bioihbjkbjnl/mcl2 huggingface dataset:
H5N1 Mix and Match With MF59
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 216, and up to 270, healthy males and non-pregnant females, 18 to 49 years old,
      inclusive, will be enrolled over a 5-month period into this multicenter, randomized,
      double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study
      and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted
      vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular
      subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given
      with the adjuvant MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2
      doses separated by approximately 21 days.
    

Detailed description: 
      This is a randomized, double-blinded, controlled, Phase I study in healthy male and
      non-pregnant female subjects, 18 to 49 years old, inclusive, designed to assess the safety,
      reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent
      influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur
      administered at different dosage levels (3.75, 7.5 or 15 mcg) given with the MF59 adjuvant
      manufactured by Novartis or PBS diluent.
    

Intervention name(s): Phosphate Buffered Saline (PBS) diluent; MF59 Adjuvant; H5N1 Antigen
Intervention type(s): Other; Drug; Biological
Intervention description(s): Placebo/diluent provided be sanofi pasteur; Adjuvant/diluent manufactured by Novartis; Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, , administered at 3.75, 7.5, or 15mcg, with either MF59 adjuvant or PBS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: H5N1, vaccine, influenza
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled, dose escalation study. There will be 3 cohorts
      of patients defined by the antigen dose (10, 30 or 100 µg of each antigen), and within each
      cohort, patients will be randomized at a ratio of 3:1:1 to one of the following:

        1. GEN-003/M2: GEN-003 plus Matrix M-2 adjuvant (50 µg per dose)

        2. GEN-003: Antigens alone

        3. Placebo (DPBS diluent)

      Each Cohort is divided into 2 Groups. For each dose cohort, immunizations begin with a Pilot
      Group. Immunization of the remainder of the Group "Continuation Group") is contingent upon
      successful review of data from the Pilot Group through Day 7 after immunization. Dose
      escalation to the next dose level Cohort proceeds after evaluation of safety data from all
      patients in the prior Cohort and only after all specified safety criteria are met. The total
      numbers of patients in each Group and Cohort are as follows:

        -  10 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)

        -  30 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)

        -  100 µg Cohort: 10 Pilot Group, 40 Continuation Group (50 Total)

        -  Totals per group: 30 Pilot Group, 120 Continuation Group (150 Total Patients)

      Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at
      3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done
      twice daily for 28 days prior to the first immunization (baseline shedding), and again
      following the last immunization. Follow-up for safety monitoring will be conducted for 12
      months after the last immunization.
    


Intervention name(s): GEN-003 with Matrix M-2; GEN-003; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.; IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).; IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
Other intervention name(s): PBS; DPBS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSV; Herpes; genital infection; vaccine
Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn
Condition: Postprandial Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical
      trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in
      postprandial heartburn.

      The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in
      terms of efficacy for postprandial heartburn treatment.
    


Intervention name(s): IQP-LH-101 tablet; IQP-LH-101 liquid; Placebo
Intervention type(s): Device; Device; Other
Intervention description(s): Oral medical device in the form of a chewable tablet; Oral medical device in the form of a liquid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Efficacy and Safety of E004 in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week
      study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo
      HFA-MDI in pediatric patients who are 4-11 years of age with asthma.
    


Intervention name(s): E004 (Epinephrine Inhalation Aerosol) HFA-MDI; Placebo-HFA
Intervention type(s): Drug; Drug
Intervention description(s): E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID; Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild bronchial asthma
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
Condition: Controlled Ovarian Simulation
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing
      pregnancy rate in women undergoing controlled ovarian stimulation.
    


Intervention name(s): Follitropin alfa; Follitropin delta
Intervention type(s): Drug; Drug
Intervention description(s): GONAL-F dose was fixed for the first 5 stimulation days.; REKOVELLE (FE 999049) was fixed throughout the stimulation period.
Other intervention name(s): GONAL-F; FE 999049; REKOVELLE
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Mindfulness-based Cognitive Therapy Undergoing Post Stroke Rehabilitation
Condition: Stroke; Rehabilitation; Mindfulness
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate the efficacy of mindfulness-based cognitive
      therapy compared to usual care for stroke survivors undergoing inpatient rehabilitation.
    

Detailed description: 
      It was hypothesized that group-based MBCT would lead to improving mood, mindfulness, social
      support, physical, and neurocognitive function; and that these improvements would be
      maintained over the 3-month follow-up period. Participants in the control group received only
      usual care, the intervention group were involved in MBCT intervention in addition to usual
      care. MBCT intervention was designed to consist of eight 1.5-hour group sessions over 6
      consecutive weeks.
    

Intervention name(s): Mindfulness-based intervention therapy; usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Mindfulness-based cognitive therapy consists of meditation techniques to stay in the present moment with acceptance (breathing exercises, body scan, gentle yoga, awareness of thoughts and feelings) and some aspects of cognitive therapy, and psycho-education.; Usual care means received standard multidisciplinary stroke care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of a Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Condition: Cachexia
MeSH terms: Cachexia
Study type: Observational

Summary: 
      The long-term objective of this research is to develop a non-invasive approach for early
      assessment of which patients are at high risk for future development of skeletal muscle
      atrophy. The investigators hypothesize that the rate constant for the terminal portion of the
      isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine
      (D-3MH) provides an accurate measure of this increased risk and that this rate constant can
      be measured non-invasively from timed spot urine samples. In addition, the investigators
      hypothesize that ingestion of a meat-containing meal will stimulate synthesis of skeletal
      muscle proteins to a greater extent than a non-meat-containing meal.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample of healthy males and male lung cancer patients
Channel Interaction in Cochlear Implant and Speech Understanding in Noise
Condition: Cochlear Implants
Study type: Interventional

Summary: 
      The goal of this study is to take into account channel interaction in the cochlear implant
      (CI) fitting process. Designing a fast and accurate method of measurement would help to
      customize the fitting procedures to patients' specificities in order to maximize speech
      understanding in every day conditions especially in noise.
    


Intervention name(s): speech audiometry in noise; Psychophysical tuning curves in forward masking; Electrically-evoked Auditory Brainstem Response (EABR); Tonal audiometry; Auditory canal examination
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.; Sounds of variable center frequency are used as maskers, and a tone with a fixed frequency at a fixed level is the target. What is tested here is the level of masker that just masks the target.; Channel interaction assessment using eABRs (auditory nerve responses). The method consists of two measurements: 1) eABR measurements with stimulation by a single electrode of the cochlear implant at 70% of the dynamic range (four different electrodes are tested); 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, indicates the electrical and neural interactions between the electrodes.; Tonal audiometry will be performed with headphones; Otoscopic examination of external auditory canal and eardrum
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: speech audiometry; psychophysical tuning curve; electrophysiology; auditory brainstem response
Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia
Condition: Placental Malaria Infection; HIV Infections; Stillbirth; Prematurity; Neonatal Deaths
MeSH terms: Infections; Communicable Diseases; Malaria; HIV Seropositivity; Stillbirth; Perinatal Death
Study type: Interventional
Phase: Phase 4

Summary: 
      Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia
      and its serious impact on both maternal and infant survival. Intermittent presumptive
      treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing
      the risk of malaria in pregnancy. However, based on a study done in western Kenya,
      HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis
      rather than the standard 2-dose regimen given during the second and third trimesters, as HIV
      appears to reduce the effectiveness of the SP drug combination. The goal of this study was to
      evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP
      dosing schedule in HIV-positive women.
    

Detailed description: 
      Primary Objectives

      To compare the efficacy of IPT with monthly SP versus a two-dose regimen given once in the
      second and once in the third trimester in HIV-infected women on the:

        -  Prevalence of placental malaria infection

        -  Prevalence of maternal peripheral parasitemia

      Secondary objectives

      To compare IPT with monthly SP versus a two-dose regimen given once in the second and once in
      the third trimester in HIV-infected women on:

        -  Birth weight, including the proportion of LBW infants

        -  Incidence of prematurity

        -  Neonatal and fetal death and third trimester stillbirth

        -  Incidence of neonatal jaundice

        -  Third trimester anemia

        -  Third trimester severe anemia

        -  Proportion of mothers who develop symptomatic malaria during the course of pregnancy
    

Intervention name(s): Sulfadoxine-pyrimethamine (Fansidar)
Intervention type(s): Drug
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Malaria; Placental diseases; Birth complications; Plasmodium falciparum; Zambia; HIV-seropositive; HIV
STN-DBS and the Risk of Sialorrhea
Condition: Parkinson Disease
MeSH terms: Sialorrhea; Parkinson Disease
Study type: Interventional

Summary: 
      OBJECTIVE: The aims of this study were to assess the incidence rate and risk factors for
      sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's
      disease [84 with deep brain stimulation (DBS) and 86 on medical treatment].

      Design, setting, and participants: This study was a multi-center prospective non-randomized
      concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS
      between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary
      outcome follow-up visit was conducted 36 months after DBS.
    

Detailed description: 
      IMPORTANCE: Sialorrhea is a frequent and disabling symptom in patients with PD. No
      prospective study has been specifically designed to test the effects of DBS on sialorrhea
      development.

      OBJECTIVE: The aims of this study were to assess the incidence rate and risk factors for
      sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's
      disease [84 with deep brain stimulation (DBS) and 86 on medical treatment].

      Design, setting, and participants: This study was a multi-center prospective non-randomized
      concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS
      between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary
      outcome follow-up visit was conducted 36 months after DBS.

      INTERVENTIONS: Bilateral subthalamic nucleus DBS was performed in one study arm and not
      performed in the other. Both arms of the study completed the drooling rating scale (DRS), the
      drooling severity and frequency scale (DSFS) and examination of salivary secretion rate.

      MAIN OUTCOMES AND MEASURES: The primary outcome was the DRS scores of the patients with PD,
      with or without STN-DBS 36 months postoperatively. The secondary outcomes included the DSFS
      scores, saliva secreting rate, ratio of botox injection in different group.
    

Intervention name(s): STN-DBS
Intervention type(s): Device
Intervention description(s): STN-DBS was implanted according normal process
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: A total of 234 participants were enrolled between June 2019 and July 2021; 198 patients with PD receive STN-DBS (n=99) or medication (n=99)
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Deep Brain Stimulation; Sialorrhea
BT200 in Hereditary Bleeding Disorders
Condition: Von Willebrand Diseases; Hemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Von Willebrand Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      BT200 is a PEGylated aptamer that binds to the A1 domain of human von Willebrand factor
      (VWF). At low doses, BT200 blocks the clearance of VWF antigen (VWF Ag) from the circulation
      and causes an increase in concentrations of both VWF Ag and Factor VIII (FVIII), but has
      negligible effect on the activity of either. At higher doses, BT200 blocks clearance of VWF
      and also inhibits its activity, but still does not inhibit FVIII activity. Therefore, low
      dose BT200 could potentially be used to correct deficiency of VWF and/or FVIII in patients
      with hereditary bleeding disorders. This study is designed as a "basket design" pilot study
      to determine the relevant dose and pharmacological activity of BT200 in such patients.

      In this open basket study up to 25 patients with the following congenital blood-clotting
      disorders are to be included: Patients with hemophilia A, heterozygous carriers of hemophilia
      A with subnormal FVIII levels; patients with von Willebrand syndrome (VWD) type 1, "Vicenza
      type", and with VWD type 2b.

      Participants will receive BT200 subcutaneously on day 0, day 4 and day 7 in the first week
      and then once a week for a total of five weeks - initially in a dose of 3 mg, then in week 3
      individually after response in a dose of 3 to 9 mg.

      Subsequently, blood samples are taken once a week for a further three weeks (wash-out phase).

      Patients may be enrolled in an additional pharmacokinetics sub-study. For this purpose,
      approximately three blood samples are taken to estimate the half-life of substituted FVIII
      under the influence of BT200.

      The primary objective of this study is to obtain clinical proof of mechanism for BT200 in one
      or more hereditary bleeding disorders.
    


Intervention name(s): BT200
Intervention type(s): Drug
Intervention description(s): BT200 is a PEGylated synthetic RNA oligonucleotide
Intervention model: Single Group Assignment
Intervention model description: Open-label, individual dose titration-to-response, basket trial
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed
      primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is
      a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by
      GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the
      immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The
      immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to
      safety.
    


Intervention name(s): FMP012 with AS01B adjuvant system; P falciparum Controlled Human Malaria Infection (CHMI)
Intervention type(s): Biological; Other
Intervention description(s): Candidate malaria vaccine based on the recombinant protein FMP012, which is Escherichia coli-expressed Plasmodium falciparum cell-traversal protein for ookinetes and sporozoites (PfCelTOS)
Other intervention name(s): FMP012 antigen adjuvanted with AS01B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria vaccine
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
Condition: Breast Cancer; Osteoporosis
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in
      postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of
      broken bones, and help patients live more comfortably.

      PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with
      primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether there is a clinically relevant difference in bone mineral density
           (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without
           osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol
           CAN-NCIC-MA27.

      OUTLINE: This is a multicenter, companion study. Patients are stratified according to
      baseline bone mineral density (BMD) measurement (T-score* ≥ -2.0 standard deviation [SD] [no
      osteopenia or osteoporosis] vs T-score* < -2.0 SD).

      NOTE: *The lowest of the two T-scores: L1-L4 or total hip

      Blood samples for the identification of bone biomarkers (formation marker: serum
      amino-terminal procollagen 1 extension peptide [P1NP] and resorption marker: serum
      N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by
      dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as
      long as patient is receiving treatment on protocol CAN-NCIC-MA27).

      Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with
      osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy

      PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
    

Intervention name(s): calcium carbonate; calcium citrate; cholecalciferol; alendronate sodium; calcium gluconate; risedronate sodium; laboratory biomarker analysis; dual x-ray absorptometry
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug; Drug; Drug; Other; Procedure
Intervention MeSH terms: Calcium, Dietary; Cholecalciferol; Alendronate; Risedronic Acid; Calcium Carbonate; Calcium
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: osteoporosis; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer