bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
Condition: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the maximum tolerated dose (MTD) of intravenous
      weekly paclitaxel given with intravenous carboplatin and bevacizumab in patients with
      epithelial ovarian, primary peritoneal, or fallopian tube carcinoma that are to receive
      neoadjuvant chemotherapy (prior to surgical cytoreduction). Patients will then undergo
      surgery which will allow an objective measure of response to the above regimen as well as
      assessment of surgical outcomes.
    

Detailed description: 
      Phase I study proposed to evaluate:

        -  Tolerability of IV regimen carboplatin, paclitaxel and bevacizumab in the neoadjuvant
           setting prior to surgery.

        -  Safety/Toxicity of IV regimen in this patient population

        -  Treatment is Carboplatin area under the concentration curve (AUC) 5, Bevacizumab
           15mg/m2, and starting dose of paclitaxel of 60mg/m2 and will be escalated in intervals
           of 10mg/m2 to a maximum dose of 80mg/m2.

        -  Patients will receive cycles 1-3 of carboplatin, bevacizumab, and paclitaxel and then
           cycle 4 will be carboplatin and paclitaxel followed by surgical intervention within 6
           weeks of cycle 4.

        -  Post surgical treatment per physician discretion
    

Intervention name(s): carboplatin; Bevacizumab; Paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.; Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.; 60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
Other intervention name(s): Paraplatin®; CBDCA; Avastin; Taxol; Abraxane
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bevacizumab; paclitaxel; carboplatin; ovarian; cancer; fallopian tube; primary peritoneal
Study of Artesunate in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer; Locally Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluation the tolerability of an add-on therapy with
      artesunate with a duration of 4 weeks in patients with advanced breast cancer.
    

Detailed description: 
      Additional objectives are:

        -  parallel sampling of blood and saliva for the determination of drug concentrations and
           pharmacokinetic parameters in a substudy on the day of first application and during
           steady state

        -  attempt to establish a therapeutical drug monitoring

        -  collection of further safety data during prolonged add-on treatments (compassionate use)
    

Intervention name(s): artesunate
Intervention type(s): Drug
Intervention description(s): add-on therapy with daily single oral doses of 100, 150 or 200 mg of artesunate
Other intervention name(s): artesunic acid hemisuccinate; dihydroqinghaosu hemisuccinate
Intervention MeSH terms: Artesunate
Intervention model: Sequential Assignment
Intervention model description: dose escalation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I; safety
Glycemic Response After Palaeolithic-type Meals
Condition: Glycemic Index of a Meal
Study type: Interventional

Summary: 
      The objective of the study is to show post-prandial benefits of Palaeolithic-type meals as
      compared to a meal constructed along the lines of the WHO dietary recommendations.
    

Detailed description: 
      The effects of this set of meals will be assessed with respect to blood

        -  blood glucose

        -  plasma insulin

        -  satiety scores

        -  plasma gut hormones It is hypothesised that lower post prandial blood glucose
           concentration, a lower insulin response and increased satiety will be seen after the
           Palaeolithic meals compared with a reference meal
    

Intervention name(s): Palaeolithic meal 1; Palaeolithic meal 2; Reference meal
Intervention type(s): Other; Other; Other
Intervention description(s): Based on estimated ratios for protein, fat and carbohydrates that are typical of Hunter-Gatherers and does not contain ingredients that were not available in pre-neolithic times; Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times; Based on WHO dietary guidelines for protein, fat and carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucose, insulin, post prandial
A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-group study will investigate the effect of food (Group 1) and esomeprazole (Group 2)
      on the single oral dose pharmacokinetics of alectinib in healthy volunteers.

      Participants in Group 1 will be randomly assigned to a two period treatment sequence (AB or
      BA) in which they will receive a single, oral dose of alectinib per period separated by at
      least 10 days. Each participant will receive single, oral doses alectinib given under fasted
      conditions (Treatment A) or following the ingestion of a high fat, high calorie meal
      (Treatment B) as determined by their assigned sequence.

      Participants in Group 2 will be given a single, oral dose of alectinib following a standard
      meal. After a washout period of at least 10 days, they will receive an oral dose of
      esomeprazole (40 mg) once daily for 6 days. On the 6th day of esomeprazole administration, a
      single, oral dose alectinib will be given after ingestion of a standard meal.

      In all groups, pharmacokinetics will be assessed in the 4 days following alectinib
      administration.
    


Intervention name(s): Alectinib; Esomeprazole; High Fat and Calorie Meal; Standard Meal
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): A single 600-mg oral dose of alectinib will be administered in a fasted or fed condition.; Esomeprazole 40 mg will be administered orally once daily for 6 days prior to alectinib administration.; High fat and calorie meal served prior to alectinib administration; Standard meal served prior to alectinib administration
Other intervention name(s): RO5424802
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tobacco Cessation in Postmenopausal Women (Part II) - 2
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of ERT on appetitive behavior and
      withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine
      replacement
    


Intervention name(s): Nicotrol
Intervention type(s): Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Smoking
Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A placebo controlled study of the impact on insulin sensitivity and lipid profile of
      maraviroc 300 mg twice daily in HIV negative male volunteers.
    


Intervention name(s): Maraviroc; Maraviroc
Intervention type(s): Drug; Drug
Intervention description(s): Maraviroc 300 mg twice daily for the first 14 days of the study. Placebo twice daily for the last 14 days of the study; Placebo twice daily for the first 14 days of the study.
Maraviroc 300 mg twice daily for the last 14 days of the study.
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS
Condition: Smoking; Tobacco Smoking; Tobacco Use
Study type: Interventional

Summary: 
      This is a randomized, controlled, open-label, 4 parallel arm study with a stratified
      randomization by sex (a quota for each sex [females and males] of at least 40% overall).

      This study aims to demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected
      Harmful and Potentially Harmful Constituents (HPHC) in smokers switching from cigarettes
      (CIG) to each of the Tobacco Heating System (THS) variants with different heating technology
      (Blade device, Induction Mono device, or Induction Mid device, respectively), compared with
      smokers who continue to smoke CIG. A reduction of exposure to HPHC is expected in CIG smokers
      when switching completely to THS.
    

Detailed description: 
      The exposure period in confinement will provide information on exposure reductions achievable
      in a well-controlled environment with full control on daily THS stick consumption and
      compared to CIG smoking.

      The primary hypothesis tested in this study is that BoExp considered for the primary
      objective will be reduced for each THS variant (Blade device, or Induction Mono device, or
      Induction Mid device, respectively) in subjects who adhere to switching to THS for 5 days,
      compared to subjects continuing CIG smoking.
    

Intervention name(s): THS Blade device; THS Induction Mono device; THS Induction Mid device; CIG
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Tobacco Heating System (THS) device with Blade technology for Blade tobacco stick use; Tobacco Heating System (THS) device with Induction technology (combined Charger-Holder device for Induction tobacco stick use).; Tobacco Heating System (THS) device with Induction technology (device with Induction stick Holder for Induction tobacco stick use and separate Charger).; Subject's preferred brand of commercially available regular (non-mentholated) cigarettes. (Cigarettes are not provided by the study sponsor.)
Other intervention name(s): IQOS (THS blade device); HEETS (blade heated tobacco sticks); IQOS Iluma One (THS induction device); TEREA (induction heated tobacco sticks); IQOS Iluma (THS induction device); TEREA (induction heated tobacco sticks); Cigarette (non-mentholated)
Intervention MeSH terms: Pyrithione zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, controlled, open-label, 4 parallel arms study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exposure Response; Smoking; Tobacco Heating System; Heated Tobacco
CO2 Laser in the Treatment of the GSM - (Genitourinary Syndrome of Menopause) Genitourinary Syndrome of Menopause
Condition: Menopause; Vaginal Atrophy; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Atrophy
Study type: Observational

