bioihbjkbjnl/mcl2 huggingface dataset:
New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection.
      Preliminary patient studies with our dual-detector system indicate that this system is
      capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides
      the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor
      uptake and washout may be predictors to response to neoadjuvant therapy for patients with the
      diagnosis of breast cancer. We propose that in patients with breast cancer who undergo
      neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an
      accurate test for assessing response rate to neoadjuvant therapy.
    

Detailed description: 
      Adjuvant therapy after surgery for breast cancer has provided significant benefits to
      patients at risk for relapse. However, the success of therapy for each individual patient
      will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent as
      an initial treatment for inoperable and large operable breast cancers. Tumor regression can
      be achieved in the great majority of patients and downstaging frequently reduces the need for
      mastectomy and it has become clear that pathologic complete response is a good prognostic
      marker. Data from current trials suggest that survival is at least as good with preoperative
      as with postoperative neoadjuvant therapies (1). With this observation preoperative medical
      therapy has the advantage over post-operative neoadjuvant therapy that it can be used as a
      short term surrogate marker for long-term outcome. With this translational approach, the
      therapy for each patient can be more targeted and individualized leading to higher success
      rates; and further, new therapies for early breast cancer can be assessed much more quickly
      than is currently possible through protracted trials of neoadjuvant therapy (2). This
      approach is therefore being increasingly utilized in patients with lower stage breast
      cancers.
    

Intervention name(s): Molecular Breast Imaging
Intervention type(s): Procedure
Intervention description(s): A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.
Other intervention name(s): MBI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MBI; Breast Cancer; Neoadjuvant Therapy; Molecular Breast Imaging
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
Condition: Pediculosis Capitis (Head Lice)
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an
      investigational treatment for head lice and nits, in normal, healthy infants.
    

Detailed description: 
      There are millions of children and adults affected with head lice each year in the United
      States. It has become a major nuisance in school children resulting in many lost school days
      and frustrated parents. Lice and nit resistance to current OTC products is being widely
      reported. Compliance with product instructions is thought to be low. Therefore a safe and
      effective alternative to these products is desirable.

      Spinosad (the active ingredient in NatrOVA) and its formulations have been approved as
      agricultural insecticides in the US, Canada and Australia, and has received provisional
      approval in the UK, Spain and several other European Union countries.

      Spinosad is being formulated into a creme rinse product (NatrOVA) using excipients that are
      widely used and are "generally regarded as safe" (GRAS)

      This study is intended to measure the absorption (or lack thereof) of Spinosad through the
      scalp of infants aged 6 to 24 months, as well as to observe any adverse events related to use
      of the study drug. A validated method for determining the levels of Spinosad in plasma will
      be utilized.
    

Intervention name(s): NatrOVA Creme Rinse (1%)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediculosis Capitis; Head Lice; Crawlers; Ova; Nits
Study to Compare the Effect of a Combination of Dipyridamole With Sustained Release and Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate whether psychomotor performance which is necessary for safety driving a
      car or operating machinery and safely participating in daily life is changed by Aggrenox®.
      Also to investigate whether Aggrenox® impairs performance in combination with alcohol more
      than alcohol alone. Derived from this: Statement on whether a warning for drivers is
      necessary
    


Intervention name(s): Aggrenox®; Placebo; Ethanol
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Ethanol; Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Psychosocial Intervention for Women With Mood Disorders Seeking Treatment for Obesity
Condition: Obesity; Mood Disorders
MeSH terms: Obesity; Mood Disorders
Study type: Interventional

Summary: 
      Women with mood disorders are vulnerable to the negative consequences associated with
      obesity, and face considerable challenges with adherence to behavioral weight management
      interventions. Strategies are needed to support the psychological well-being of this
      population, and improve adherence to weight-related treatment. The goal of this preliminary
      study is to determine the acceptability of a group-based compassion-focused psychoeducational
      intervention among women with mood disorders who are attending a behavioral weight management
      program.
    

Detailed description: 
      Pilot feasibility trial to examine the acceptability and efficacy of compassion-based
      intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood
      symptoms), and improving weight management outcomes (i.e., physical activity behaviour,
      dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight
      management. In this proof of concept study, adult females with a diagnosis of major
      depressive disorder of bipolar disorder will be randomized into two arms: weight management
      treatment as usual + psychoeducation group; weight management as usual + control.
    

Intervention name(s): Compassion-focused psychoeducation group
Intervention type(s): Behavioral
Intervention description(s): Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: weight management; compassion-focused treatment; internalized weight bias; depressive symptoms
Cold Therapy in the Treatment of Exercise-induced Muscle Damage
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      Subjects were randomly placed in five groups: (1) single exposure at 5°C in cold water
      immersion, (2) single exposure at 15°C in cold water immersion, (3) multiple exposures at
      10°C in cold water immersion, (4) whole body cryotherapy (WBC) at 110°C and (5) passive
      recovery (control group). The single exposure groups performed cold water immersion
      immediately after exercise-induced muscle damage (EIMD) for 20 minutes. The multiple
      exposures group performed cold water immersion immediately, 24h, 48h and 72h after EIMD (once
      a day) for 20 minutes. The WBC group remained in the cabin immediately after EIMD for 3 min.
      The control group was not exposed to treatment after the EIMD protocol. The subjects were
      asked to visit the laboratory on seven occasions. The first visit was the familiarization of
      the subjects with experimental procedures and their anthropometric assessment. One week after
      familiarization, on visit two, volunteers performed the exercise-induced muscle damage (EIMD)
      protocol and they were allocated to one of experimental groups. Indirect markers of muscle
      damage and inflammatory responses were evaluated at baseline (pre), immediately post, 24h,
      48h, 72h, 96h, and 168h following the EIMD protocol by measuring anterior thigh muscle
      swelling, isometric knee extensors peak torque, knee extensors muscle soreness,
      countermovement vertical jump and blood sample analyzes.
    

Detailed description: 
      To avoid circadian influences, subjects were asked to visit the laboratory always at the same
      time of day. Volunteers were asked to not perform any vigorous physical activities or
      unaccustomed exercise during the experiment period. In addition, they were instructed not to
      intake medications or supplements during the study.
    

Intervention name(s): single exposure at 5°C in CWI; single exposure at 15°C in CWI; multiple exposures at 10°C in CWI; whole body cryotherapy (WBC); passive recovery
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): The subjects of this group performed cold water immersion immediately after exercise-induced muscle damage (EIMD) a single exposure at 5°C for 20 minutes.; The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.; The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.; The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.; The control group was exposed to treatment after the EIMD protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise-induced muscle damage; skeletal muscle injury recovery; cryotherapy; recovery of function; rehabilitation
The Correlation Between Family Member Presence and The Consent for Regional Anaesthesia for Caesarean Section
Condition: Acceptability of Health Care
Study type: Observational [Patient Registry]

Summary: 
      Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians.
      According to evidence guidelines, and quality markers, regional anesthesia is preferred over
      general in obstetric surgery. Already a high level of anxiety is present in obstetric
      patients preoperatively.
    

Detailed description: 
      Hospital anxiety is commonly encountered, and it is reported to be seen in 60%-80% of
      patients who undergo surgery. There are many causes of preoperative anxiety including fear of
      death due to anesthesia or surgical procedure and fear of preoperative or postoperative pain.

      Preoperative anxiety varies according to the patient's age, gender, educational status,
      history of previous operations, and medical status as well as the type of surgery and type of
      anesthesia. Patient's safety and satisfaction are major concerns of anesthesiologists and
      obstetricians. According to evidence guidelines, and quality markers, regional anesthesia is
      preferred over general in obstetric surgery. Already a high level of anxiety is present in
      obstetric patients preoperatively.

      The anxious patients tend to prefer general anesthesia (GA) for cesarean section (CS). The
      patient refusal is the main contraindication for applying spinal anesthesia (SA) during CS.
      The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods including
      preoperative visit, information, and music, listening to Holy Quran recitation, hypnosis,
      nitrous oxide, and benzodiazepines. Intravenous sedation can control the anxiety in 90% of
      patients subjected to spinal procedures. While the evidence supports the benefits of
      procedural sedation for distressed, anxious pregnant women.
    

Intervention name(s): Presence of Family member
Intervention type(s): Behavioral
Intervention description(s): The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        110 primi gravida Patients aging 20_40 years, ASA physical status I undergoing elective CS
        •
      
Keywords: Caesarean Section; Regional anaesthesia; Consent
Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Condition: Immunomodulation Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs
      transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and
      gut microbiota, and the interaction) analysis was used to profile immune alternation of
      infants with intravenous ACBMNC infusion in very preterm monozygotic twins
    

Detailed description: 
      This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of
      VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants
      were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously,
      within 24-h post-enrollment within each pair. Multi-omics (analysis of peripheral blood
      immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine
      profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis
      was used to profile immune alternation of infants with ACB-MNCs infusion, along with paired
      controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in
      both short and long term were also assessed.
    

Intervention name(s): autologous cord blood mononuclear cells; normal saline
Intervention type(s): Biological; Biological
Intervention description(s): preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (2-10×107cells/kg) within 24 hours after birth; preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: autologous cord blood mononuclear cells; monozygotic twins; very premature infants
Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in
      adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will
      receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects
      will receive HMS5552 for 28 weeks.
    

Detailed description: 
      This study is a phase III study in subjects with T2DM. As designed, the study will start with
      a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for
      screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID
      group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then
      all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week
      treatment, all investigational drugs should be discontinued, followed by 1 week for safety
      evaluation.
    

Intervention name(s): HMS5552; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BID Oral administration; BID Oral administration
Other intervention name(s): Glucokinase Activator (GKA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GKA; T2DM; HMS5552; monotherapy
Manual Therapy and Exercise in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Non-specific low back pain is one of the main causes of disability for health care worldwide.
      The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the
      treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover,
      can these techniques be combined?
    

Detailed description: 
      Non-specific low back pain is one of the main causes of disability for health care worldwide.
      Nowadays, the mostly used technique to research low back muscular activity is
      electromyography.

      Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and
      of manual therapy in the treatment of low back pain is evaluated, but not a comparison of
      these techniques.

      The main objective that is aimed by this thesis, is the evaluation of muscular activation in
      the reduction of non-specific low back pain through a 12 weeks procedure programme, which
      includes therapeutic exercise combined with other treatment techniques, and assessing the
      psycho-social characteristics of pain.

      This study's population will be composed by at least 16 individuals per group, both male and
      female, with ages among 20 and 80.

      Participants will be randomly and blindly divided in three groups of intervention. The three
      groups will be: the experimental group or EXP Group (all participants subject to therapeutic
      exercise), the experimental group, which will also be subject to manual therapy (MT Group)
      and finally, the experimental group, which will also be subject to kinesio tape work (KT
      Group).
    

Intervention name(s): Exercise
Intervention type(s): Procedure
Intervention description(s): All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
Other intervention name(s): musculoskeletal manipulation; kinesiotaping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: chronic pain; manipulation, musculoskeletal; catastrophisation; kinesiotaping; exercise
A Retrospective Study of the Relationship Between White Matter Hyperintensities(WMHs) Within the Cholinergic Pathways and the Cognition of PD Patients After Bilateral STN DBS
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      To retrospectively investigate the relationship between the Cholinergic Pathways
      Hyperintensities Scale (CHIPS) score and the change of cognitive status of Parkinson's
      disease (PD) patients after bilateral subthalamic nucleus deep brain stimulation (STN DBS).
    

Detailed description: 
      In this observational study, we will retrospectively analyze 38 PD patients who received
      bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University during the year
      of 2008-2012. All patients will be evaluated by Unified Parkinson's Disease Rating Scale part
      III(UPDRSIII) before and after operation. Mini-Mental State Examination (MMSE), Montreal
      Cognitive Assessment(MoCA) in the on medication condition pre-operation and on stimulation on
      medication condition post-operation. The follow-up time points are one week pre-operation and
      6, 12, 24 months post-operation. Before operation, white matter hyperintensities（WMHs）in the
      cholinergic pathways will be determined on a 3.0 Tesla MRI, using the visual rating scale of
      Cholinergic Pathways Hyperintensities Scale (CHIPS). A correlation analysis will be conducted
      to investigate the relationship between CHIPS score and the change of cognitive status of PD
      patients after bilateral STN DBS retrospectively.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        PD patients treated with bilateral STN DBS in the First Affiliated Hospital during the year
        of 2008-2012.
      
Keywords: subthalamic nucleus; deep brain stimulation; cognition; white matter hyperintensities
A Study of Multiple Ascending Doses MY008211A in Healthy Adults
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation, and
      multiple-dose study to evaluate safety, tolerability, PK and PD of MY008211A Tablets in
      healthy subjects.
    

Detailed description: 
      MY008211A Tablets, low/moderate/high dose orally, continually 7 days
    

Intervention name(s): MY008211A tablets; MY008211A tablets matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): MY008211A tablets, low/moderate/high dose orally, for 7 days; MY008211A tablets matched placebo, low/moderate/high dose orally, for 7 days
Other intervention name(s): no other name; placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment