bioihbjkbjnl/mcl2 huggingface dataset:
Developing an Objective Measure of Experienced Pain
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Pain is a public health challenge around the world. However, there is no single standardized
      measure of pain, to the point that the estimated prevalence of chronic pain in adults ranges
      between 2% and 64% depending on the methods and definitions used. Existing measures of pain
      are known to present several problems and results can be hardly compared between people.

      The investigators propose and empirically validate a new, simple method to measure
      experienced pain in clinical trials. The method provides an objective, cardinal measurement
      of experienced pain which is comparable between people and the investigators test whether it
      is better able to measure experienced pain than existing procedures. The investigators test
      the new method in healthy participants using standard protocols (electrical and heat
      stimuli). The investigators also aim to validate the measure using a causal manipulation
      which relies on the administration of a topical analgesic product compared to a placebo.
    

Detailed description: 
      The aim of this study is to establish and validate the proposed method of measuring pain
      using different pain stimuli. The investigators correlate these measurements with
      physiological data such as skin-conductance, heart-rate variability, pupil dilation, and with
      established measures of pain such as Numeric rating scale (NRS), Visual analog scale (VAS),
      general Labeled Magnitude Scale (gLMS). In addition, the investigators study the test-retest
      reliability of our measure of pain and its ability to capture a reduction in experienced pain
      due to a topical analgesic product compared to a placebo treatment.
    

Intervention name(s): Developing an objective measure of experienced pain
Intervention type(s): Behavioral
Intervention description(s): At the beginning of each study, participants are randomly allocated into one of two groups.
Within each group all participants are exposed to the same painful stimulus. One group experiences a painful stimulus of higher intensity compared to that of the other group. The painful stimuli are physically identical for every subject within the same group and within the standard of previous pain research.
Participants are then asked to evaluate the painful stimulus they just received according to a self-reported scale (NRS, VAS, gLMS, NRS-MB). Participants are also asked to decide multiple times whether they prefer a larger amount of money and experience the same or more painful stimulus they received before or a smaller amount of money and no (or a less) painful stimulus. The smaller amount of money is progressively increased across choices until it matches the larger amount, similar to multiple price-list methods (MPL) which are standard in economics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Measurement of Pain; Pain
Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
Condition: Diffuse Large Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in
      refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible
      for autologous transplantation.
    

Detailed description: 
      This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy
      and the safety of R-GEMOX in refractory/relapsed patients aged from 18 to 75 years with
      CD20-positive large B-cell lymphoma non eligible for autologous transplantation.

      It is anticipated that 50 subjects will be enrolled over 4 years (from April 2003/January
      2007), but inclusion could stop earlier according to the analysis performed every 5 patients
      (based on triangular test).

      The duration of the treatment period is approximately 16 weeks and patients are followed
      until death.

      The total duration of the study is expected to be 3 years.
    

Intervention name(s): Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
Intervention type(s): Drug
Intervention MeSH terms: Rituximab; Gemcitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: B-cell lymphoma; Salvage Therapy; rituximab; oxaliplatine; gemcitabine
Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506)
      combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.
    

Detailed description: 
      1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment
           of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.

        2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX
           pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN.

        3. To explore the dosing of FK506 combined with MMF and their effective range of blood
           concentration.
    

Intervention name(s): Multitherapy
Intervention type(s): Drug
Intervention description(s): Tacrolimus,4mg/d, MMF 1.0g/d
Other intervention name(s): FK506,Prograf,Tacrolimus; MMF,cellcept,mycophenolate mofetil
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Mycophenolate mofetil; Cyclophosphamide; Lupus nephritis; Treatment
Effect of Omega 3 on Atrophic Vaginitis in Breast Cancer Survivors
Condition: Ductal Breast Carcinoma in Situ; Breast Cancer, Stage I; Breast Cancer, Stage II; Breast Cancer, Stage III
MeSH terms: Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Vaginitis; Atrophic Vaginitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized double-blind clinical trial studied the effect of oral omega-3 fatty acid on
      atrophic vaginitis in postmenopausal breast cancer survivors (N=52). Omega-3 fatty acid may
      reduce inflammation and improve vaginal symptoms in postmenopausal breast cancer survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To examine the ability of oral omega-3 fatty acids to improve symptoms of atrophic
      vaginitis as reported by postmenopausal breast cancer survivors as compared to survivors not
      taking omega 3.

      II.To examine the ability of oral omega-3 fatty acids to decrease inflammation related to
      atrophic vaginitis in postmenopausal breast cancer survivors as compared to survivors not
      taking omega 3.

      III. To examine the ability of oral omega-3 fatty acids to uptake systemically and to
      validate adherence; these measures will be compared to demographic data including body mass
      index to observe if differences exist in postmenopausal breast cancer survivors vs. those not
      taking omega 3.

      IV. To examine the effect of oral omega 3 fatty acids as compared to placebo of dietary
      supplement on serum female hormone levels in postmenopausal breast cancer survivors.

      V. To examine cytokine levels in women taking oral omega 3 fatty acids as compared to women
      not taking omega 3 to determine effect.

      OUTLINE: Patients were randomized to 1 of 2 treatment arms.

      ARM I: Patients received 3.5g omega-3 fatty acid orally (PO) daily for 6 months.

      ARM II: Patients received placebo of dietary supplement (7 capsules) PO daily for 6 months.
    

Intervention name(s): omega-3 fatty acid; placebo; Questionnaire administration
Intervention type(s): Dietary Supplement; Other; Behavioral
Intervention description(s): Given PO (by mouth) daily; Given PO(by mouth)daily; Measures of self-reported outcomes: Self-reported symptoms will be documented with the Urogenital Atrophy Questionnaire (UAQ), Menopausal Rating Scale (MRS), Female Sexual Function Index (FSFI), Center for Epidemiological Studies Short Depression Scale (CES-D 10), and Brief Pain Inventory (BPI).
Other intervention name(s): fish oil; n-3 fatty acid; O3FA; PUFAs; PLCB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: breast cancer; vaginal dryness; dyspareunia; genital irritation
A Study to Investigate the Effect of Increased Gastric pH on the Oral Bioavailability of the Orexin-2 Receptor Antagonist JNJ-42847922 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of daily administration of rabeprazole on
      the single-dose pharmacokinetics of JNJ-42847922 in healthy participants.
    

Detailed description: 
      This is an open-label, single-center, fixed-sequence study designed to assess the effects of
      multiple oral administration of rabeprazole (a PPI) on the pharmacokinetics of a single oral
      dose of JNJ-42847922 in healthy participants. The study consists of 3 phases: a Screening
      Phase of approximately 4 weeks (Days -29 to -2); an Open Label Treatment Phase (Days -1 to
      7); and an End-of-Study Phase occurring from 7 to 14 days after the last dose of study drug.
      All participants will receive JNJ-42847922, orally on Day 1 (alone) and Day 6 (along with
      rabeprazole).Rabeprazole will be administered orally on Day 2 to Day 6. Pharmacokinetics will
      primarily be for JNJ-42847922, M12 metabolite and M16 metabolite. Participant's safety will
      be monitored throughout the study.
    

Intervention name(s): JNJ-42847922; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-42847922 will be administered as 20 mg tablet orally.; Rabeprazole will be administered as 20 mg tablet orally.
Intervention MeSH terms: Rabeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Rabeprazole; JNJ-42847922
BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To identify the Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine
           i.v. by assessment of Dose Limiting Toxicities (DLT);

        -  To assess safety and anti-tumour efficacy and determine pharmacokinetic characteristics
           of afatinib and vinorelbine i.v.
    


Intervention name(s): afatinib 20mg; afatinib 40mg; vinorelbine IV 25 or 20mg/m2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): patient to receive afatinib low dose po daily in combination with vinorelbine iv; patient to receive afatinib high dose po daily in combination with vinorelbine iv; patient to receive standard dose vinorelbine once a week for four times per cycle
Intervention MeSH terms: Vinorelbine; Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Application of Vaginal Manipulator in Abdominal Hysterectomy Operations
Condition: Abdominal Hysterectomy
Study type: Interventional

Summary: 
      If a vaginal manipulator is used for abdominal hysterectomy, the vagina can be cut and
      separated from the cervix without cutting the Cardinal and Sacrouterine ligaments and
      protecting the top of the vaginal tissue (Portio vaginalis). In this way, both the shortening
      of the vagina and the prolapse of the vaginal cuff can be prevented. In addition, the
      duration of hysterectomy surgery is significantly shortened.
    

Detailed description: 
      In a classical abdominal hysterectomy, the Cardinal ligaments and the Sacrouterine ligaments
      are cut before the uterus leaves the vagina, and the vaginal cuff is cut deeper in the vagina
      over the cervix and separated from the vagina. During this procedure, the vaginal tissue in
      the Portio vaginalis comes out and causes a loss of vaginal length. If a vaginal manipulator
      is used for abdominal hysterectomy, the vagina can be cut and separated from the cervix
      without cutting the Cardinal and Sacrouterine ligaments and protecting the top of the vaginal
      tissue (Portio vaginalis). In this way, both the shortening of the vagina and the prolapse of
      the vaginal cuff can be prevented. In addition, the duration of hysterectomy surgery is
      significantly shortened.
    

Intervention name(s): Manipulation of vagina during abdominal hysterectomy operation; Classical conventional abdominal hysterectomy operation
Intervention type(s): Procedure; Procedure
Intervention description(s): The manipulator applied vaginally prevents unnecessary vaginal length loss by ensuring that the vaginal cuff is cut from the top point.; Classical conventional abdominal hysterectomy operation without any manipulation from the vagina.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaginal Manipulator
Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood
      pressure in patients with mild to moderate hypertension.
    

Detailed description: 
      Renin-Angiotensin system blockade is a well established target for treatment of high blood
      pressure. Blocking the system at the initial step, however, is a rather new concept that
      could only be implemented very recently through the availability of novel, oral, renin
      inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor,
      SPP635.
    

Intervention name(s): SPP635 (drug)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Vitamin/Mineral Supplement for Children With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for
      children with autism.
    

Detailed description: 
      This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for
      children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and
      laboratory tests. Typically-developing children will be assessed at baseline only (no
      treatments) for comparison.
    

Intervention name(s): ANRC Essentials Plus
Intervention type(s): Dietary Supplement
Intervention description(s): a vitamin/mineral supplement designed for children and adults with autism
Intervention model: Single Group Assignment
Intervention model description: All study participants with ASD will receive the vitamin/mineral supplement
Masking: None (Open Label)
Primary purpose: Treatment
An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
Condition: Stimulant Dependence
Study type: Observational

Summary: 
      The purpose of this study is to determine whether performance on neurocognitive measures
      predicts treatment outcomes in individuals with substance abuse disorders. A second purpose
      is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in
      people with substance abuse disorders to that of people who do not have substance abuse
      disorders.
    

Detailed description: 
      The primary objective of this study is to replicate the finding that performance on the
      Stroop color-word interference task is predictive of treatment completion in participants
      with cocaine use disorders and to extend this finding to participants with Methamphetamine
      use disorders. Secondary objectives include evaluating whether:

        1. performance on various neurocognitive measures, including the Stroop, Rey
           Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting
           Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal
           Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use
           outcomes in METH/cocaine abusers;

        2. neurocognitive test performance is associated with oxidative damage, a severe
           consequence of oxidative stress, in METH/cocaine abusers;

        3. oxidative damage is predictive of treatment attrition and substance use outcomes in
           METH/cocaine abusers,

        4. oxidative damage in METH/cocaine abusers is significantly greater than that of a normal
           comparison group and

        5. exploratory analyses reveal a significant relationship among oxidative stress,
           neurocognitive function, and treatment outcomes in METH/cocaine abusers.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12
        Study (CTN-0031- NCT00573183)
      
Biospecimen description: 
      Blood sample for the oxidative stress/damage analysis
Adherence in Pediatric Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Disease modifying therapies (DMT) are widely used for children and adolescents with MS.
      Nonetheless, many pediatric patients continue to relapse and therefore require changes in
      therapy. We designed this research study to learn more about medication use in children and
      adolescents with MS. We are also interested in learning what a behavioral feedback
      intervention can tell us about adherence to medicine. Finally, we hope this research project
      will inform the way we provide clinical care for children and adolescents with MS.
    


Intervention name(s): Motivational Interview; Video Attention Control
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
Condition: Spinal Cord Injury, Chronic
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo
      controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age
      affected with chronic traumatic spinal cord will enter the study with the objective to assess
      the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's
      jelly mesenchymal stem cells.
    

Detailed description: 
      This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo
      controlled, clinical trial in which 10 patients from 18 to 65 years of age affected with
      chronic traumatic spinal cord will enter the study with the objective to assess the safety
      and to obtain efficacy data in intrathecal administration (L3 level) of expanded Wharton's
      jelly mesenchymal stem cells. Following the administration patients will remain for 24 h at
      the hospital and thereafter will be discharged. For the first period, the follow-up is
      planned at day 7 and at 1, 3 and 6 months. At month 6, the patients will be treated in a
      crossover way (second period) and will follow the same schedule for the follow-up. First
      clinical trial evaluation will be performed at 12 month follow-up. From 12 to 18 month after
      the first infusion, patients will be randomized again to active treatment or placebo
      (double-blind) in order to assess the safety and efficacy of a second dose at 12 month
      follow-up. Thereafter, patients will be followed up at 24 and 36 months as part of a
      long-term follow-up.
    

Intervention name(s): XCEL-UMC-BETA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal allogeneic cell therapy in a blinded syringe; Placebo in a blinded syringe
Other intervention name(s): Expanded MSC from Wharton Jelly
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Resistance Training Program and Cardiovascular Exercise in Increasing Muscle Mass in Adolescent and Young Adult Stem Cell Transplant Survivors
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This pilot trial studies how well a resistance training program and cardiovascular exercise
      work in increasing muscle mass in adolescent and young adult stem cell transplant survivors.
      Resistance training and cardiovascular exercise may increase physical activity, muscular
      strength and improve lean body mass which is beneficial to improving the overall health of
      stem cell transplant survivors.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the feasibility of a 12-week resistance training (RT) intervention in adolescent
      and young adult (AYA) hematopoietic cell transplant (HCT) survivors starting +100 days
      post-HCT.

      SECONDARY OBJECTIVES:

      I. Examine the change from baseline of a RT intervention on muscle strength and body
      composition at day +200 and day +365.

      II. Determine the effectiveness of RT exercise on improving the cardio-metabolic risk factor
      profile at day +200 and day +365.

      III. Determine the effectiveness of RT exercise on improving quality of life (QOL) measures.

      IV. Compare day +80 and day +365 assessments to subjects in a historical control population.

      OUTLINE:

      Patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and
      complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of
      each exercise, 3 days per week for 12 weeks. Patients also participate in weekly phone calls
      with an exercise physiologist to ensure adherence to the program and to provide support.

      After completion of study intervention, patients are followed up within 2 weeks, then at 365
      days post HCT.
    

Intervention name(s): Exercise Intervention; Quality-of-Life Assessment; Questionnaire Administration; Telephone-Based Intervention
Intervention type(s): Behavioral; Other; Other; Behavioral
Intervention description(s): Undergo resistance training program and cardiovascular exercise; Ancillary studies; Ancillary studies; Participate in phone calls with exercise physiologist
Other intervention name(s): Quality of Life Assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care