bioihbjkbjnl/mcl2 huggingface dataset:
What Concept of Manual Therapy is More Effective?
Condition: Quality of Life; Self Efficacy; Kinesiophobia; Catastrophizing; Central Sensitisation; Anxiety; Depression; Sleep
MeSH terms: Kinesiophobia
Study type: Interventional

Summary: 
      The aim of the study will be to find out which manual therapy approach is most effective for
      the improvement of symptoms (sensory, cognitive, emotional and social) in people with
      Fibromyalgia.
    

Detailed description: 
      A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will
      undergo a myofascial treatment approach or a passive mobilization treatment approach. Data
      will be collected on the improvement of symptom severity, quality of life, self-efficacy,
      kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After
      the treatments, follow-ups will be made, and the results are expected to be disseminated to
      the scientific community during and after the end of the study.
    

Intervention name(s): Myofascial Therapy Treatments; Passive Mobilizations Approach
Intervention type(s): Other; Other
Intervention description(s): • Myofascial approach: After the bibliographic review of myofascial therapy treatments in fibromyalgia patients based on the articles by CastroSánchez AM et al., and an expert consensus, the following approach was decided: patients would have 4 sessions in total with 1 session per week of 30 minutes each.
Transverse planes in the thoracolumbar fascia (TCL) and abdomen: Performing a myofascial induction as described by Pilat.
Transverse planes at C7-D3 and sternum: Performing a myofascial induction as described by Pilat.
Suboccipital inhibition: Performing a myofascial induction as described by Pilat; • Approach with passive mobilizations: After the literature review of manual therapy treatments in fibromyalgia patients and a consensus of experts in Manual Therapy with more than 15 years of experience, the following approach was agreed upon by the expert: patients would have 4 sessions in total with 1 session per week of 30 minutes each.
Postero-anterior cervical sliding
Postero-anterior lumbar slippage
Postero anterior dorsal slippage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized clinical trial will be conducted between October 2022 and April 2023 in 52 female patients impacted by Fibromyalgia who will undergo a myofascial treatment approach or mobilization treatment approach , with 3 months of follow-up post-treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Manual Therapy; Chronic Pain; Fibromyalgia; Passive Mobilizations; Myofascial Approach; Symptom Severity
Documented Candida or Aspergillus Infections in Pediatric Patients (0991-043)
Condition: Aspergillosis; Candidiasis
MeSH terms: Candidiasis; Aspergillosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is an open label, noncomparative study using an investigational agent for the
      treatment of documented Candida or Aspergillus infections in pediatric patients (ages 3
      months-17 years).
    


Intervention name(s): caspofungin acetate
Intervention type(s): Drug
Intervention description(s): Duration of Treatment - 7-90 days
Other intervention name(s): MK0991
Intervention MeSH terms: Caspofungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
POLish Bifurcation Optimal Stenting Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary
      interventions (PCI) and are associated with higher rates of periprocedural complications as
      well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal
      approach to coronary bifurcations treatment is still a subject of debate, especially when the
      side branch is large, not easily accessible and narrowed by a long lesion. One of the
      proposed alternatives are dedicated bifurcation stents (DBS). However, there is large
      scarcity of randomized trials with DBS.

      The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two
      intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any
      regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting
      of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®
      (Balton, PL).
    


Intervention name(s): Coronary angioplasty with stent implantation
Intervention type(s): Procedure
Intervention description(s): Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
Other intervention name(s): Device: LucChopin (Balton, Poland); Device: Prolim (Balton, Poland); Device: Xience Pro (Abott Vascular); Device: Biomatrix (Biosensors); Device: Promus (Boston Scientific); Device: Cypher (Cordis); Device: Taxus (Boston Scientific); Device: Coroflex Please (BBraun); Device: Resolute Integrity (Medtronic)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: provisional T stenting; dedicated bifurcation stent
Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of this study was to assess and compare the efficacy of a commercially available novel
      herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a
      placebo and non herbal potassium nitrate over a period of 12 weeks.
    

Detailed description: 
      A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the placebo
      mouthwash, Group 2 was given the herbal mouthwash ( Hiora K, which contains potassium nitrate
      derived from Suryakshara plant) and Group 3 was given the non herbal mouthwash (Containing
      non herbal potassium nitrate). Sensitivity scores (VAS score) were recorded at baseline, 3
      weeks, 6 weeks and 12 weeks.
    

Intervention name(s): placebo mouthwash; Herbal Mouthwash; Non Herbal Mouthwash
Intervention type(s): Other; Other; Other
Intervention description(s): 15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks; 15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks; 15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dentinal Hypersensitivity; Gingival Recession; Visual Analogue Score
18348-Human Phototoxicity Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects
    


Intervention name(s): Sunscreen Lotion (BAY987521); Untreated Skin
Intervention type(s): Other; Other
Intervention description(s): 50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.Formulation A: Y49-103, Formulation B: Y71-150.; This site is patched without treatment as irradiated control
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Efficacy of Simvastatin for the Treatment of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy
      of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B:
      body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric
      acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind,
      placebo control study. Population: 18 males with stable COPD between 40-80 years of age,
      exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted
      post-bronchodilation.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Simvastatin 40 mg once a day during 12 weeks; Placebo once a day during 12 weeks
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Bronchitis; Statins; Endothelial dysfunction; Systemic inflammation; BODE index; Uric acid; Vascular growth factors
Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL
Condition: Chronic Shift Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the overnight efficacy and plasma concentration-time
      profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive
      sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).
    

Detailed description: 
      A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and
      Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with
      Chronic Shift Work Sleep Disorder
    

Intervention name(s): PROVIGIL 200 mg; Armodafinil 250 mg; Armodafinil 200 mg; Armodafinil 150 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PROVIGIL 200 mg/day; Armodafinil 250 mg/day; Armodafinil 200 mg/day; Armodafinil 150 mg/day; Matching placebo tablets
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
Condition: Bipolar Disorder; Major Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to find out what parts of the brain have increased or decreased
      activity and connectivity in individuals who have bipolar disorder, major depression, or no
      history of mood disorder. Another purpose of this study is to use MRI images to determine
      which young adults with major depression may be at greater risk for developing mild or more
      severe symptoms of mania which suggests a diagnosis of bipolar disorder.
    

Detailed description: 
      The study involves two phases, phase one includes the screening visit and MRI. The second
      phase, for depression participants, involves in person follow ups for up to two years. The
      second phase, for healthy and bipolar participants, involves phone follow ups, every three
      months for up to two years. The purpose of this study is listed above. We plan to enroll 200
      participants total.
    

Intervention name(s): Selective Serotonin Reuptake Inhibitor (SSRI)
Intervention type(s): Drug
Intervention description(s): Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
Other intervention name(s): Serotonin-norepinephrine reuptake inhibitor
Intervention MeSH terms: Norepinephrine; Serotonin; Selective Serotonin Reuptake Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Bipolar; Depression; Mania; Hypomania; fMRI; antidepressant
Assess Safety & Efficacy of Selumetinib When Given in Combination With Standard First Line Treatment for Advanced Non-small Cell Lung Cancer
Condition: Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open label multicentre study of selumetinib administered orally in
      combination with first line chemotherapy regimens to patients with advanced/metastatic NSCLC.
      The study has been designed to allow an investigation of the optimal dose of selumetinib in
      combination with various standard first line double-platinum chemotherapy regimens. Initial
      assessment will be based on tolerability of selumetinib in combination with one or more
      selected regimens that are considered to be tolerated also being assessed for preliminary
      evidence of activity.

      This study is a dose finding and optional cohort expansion; In addition all patients will be
      assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.
    

Detailed description: 
      A Phase I, Open Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics
      and Preliminary Efficacy of Selumetinib (AZD6244; ARRY-142886) in Combination with First Line
      Chemotherapy Regimens in Patients with Non-Small Cell Lung Cancer (NSCLC)
    

Intervention name(s): selumetinib; gemcitabine; cisplatin; carboplatin; pemetrexed
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy; 1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle; 75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle; If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle; Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.
Intervention MeSH terms: Carboplatin; Gemcitabine; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEK1/2 inhibitor,; Non Small Cell Lung Cancer,; metastatic,; first line treatment for Non Small Cell Lung Cancer
Transcutaneous Electrical Nerve Stimulation for Labor Pain Control
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical
      modality used for several pain conditions including labor pain control. Despite several years
      of research, there is still no agreement within the literature regarding the selection of
      TENS parameters. It is aimed to investigate two types of TENS frequencies (TENS1 alternating
      between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.
    

Detailed description: 
      Midwives and the study investigator will ask parturients, who are admitted to the labor ward
      at Region Hospital Herning satisfying the inclusion and exclusion criteria, whether they are
      interested in attending the experimental session.

      The study will be conducted as soon as the subject is admitted at the labor ward. The study
      will only be conducted during early and active labor and not during the birth of the baby.

      The subject in this study includes the package of a parturient and her neonate (after birth)
      as we also obtain data about the neonate. Hereby, two consent forms will be obtained. As this
      study is a non-invasive study, it is decided to have at least the consent of one parent.

      The investigator will fill out a questionnaire about the parturient in cooperation with the
      subject and midwife, including screening questions related to inclusion and exclusion
      criteria before the experimental session starts.

      The study will last approximately one hour and will be conducted during laboring
      circumstances. KT (Kenoja Thuvarakan) will carry out the experiment, and she will be present
      in the delivery room during the whole session.

      The study includes several outcomes, including subjective and semi-objective pain measures.
      The primary outcome is VAS (0-10 cm scale), while secondary outcomes include PPT and
      satisfaction questionnaire (only at the end of the study). The subjects will be asked before,
      and immediately after the experimental exposure about the four outcomes (VAS and PPT). The
      subjects will be exposed to one of the two combinations of TENS stimulation (low and high
      alternating frequency), which will be compared to sham-TENS.
    

Intervention name(s): DS5 electrical stimulator
Intervention type(s): Device
Intervention description(s): TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups (TENS1, TENS2, and sham)
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TENS; Labor pain; Childbirth; RCT; Pilot study
A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
Condition: Intrauterine Devices, Medicated
Study type: Observational

Summary: 
      A cross-sectional, observational multicenter study to assess the reasons for choosing the
      3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years. The study
      will be conducted in standard clinical practice conditions at public and private gynecology
      clinics and during a single study visit.

      Approximately 1,000 women aged 18 to 29 years who have freely chosen the 3 year hormonal IUD
      as their contraceptive method will be included in the study.
    


Intervention name(s): Levonorgestrel (Jaydess, Skyla, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of women aged 18-29 years, who have freely chosen Jaydess
        for contraception after being adequately counseled and informed of all contraceptive
        options by their physician at a previous visit to the study visit in a routine clinical
        practice setting
Mental Health Services for Toddlers in Foster Care
Condition: Behavior Problems
MeSH terms: Problem Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      Toddlers (2- to 3-year-old children) in foster care often have difficulty regulating behavior
      and biology, and are at risk for a host of mental health problems. Critical issues for
      toddlers straddle the challenges of infancy and preschool years. In particular, toddlers in
      foster care face significant challenges in forming new attachment relationships and
      developing behavioral and biological regulatory capabilities. This project will assess the
      effectiveness of an intervention that targets these issues. Attachment and Biobehavioral
      Catch-up for Toddlers in Foster Care (ABC-T) was developed to help parents: provide nurturing
      care so that children develop secure, trusting relationships; and supporting children when
      they become overwhelmed that enhance children's ability to regulate behavior and biology.
      This intervention's effectiveness will be assessed in a randomized clinical trial.
    

Detailed description: 
      This study assesses the efficacy of a 10-session intervention for young children in the
      foster care system. Children are randomly assigned to the experimental condition (ABC-T) or
      to a treatment control (DEF). In the Attachment and Biobehavioral Catch-up for Toddlers
      (ABC-T) condition, children's foster parents receive an intervention that focuses on
      nurturance, following children's lead, and helping children settle when they become
      overwhelmed. In the Developmental Education for Families (DEF) intervention, children's
      foster parents receive an intervention that focuses on enhancing children's cognitive and
      motor skills. Both of the interventions are provided in families' homes for 10 sessions of
      about 60 minutes duration. Outcomes include attachment (assessed in the Preschool Strange
      Situation), cortisol production (assessed diurnally), child behavior problems (assessed
      through laboratory procedures that stress children), and through psychiatric interviews.
    

Intervention name(s): Attachment and Biobehavioral Catch-up; Developmental Education for Families
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Enhances nurturance, following the lead, and calming behaviors; Attention control: Enhances parents understanding of developmental milestones
Other intervention name(s): ABC; ABC-T; Attachment and Biobehavioral Catch-up for Foster Toddlers; DEF; Occupational Therapy/Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
In Vitro/in Vivo Correlation (IVIVC) for Oral Slow Release (SR) Tablets Pramipexole in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study was to estimate the magnitude of the error in the
      prediction of in vivo bioavailability (AUC0-30,Cmax) by means of in vitro dissolution data
      applying the methods of IVIVC. The secondary objective of the study was to investigate
      whether the intake of food 30 minutes prior to drug administration affects the systemic
      exposure of pramipexole SR C2 or not
    


Intervention name(s): High fat, high caloric meal; Pramipexole IR tablets; Pramipexole SR C; Pramipexole SR C2; Pramipexole SR C2A; Pramipexole SR C2B
Intervention type(s): Other; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Condition: Distal Bile Duct Obstruction
MeSH terms: Cholestasis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the rate of long-term stent failure, defined as need
      for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of
      inoperable malignant distal bile duct obstruction.
    


Intervention name(s): Covered Self-expanding metal biliary stents (C-SEMS); Uncovered Self-expanding metal biliary stents (U-SEMS)
Intervention type(s): Device; Device
Intervention description(s): Used for palliation of inoperable malignant distal bile duct obstruction.; Used for palliation of inoperable malignant distal bile duct obstructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pancreatic cancer; cholangiocarcinoma; metastatic malignancy; jaundice