is assigned by chance), placebo-controlled
      (placebo is a substance that appears identical to the treatment and has no active
      ingredients), parallel arm study (each group of patients will be treated at the same time).
      The study will consist of a screening phase of up to 4 weeks, a 4-week double-blind treatment
      phase (Day 1 to Day 29), and a 3-week post treatment (follow up) phase. In the double-blind
      phase, patients will receive over 4 weeks either intravenous (IV) infusions of placebo (2 or
      3 times weekly) or IV infusions of ketamine (2 or 3 times weekly). The total study duration
      for each patient will be a maximum of 13 weeks.
    

Intervention name(s): Placebo; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.; Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; Treatment-resistant depression; Ketamine
Evaluation of GSK561679 in Women With Post-Traumatic Stress Disorder
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the hypothesis of whether an antagonist at the corticotropin releasing
      factor type 1 (CRF1) receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of
      post-traumatic stress disorder (PTSD).
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is a chronic and common anxiety disorder that follows
      exposure to an overwhelming traumatic event. The majority of patients with PTSD also meet
      criteria for other psychiatric disorders and PTSD is associated with an increased risk for
      suicide attempts.

      PTSD is responsive to psychological and pharmacological treatments, such as selective
      serotonin reuptake inhibitors (SSRIs), but response rates rarely exceed 60%, and even fewer
      patients (20-30%) achieve clinical remission. Thus, there is a clear need to develop novel
      and improved therapeutics for PTSD.

      The study is divided into 4 phases:

      Phase 1 (Screening): a 1 week no drug screening period to assess study eligibility.

      Phase 2 (Pre-Treatment Testing Period): Eligible patients will be enrolled into a 1 week
      Testing Phase, which will include neuropsychological and neurophysiological testing as well
      as blood draws and electrocardiogram.

      Phase 3 (Treatment Period): Eligible patients will be enrolled in a two-armed 6-week period
      of double-blind placebo-controlled acute treatment. All subjects who continue to meet
      eligibility criteria will be randomized to one of two groups: GSK561679 (at a fixed dose of
      350 mg/day) or placebo. Randomization will be performed at a 1:1 ratio into two treatment
      groups. Neuropsychological and neurophysiological testing will be repeated after 5 weeks of
      the double-blind treatment period.

      Phase 4 (Follow-up Period): Safety follow-up visits will be conducted 1 week and 1 month
      after the end of the treatment Phase 3.
    

Intervention name(s): GSK561679; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK561679, oral administration, 350mg/day, 6 week administration; Matching placebo, oral administration, 1 pill/day for 6 weeks
Other intervention name(s): CRF1 antagonist; Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: PTSD; Anxiety Disorder; Corticotropin releasing factor; Women
Maraviroc in Patients With Moderate and Severe COVID-19
Condition: COVID
Study type: Interventional
Phase: Phase 1

Summary: 
      Maraviroc, a C-C Chemokine Receptor 5 (CCR5) antagonist, is well-tolerated without
      significant side effects in its current use in patients with HIV. CCR5 antagonism prior to
      the 'second wave' of inflammatory mediator expression in SARS-CoV-2 may reverse lymphoid
      depletion and may alter cell trafficking of inflammatory cells, both increasing viral control
      capacity and dampening damage to lung tissue, respectively. This study seeks to establish
      whether one week of treatment with Maraviroc, used at its approved dosage for HIV, is safe
      and tolerable in patients with SARS-CoV-2.
    


Intervention name(s): Maraviroc
Intervention type(s): Drug
Intervention description(s): Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy. The cytokine panel will consist of CCL5, IL-6, and Chitinase 3-like 1(Chi3l1).
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maraviroc; CCR5 Antagonist
A Clinical Trial on the Antipsychotic Properties of Cannabidiol
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is
      effective in the treatment of acute schizophrenic or schizophreniform psychosis in a
      placebo-controlled, randomized double-blind study.
    