Summary: 
      Menopause is a woman's hormonal status one year after her ovulatory failure, when the
      decrease of circulating estrogen levels leads to a group of symptoms named Genitourinary
      Syndrome of Menopause (GSM), such as: vaginal dryness, dyspareunia, dysuria, epithelial
      fragility with recurrent bleedings, loss of genital elasticity and pH alterations causing
      recurrent infections. The CO2 laser is a fractional ablative source of light, capable of
      inducing neocollagenesis within the skin, reversing atrophies, increasing blood supply and
      reorganizing the architectural structure of the treated epithelium. Recent studies in the
      laser field show great improvement of the SGM, with satisfying results in female's sexual
      disfunction. Nevertheless, there is still a lack of studies that show, at the same time, the
      improvement in both patient's subjective reports and objective measurements, such as
      cytology, histology and immunohistochemistry. This study aims to thoroughly analyze the
      benefits of the CO2 laser in the treatment of the GMS, comparing the improvement found in
      questionnaires to the results of cytology, histology and immunohistochemistry for collagen I
      and III from vaginal biopsies before and after the laser treatment. Therefore, fourteen women
      after menopause complaining of symptoms of the GSM were selected from the ambulatory of the
      Hospital Universitário Antônio Pedro. The patients will be submitted to three CO2
      intravaginal laser (Femilift®), with a 30-days interval between them. Biopsies of the vaginal
      wall will be taken one month before the start and one month after the end of the laser
      sessions, and material will be sent to histology, cytology and immunohistochemistry analysis.
      Results obtained will be compared to the patients' reports, in order to evaluate subjective
      and objective improvement due to the treatment.
    


Intervention name(s): CO2 fractional ablative laser
Intervention type(s): Radiation
Intervention description(s): 3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteer women from 40 to 70 years, healthy and with regular gynecologist follow up, not
        willing or not eligible to take hormones to treat the GSM, experimenting difficulties in
        their sexual life and their daily routine, due to vaginal atrophy and urinary incontinence.
      
Keywords: menopause; vaginal atrophy; urinary incontinence; CO2 laser; fractional laser; dyspareunia; vaginal dryness; vaginal lubrication
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will assess the safety, tolerability, and pharmacokinetics (PK) of
      QPX7831, a beta-lactamase inhibitor, when administered orally in single ascending doses and
      in multiple ascending doses to heathy adult subjects.
    

Detailed description: 
      Qpex Biopharma, Inc. is developing an oral dosage form that delivers QPX7728, a new
      boron-based beta-lactamase inhibitor with activity against both serine and
      metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic.

      The objectives are:

        1. To assess the safety and tolerability of QPX7831 when administered orally in single
           ascending doses (SAD) and in multiple ascending doses (MAD) to healthy adult subjects.

        2. To assess the PK of single and multiple doses of oral QPX7831 when administered to
           healthy adult subjects to determine if the target exposures identified in preclinical
           studies can be attained in healthy adult subjects.
    

Intervention name(s): QPX7831; placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): capsule; oral matched placebo capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Double-blind, placebo-controlled, sequential, ascending single-and multiple-dose design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: beta-lactamase inhibitor
A Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
Condition: B-cell Small Lymphocytic Lymphoma Recurrent
MeSH terms: Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1 multicenter study of bendamustine, rituximab and TRU-016 (BRT) in subjects
      with relapsed indolent B-cell lymphoma. This was a multiple-dose escalation study to
      determine the maximum-tolerated dose (MTD) of TRU-016 given in combination with rituximab and
      bendamustine and to determine a safe dosing regimen for the combination in up to 12 subjects
      with relapsed indolent lymphoma.

      The originally planned Phase 2 portion, an open-label, randomized study to evaluate the
      efficacy of BRT compared with BR, was not conducted.
    

Detailed description: 
      This study was planned to be conducted in 2 parts: a Phase 1b component designed to determine
      a safe dosing regimen, and a Phase 2 component designed to evaluate the efficacy of BRT
      compared to BR in subjects with relapsed indolent lymphoma. The Phase 2 component was not
      conducted.

      This was an open-label, non randomized, multiple-dose escalation study to determine the MTD
      of BRT and to determine a safe dosing regimen for the combination in subjects with relapsed
      indolent lymphoma.

      The study consisted of a screening period lasting up to 21 days, a treatment period lasting
      up to 6 cycles (28 days each), and a 60-day follow-up period. Up to 12 subjects (2 cohorts of
      6 subjects each) were planned for enrollment. Two dose levels (10 and 20 mg/kg) of TRU-016
      combined with rituximab 375 mg/m2 and bendamustine 90 mg/m2 were evaluated during up to 6
      cycles (28 days each). TRU-016 was administered by intravenous (IV) infusion on Days 1 and 15
      of each cycle. Rituximab was administered by IV infusion on Day 2 of each cycle. Bendamustine
      was administered by IV infusion on Days 1 and 2 of each cycle. Subjects received study
      treatment for up to 6 cycles.
    

Intervention name(s): TRU-016; Bendamustine; Rituximab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle; Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.; Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle.
Other intervention name(s): otlertuzumab; Treanda; rituxan
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: follicular lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; non-Hodgkin's lymphoma; indolent lymphoma
A Study of Macitentan/Tadalafil Combination Administered a Fixed-dose Combination Formulation Compared to the Reference Free Combination of Macitentan and Tadalafil
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of macitentan and
      tadalafil following administration of a single oral dose of a fixed-dose combination (FDC) of
      10 milligram (mg)/20 mg macitentan/tadalafil (test), compared to the coadministration as a
      free combination (reference) of 10 mg macitentan and 20 mg tadalafil under fasted conditions
      in healthy adult participants.
    


Intervention name(s): FDC of macitentan/tadalafil (10 mg/20 mg); Macitentan 10 mg; Tadalafil 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC of macitentan/tadalafil (10 mg/20 mg) tablet will be administered orally as per assigned treatment sequence.; Macitentan 10 mg tablet will be administered orally as a free combination as per assigned treatment sequence.; Tadalafil 20 mg tablet will be administered orally as a free combination as per assigned treatment sequence.
Other intervention name(s): Opsumit; Adcirca; Opsumit; Adcirca
Intervention MeSH terms: Tadalafil; Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Observational

Summary: 
      This is a multisite, open-label, prospective and registered study designed to evaluate the
      efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
    

Detailed description: 
      This is a multisite, open-label, prospective and registered study designed to evaluate the
      efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic
      syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study
      for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the
      data included demographic characteristics, information about PNS, laboratory tests and
      adverse events.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children are diagnosed with primary nephrotic syndrome
      
Keywords: Huaiqihuang granule; primary nephrotic syndrome; multisite; prospective; open-label
TRIAD - Treatment of Insomnia and Depression
Condition: Sleep Initiation and Maintenance Disorders; Depression
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the proposed three-site study is to increase the rate of full remission from major
      depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both
      major depressive disorder and insomnia.
    

Detailed description: 
      Participants with major depressive disorder and insomnia who meet all study criteria will
      receive state-of-the-art antidepressant medications and one of two insomnia therapies. The
      specific therapy for insomnia will be determined by chance (like a flip of a coin), with an
      equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization
      psychotherapy for insomnia. The study physician will select an initial antidepressant
      medication from a list of three possible medications . If that medication is not helpful,
      another medication may be tried after 8 weeks or in the event of severe side effects.
    

Intervention name(s): Antidepressant; Desensitization Therapy for Insomnia; Cognitive Behavioral Therapy for Insomnia
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment