bioihbjkbjnl/mcl2 huggingface dataset:
A Paroxetine- and Placebo-Controlled Study of 50 mg/Day and 100 mg/Day of EB-1010 Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main research hypothesis for this study is that, among patients with Major Depressive
      Disorder (MDD) who have responded inadequately to treatment with SSRIs or SNRIs, the degree
      of improvement, as measured by the change from baseline of the Montgomery-Asberg Depression
      Rating Scale (MADRS)will be significantly greater among patients treated with EB-1010 (at the
      dose of 50 mg/day or 100 mg/day) than among those treated with placebo using the sequential
      parallel comparison design. The secondary research hypothesis for this study is that, among
      patients with MDD who have responded inadequately to treatment with SSRIs or SNRIs, the
      degree of improvement in depressive symptoms, as assessed by the MGH Cognitive and Physical
      Functioning Questionnaire (MGH CPFQ) will be significantly greater among those treated with
      EB-1010 (50 mg/day or 100 mg/day) than those treated with the SSRI paroxetine.
    


Intervention name(s): EB-1010 25mg BID; SSRI Active; EB-1010 50mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsule once daily; Active Comparator; Experimental Active; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Outpatient
Antenatal Micronutrient Supplementation and Birth Weight
Condition: Low Birth Weight; Infant Mortality; Pregnancy; Nutritional Status
MeSH terms: Body Weight; Birth Weight; Infant Death
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the effects of providing supplements containing
      alternative combinations of micronutrients during pregnancy on birth weight and other infant
      and maternal health and nutritional outcomes in a rural area of Nepal.
    

Detailed description: 
      Maternal micronutrient deficiencies are common in the developing world and may influence
      intrauterine growth and fetal and neonatal health and survival. Currently, policies for
      antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet,
      the efficacy of such supplementation strategies has not been well established. Specifically,
      it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn
      health and survival compared to single or smaller combinations of micronutrients. Also, while
      birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality
      needs direct examination.

      Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus
      iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with
      vitamin A compared to a control group that received only vitamin A.
    

Intervention name(s): Nutritional supplements
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Micronutrients; Supplementation; Pregnancy; Birth weight; Infant mortality
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted in healthy subjects and in subjects with a mild or moderate
      decrease in GFR (subjects with renal impairment).
    

Detailed description: 
      To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145
      in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
    

Intervention name(s): MGTA-145
Intervention type(s): Biological
Intervention description(s): MGTA-145 will be given intravenously
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Specific Molecular Imaging of DX600 Labeled by PET Radionuclide Targeting ACE2 in Patients
Condition: Solid Tumor
Study type: Interventional

Summary: 
      Angiotensin-converting enzyme 2 (ACE2) plays an important role in renin-angiotensin system
      (RAS) and has been reported to relate with cancer. Recently, it has also been proved as the
      key target for COVID-19 infection.

      DX600 is a polypeptide that can specific binding to ACE2 specifically with nanomolar affinity
      reported in literature. This study constrcuted a radio-tracer, DX600 Labeled by PET
      Radionuclide, to monitoring biodistribution ACE2 in human beings, evaluate the detection
      ability of radio-tracer in ACE2 over-expression tumors and dynamic changes of ACE2 expression
      under therapy.
    


Intervention name(s): 68Ga-DX600 PET/CT
Intervention type(s): Other
Intervention description(s): DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the efficacy of switching to tenofovir
      disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining
      virologic suppression in HIV-1 infected children.
    


Intervention name(s): Tenofovir DF; Zidovudine; Stavudine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tenofovir DF (oral powder or tablet): 300-mg tablets for participants > 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to > 37 kg may be switched from the oral powder to the tenofovir DF tablet.; Zidovudine as prescribed by the investigator prior to study entry (pediatric participants < 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).; Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m^2 every 8 hours; pediatric participants > 12 years of age: 300 mg twice daily).
Other intervention name(s): Viread®
Intervention MeSH terms: Tenofovir; Zidovudine; Stavudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 3; Randomized, Open-Label; Treatment-Experienced; Highly Active Antiretroviral Therapy; HIV; Tenofovir DF; Pediatrics
A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150
      mg) in healthy adult subjects and will assess the safety, tolerability, and dose
      proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.

