bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the relative difference in PK between extensive
      metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and
      venlafaxine ER when a single dose is administered.
    


Intervention name(s): desvenlafaxine SR; venlafaxine ER
Intervention type(s): Drug; Drug
Intervention MeSH terms: Venlafaxine Hydrochloride; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Major Depressive Disorder; Depression; Cytochrome P-450 CYP2D6; Pharmacokinetics; Health
Clinical Efficacy of Qingxin Zishen Decoction in Treating Menopausal Syndrome and Neuroendocrine Mechanism of Regulating KNDy Neurons
Condition: Menopause
Study type: Interventional

Summary: 
      The goal of this clinical trial is to determine the effects of estrogen (Fenmotong) and
      Qingxin Zishen Decoction on the levels of kisspeptin, NKB, and dynorphin expressed in human
      KNDy neurons Between patients with menopausal syndrome. The aims of the study are as follows:

        -  Find a new neuroendocrine mechanism of Qingxin Zishen Decoction in the treatment of
           menopausal syndrome.

        -  Evaluate the changes of new neuroendocrine indicators in the clinical treatment of
           menopausal syndrome.

        -  Develop non-hormonal drugs with definite efficacy in the treatment of menopausal
           syndrome.

      Participants will randomly divided into the experimental group and the control group, the
      experimental group will be oral fenmotong, and the control group will be oral Qingxin Zi
      Kidney Decoction, and the efficacy, sex hormone levels and neuroendocrine index changes of
      the two groups will be compared.
    


Intervention name(s): Femoston; Qingxin Zishen Decoction
Intervention type(s): Drug; Drug
Intervention description(s): Fenmorphone (this product is a compound preparation, estradiol tablets contain estradiol 2mg; Estradiol dydrogesterone tablets contain estradiol 2 mg and dydrogesterone 10 mg).
Usage: 1 time/day: 1 tablet orally every day, every 28 days as a course of treatment.; Qingxin Zi Kidney Decoction is a traditional Chinese medicine decoction, after regular decoction, 1 dose/day, divided into 2 doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery
Condition: Induced; Birth
Study type: Interventional

Summary: 
      Seventy ladies indicated for induction of delivery will be recruited. Two ways of assessment
      of their cervices will be done before actual induction of labor. First, ultrasound will be
      done to assess the angle and the length of the cervix. Then vaginal examination will be done
      to assess the characteristics of cervix. Analysis will be done to identify the best predictor
      of successful induction of labour.
    

Detailed description: 
      Seventy patients indicated for induction of labor will be recruited. Two ways of assessment
      of their cervices will be done before actual induction of labor. First, transvaginal
      ultrasound will be done to assess the posterior angle and the length of the cervix. Then
      vaginal examination will be done to measure the Bishop score. Analysis will be done to
      identify the best predictor of successful induction of labour.
    

Intervention name(s): Transvaginal ultrasound; Vaginal examination
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length; Vaginal examination will be done for assessment of Bishop score
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: induction of labor; Bishop score; posterior cervical angle; cervical length
Optimisation of Follicular Recruitment in IVM Cycles
Condition: Infertility, Female; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will focus on important aspects related to follicle recruitment using exogenous
      gonadotropins in patients with polycystic ovaries:

        1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin
           alfa: does administration of this drug result in earlier and higher FSH (follicle
           stimulating hormone) concentrations above the threshold for follicle recruitment in an
           IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in
           comparison to normal daily administration of rFSH (recombinant follicle stimulating
           hormone, Puregon)?;

        2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media
           registered for clinical use: does stimulation with corifollitropin alfa versus
           recombinant FSH have an impact on the maturation rate and developmental capacity of the
           oocytes ?
    


Intervention name(s): blood sampling; transvaginal ultrasound scanning; oocyte retrieval for IVM; Corifollitropin Alfa; Follitropin beta; oral contraceptive pill pretreatment (Marvelon)
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): comparison between corifollitropin alfa and follitropin beta in IVM cycles; comparison between corifollitropin alfa and follitropin beta in IVM cycles; comparison between corifollitropin alfa and follitropin beta in IVM cycles; Single injection of 100 micrograms of corifollitropin alfa; Daily injection (three days) of follitropin beta; Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.
Intervention MeSH terms: Contraceptive Agents; Desogestrel; Contraceptives, Oral; Contraceptives, Oral, Combined; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered
      once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza
      vaccine as measured by humoral responses compared to participants on an iDMT.
    

