bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Evacetrapib (study drug) is an investigational drug being developed with the aim to help
      people at high risk of heart problems in the future.

      In this study we will be comparing how much of the study drug gets into the blood stream when
      it is given as a single dose (in tablet form) compared to an intravenous injection (given
      directly into a vein via a small needle).

      The study is expected to last at least 15 days for each participant, not including screening.
      Screening will occur up to 28 days before the study drug is given.
    


Intervention name(s): Evacetrapib Tablet; Evacetrapib Intravenous
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Intravenous administration
Other intervention name(s): LY2484595; LY2484595
Intervention MeSH terms: Evacetrapib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Topical Corticosteroids on the Incidence of Postinflammatory Hyperpigmentation After QsNdYAG Laser
Condition: Lentigines; Post Inflammatory Hyperpigmentation
MeSH terms: Hyperpigmentation; Lentigo
Study type: Interventional

Summary: 
      To investigate the benefit of the application of topical high potency steroid on the
      incidence of post inflammatory hyperpigmentation after laser treatment.
    

Detailed description: 
      -  The incidence of post inflammatory hyperpigmentation (PIH) after treating lentigines
           with Q-switched Nd:YAG laser was 78.3%.

        -  It has been found that the incidence of PIH decreased to 40% after applied topical high
           potency steroid 2 days after the laser treatment.

        -  By these anti-inflammatory and anti-PIH effects of the high potency steroid, the
           investigators aimed that the application of steroid 2 days before and 2 days after the
           laser treatment would be better reduction in the incidence of PIH after Q-switched
           Nd:YAG laser.
    

Intervention name(s): topical 0.05% Clobetasol propionate ointment; Q switched Nd:YAG laser 532 nm
Intervention type(s): Drug; Device
Intervention description(s): Apply only on the treated area twice a day as mentions; Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Post inflammatory hyperpigmentation; topical high potency steroid; Qs NdYAG laser
Efficacy and Safety of DA-3002 in Short Children Borns SGA.
Condition: Infant, Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      A study demonstrates the non-inferiority of DA-3002 when compared with Genotropin® in short
      children born small for gestational age.
    


Intervention name(s): DA-3002; Genotropin®
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic
      migraine
    

Detailed description: 
      This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in
      adult patients with episodic migraine. The subjects were randomized to receive either
      erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening
      period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline
      period. After randomization/Day 1, visits occurred at four week intervals until Week 12,
      which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety
      Follow-Up visit, which occurred 12 weeks later, at Week 24.
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 70 mg/mL pre-filled syringe administered subcutaneously; Matching placebo in pre-filled syringe administered subcutaneously
Other intervention name(s): AMG334
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: AMG334; erenumab; episodic migraine; headache; CGRP; Calcitonin Gene-related; migraine; adult
Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis
Condition: Lupus Nephritis; Mesenchymal Stem Cells
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem
      cell (hA-MSC) for the treatment of lupus nephritis (LN).
    

Detailed description: 
      Eleven patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous
      infusion, dose 1×106/kg cells, once every month for three times). At the same time, five
      patients with LN who were not given hA-MSC as the blank control group. All patients did not
      received intravenous corticosteroids pulse therapy, but the use of oral corticosteroids and
      intravenous cyclophosphamide, or oral mycophenolate mofetil, tacrolimus , leflunomide were
      allowed.
    

Intervention name(s): human amniotic mesenchymal stem cell
Intervention type(s): Drug
Intervention description(s): human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lupus Nephritis; Human Amniotic Mesenchymal Stem Cell; cell therapy; clinical trail
Omega-3 Fatty Acids in Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 12 month study of omega-3 fatty acids in bipolar disorder. This study will be a
      12-month, parallel group, double-blind comparison of the prophylactic efficacy of omega-3
      fatty acids vs. placebo in 120 bipolar I patients. All subjects entering the primary
      prophylactic study will be euthymic or have only subsyndromal mood symptoms for at least 4
      weeks. In addition, their concomitant medication (only lithium, divalproex, or no medication
      will be permitted) will also be stable and at accepted therapeutic levels for at least 4
      weeks. An 8-week lead-in phase will be available to subjects who do not meet the current
      symptom and concomitant medication inclusion criteria (however, subjects must meet all of the
      other inclusion/exclusion criteria): 1. 4 weeks of euthymic or subsyndromal mood. 2. Subjects
      who are not already receiving lithium or divalproex. 3. Subjects receiving other psychotropic
      medications.
    


Intervention name(s): Omega-3 Fatty Acids
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bipolar disorder; omega-3 fatty acids; eicosapentaenoic acid; docosahexaenoic acid
Nitrous Oxide for Major Depressive Disorder
Condition: Depressive Disorder; Major Depressive Disorder; Treatment Resistant Depression; Depressive Disorder, Major; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims at investigating the persistence of antidepressant effect of Nitrous Oxide
      (N2O) for Treatment-Resistant Depression(TRD). The investigators also aim to assess the
      effect of N2O on the electroencephalograph, multimodal magnetic resonance imaging(MRI), blood
      cytokines, feces bacteria flora and neuropsychological performance in patients with TRD. The
      investigators further aim to identify the predictors of N2O's antidepressant effeect using
      the above techniques.
    


Intervention name(s): Nitrous Oxide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An 1-hour session of inhaled nitrous oxide at concentrations of 50%.; An 1-hour session of mixed oxygen-air gas(inspired oxygen concentration ~50%)
Other intervention name(s): Laughing Gas; Xiao Qi; 笑气; Air oxygen mixture
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nitrous Oxide; Laughing Gas
Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the effect of multiple doses of
      itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of
      safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore,
      the pharmacokinetics of the metabolite BI 1072668 will be explored.
    


Intervention name(s): BI 1026706; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of BI 1026706 on Day 1; 7 days of itraconazole treatment combined with a single dose of BI 1026706 on the fourth day
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain
      and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme
      in animals and healthy human volunteers. The purpose of this study is to evaluate whether
      PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and
      whether this results in these patients experiencing less pain.
    


Intervention name(s): PF-04457845; PF-04457845; Naproxen; Naproxen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-04457845 4 mg tablet once daily / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo; Naproxen 500 mg tablet twice daily / matched placebo; Naproxen 500 mg tablet twice daily / matched placebo
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
Condition: Painful Lumbar Radiculopathy; Healthy
MeSH terms: Radiculopathy; Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of a range of
      single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a
      range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy.
      Secondary objectives of this study are to determine the single IV and SC dose
      pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of
      bioavailability by comparing SC exposure to IV exposure in each participant, to determine the
      multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to
      assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess
      the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar
      radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC
      administrations in participants with painful lumbar radiculopathy.
    


Intervention name(s): BG00010 IV; BG00010 SC; Placebo IV; Placebo SC
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): Ascending Doses intravenous (IV) of BG00010; Ascending Doses subcutaneous (SC) of BG00010; Ascending Doses intravenous (IV) of Placebo; Ascending Doses subcutaneous (SC) of placebo
Other intervention name(s): Neublastin; Neublastin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sciatica
Safety Study of S-Caine Peel (Skin Numbing Cream) Before a Painful Dermatologic Procedure in Children
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of one treatment of S-Caine™ Peel (skin
      numbing cream) applied on healthy skin before a painful dermatologic procedure in children.
      This study will also evaluate how well the S-Caine™ Peel eases the pain of the procedure.
    

Detailed description: 
      The practice of dermatology is seeing a rise in the number of surgical and laser procedures
      as technological advances have expanded the number of conditions amenable to these evolving
      therapies. Skin biopsies, shave excisions, deep excisions, electro-surgical procedures,
      intralesional injections, and laser surgery are frequently performed by dermatologists on a
      daily basis. Some pain accompanies almost all of these procedures, and a local anesthetic is
      commonly used. Traditionally, intracutaneous injection of lidocaine (with or without
      epinephrine) has been the anesthetic of choice. However, patients undergoing these procedures
      are often afraid of needles and syringes and the pain associated with injections. As a
      result, topical anesthetic agents have been explored and developed as painless alternatives
      to injected anesthesia.

      S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) consists of a new eutectic formulation
      of lidocaine and tetracaine. S-Caine Peel is a topical local anesthetic cream that forms a
      pliable peel on the skin when exposed to air. S-Caine Peel is not occluded during
      application.

      The pain associated with medical procedures is often under-treated in children. Children
      often undergo painful procedures with little or no anesthetic, even when effective therapy is
      available. Reasons for not providing available therapy in children include concerns over
      adverse side effects, as well as the length of time necessary to provide adequate anesthesia.
      Recent guidelines strongly advocate for the proactive treatment of pain in children,
      including the pain associated with medical procedures.
    

Intervention name(s): S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain
Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to
      efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with
      standard doxorubicin formulation was used. The study aimed to determine whether the
      combination of PLD-docetaxel would increase tumour response in patients with breast cancer.
    


Intervention name(s): Pegylated Liposomal Doxorubicin and docetaxel
Intervention type(s): Drug
Other intervention name(s): Pegylated Liposomal Doxorubicin 30-35 mg/m (2) and docetaxel 75-80 mg/m(2) were both administered on day 1,intravenous, Cycles were repeated in 3-week intervals,for 6 cycles.
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes
    


Intervention name(s): rosuvastatin calcium; atorvastatin
Intervention type(s): Drug; Drug
Other intervention name(s): Crestor; Lipitor
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Papillary Thyroid Cancer and Central Lymp Node Dissection
Condition: Papillary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Thyroid Diseases
Study type: Observational

Summary: 
      Papillary cancer is a disease that spreads through lymphatic ways and its treatment is
      surgery. We performed prophylactic central dissection in addition to bilateral total
      thyroidectomy in patients with bethesda 5 and bethesda 6 biopsy results. We evaluated the
      pathology results retrospectively.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with B5 and B6 biopsy results who underwent bilateral total thyroidectomy and
        central lymph node dissection
      
Keywords: papillary thyroid cancer
Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)
Condition: Non-ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Thrombosis; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is
      recommended by current guidelines, there are insufficient data to unequivocally support
      thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus
      containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is
      a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The
      hypothesis is that under the background of early revascularization, adjunctive thrombectomy
      in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less
      microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in
      patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two
      treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints
      include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well
      as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and
      myocardial blush grade. Furthermore, clinical endpoints including death, myocardial
      reinfarction, target vessel revascularization and new congestive heart failure will be
      recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the
      TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve
      myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit
      vessel reperfused by early PCI.
    


Intervention name(s): Thrombectomy; Standard percutaneous coronary intervention
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.; In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-ST-elevation myocardial infarction; thrombectomy; magnetic resonance imaging; microvascular obstruction
Exercise Intervention and Running Biomechanics in Older Adults
Condition: Aging; Physical Activity
Study type: Interventional

Summary: 
      The goal of this study is to understand the effects of muscle strengthening and stretching
      exercise intervention on isometric muscle strength, joint flexibility and running
      biomechanical patterns in older recreational runners. To do so, the subjects will be assessed
      before and after they engage in a 8-week exercise intervention program.
    


Intervention name(s): Muscle strengthening exercises; Muscle stretching exercise
Intervention type(s): Other; Other
Intervention description(s): The group will perform 8-week home based muscle strengthening exercises with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist.; The group will perform 8 week home based exercise intervention with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention