bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Extension Study to Evaluate MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of
      glabellar lines.
    


Intervention name(s): MBA-P01
Intervention type(s): Drug
Intervention description(s): MBA-P01 will be injected into the Glabellar line.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study were to assess the safety and tolerability of LDP-02 in patients
      with active Crohn's disease who were not receiving corticosteroids or immunosuppressives, to
      assess the ability of LDP-02 to reduce Crohn's disease activity, and to obtain
      pharmacokinetic (PK) and pharmacodynamic(PD)information for LDP-02 in patients with active
      Crohn's disease.
    


Intervention name(s): LDP-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each patient in arms 2 & 3 received a single IV dose of study drug at 0.5 or 2.0 mg/kg LDP-02 on Days 1 and 29.; Each patients in arm 1 received a single IV dose of placebo on Days 1 and 29.
Other intervention name(s): MLN0002, MLN02; MLN0002, MLN02
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Condition: Hepatic Cirrhosis; Hepatic Encephalopathy (HE)
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main reason for this study is to see how the study drug interacts with the body.

      It will compare different doses of the study drug with a drug already in use.

      Participants will be adults with liver disease that has affected the brain in the past.
    


Intervention name(s): MNK6106; Rifaximin
Intervention type(s): Drug; Drug
Intervention description(s): 1 gram tablet of MNK6106 for oral administration; 550 mg tablet of rifaximin for oral administration
Other intervention name(s): Study Drug; L-Ornithine Phenylacetate; Xifaxan
Intervention MeSH terms: Rifaximin; Phenylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurocytotron on Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This is a randomized, double-blinded, two-arm, placebo-controlled clinical study. The
      enrollment will be randomized 1:1 to Neurocytotron treatment or mock treatment (placebo).

      Upon the completion of the study period, the placebo group will receive treatment, if the
      study results show benefits to patients.
    

Detailed description: 
      The study proposes to investigate the use of non-thermal and non-radioactive radiofrequency
      pulses in the brain for improving the symptoms of cerebral palsy. The proposed treatment will
      deliver radiofrequency pulses to the brain of patients in a non-invasive manner. The duration
      of the treatment will be 1 hour per day, for 28 days. After treatment, participants will be
      monitored for two months to detect potential adverse events and any signs of symptoms
      improvement. The study will be closed once 48 subjects complete the study. At the end of the
      study, the placebo group will have the opportunity to receive treatment with the
      Neurocytotron, based on the benefits shown by study results.
    

Intervention name(s): Neurocytotron; Placebo
Intervention type(s): Device; Device
Intervention description(s): Neurocytotron utilizes a combination of instantaneous magnetic field and low-spectrum radiofrequency waves for therapeutic purpose. Its working principle is based on the theory of magnetic resonance.; Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Povidone Iodine and Cesarean Section Wound Infections
Condition: Wound Infections
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by
      Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section
      wound infections & compare side effects of both agents.
    

Detailed description: 
      For centuries, hand washing with soap and water has been considered the main approach for
      personal hygiene. In the community, hand hygiene has been known to prevent infectious
      diseases and to decrease the burden of disease. Currently, hand hygiene is considered the
      most important measure for preventing the spread of pathogens in health-care settings.

      There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine,
      iodine/iodophors, para-chloro-meta-xylenol & triclosan. Ideally, the optimum antiseptic used
      for scrub should have broad spectrum of activity, persistent effect & fast acting.
      Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring
      hand bacterial colony counts. No randomized clinical trials have evaluated the impact of
      surgical scrub choice on surgical site infection risk & proven its efficiency.
    

Intervention name(s): Povidone Iodine 10% vand cesarean section wound infections; Povidone Iodine 7.5% vand cesarean section wound infections
Intervention type(s): Drug; Drug
Intervention MeSH terms: Iodine; Cadexomer iodine; Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Betadine; Povidine Iodine; Hand scrubbing; Cesarean section wound infections; post cesarean section
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.
    


Intervention name(s): anti-IL-20; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.; Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of IV Lidocaine Infusions on Pain
Condition: Pain
Study type: Interventional

Summary: 
      Our goals for this study involve using intravenous lidocaine as it is normally used in the
      Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic
      pain. Studies have been done determining the efficacy of intravenous lidocaine for treating
      pain but little research has been done to determine the effects of an intravenous lidocaine
      infusion on the different components of the pain experience. Our study will incorporate pain
      quality measures both before and during the infusions of lidocaine to determine changes in
      present pain intensity.
    

Detailed description: 
      Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a
      computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a
      step-wise manner, keeping the concentration during each infusion step constant. Plasma
      concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of
      the medical team. This will be conducted according to standard medical practice for the
      infusion and the study procedures will not affect the infusion paradigm. Total infusion time
      is approximately 1-2 hours. During the course of the study, the primary outcome measure was
      changed from blood oxygenation level dependent (BOLD) signal to pain intensity.
    

Intervention name(s): Intravenous lidocaine
Intervention type(s): Drug
Intervention description(s): Intravenous lidocaine administered up to 5 µg/ml.
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control
Condition: Diabetes; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      the purpose of this study is to determine whether appropriate control of diabetes around the
      PCI time is related with MACE and outcome of diabetic patients.
    

Detailed description: 
      Despite recent advances in coronary revascularization, cardiovascular disease accounts for
      about 75% of all hospital admissions in diabetic patients.although the introduction of
      drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients
      undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate
      whether a pre and post procedural glycemic control in diabetic patients,as reflected by
      HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events
      (MACE) during 3 year follow up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing per-cutaneous coronary intervention between October 2007 and December
        2009
Comparative Effects of Perindopril and Zofenopril on Blood Pressure Control and Oxidative Status Blacks Hypertensive Patients.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to compare the short term effect of perindopril and zofenopril in the
      management of hypertension and the oxydative stress in blacks hypertensive patients.

      PEZO-HP is a double-arm, double-blind, randomized and parallel clinical trial conducted at
      the Yaoundé Central Hospital.
    

Detailed description: 
      Aim: to determine and compare the short term effect of angiotensin converting in the
      management of hypertension as well as the oxidative effect of Zofenopril and perindopril in
      blacks hypertensive patients in the Yaoundé Central Hospital.

      Method: A double-arm, double-blind, randomized and parallel clinical trial conducted at the
      Yaoundé Central Hospital. Hypertensive patients who are not taking angiotensin-converting
      enzyme inhibitor or angiotensin receptors blockers, are randomize into 2 groups. Depending on
      the group, the intervention consisted of the administration of Perindopril 10 mg daily or
      Zofenopril 30 mg daily for 08 weeks. The endpoints were the nycthemeral blood pressure
      profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (Ferric reducing
      antioxidant).

      Progress: Recruitment for PEZO-HP was completed in May 2019 with 24 patients.
    

Intervention name(s): Perindopril Arginine; Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.; 30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
Other intervention name(s): Perindopril; Zofenopril
Intervention MeSH terms: Perindopril; Zofenopril; Captopril; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: PEZO-HP trial is a double blind, randomized, controlled parallel clinical trial conducted at the Yaounde central hospital, Cameroon
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Angiotensin Converting Enzymes Inhibitor; Angiotensin II Receptor Blockers; Blood pressure; Oxidative status
Lantus in Prediabetes
Condition: Hyperglycemia; Diabetes Mellitus
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes
      (IFG or IGT).
    


Intervention name(s): Lantus® (insulin glargine)
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Glargine; prediabetes; impaired glucose tolerance; impaired fasting glucose
Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis
Condition: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic; Arthrosis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee
      prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score,
      and postoperative ROM after one year will be compared.
    

Detailed description: 
      Mobile bearing tibial platform designs are advocated to improve functional results of total
      knee replacement (TKR), and to reduce wear in the longer term. This study investigates short
      term functional results with two patient groups who are systematically different in the fixed
      or mobile tibial bearing only.

      Methods: 100 knees in 97 patients are stratified according to age and gender and randomized
      into two groups fixed bearing (FB) with 52 knees and mobile bearing (MB) with 48 knees. All
      receive the same posterior cruciate retaining implant but the tibial tray and bearing (B.
      Braun Aesculap Columbus CR and RP) by two experienced surgeons and follow an identical
      rehabilitation regime. Physical examinations are performed in a double-blinded manner before
      the operation and three, six and twelve months thereafter, using the Oxford and Knee Society
      scoring systems.
    

Intervention name(s): Total Knee Arthroplasty
Intervention type(s): Device
Intervention description(s): All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.
Other intervention name(s): Columbus Knee Prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prosthesis Design; Range of Motion, Articular; Arthroplasty, Replacement, Knee
Project EQuIP: Empowering Queer Identities in Psychotherapy
Condition: Sexual Minority Stress
Study type: Interventional

Summary: 
      The aim of this study is to develop an evidence-based psychosocial intervention for sexual
      minority women. This intervention will specifically target the adverse mental and behavioral
      health outcomes disproportionately experienced by sexual minority women, including
      depression, suicidality, and alcohol abuse, which are known to be driven by stigma-related
      stressors associated with their sexual orientation (i.e., minority stress processes).
    

Detailed description: 
      The purpose of this study is to adapt ESTEEM (Effective Skills to Empower Effective Men),
      developed by Dr. John Pachankis, to simultaneously target the multiple adverse health
      outcomes sexual minority women disproportionately face, including depression, suicidality,
      and alcohol abuse, that are linked to minority stress processes.

      Project EQuIP will adapt the ESTEEM program for sexual minority women in three distinct
      phases. The focus of this registered protocol will be Phase 3, however Phases 1, 2 and 3 are
      described below.

      Phase 1 will involve conducting interviews with 20 sexual minority women (SMW) who report
      experiencing depression, suicidality, and alcohol abuse. Information from these interviews
      will be used to gather insight from participants that can help inform the adaptation of a
      cognitive-behavioral treatment approach to specifically target sexual minority women's unique
      experiences with minority stress.

      Phase 2 will involve consultation interviews with 10 community-based mental health experts
      who treat psychosocial health problems among at-risk SMW. Involvement of key community
      members in intervention design optimizes intervention dissemination and allows frontline
      professionals to shape the intervention that they would be most willing to implement. Input
      of mental health experts working with the SMW community will be used in order to translate
      existing, but largely untapped, clinical wisdom regarding SMW's minority stress experiences,
      mental health, and alcohol use into the development of the intervention.

      Phase 3 will involve pilot testing the adapted cognitive-behavioral treatment through a
      randomized controlled trial with 60 SMW who report experiencing depression, anxiety, and
      alcohol abuse.
    

Intervention name(s): EQuIP (Empowering Queer Identities in Psychotherapy)
Intervention type(s): Behavioral
Intervention description(s): Individuals assigned to therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, that address minority stress mechanisms underlying SMW's depression, anxiety, and alcohol abuse.
Other intervention name(s): ESTEEM (Effective Skills to Empower Effective Men) for Women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina
Condition: Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      ORBITA-2 is a double blinded randomised placebo-controlled trial comparing the effects of
      coronary angioplasty versus placebo procedure on symptoms of stable angina without background
      anti-anginal therapy. Follow-up will be at 12 weeks.
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
Other intervention name(s): Coronary angioplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable Angina
Diagnosis and Characterization of Dengue Fever in Children
Condition: Dengue Fever
MeSH terms: Dengue; Fever
Study type: Observational

Summary: 
      Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and
      mortality among children in tropical regions, especially in resource limited countries. The
      objective of this protocol is to compare the sensitivity and specificity of clinical gestalt
      and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes
      in distinct dengue fever disease phenotypes module-based RNA microarray technology.
    

Detailed description: 
      This is a biology protocol with no treatment regimen associated. Blood collection will be
      drawn from subjects in El Salvador to be tested in an effort to improve detection and test
      sensitivity and specificity of a dengue NS1 Ag ELISA, dengue NS1 Ag STRIP, and clinical
      suspicion for the detection of dengue virus infection in children in San Salvador, El
      Salvador compared to the gold standard, PCR. This protocol will also seek to identify and
      compare gene transcription patterns characteristics of each dengue virus disease phenotype in
      children.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El
        Salvador.
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of AMG 139 following
      multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and in
      subjects with mild to severe Crohn's disease (CD).
    


Intervention name(s): AMG 139
Intervention type(s): Drug
Intervention description(s): Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amgen; AMG 139; Crohn's Disease
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the safety, tolerability and immunologic response
      to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that
      have never received a previous dose of 23vPS.
    


Intervention name(s): 13 valent Pneumococcal Conjugate Vaccine; 13 valent Pneumococcal Conjugate Vaccine; 13 valent Pneumococcal Conjugate Vaccine; 23-valent Pneumococcal Polysaccharide Vaccine; 23-valent Pneumococcal Polysaccharide Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; 0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1; 0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccines, Pneumococcal Conjugate Vaccine