Detailed description: 
      Vaccinations against influenza are an important part of effective management of multiple
      sclerosis (MS).

      Ofatumumab is a human anti-CD20 monoclonal antibody (mAb) which depletes B-cells, a component
      of the immune system. This study investigates if ofatumumab treated patients can have an
      immune response that may be protective after receiving the influenza vaccine.

      There will be a one week screening period to assess eligibility for the trial. All eligible
      participants will receive an influenza vaccine during the Screening Period prior to the
      Investigational Period. This study will enroll 66 participants with relapsing multiple
      sclerosis into three cohorts in multiple centers. Up to 44 of the participants will begin
      treatment with ofatumumab or will already be receiving commercial ofatumumab. The remaining
      22 participants will remain on their Injectable Disease Modifying Therapy (iDMT). There will
      be 4 weekly visits during the Investigational Period which will last 4 weeks. There will also
      be an optional, 6 month Extension Period for Cohorts 1 and 2, who received ofatumumab, to
      further evaluate immune response. Cohort 3 will not enter the Extension Period.
    

Intervention name(s): Quadrivalent influenza vaccine; Ofatumumab
Intervention type(s): Biological; Drug
Intervention description(s): 2020-2021, 2021-2022, or 2022-2023 inactivated quadrivalent influenza vaccine; Auto-injector containing 20 mg sc ofatumumab (20 mg/0.4ml) for subcutaneous administration.
Novartis will supply participants in Cohort 1 with ofatumumab treatment in the Investigational Period and the optional 6-month Extension Period.
Participants in Cohort 2 will continue on their commercially prescribed ofatumumab treatment during the Investigational Period. Novartis will supply participants in Cohort 2 with ofatumumab treatment in the optional 6-month Extension Period.
Intervention MeSH terms: Ofatumumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel, prospective study
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition
Condition: Body Composition Measurement
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance
      analyzer is comparable to a predicate device in measuring human body composition.
    

Detailed description: 
      The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance
      analyzer is comparable to a predicate device in measuring human body composition under normal
      patient conditions. Specifically, the goal of this study is to compare impedance measurements
      (R and Xc) determined by using each bioelectrical impedance device and the estimated body
      compositional estimates [total body water (TBW); fat-free mass (FFM); and fat mass (FM)]
      calculated by using the same prediction equation (models) as the predicate device.
    

Intervention name(s): Akern USA EFG; RJL Impedance analyzer
Intervention type(s): Device; Device
Intervention description(s): Impedance measurement device; Impedance analyzer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of Er:YAG pulse therapy for achieving
      pulpal analgesia in pediatric patients and to quantify the duration and extent of any effects
      assessed.

      Design: a randomized split-mouth study with two-way repeated measures design.
    

Detailed description: 
      The intention of the technique of "pre-emptive laser analgesia" is to reduce sensation in
      that small percentage of patients who may experience unpleasant sensations during caries
      removal. Laser analgesia is a non-invasive, non-thermogenic bio-modulation of the dental pulp
      reactivity aiming for reduction of impulse formation of the pulpal nociceptors. It is based
      on the idea that parallel with the ablative high-energy level laser action, simultaneous low
      level laser therapy (LLLT) may occur. We hypothesize that when operating at pulse energies
      below the Er:YAG laser ablation threshold of tooth structure, the laser energy leads to loss
      of impulse conduction of type A-delta nerve fibers in the dental pulp, leading to an
      analgesic effect.
    

Intervention name(s): Laser analgesic procedure; Placebo analgesic procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Water mist spray set to "maximum", non-contact handpiece with sapphire tip. Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer. Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action. Pulse energy - 0.2 W/ 10 Hz/ 20 mJ. Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ. Total duration of LA-induction - 240s.; Performing imitation of laser analgesic procedure. No pulse energy applied, non-contact handpiece with sapphire tip. Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth. Total duration of placebo analgesia induction - 240s.
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Allocation: Randomized Intervention Model: Split-mouth assignment with two-way repeated measures design Masking: Double (Participant, Outcomes Assessor)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laser analgesia; pediatric dentistry
Complete Decongestive Therapy Versus Compression Bandaging in Advanced Secondary Lymphedema
Condition: Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      The purpose of this study is to:

      Find out the efficacy of using complete decongestive physiotherapy on limb volume in advanced
      secondary upper and lower extremity lymphedema patients.

      Find out the efficacy of compression bandaging on limb volume in advanced lymphedema
      patients.

      This study was conducted to compare between the efficacy of complete decongestive therapy
      (CDT) and compression bandaging in advanced secondary lower extremity lymphedema.
    

Detailed description: 
      The study was conducted at the department of plastic surgery, Kasr Al-Ainy hospital. Sixty
      patients of both genders aged from 40 to 55 years old were participated in this study, and
      they were randomly assigned to two study groups.

      Group I: Thirty patients received CDT (60 min of manual lymph drainage MLD, compression
      bandaging, exercises, and skin care).

      Group II: Thirty patients received compression bandaging alone. The same bandaging scheme
      used for both groups. The therapy included 12 interventions performed 5 days a week, during
      the first two weeks in addition to another successive two sessions at the third week, i.e.,
      for a total of twelve sessions.

      Evaluation of limb volume using water volumetry and 4-cm truncated cone circumferential
      measurements were done before treatment application, after 6 sessions (post 1) and after 12
      sessions (post 2).
    

Intervention name(s): Physiotherapy Treatment
Intervention type(s): Other
Intervention description(s): Physical Therapy sessions for treatment of advanced Lymphedema Cases
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The purpose of this report is to compare short-term outcomes of complete decongestive therapy and compression bandaging on patients with advanced secondary upper and lower extremity lymphedema.
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Gingival Crevicular Fluid microRNAs on Orthodontic Tooth Movement
Condition: Orthodontic Tooth Movement
Study type: Interventional

Summary: 
      A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on
      the expression of gingival crevicular fluid miRNAs related to inflammation and
      osteoclastogenesis during canine distalization following asymmetrical extraction treatment of
      upper first premolars.

      Samples of gingival crevicular fluid on the mesial and distal side of the canines to be
      examined will be performed during the baseline and during various follow-ups.
    

Detailed description: 
      A split-mouth study is conducted in order to evaluate the impact of orthodontic movement on
      the expression of gingival crevicular fluid miRNAs related to inflammation and
      osteoclastogenesis during canine distalization following asymmetrical extraction treatment of
      upper first premolars.

      Orthodontic tooth movement induces bone remodeling by various signaling pathways. The
      variations in miRNAs expression and their impact in inflammation and osteoclastogenesis
      during the various stages of orthodontic tooth movements is not fully understood.

      58 patients requiring asymmetrical upper first premolar extraction for orthodontic purposes
      have been enrolled for this split-mouth study: the canines to be distalized on the extractive
      site are considered as the test group, the controlateral canines (on the side without first
      premolar extraction) areconsidered as normal controls.
    

Intervention name(s): Elastomeric powerchain
Intervention type(s): Device
Intervention description(s): Canine distalization by engaging the elastomeric power chains onto the canine brackets.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The main objective of the study is to evaluate the impact of orthodontic tooth movement on gingival crevicular fluid miRNAs related to inflammation and osteoclastogenesis.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Reversibility of Dual Antiplatelet Therapy by Platelets
Condition: Bleeding
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to test the hypothesis whether or not autologous stored
      platelets are able to offset the antiplatelet effect of aspirin and clopidogrel as assessed
      by state-of-the-art platelet function assays.
    

Detailed description: 
      Dual antiplatelet therapy with aspirin and clopidogrel is a well established strategy to
      prevent thrombotic complications in patients with high platelet reactivity following plaque
      rupture in acute coronary syndromes (ACS) or percutaneous coronary interventions. Current
      practice guidelines for antiplatelet therapy advocate a one to 12 months dual antiplatelet
      therapy after bare metal stent PCI and a 12 months dual antiplatelet therapy after PCI in
      patients with ACS and drug eluting stent PCI. Although oral antiplatelet therapy is
      associated with both, short- as well as long-term clinical efficacy, irreversible platelet
      inhibition carries a substantial risk of bleeding particularly in patients presenting for
      surgery. Empiric therapy of bleeding consists of platelet transfusion. However, there are
      currently no pharmacodynamic studies assessing the effect of stored platelets on in-vitro
      platelet function tests.

      Healthy volunteers will donate platelets, take aspirin and clopidogrel for 3 days (loading
      dose aspirin 300 mg, clopidogrel 300 mg, maintenance dose aspirin 100 mg, clopidogrel 75 mg)
      and platelets will be retransfused on the 4th day. Pharmacodynamic measurements of platelet
      function will be performed at baseline, after drug intake before retransfusion, immediately
      after retransfusion and 24 hours thereafter.
    

Intervention name(s): autologous stored platelets; administration of autologous stored platelets; autologous stored platelets
Intervention type(s): Other; Other; Biological
Intervention description(s): Administration of autologous stored platelets; administration of autologous stored platelets; transfusion of autologous stored platelets
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aspirin, clopidogrel, pharmacodynamics, platelet transfusion
Dehydroepiandrosterone (DHEA)Supplementation Pre-IVF(In Vitro Fertilization) Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the effect of pre-IVF cycles treatment with and
      without DHEA(Dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes
      obtained and IVF(in vitro fertilization) outcomes of DOR(diminished ovarian reserve) patients
      and the expression of BMP-15(bone morphogenetic protein 15),GDF-9（growth differentiation
      factor 9) and IGF-I(insulin-like growth factors-1) in follicular fluid.
    

Detailed description: 
      78 patients were enrolled according to the inclusion criterion. They were randomized into two
      groups, 40 were in DHEA group and 38 were in control group. The DHEA group received DHEA (Lab
      Hercules™) 25mg three times a day continuing more than 12 weeks prior to the start of IVF
      treatment till the day of egg collection and the control group got without any DHEA
      treatment. All of the IVF women patients were given CC(clomifene citrate)+HMG(human
      menopausal gonadotropin) protocol for controlled ovarian hyperstimulation. Hormonal profile
      including E2(estradiol),FSH(follicle-stimulating hormone) ,P(progesterone) ,LH (luteinizing
      hormone),T(testosterone),AFC(antral follicle account),serum and follicle AMH(anti-Mullerian
      hormone)levels will be repeated in follicular phase (D2 or 3) of cycle followed by an IVF
      treatment using CC+HMG protocol based on our standard departmental regimen. Improvement of
      ovarian reserve markers would be assessed by the change in serum and follicle AMH levels.
      Cycle characteristics including the dose of gonadotrophins use, duration of stimulation,
      number of oocytes obtained, number of fertilized embryos and good quality embryos will be
      recorded and follicular fluid will be saved for the test of DHEA-S(Dehydroepiandrosterone
      sulfate) and IGF-I. BMP-15 and GDF-9 expression in the follicular fluid were detected with
      western blot.
    

Intervention name(s): DHEA
Intervention type(s): Drug
Intervention description(s): Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
Other intervention name(s): Dehydroepiandrosterone
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Dehydroepiandrosterone（DHEA）; DOR（Diminished Ovarian Reserve); IVF(In vitro fertilization); BMP-15(Bone Morphogenetic Protein 15)
Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women
Condition: Postmenopause
Study type: Observational

Summary: 
      This post-marketing study will provide local safety and tolerance data on the use of
      Premarin® vaginal cream.
    


Intervention name(s): Conjugated Estrogen Cream (Premarin®)
Intervention type(s): Drug
Intervention MeSH terms: Estrogens; Estrogens, Conjugated (USP)
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination
      with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C
      genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3
      different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS,
      PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.
    


Intervention name(s): Albuferon; Ribavirin; PEG-IFNalfa2a
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C