Detailed description: 
      Despite recent advances in the treatment of schizophrenia and schizophreniform disorders,
      there is still a need to develop efficient and better tolerated psychopharmacological
      approaches to this group of diseases. The endogenous cannabinoid system provides a promising
      target in the pharmacotherapy of these disorders. This approach is based upon recent findings
      indicating that the human endogenous cannabinoid system is significantly involved in the
      pathogenesis of schizophrenia and that cannabidiol is effective in treating acute psychotic
      symptoms of schizophrenic patients. We will investigate cannabidiol versus placebo in a
      randomized, double blind design with extensive safety measures.

      The primary hypothesis to be tested is that Cannabidiol is expected to be superior to placebo
      in the treatment of acute schizophrenic and schizophreniform psychoses with regard to its
      antipsychotic efficacy.
    

Intervention name(s): Placebo/Cannabidiol; Cannabidiol/Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg/day, oral, capsules, 2 weeks, than cross-over; 600 mg/day, oral, capsules, 2 weeks, than cross-over
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia and Disorders with Psychotic Features
Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapies in Subjects With Aggressive B-cell Lymphomas
Condition: Relapsed/Refractory Aggressive B-cell Lymphomas
MeSH terms: Lymphoma; Lymphoma, B-Cell; Aggression
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680
      in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2
      prior lines of therapy.
    

Detailed description: 
      This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with
      immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics,
      immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive
      B-cell lymphomas
    

Intervention name(s): MEDI-551 12 mg/kg; MEDI0680 2.5 mg/kg; MEDI0680 10 mg/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13; Participants will receive IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.; Participants will receive IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aggressive lymphoma, DLBCL, NHL
Cefixime / Azithromycin pK Study
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q
      8-hour schedule) alone and also co administered with a single 1000 mg oral dose of
      azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels
      of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and
      whether there are significant changes in cefixime PK after co-administration. The primary
      pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg
      doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds
      2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg
      doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,
      achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to
      evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen
      of 800
    

Detailed description: 
      This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q
      8-hour schedule) alone and also co administered with a single 1000 mg oral dose of
      azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels
      of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and
      whether there are significant changes in cefixime PK after co-administration. The primary
      pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg
      doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds
      2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg
      doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin,
      achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to
      evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen
      of 800 mg cefixime given on a q 8-hour schedule. The primary safety objectives are to assess
      the safety and tolerability of a treatment regimen that includes three doses of 800 mg
      cefixime; to assess the safety and tolerability of a treatment regimen that includes three
      doses of 800 mg cefixime co-administered with a single 1000 mg dose of azithromycin. The
      study will take place for 10 weeks.
    

Intervention name(s): Azithromycin; Cefixime
Intervention type(s): Drug; Drug
Intervention MeSH terms: Azithromycin; Cefixime
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Azithromycin; Cefixime; Duration; High-Dose; Neisseria gonorrhoeae; Pharmacokinetics; Susceptibility
Role of Overjet and Trauma in Libyan Children
Condition: Trauma; Overjet
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Traumatic dental injuries are one of the commonly encountered dental emergencies. Missing
      anterior tooth in children due to any injury can be a source of considerable physical and
      psychological discomfort for the child. These consequences also have significant impact on
      parents, who are generally concerned with esthetic and economic aspects of this problem. It
      varies from small crack in the enamel to complete loss of the tooth. Injury to children teeth
      can be both painful and traumatic to the children
    

Detailed description: 
      Traumatic injuries to anterior teeth have reported by several investigators. In Asia and
      Africa, the prevalence of TDI to anterior teeth among adolescents ranges from 4% to 35% and
      15% to 21%, respectively and in America and Europe, the prevalence varied from 15% to 23% and
      23% to 35%, respectively . 50% of school children have sustained traumatic injuries prior to
      graduation . A contributing factors make children susceptible to injuries have been widely
      investigated. These factors included Class-II, div.1 malocclusion, increased overjet . 71% to
      92% of all injuries sustained in a lifetime occur before the age of 19 years, which occur at
      home, followed by school and public places.The aim of this study is to assess the mean
      overjet value in Libyan children and to examine the relationship between increased overjet
      and trauma to permanent incisor teeth
    

Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        . Total of 2015 Libyan school children aged 7 to 16 years from urban (Tobruk) and rural
        (Kufra) areas were examined in the main study. The children were of almost equal number of
        both sexes from each age group
      
Keywords: trauma; overjet; libya; schoolchildren
BE Study of Two Formulations of Rivaroxaban 2.5 mg in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the pharmacokinetic profiles and bioequivalence of
      rivaroxaban after a single oral dose of rivaroxaban 2.5 mg tablet in healthy Korean subjects.
    

Detailed description: 
      This study was a randomized, open-label, single-dose, two-period, crossover study which
      included 34 healthy adult male and female subjects under fasting conditions. A single dose of
      experimental drug or comparator was administered in each of the two study periods (separated
      by a washout period of 1 week). Serial blood samples were collected up to 36 hours post-dose.
      Plasma drug concentrations were measured by liquid chromatography/tandem mass spectrometry
      (LC-MS/MS). Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and
      area under the plasma concentration versus time curve from dosing to the last measurable
      concentration (AUCt), were determined by non-compartmental analysis. The geometric mean
      ratios and associated 90% confidence intervals (CIs) of log-transformed Cmax and AUCt were
      calculated to evaluate pharmacokinetic equivalence.
    

Intervention name(s): YHP1807 Tab. 2.5mg; YHR1901 Tab. 2.5mg
Intervention type(s): Drug; Drug
Intervention description(s): Rivaroxaban 2.5mg; Rivaroxaban 2.5mg
Other intervention name(s): Experimental; Active comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intra-pocket Application of Tea Tree Oil Gel in the Treatment of Stage-2 Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to assess clinically and biochemically the effect of intrapocket application
      of tea tree oil (TTO) gel adjunctive to SRP in the management of stage 2(moderate)
      periodontitis and to correlate the biochemical levels with clinical response.
    

Detailed description: 
      A randomized, controlled clinical trial included thirty patients with stage 2 periodontitis.
      They were equally divided into two groups: Group 1 (control group) treated with scaling and
      root planning (SRP) alone and Group 2 (test group) managed by SRP and locally delivered 5%
      tea tree oil (TTO) gel.
    

Intervention name(s): Scaling and Root Planing; Scaling and Root Planing with tea tree oil
Intervention type(s): Procedure; Drug
Intervention description(s): Supra- and sub-gingival calculus and debris were removed; Supra- and sub-gingival calculus and debris were removed and 5% tea tree oil was applied
Intervention MeSH terms: Tea Tree Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
Condition: DME
MeSH terms: Macular Edema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of
      diabetic macular edema (DME) with intravitreal bevacizumab (IVB).

      Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic
      Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a
      randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with
      best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have
      had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized
      into two groups. Both groups received two IVB injections with 6-week interval. One group
      received topical ketorolac every 6 hour in the first interval and then artificial tear every
      6 hour as a placebo in the second interval. The other group received the opposite
      medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
      evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks.
      The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes.
      The interim analysis of this study is presented in this report.
    


Intervention name(s): prescription topical ketorolac in group 1; prescription artificial tear in group 2; prescription topical ketorolac in group 2; prescription artificial tear in group1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.; artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.; artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.; topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin
Condition: Cataract Senile; Endophthalmitis; Antibiotic Side Effect; Safety Issues
MeSH terms: Endophthalmitis; Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative
      infection prophylaxis
    

Detailed description: 
      Randomized clinical trial comparing corneal and retinal changes after intracameral
      levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing
      uncomplicated phacoemulsification.
    

Intervention name(s): Levofloxacin Ophthalmic; Moxifloxacin Ophthalmic
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 ml of unpreserved 0.5% levofloxacin; 0.1 ml of unpreserved 0.5% moxifloxacin
Intervention MeSH terms: Moxifloxacin; Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: levofloxacin; moxifloxacin; prophylaxis; endophthalmitis; cataract surgery
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
Condition: Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a
      three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
    


Intervention name(s): Infanrix™-IPV/Hib
Intervention type(s): Biological
Intervention description(s): Intramuscular, three doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Combined vaccine