      The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the
      food effect, while Part 2 will assess dose proportionality.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): omaveloxolone
Intervention type(s): Drug
Intervention description(s): Omaveloxolone 50 mg capsules
Other intervention name(s): RTA 408
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omaveloxolone; omaveloxolone capsules; RTA 408
Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures
Condition: Impacted Canine
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Impacted canine causes many problems for patients, such as damage to the adjacent teeth
      roots, effects on gingival tissues, aesthetic problems, difficulty, and prolonged orthodontic
      treatment duration. Therefore, solutions to accelerate the movement of impacted canines with
      the help of surgical procedures to reduce treatment time will be investigated, such as
      intra-operative alveolar perforations and piezocision. We also aimed to evaluate periodontal
      changes associated with such accelerating procedures compared with the conventional traction
      method.
    

Detailed description: 
      Patients with palatally impacted maxillary canines will be treated using fixed appliances
      assisted by some surgical procedures. The effects of this treatment approach on the
      periodontal status will be assessed using periodontal measurements.

      There are two groups :

        1. conventional treatment group

        2. minimally-invasive corticotomy-assisted treatment group Patients will be allocated to
           the two groups randomly. Data will be collected using periodontal variables.
    

Intervention name(s): Fixed appliances; Corticotomy
Intervention type(s): Device; Procedure
Intervention description(s): Metal brackets with a straight-wire prescription will be used. Patients will be treated conventionally.; Patients will be treated in conjunction with a surgical intervention using metal brackets with a straight-wire prescription. Corticotomy (alveolar perforation and piezocision) will induce acceleration in canine traction movement during the orthodontic treatment in only one group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impacted canine; accelerate canine traction; periodontal index; periodontal status
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro
Condition: Cytopenia
MeSH terms: Anemia; Leukopenia; Thrombocytopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the sequential infusion
      of allogeneic mesenchymal stem cells (MSC), expanded "in vitro" with platelet lysate without
      addition of animal products in the treatment of patients undergoing allo-HSCT who developed
      one or more cytopenias.
    


Intervention name(s): Sequential infusion of allogeneic mesenchymal stem cells expanded "in vitro"
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytopenia
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A single oral dose study to investigate the PK and safety of olorofim in subjects with severe
      renal impairment compared to subjects with normal renal function.
    


Intervention name(s): Olorofim
Intervention type(s): Drug
Intervention description(s): Single oral dose
Other intervention name(s): F901318
Intervention MeSH terms: Olorofim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.
    

Detailed description: 
      The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will
      receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine
      medicated gum given as single doses at separate treatment visits. Periods without NRT,
      lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic
      analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well
      as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also
      be monitored to capture any adverse events that may occur. The trial is blind in the sense
      that treatment labels will not be revealed to subjects and trial personnel. Also the
      bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.
    

Intervention name(s): 6 mg Experimental nicotine gum; 4 mg Nicotine Gum/; 2 mg Nicotine Gum
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits; A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits; A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
Other intervention name(s): Not marketed; Nicorette® Gum; Nicorette® Gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Effect of the Auricular Acupunture of the Lower Limbs on the Equilibrium Response Evaluated by Static Stabilometry
Condition: Balance, Postural
Study type: Interventional

Summary: 
      By using a static stabilometry platform, the investigators believe the possible verification
      of the efficiency of auricular acupuncture points that correlates with regions of our body
      that may interfere with static equilibrium.

      The present work aims to analyze the effect of the stimulation of atrial points of the lower
      limbs on the equilibrium response evaluated by static stabilometry.
    

Detailed description: 
      Balance is an extremely relevant subject because of the large and increasing incidence of
      falls mainly in the elderly population. This leads to a significant social impact since falls
      can lead an elderly to increasing dependence on the family and can be the cause of depression
      and reduce their quality of life. Studies have already demonstrated the efficacy of
      acupuncture stimulation in the treatment of vertigo and also for the improvement of postural
      control. For this, the option of auricular acupuncture was chosen because it is a
      non-invasive and safe method. Thus, the objective of this study will be to analyze the
      effects of atrial stimulation of the lower limbs on the equilibrium response by static
      stabilometry. Participants in this study were 40 healthy individuals aged between 18 and 30
      years who will be divided into two groups: GA (acupuncture group) (n = 20) and CG (control
      group) (n = 20). The acupuncture group will be stimulated unilaterally according to the motor
      preference side of each individual in the points referring to the three joints of the lower
      limb (knee and ankle hip). The control group will not receive stimulation. Balance
      evaluations will be performed before the stimuation (initial), 20 minutes after the
      initiation of the protocol (second evaluation) and 5 minutes after the second evaluation,
      with eyes open and closed. Participants will be positioned standing with their arms along
      their body, mouth closed not with force and parallel feet. Statistical analysis will be
      performed by means of a one-way analysis of variance (ANOVA) and the differences between the
      data will be evidenced by Holm Sidack's post-test. Values of p≤0.05 will be considered
      significant.
    

Intervention name(s): Auricular acupunture; Control
Intervention type(s): Device; Other
Intervention description(s): Evaluation of balance before, during and after applying of auricular acupuncture.; Not receive stimulation.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study is a randomized controlled clinical trial to analyze the influence of auricular points on lower limbs on the equilibrium response assessed by static stabilometry
Masking: None (Open Label)
Primary purpose: Other
Keywords: Acupunture; Acupunture Therapy; Acupunture Points; Acupunture Ear; Postural Balance
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
Condition: Sever Aplastic Anaemia
MeSH terms: Anemia, Aplastic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, open-label, phase I clinical study evaluating the PK of hetrombopag in
      subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic
      impairment (Child-Pugh Class B), as well as age-, weight-, and gender-matched subjects with
      normal hepatic function.
    


Intervention name(s): Hetrombopag Olamine Tablet
Intervention type(s): Drug
Intervention description(s): Hetrombopag Olamine Tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Intrathecal Magnesium Sulfate on Shivering
Condition: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use; Postoperative Shivering; Cesarean Section Complications
Study type: Interventional

Summary: 
      Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be
      used intrathecally, is effective in preventing tremor. But what is the ideal dose?
    

Detailed description: 
      Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is
      clinically common, but its treatment is often neglected.

      When the literature is scanned, perioperative tremors are seen in 55%-60% of patients
      undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully
      elucidated. Possible factors that can cause tremor can be listed as follows:

        1. Loss of thermoregulatory vasoconstriction below the block level,

        2. The displacement of body temperature from the central to the periphery due to
           vasodilation,

        3. Increased sweating threshold and decreased peripheral vasoconstriction Perioperative
           shivering is a complication that needs to be treated because it causes dangerous
           consequences in patients with low cardiopulmonary reserve due to increased oxygen
           consumption and impairs patient and surgeon comfort.

      Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect
      profile in the treatment of tremor after noxial block.
    

Intervention name(s): 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
Intervention type(s): Drug
Intervention description(s): It will be evaluated whether there is postpinal shivering in the cases.
Other intervention name(s): 50 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey); 75 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey); 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey)
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bupivacaine; cesarean section; intrathecal magnesium sulfate; shivering; spinal anesthesia
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
Condition: Patients With Impaired Renal Function and Haemodialysis
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in
      patients with impaired renal function and haemodialysis.
    


Intervention name(s): ASP8825
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): gabapentin enacarbil
Intervention MeSH terms: Gabapentin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Impaired renal function; Haemodialysis; ASP8825; XP13512
Patient Satisfaction With the Management of a Stopped Pregnancy in the First Trimester
Condition: Pregnancy Loss, Early
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      The clinical practice recommendations highlight the fact that the patient's choice concerning
      the management of her aborted pregnancy in the first trimester should be privileged, after
      clear and appropriate information on the available treatments, in order to improve his
      experience and reduce the negative psychological symptoms that can generate an alteration in
      the quality of life, in the aftermath of the loss of pregnancy.

      The present study will describe the efficacy, satisfaction and tolerance of patients
      benefiting from medical treatment with Mifégyne® and MisoOne® versus those benefiting from
      surgical treatment by endo-uterine aspiration for the management of a pregnancy stopped
      during the first trimester at the Toulouse University Hospital
    


Intervention name(s): Medical treatment with Mifégyne® and MisoOne®; Endo-uterine aspiration
Intervention type(s): Drug; Procedure
Intervention description(s): When participants arrive for their uterine emptiness check-up, 12 days after treatment, patients will be asked to drop off the study questionnaire the same day in a box provided for this purpose in the department.; When patients arrive in hospital on the day of the surgery, participants will be asked to complete a questionnaire at home 1 week after surgery and return it to investigators.
Intervention MeSH terms: Mifepristone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, double-blind, single-injection, active-controlled,
      parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.
    


Intervention name(s): CKDB-501A; Botox®
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection CKDB-501A; Intramuscular injection Botox®
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment