bioihbjkbjnl/mcl2 huggingface dataset:
The Objectives of This Study Are Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza Vaccine in Volunteers Aged 18-60 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of the Reactogenicity, Safety and Immunogenicity of Flu-M Inactivated Split Influenza
      Vaccine in Volunteers Aged 18-60 Years
    

Detailed description: 
      All subjects will be followed up for 21 days post-randomization. The subjects will further be
      assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be
      collected for reactogenicity and safety and immunogenicity assessments before injection and
      21 days after vaccination.
    

Intervention name(s): Inactivated Split Influenza Vaccine; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: influenza; flu; vaccine; Flu-M
Metastatic Breast Carcinoma and Women Sexual Quality of Life
Condition: Metastatic Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms
Study type: Observational

Summary: 
      Sexual health is one of the relevant parameters for assesing the quality of life.

      Improvement sexual and emotional function improves quality of life scores and depression or
      anxiety in curative phase.

      The purpose of the study is to assess the quality of sexual life of postmenopausal women with
      metastatic breast cancer in couples and to establish links with overall quality of life and
      the quality of the relationship.
    

Detailed description: 
      We use a quantitative methodology to assess quality of female sexual life, quality of life
      and quality o relationship with validated scientific questionnaires.

      The sexual and emotional intimacy will be explored by semi structured interview, not
      mandatory for patients.
    

Intervention name(s): Medical questionnaire
Intervention type(s): Other
Intervention description(s): Brief Index of Sexual Functioning for Women questionnaire
Quality of life questionnaire (EORTC QLQ-BR23)
Partnership questionnaire (partnerschaftsfragebogen; PFB)
Short interview about their sexual intimacy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and
        living in a couple and followed at the Lorraine Institute of Oncology.
      
Keywords: Cancer; Sexuality; Quality of life; Intimacy; BISF-WBrief Index of Sexual Functioning for Women questionnaire; Quality of life questionnaire (EORTC QLQ-BR23):; Partnership questionnaire (partnerschaftsfragebogen; PFB)
Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women
Condition: Hemodynamic Changes in Pregnancy
Study type: Observational

Summary: 
      Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive
      monitoring devices are desirable, but until now, no equipment has proven validity. This study
      aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in
      pregnant women.
    

Detailed description: 
      Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive
      measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO
      Plus. Both comparison of absolute values and the two different devices trending abilities
      will be analyzed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy singleton pregnancies at term scheduled for cesarean delivery under spinal
        anesthesia
      
Keywords: Pregnancy, cesarean delivery, blood pressure, cardiac output
Neurophysiological Mechanisms Involved in Knee Osteoarthritis
Condition: Knee Osteoarthritis; Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Observational

Summary: 
      Introduction: Total knee arthroplasty (TKA) is an effective intervention to relieve people
      with osteoarthritis (OA). Nevertheless, 15 to 30% of patients continue to experience severe
      pain following surgery. Recent data suggest that central nervous system (CNS) changes may
      play a role in OA pain and possibly explain why some patients have poorer clinical outcomes
      following TKA. Objectives: Our main objectives are to explore the relationship between OA
      pain and (1) the integrity of corticospinal system, (2) the efficacy of descending pain
      inhibition circuits. Methods: Fifty-two patients waiting for TKA will be recruited. The
      integrity of the corticospinal projections will be measured using transcranial magnetic
      stimulation (recruitment curve of the affected quadriceps femoris muscle) and the descending
      pain inhibition circuits (bulbospinal projections) will be assessed by a counter-irritation
      paradigm (i.e., conditioned pain modulation with immersion of the arm in painfully cold
      water). Diffuse tension imaging (DTI) will also be used to quantify the strength of these
      corticospinal and bulbospinal projections. Clinical outcomes will be evaluated before and
      after arthroplasty with a series of validated questionnaires such as the WOMAC Scale, the
      McGill Pain Questionnaire and the Brief Pain Inventory. These different neurophysiological
      and clinical measures will be taken before surgery, 6 months after surgery and 1 year
      post-surgery. Anticipated results: The investigators expect a moderate association between
      pain and the strength of the corticospinal and bulbospinal projections. Moreover, it is
      expected that there will be a moderate association between the strength of the
      corticospinal/bulbospinal projections and the clinical evolution of patients.
    

Detailed description: 
      See outcome measures
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary
        arthroplasty
      
Keywords: Arthritis; Chronic pain; Transcranial magnetic stimulation (TMS); Magnetic resonance imaging (MRI); Conditioned pain modulation (CPM); Clinical measures; Knee osteoarthritis
Three Levels of Force Application for Maxillary Protraction
Condition: Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study is to evaluate dentoskeletal changes concomitant with different three
      levels of force application for maxillary protraction in growing patients with skeletal class
      3 malocclusion.
    

Detailed description: 
      Nanda reported that numerous experimental studies on primates have shown orthopedic changes
      in response to extraoral forces; however, very few studies have made an attempt to analyze
      the different force variables and their relationship to facial sutures. In consideration of
      the variables, experimental and clinical studies were initiated in their laboratory in 1972.
      A study on protraction of midfacial bones on primates reported that the point of force
      application significantly influences the center of rotation of the maxilla in rhesus monkeys.
      Our unpublished data also show that centers of rotation are influenced by the magnitude of
      force. The study showed that the maxilla can be successfully protracted by means of carefully
      controlled forces.

      Based on the aforementioned data, we can hypothesize that the point of force application for
      maxillary protraction in relation to the center of resistance of maxilla could be utilized in
      order to correct skeletal class 3 malocclusions with different vertical dimension
      discrepancies.
    

Intervention name(s): Petit typeface mask
Intervention type(s): Device
Intervention description(s): (Intraoral) Hyrax expander for maxilary sutures disarticulation through expansion, (Extraoral) Face mask for generating maxillary protraction forces and head gear face-bow to act as a connector between both intra and extra oral parts.
Other intervention name(s): Hyrax expander, Head gear face-bow (Denturum)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of a Shared Decision Making Portal for Pediatric Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This pilot intervention study will test the feasibility and acceptability and explore the
      outcomes of a primary care-based shared decision making (SDM) electronic medical record
      (EMR)-based portal that provides education, elicits and tracks patients/families' treatment
      concerns and goals, assesses symptoms and asthma control over time, and provides decision
      support to clinicians and families.
    


Intervention name(s): MyAsthma Patient Portal
Intervention type(s): Other
Intervention description(s): Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Goals; Shared Decision Making; Patient Portal; Electronic Medical Record
Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in
      men and women. Several types of HPV infection are transmitted by sexual activity and, in
      women, can infect the cervix (part of the uterus or womb). This infection, if it persists,
      can lead over a long period of time to cancer of the cervix in women. In collaboration with
      MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic
      types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating
      novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a
      novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately
      376 study subjects will receive the novel HPV vaccine or the control vaccine administered
      intramuscularly according to a 0-1-6 month schedule.
    


Intervention name(s): HPV 16/18 L1 AS04; HPV-16/18/31/45 L1 AS04 Formulation 1; HPV-16/18/31/45 L1 AS04 Formulation 2; HPV-16/18/31/45 L1 AS04 Formulation 3; HPV-16/18/31/45 L1 AS04 Formulation 4; HPV-16/18/31/45 L1 AS04 Formulation 5; HPV-16/18/31/45 L1 AS04 Formulation 6
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim is to investigate whether 16 weeks of high intensity interval training, followed by
      36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic
      Ovary Syndrome (PCOS) compared with a non-exercising control group.
    


Intervention name(s): 4x4 minutes high intensity interval training; 10x1 minute high intensity interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.; Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
Other intervention name(s): High-intensity exercise; Aerobic exercise; High-intensity exercise; Aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise therapy; Reproductive Physiological Processes; Fertility
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Condition: Healthy
Study type: Interventional

Summary: 
      Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of
      stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United
      States. These viruses are sometimes found in drinking water, ice, shellfish and in other
      foods. They can be spread easily from contact with water, food, objects or hands that have
      even small amounts of feces from someone who was sick.

      The purpose of this research study is to the effectiveness of high hydrostatic pressures
      processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in
      shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on
      the surface and on the interior of the food. The goal of the study is to determine whether
      HPP treatment on oysters spiked with norovirus will reduce infection rates in people
      consuming raw infected oysters.
    


Intervention name(s): High Hydrostatic Pressure Processing
Intervention type(s): Procedure
Intervention description(s): High Hydrostatic Pressure Processing is a technology, used in the food service industry, where foods are subjected to high pressure. These high pressures kill many pathogens without affecting the quality of the food.
Other intervention name(s): HPP
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Norovirus; Gastroenteritis; Clinical Trial; Stomach flu; Oysters; Shellfish; high hydrostatic pressures
Efficacy of Swedish Massage Therapy on Cancer-related Fatigue in Cancer Survivors
Condition: Cancer Related Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      With approximately 12 million cancer survivors today in the United States alone, increased
      attention is being given to quality of life after cancer treatment. Cancer-related fatigue
      (CRF) is one of the most prevalent and debilitating symptoms experienced by people with
      cancer. It can persist for months or years after cancer therapy is completed and has a
      negative impact on all areas of function. Meaningful evidence-based treatment options for CRF
      are extremely limited and finding safe, inexpensive, and effective interventions for managing
      this distressing symptom are urgently needed. Basic research has shown that activation of the
      immune system can cause potent changes in behavior including reduced activity, fatigue, and
      decreased social behavior. Furthermore, research over the last decade has found a
      relationship between levels of CRF with increased inflammation. Thus, study of therapies that
      may decrease immune system activation in the setting of CRF represents a possible target for
      intervention. Massage therapy is one of the fastest growing alternative therapies and has a
      high rate of acceptance for symptom management among cancer patients. Massage has been shown
      in smaller studies with cancer patients to modulate the immune system. Moreover, massage has
      been demonstrated to significantly decrease markers of immune system activation in normal
      subjects. There are no published randomized controlled trials examining either the role of
      massage as an intervention primarily for CRF or investigating whether massage related
      decreases in immune system activation are responsible for improvement in CRF. This proposal
      investigates the effects of massage therapy on CRF among breast cancer survivors. The
      investigators' primary hypothesis is that Swedish Massage Therapy (SMT) will decrease CRF
      compared to a light touch condition and wait list control. The investigators' secondary
      hypothesis is that SMT will decrease CRF by reducing immune system activation. The
      investigators' main exploratory hypothesis is that a decrease in CRF will increase quality of
      life among cancer survivors.
    


Intervention name(s): Swedish massage therapy; Light touch therapy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: swedish massage; fatigue; light touch; inflammation
Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is intended to determine whether topiramate is an efficacious and safe treatment
      for restless legs syndrome.
    

Detailed description: 
      Benzodiazepines, levo-dopa/carbidopa, dopamine agonists, anticonvulsants, and opioids have
      been used with variable success, to treat RLS. Often, RLS patients treated with a
      benzodiazepine, over the course of several months, develop tolerance to the medication. Also,
      benzodiazepines can cause confusion or daytime sleepiness and may be addictive. Patients may
      also develop tolerance to levo-dopa/carbidopa treatment. Because of the short half-life,
      symptoms may be suppressed for only the first part of the sleep period and then recur later
      during the night. Rebound has been reported. Worse yet, augmentation, the occurrence of RLS
      symptoms, often more severe than before treatment began, earlier in the day, may occur in up
      to 80% of RLS patients treated with levod-dopa/carbidopa. Dopamine agonists, including
      pergolide, pramipexole, and ropinirole, are effective for some patients but not for others.
      Common side effects of these drugs include coryza, hypotension, and rash. Of the
      anticonvulsants, preliminary reports suggest that gabapentin, carbamazepine, and divalproex
      can suppress RLS symptoms in some patients, especially those with mild RLS. Side effects
      include sleepiness, ataxia, and weight gain. Opioid treatment for RLS has been described as
      effective but, aside from the stigma of taking controlled substances regularly, side effects
      may include nausea, sedation, constipation, and dysequilibrium. Iron supplementation is
      therapeutic in some patients with iron deficiency and RLS.

      Preliminary anecdotal data suggest that topiramate reduces RLS symptoms. Topiramate has
      several potential mechanisms of action including enhancement of GABA-mediated inhibition,
      which may account for the observed benefit in patients with RLS.

      Topiramate may be a better alternative than the currently available treatments to suppress
      RLS symptoms. Like gabapentin, it offers the possibility of decreasing RLS symptoms while
      also diminishing pain, especially in those patients who have limb pain from neuropathy,
      radiculopathy, or other causes. Unlike gabapentin, topiramate may help overweight patients
      with RLS lose weight, if anedotal reports on weight reduction with the medication are
      correct.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Keywords: Restless Legs Syndrome; Topiramate; Actigraphy; Polysomnography
A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies
Condition: Advanced Solid Malignancies
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this
      study will be to investigate the safety and tolerability of Fluzoparib Capsule when given
      orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic
      profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.
    


Intervention name(s): Fluzoparib
Intervention type(s): Drug
Intervention description(s): Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.
Intervention MeSH terms: Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PARP; Advanced Solid Malignancies; Fluzoparib; Ovarian Cancer; BRCA