bioihbjkbjnl/mcl2 huggingface dataset:
A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2
      dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK)
      profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in
      participants with advanced solid tumors.
    


Intervention name(s): ABBV-428; Nivolumab
Intervention type(s): Drug; Drug
Intervention description(s): ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.; Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
Other intervention name(s): OPDIVO
Intervention MeSH terms: Nivolumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Neoplasm; Advanced solid tumor; Nivolumab; Non-small cell lung cancer (NSCLC); Non-squamous NSCLC; Ovarian cancer
Multimodal Stimulation Before and After Sacral Nerve Stimulation for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Sacral nerve stimulation (SNS) has become a well-established treatment for patients with
      fecal incontinence since 1995. The mechanism of action of SNS is still not fully understood
      but recent studies have shown changes in both colonic motility and rectal sensibility. The
      investigators have previously shown IBS patients to benefit from sacral nerves stimulation.
      With the present study, the investigators aim to evaluate if sacral nerve stimulation alters
      the gastro-colic response in IBS patients.
    

Detailed description: 
      Twenty four patients with IBS-D or IBS-M according to the ROME III criteria, will be enrolled
      in the study.

      Having meet inclusion criteria, the patients will be examined with Multimodal Stimulation at
      baseline and at six weeks in the sacral nerve stimulation test period.

      During the Multimodal Stimulation the patients will have impedance planimetry conducted
      before and after a standardised meal to evaluate on their gastro-colic response without and
      during sacral nerve stimulation.

      The patients enrolled in the study will in the same time period participate in another study
      evaluating subsensory sacral nerve stimulation. A study registered at clinical trials.

      Here patients are randomised to receive either OFF-subsensory or subsensory-OFF stimulation
      in a 2+2-week period followed by 2 weeks of suprasensory stimulation. Hereby rendering a
      stimulation test period of a total of 6 weeks (a permanent electrode is used).
    

Intervention name(s): sacral nerve stimulation
Intervention type(s): Device
Intervention description(s): Sacral nerve stimulation
Other intervention name(s): External pacemaker, model 3625, Medtronic Inc.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Sacral Nerve Stimulation; Gastro-colic response; Multimodal Stimulation
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery
Condition: Arthroscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients
      treated with celecoxib versus placebo.
    


Intervention name(s): Celecoxib; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery; Matched placebo
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Knee Surgery; Arthroscopic Surgery
A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the RebiSmart™ for

        -  ease of use

        -  multiple domains related to subject's acceptability and satisfaction

        -  reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in
           subjects with RMS.
    


Intervention name(s): RebiSmart™
Intervention type(s): Device
Intervention description(s): The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Self-administered tDCS in Patients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder
      were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment
      responses were evaluated biweekly over six weeks.
    

Detailed description: 
      Patients were randomized to receive either real or sham-tDCS as well as anti-depressant
      drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal
      cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2
      weeks. They were evaluated every 2 weeks.
    

Intervention name(s): tDCS treatment; Antidepressant Drug(escitalopram)
Intervention type(s): Device; Drug
Intervention description(s): Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).; Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
Intervention MeSH terms: Antidepressive Agents; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase I Trial Evaluating Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in BCG Vaccinated Adults
Condition: Tuberculosis (TB)
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313
      vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
    


Intervention name(s): MVA85A-IMX313; MVA85A
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313); Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A)
Other intervention name(s): AERAS-485
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Vaccine; Immunogenicity
A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of
      aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy
      volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the
      other period volunteers will receive placebo.
    


Intervention name(s): Aleglitazar; Microgynon®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple oral doses; Multiple oral doses; Multiple oral doses
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Safety, Pharmacokinetics and Pharmacodynamics of Elbasvir (MK-8742) in Hepatitis C Infected Males (MK-8742-002)
Condition: Hepatitis, Viral, Human
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis, Viral, Human; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetics (PK) and pharmacodynamics
      of elbasvir (MK-8742) in Hepatitis C Virus (HCV)-infected participants. There will be 3 parts
      to this study; Part I will enroll only genotype (GT) 1 HCV-infected participants, Part II
      will enroll GT3 HCV-infected participants, and Part III will enroll only GT1a HCV-infected
      participants. All parts may run concurrently, or Parts II and III may be staggered.

      Hypothesis (Part I): At a once-daily dose that is sufficiently safe and well tolerated in
      HCV-infected participants, elbasvir administered for 5 consecutive days has superior
      antiviral activity in GT1 HCV-infected participants compared to placebo, as measured by
      change from baseline in plasma HCV ribonucleic acid (RNA; log 10 copies/mL) at Day 5, 24-hour
      postdose timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).

      Hypothesis (Part II): At a dose that is sufficiently safe in GT3 HCV-infected participants,
      the mean maximum reduction in HCV viral load is greater following multiple dose oral
      administration of elbasvir as compared to placebo.

      Hypothesis (Part III): At a once-daily dose that is sufficiently safe and well tolerated in
      HCV-infected participants, elbasvir administered for 5 consecutive days has superior
      antiviral activity in GT1a HCV-infected participants compared to placebo, as measured by
      change from baseline in plasma HCV RNA (log 10 copies/mL) at Day 5, 24-hour postdose
      timepoint. (a true mean viral RNA reduction of at least 3 log10 is anticipated).
    


Intervention name(s): Elbasvir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Elbasvir was administered orally by tablet(s); Dose-matched placebo tablets were administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Surgical Outcomes Using Variable Rod Diameters in the Treatment of Idiopathic Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

Summary: 
      There are two rod sizes routinely used for the correction of juvenile and adolescent
      idiopathic scoliosis, 5.5mm and 6.35mm, typically stainless steel. Currently there is no
      scientific evidence supporting the superiority of one size rod relative to the other. This
      study will evaluate the amount of radiographic correction obtained using the 5.5mm versus the
      6.35mm spinal instrumentation rods.
    

Detailed description: 
      For the correction of Juvenile and Adolescent idiopathic scoliosis, companies offer and
      surgeons use varying rod sizes not based on scientific evidence, but because of personal
      preference, availability and company loyalty. To date there has been no literature evaluating
      the benefit or harm of one rod size versus the other. Our dual-arm prospective study will
      evaluate the amount of radiographic correction obtained using the 5.5mm versus the 6.35mm
      stainless steel instrumentation rods. These are both standard rods used in the community for
      this particular procedure, thus no additional risk exists for the patient. The results of
      this study will help guide surgeons in their decision making process when faced with the
      multitude of options offered by implant manufactures.

      Comparison(s): 5.5mm stainless steel spinal rod versus 6.35mm stainless steel spinal rod for
      correction of juvenile and idiopathic scoliosis curves.
    

Intervention name(s): Spinal rod
Intervention type(s): Device
Intervention description(s): Posterior spinal fusion using a 5.5 or 6.35 size rod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Juvenile Scoliosis; Adolescent Scoliosis; Scoliosis Management; Spinal Fusion; Scoliosis instrumentation; Juvenile or Adolescent Idiopathic Scoliosis
Occupational Hand Eczema - Testing of a Prevention-concept
Condition: Occupational Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional

Summary: 
      Randomised controlled trial examining the effect of decreased waiting time for the first
      doctors' appointment, patient education, glove counselling and counselling at departments of
      social or occupational medicine on severity of hand eczema, quality of life, use of
      corticosteroids, and jobsituation 3-12 months after intervention in patients with suspected
      occupational contact dermatitis of the hands.
    

Detailed description: 
      Patients with suspected occupational hand eczema are recruited to the study on basis of their
      referral from general practitioner to dermatologist. Patients are randomised to either
      control or intervention group. The control group is treated and followed-up by the
      dermatologist they have been referred to, while the intervention group is treated and
      followed-up at Gentofte Hospital skin department with a maximum waiting time of 3 weeks. At
      the skin department at Gentofte Hospital, the patients in the intervention group receive
      patient education in prevention and treatment of hand eczema, glove counselling, personal
      product screening by a chemistry engineer, extended allergy testing and the standard
      treatment of hand eczema. Patients in both the control and intervention group are asked to
      fill out a questionnaire at 3, 6, 9 and 12 months after inclusion in the study. The
      questionnaire contains questions about quality of life, severity of hand exzema,
      jobsituation, use of healthcare service and use of medicine. Furthermore, prescriptions of
      medicine are registered in both control and intervention group at 3, 6, 9 and 12 months.
    

Intervention name(s): Treatment at the skin department at Gentofte Hospital
Intervention type(s): Other
Intervention description(s): Treatment in a hospital setting at Gentofte Hospital skin department
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Adipose Derived Mesenchymal Stem Cell Characteristics in Anal Fistulas
Condition: Perianal Fistula; Adipose Tissue; Tissue Transplantation
MeSH terms: Rectal Fistula; Fistula
Study type: Interventional

Summary: 
      This study investigated the cellular and molecular characteristics of AT-MSCs obtained from
      autologous AT therapy in patients with high transphincteric perianal fistulas of
      crytoglandular origin. Adipose tissue was injected into anal fistulas. Characteristics of
      adipose tissue mesenchymal stemcells (AT-MSC) was investigated and compared in patients with
      fistula that healed after the treatment (responders) to patients who failed to heal
      (non-responders)
    

Detailed description: 
      Injection with allogene or autologous stem cells has been reported to be efficient treatment
      of perianal fistulas. An alternative to this treatment could be injection with freshly
      collected autologous adipose tissue. In this study 27 patients with cryptoglandular anal
      fistulas were treated with freshly collected autologous adipose tissue.A clinical assessment
      of the patient prior to inclusion was undertaken and a loose seton placed for at least 6
      weeks prior to fat injection. An MRI of the pelvis was performed before inclusion. Fistulas
      with secondary tracts and/or cavities were excluded. The operation was performed in one
      procedure including liposuction and injection of adipose tissue. A sample of adipose tissue
      from all 27 patients was analyzed. AT-MSCs were isolated and characterized using cellular and
      molecular analyses. Clinical and MRI-scanning evaluation of fistula healing and evaluation of
      ano-rectal function was performed after 6 months. AT-MSCs phenotype was compared between
      responders and non-responders with respect to fistula healing. The evaluation of the AT-MSCs
      was performed in a blinded manner.
    

Intervention name(s): Injection of autologous adipose tissue in anal fistula
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autologous adipose tissue, mesenchymal stem cells, perianal fistula
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: The objective of this study is test the hypothesis that delivering a higher
      percentage of the radiation dose as external radiation versus implant will lead to higher
      tumor control rates.

      Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma
      (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy
      versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy,
      respectively).
    

Detailed description: 
      Objective: The objective of this study is test the hypothesis that delivering a higher
      percentage of the radiation dose as external radiation versus implant will lead to higher
      tumor control rates.

      Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma
      (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy
      versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy,
      respectively).

      Methodology: Patients will be randomized by the method of random permuted blocks.

      Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly
      thereafter. Treatment-related morbidity will be monitored by personal interview, using
      standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3,
      6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml
      two years after treatment will be considered to have residual or recurrent cancer and to have
      failed therapy.

      Findings: 566 patients have been randomized and the study was closed due to slowing accrual.
      A preliminary analysis shows similar morbidity between the treatment arms, and nearly
      identical cancer control rates between randomization arms.
    

Intervention name(s): Pd-103 with 20 vs 44 Gy supplemental beam XRT
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate; brachytherapy
PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase
      3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults
    


Intervention name(s): PRC-063 oral capsules; Placebo oral capsules
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose; Daily dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Labor Analgesia in the Latent Phrase
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Painless labor is an essential part in woman's health care. Labor analgesia in the active
      phrase is in popular use currently. However, parturients are still haunted by the labor
      delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore,
      we hypothesized that labor analgesia in the latent phrase of the first delivery stage would
      provide superior health care for laboring women. In addition, such analgesia technique would
      not prolong the time of uterine dilation and labor delivering.
    


Intervention name(s): Active phrase epidural analgesia; Latent phrase epidural analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Continuous epidural analgesia with sufentanil plus ropivacaine; Continuous epidural analgesia with sufentanil plus ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidural analgesia; Latent analgesia; Active analgesia; Labor delivery
Radiographic Progression of Infiltrated Caries Lesions In-vivo
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study is investigating the efficacy of caries lesion infiltration therapy as compared to
      the current preventative approach for early caries lesions.
    

Detailed description: 
      A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed
      incorporating a split-mouth intra-oral design. Young volunteers (14-35 years old) with at
      least two early lesions in posterior teeth will be enrolled into this clinical trial to
      evaluate the clinical effectiveness of arresting lesion progression by infiltrating the
      lesions. The infiltration protocol included application of on-market materials and
      applicators, and was performed in one session.
    

Intervention name(s): Resin infiltration; Caries management
Intervention type(s): Device; Behavioral
Intervention description(s): Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy; Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
Other intervention name(s): ICON (DMG, Germany); Home use of over-the-counter oral health products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental caries; Proximal surfaces; Posterior teeth; Carious lesions; Tooth diseases; Preventive therapy