bioihbjkbjnl/mcl2 huggingface dataset:
Neural Effects of Mindfulness Training on Attention
Condition: No Condition; Focus is Neural Effects of Mindfulness Training on Attention
Study type: Interventional

Summary: 
      The purpose of this study is to examine behavioral and neural changes resulting from
      Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our
      understanding of the mechanisms of attention.
    

Detailed description: 
      Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain,
      and adverse health symptoms in a varied subject population. MMT has been described as "paying
      attention in a particular way." Although attention is a key component of meditation, little
      is known about the cognitive and neural changes within the human attention system that result
      from MMT. In this study, we examine the effects of MMT on the human attention system using
      neurobehavioral measures. Here MMT comprises participation in a
      Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in
      a nutrition education course, both 8 weeks long. We compare the performance and neural
      activity of these groups both before and after participation in the course.
    

Intervention name(s): Mindfulness Meditation Training (MMT); Nutrition Education course
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8-week training course in mindfulness meditation; 8-week course in nutrition
Other intervention name(s): MBSR, Mindfulness-Based Stress Reduction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Attention; ERP; event-related potentials; fMRI; functional magnetic resonance imaging; MBSR; Mindfulness Based Stress Reduction; Mindfulness Meditation Training; MMT
Double-Blind Study of Topical WBI-1001 Cream on Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate primarily the safety and tolerability and
      secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to
      moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients,
      treated for 28 days plus a 7 day follow-up.in which the patients were divided into six
      cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID;
      Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Efficacy assessed by PGA,target lesion assessment
      and BSA. Safety assessed through vital signs, ECG, AEs and Plasma PK via Cmin, Cmax,Tmax and
      AUCo-t.
    

Detailed description: 
      Patients initiated screening within 4 weeks of commencing study treatment. Based on
      progression of the study, at day 0 patients were assigned to one of six treatment Cohorts.
      Patients were randomized to treat all areas except the face, scalp, groin and genital areas.
      Patients in Cohort 1 were treated on one side with a thin layer of active cream and the other
      with placebo; in the absence of significant AEs by 14 days after the last treatment in the
      Cohort escalation to the next Cohort was allowed, and each Cohort respectively.

      During the treatment period patients visited the study centre weekly for safety, tolerability
      and efficacy assessment. On these study visit days blood draws were done between 7.00 and
      10.00am prior to that morning's application of cream.

      The study enrolled healthy male and female patients aged 18-65 y.o. with clinical diagnosis
      of stable plaque psoriasis for >months affecting a maximum of 6% of BSA with a minimum of
      0.5% BSA on each side of the body and a minimum of one plaque at least 2x2 cm on each side
      excluding elbow and knee.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Males and female18-65 yo. inclusive Mild to moderate plaque psoriasis
      
Biospecimen description: 
      Blood plasma samples retained following PK analyses.
    
Keywords: Topical cream application; Mild to moderate psoriasis
A Pharmacokinetic Study of the Effect of Itraconazole Exposure to Orvepitant in Healthy Volunteers
Condition: Pharmacokinetic Study in Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to assess the effect of itraconazole, a strong inhibitor of CYP3A and
      P-glycoprotein, on the pharmacokinetics (PK) of orvepitant in healthy male volunteers.

      Subjects will receive two single doses of 20mg orvepitant, once alone and once in combination
      with repeat doses of itraconazole. All subjects will follow the same sequence - orvepitant
      alone followed by orvepitant in combination with itraconazole.
    


Intervention name(s): Orvepitant; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Once daily dosing for 10 days
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients
      receiving chemotherapy for cancer.

      PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or
      preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the prevalence and severity of delayed nausea and vomiting in patients with
           cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs
           placebo.

      Secondary

        -  Compare the prevalence and severity of acute nausea and vomiting in patients treated
           with these regimens.

        -  Compare the safety of these regimens in these patients.

        -  Determine whether patients can determine if they are receiving placebo or study drug,
           and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent
      antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

        -  Arm I: Patients receive lower-dose oral ginger twice daily.

        -  Arm II: Patients receive higher-dose oral ginger twice daily.

        -  Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins
           immediately after the chemotherapy treatment and continues for 3 days.

      Patients are followed at 1 week.

      PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): ginger extract; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Masking: Double
Primary purpose: Supportive Care
Keywords: nausea and vomiting; unspecified adult solid tumor, protocol specific
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
Condition: Upper Limb Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial
      involving 100 children with cast-immobilized stable upper limb fractures. These patients were
      randomized into either biobased polyester or synthetic fiberglass groups. All patients were
      regularly followed up till the cast removal which occurred approximately 3-4 weeks after
      immobilizing. Objective clinical findings and subjective patient questionnaire were all
      collected and analyzed.
    

Detailed description: 
      The clinical trial was approved by the research ethics review committee of the author's
      hospital and informed consent was obtained from the legal guardian of each patient. Between
      Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable
      upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland
      type I supracondylar fractures of the humerus) [9] diagnosed at the orthopedic outpatient
      clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.
    

Intervention name(s): the biobased polyester cast; the synthetic fiberglass cast
Intervention type(s): Other; Other
Intervention description(s): long arm casting; long arm casting
Intervention MeSH terms: Calpastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The clinical trial was approved by the research ethics review committee of the author's hospital (Number XXX) and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I9 supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric upper limb fracture; casting; Bioabased polyester; Synthetic cast
Effect of Psychological Interventions on Maternal Outcomes Undergoing Cesarean
Condition: Perioperative Psychology
Study type: Interventional

Summary: 
      Pregnancy induced psychosis is an essential factor that influencing maternal health
      postpartum. When gravidas, especially nulliparas, facing labor and delivery, they will
      undoubtedly encounter burden from their own and surrounding facts. Maternal psychosis takes a
      large part of women's psychological disorders. No matter which way, either spontaneous or
      surgical, they would choose, many factors influence their psychological state. Cesarean
      section poses higher risks for women than vaginal delivery. Therefore, how to seek effective
      methods to alleviate parturients' psychological stress response possesses pivotal clinical
      implications. Herein the investigators proposed that different linguistic interventions given
      pre-, intra- or post-operatively would produce different effect on maternal psychology and
      internal stress level.
    


Intervention name(s): Language; Language
Intervention type(s): Other; Other
Intervention description(s): Plain language without psychological intervention; Psychological linguistic intervention will be given
Other intervention name(s): Psycholinguistic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Linguistic; Stress response; Corticosteroid; Cesarean section; Anxiety; Depression; Maternal psychosis
Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to address the safety issue of whether, in patients with
      newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely
      affects the rate of damage to the insulin making cells.
    

Detailed description: 
      Type 1 Diabetes (also known as insulin-dependent diabetes) is caused by destruction of the
      insulin producing cells (Beta Cells) in the pancreas. Our group is interested in how this
      destruction could be stopped or reversed, as this may lead to development of a new generation
      of diabetes treatments which can prevent or slow down the damage, reducing or possibly even
      removing there need for insulin injections.

      In a previous study we examined the safety of our novel approach to this problem, proinsulin
      (PI) peptide immunotherapy, in longstanding diabetes patients (diagnosed more than 5 years
      before), and found it to be well tolerated and free of major hypersensitivity reactions.
      However, it remains theoretically possible that this form of immunotherapy could make the
      immune reaction to the insulin making cells worse rather than better.

      This cannot be studied directly in longstanding patients as they have no or almost no insulin
      making cells left.

      So,the principle objective of the current study is to address the safety issue of whether, in
      patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide
      therapy adversely affects the rate of damage to the insulin making cells.
    

Intervention name(s): Pro insulin peptide; Pro insulin peptide; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).; Patients will receive 10 micro gr of the peptide monthly (ever 4 weeks, 6 doses) and saline injections monthly alternating with the peptide (2 weeks interval between the drug and saline).; Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is evaluating the efficacy and safety of a topical herbal solution
      in males for the treatment of Androgenetic alopecia.
    

Detailed description: 
      This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will
      be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible
      individuals will be selected among them. Subjects were randomized to use either Topical
      Herbal Solution or Topical Minoxidil 5% for 36 weeks.

      To our knowledge, this herbal solution for the first time covers all four major causes of
      AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting
      dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple
      mechanism. The application of this new herbal solution for the treatment of AGA should be
      recommended.
    

Intervention name(s): Topical Herbal Solution; Topical Minoxidil 5%
Intervention type(s): Drug; Drug
Intervention description(s): Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.; Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
Other intervention name(s): Minoxidil
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Androgenic Alopecia; Hair Diseases; Skin Diseases; Baldness; Alopecia; Hair Loss
Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to test whether disease-related expressive writing is effective
      in the treatment of Irritable Bowel Syndrome (IBS).
    

Detailed description: 
      Expressive writing involves writing about traumatic, stressful or emotional events.
      Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve
      both physical and psychological health based on health outcome measures such as number of
      doctor's visits and hospital days, blood pressure control, lung and immune function, and
      pain. Given its simplicity, and obvious advantages in terms of cost efficiency, expressive
      writing appears to have great potential as a therapeutic tool or as a means of self-help,
      either alone or as an adjunct to traditional therapies. This modality has not been studied in
      irritable bowel syndrome (IBS), a common gastrointestinal condition, which is lacking
      well-defined etiology or treatments and is best understood in a biopsychosocial context.
    

Intervention name(s): Expressive Writing; Control Writing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects in the Intervention were instructed to write for 30-minute intervals for 4 consecutive days about their deepest thoughts and feelings related to their Irritable Bowel Syndrome.; Subjects were asked to write about the actions they performed during the last 24 hours. They were asked not to write about their feelings or thoughts related to these actions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand if ARV-471 affects how a medicine called,
      dabigatran etexilate, gets absorbed or processed into the body in healthy adults.

      All participants in this study will receive one dose of dabigatran etexilate alone by mouth
      in Period 1. In Period 2, everyone will receive one dose of dabigatran etexilate by mouth
      approximately 90 minutes after receiving one dose of ARV-471 by mouth. The levels of
      dabigatran in Period 1 will be compared to the levels of dabigatran in Period 2. This will
      help us to determine if and how ARV-471 affects dabigatran gets absorbed into the body
      differently in healthy adults.

      All participants will stay at the study clinic for approximately 8 days and 7 nights.
    


Intervention name(s): ARV-471; Dabigatran etexilate
Intervention type(s): Drug; Drug
Intervention description(s): Experimental; Probe substrate
Other intervention name(s): PF-07850327; PRADAXA®
Intervention MeSH terms: Dabigatran
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease
Condition: Parkinson
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 3

Summary: 
      Parkinson's disease (PD) is one of the most common neurodegenerative diseases, with a higher
      prevalence in the elderly. Levodopa induced dyskinesias (LID) are a major motor complications
      that impair quality of life for patients with PD. The mechanisms of these dyskinesias remain
      unclear, but several hypotheses have been put forward: non continuous, pulsatile stimulation
      of dopaminergic receptors, or alterations of other neurotransmitters within the motor
      striatum such as glutamate and serotonin.

      Few strategies are now available to treat severe LID:

        -  Medications: reduction of dopaminergic treatment, addition of amantadine,

        -  Functional neurosurgery. The purpose of this study is to investigate the efficacy of
           buspirone in PD patients suffering from dyskinesias. The role of serotonin in the
           occurrence of LID was recently demonstrated in transplant PD patients and a test
           double-blind, single dose was achieved. Following administration of 10 mg oral
           buspirone, a 5HT1A agonist, LID were clearly improved. A antidyskinetic effect of
           buspirone had already been reported in 1991 and 1994, but identification of buspirone as
           a serotonin receptor agonist has been reported more recently.

      This trial is aimed at (1) validate the serotoninergic hypothesis of hyperkinetic levodopa
      induced dyskinesias (LID) in Pakinson's disease patients, (2) evaluate, in a phase 3 trial,
      the motor efficacy of buspirone to improve LID vs placebo, (3) look at a possible dose/effect
      relationship and (4) check the hypothesis of a better therapeutic ratio using the association
      of buspirone and amantadine instead than a single drug.
    


Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules of buspirone will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon); Capsules of placebo will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon)
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson disease; Levodopa induce dyskinesia
Biomarkers in Predicting Response to Chemotherapy in Patients With Advanced or Metastatic Melanoma Previously Treated With Carboplatin and Paclitaxel With or Without Sorafenib Tosylate
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue in the laboratory from patients receiving carboplatin
      and paclitaxel with or without sorafenib tosylate may help doctors learn more about the
      effects of this treatment on cells. It may also help doctors understand how well patients
      respond to treatment.

      PURPOSE: This research study is studying biomarkers in predicting response to chemotherapy in
      patients with advanced or metastatic melanoma previously treated with carboplatin and
      paclitaxel with or without sorafenib tosylate.
    

Detailed description: 
      OBJECTIVES:

        -  To independently correlate the gene expression and promoter methylation profiles to
           chemotherapy response in patients with advanced or metastatic melanoma treated with
           carboplatin and paclitaxel with versus without sorafenib on clinical trial ECOG-E2603.

        -  To develop a predictive model of chemotherapy response utilizing integrated analysis of
           gene expression and promoter methylation data.

        -  To evaluate whether the NER pathway haplotypes are associated with platinum drug
           resistance and survival.

      OUTLINE: This is a multicenter study.

      Archived paraffin-embedded tissue samples are analyzed for gene expression and promoter
      methylation profiles, and genes involved in the NER pathway.
    

Intervention name(s): DNA methylation analysis; gene expression analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled on E2603 from whom samples were submitted for research
      
Keywords: recurrent melanoma; stage IIIC melanoma; stage IV melanoma