bioihbjkbjnl/mcl2 huggingface dataset:
Iodobenzylguanidine Meta-I131 and Topotecan in Young Patients With Refractory or Relapsed Metastatic Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radioactive drugs, such as iodobenzylguanidine meta-I131, may carry radiation
      directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as
      topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. A stem cell transplant may be able to
      replace the cells that were destroyed by iodobenzylguanidine meta-i131 and topotecan
      hydrochloride.

      PURPOSE: This phase II trial is studying the side effects of iodobenzylguanidine meta-I131
      given together with topotecan hydrochloride and to see how well it works in treating young
      patients with refractory or relapsed metastatic neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of iodobenzylguanidine meta-I131 (^131I-MIBG) and
           topotecan in young patients with refractory or relapsed metastatic neuroblastoma.

      Secondary

        -  Determine the hematological and extra-hematological toxicities of this regimen.

      OUTLINE: This is a multicenter study.

      During the 21 days before treatment begins, autologous peripheral blood stem cells (PBSC) are
      collected.

      Patients receive topotecan hydrochloride IV over 30 minutes daily on days 1-5 and
      iodobenzylguanidine meta-^131I IV over 2 hours on day 1. Treatment repeats every 21 days for
      2 courses. Patients also undergo total-body irradiation.

      On day 10 of the second course, autologous PBSC are reinfused.

      After completion of study therapy, patients are followed at 6 and 12 months.
    

Intervention name(s): Topotecan hydrochloride; Autologous hematopoietic stem cell transplantation; iobenguane I 131; total-body irradiation
Intervention type(s): Drug; Procedure; Radiation; Radiation
Intervention description(s): The topotecan hydrochloride is administered intravenously over five days to dose of 0.7 mg/ m²/day from day 1 to day 5 (first cycle), then from day 21 to day 25 (second cycle); Hematopoietic stem cells are reinjected 10 days after the second injection of 131-iodine MIBG; 444 MBq / kg of 131-iodine MIBG is administered on day 1 with activity; the dose of total-body irradiation of 4 Gy is reached during the first cycle, the second cycle is canceled (131-iodine MIBG and Topotecan)
Other intervention name(s): Topotecan; hematopoietic stem cell transplantation
Intervention MeSH terms: Topotecan; 3-Iodobenzylguanidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disseminated neuroblastoma; localized unresectable neuroblastoma; recurrent neuroblastoma; stage 4S neuroblastoma
tDCS for Increasing Exercise Adherence in Depressed Individuals
Condition: Depression; Physical Activity
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of tDCS (transcranial direct current
      stimulation) for increasing exercise adherence among low active individuals with elevated
      depressive symptoms. The investigators expect that this project will contribute much needed
      knowledge about the role that tDCS can play in changing the affective experience of exercise.
    

Detailed description: 
      Exercise adherence is a significant public health problem. Affective experiences during
      exercise predict long-term physical activity (PA) levels. Therefore, approaches to improving
      the affective experience of exercise are both important and likely to have high impact. This
      may be particularly true among individuals with elevated depressive symptoms due to their
      tendency toward more negative and less positive affect. tDCS is a noninvasive brain
      stimulation approach with a growing body of literature supporting its effects on cognitive
      and emotional processing in varied populations, including some support for those with
      depression. In addition, there is recent increased interest in utilizing tDCS in the context
      of exercise (see above) and in obesity prevention. While the effects of tDCS on behavioral
      and cognitive functioning are still developing, promising findings have emerged for tDCS used
      in repeated combination with a behavioral or cognitive intervention. Given that tDCS is
      relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise
      could be afforded a practical option for increasing and maintaining physical activity levels.

      We propose to conduct a pilot randomized controlled trial of tDCS versus sham delivered
      3x/week for 8 weeks in the context of a supervised aerobic exercise (AE) program among 72
      low-active individuals with elevated depressive symptoms. Follow-up assessments will be
      conducted at end of treatment, 3, and 6 months.
    

Intervention name(s): tDCS; Sham tDCS; Aerobic Exercise (AE)
Intervention type(s): Other; Other; Behavioral
Intervention description(s): Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.; Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.; Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Choice Architecture and Colorectal Cancer Screening Outreach
Condition: Cancer of Colon
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      This pilot study is a 3-arm randomized control trial assessing the effectiveness of
      sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy
      outreach only, in patients between 50-74 years old, who have received care at the University
      City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and
      are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control),
      Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test)
      (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active
      Choice).
    

Detailed description: 
      This pilot study is a 3-arm randomized control trial assessing the effectiveness of
      sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The
      investigators will randomize participants to one of three study arms:

      Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by
      mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT
      (Active Choice).
    

Intervention name(s): Colonoscopy only; Colonoscopy outreach + mailed FIT follow-up; Colonoscopy + Mailed FIT outreach and follow-up
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.; Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.; Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.
Other intervention name(s): Control; Sequential Choice; Active Choice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Screening
Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
Condition: Leishmaniasis, Visceral
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Observational

Summary: 
      According to recent estimates by the World Health Organization (WHO) on eastern Africa, not
      all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably
      due to limited access to accurate diagnostic tests and poor reporting. The main approach for
      VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and
      alternatively the direct agglutination test (DAT) to confirm clinically suspected cases.
      Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where
      examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available.
      Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal,
      particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT,
      based on the recombinant antigen rK28, may overcome this problem, with studies reporting
      better performance than the rK39. However, data are not definitive, as studies comparing rK28
      RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1
      (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent.
      This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1
      RDTs, as compared to the currently used rK39 RDT.
    

Detailed description: 
      Primary objective and endpoint: To evaluate the performance of different diagnostic tests in
      detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in
      particular Ethiopia, and Kenya. Evaluation of the diagnostic performance of the RDTs for
      primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative
      predictive values, as well as the degree of agreement between tests.

      Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants
      being suspected cases of VL
    

Intervention name(s): Leishmania Ab Rapid Test (CTK, Biotech)
Intervention type(s): Device
Intervention description(s): Rapid diagnostic tests to detect antibodies anti-Leishmania
Other intervention name(s): IT Leish (Bio Rad); IgG1 RDT (Coris BioConcept)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patient reporting to the participating VL treatment centres in Ethiopia, Kenya, Sudan
        and Uganda and suspected with primary VL is eligible for inclusion in the study.
      
Keywords: visceral leishmaniasis; diagnostics; RDT; Eastern Africa
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study,
      2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of
      testosterone cypionate solution for injection relative to the currently approved marked
      formulation (reference). In the first part of the study (Part 1), an estimate of the exposure
      variability will be evaluated for both test and reference. This will help guide sample size
      in Part 2. Part 2 will be powered to assess the BE of both test and reference formulations.
    


Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Biological; Biological
Intervention description(s): A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).; A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, randomized, 2-treatment, 2-period, single dose (200 mg), cross-over study, 2-part design to evaluate the bioequivalence and tolerability of a reformulated presentation of testosterone cypionate relative to a currently marketed and approved formulation
Masking: None (Open Label)
Primary purpose: Other
Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      The aim of the study was detection of pepsin in effusion in children with OME using Peptest
      as new quick and cheap method of detection and comparison results with results of other
      studies in which pepsin was detected by more demanding methods. Such a type of study hasn't
      been done so far.
    

Detailed description: 
      Children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who
      underwent adenoidectomy and myringotomy with insertion of ventilation tube were included in
      the prospective study. OME was defined as effusion in the middle ear behind intact eardrum
      longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic
      otoscopy, type B tympanometry and audiometry (in older cooperative children). Children with
      no fluid in middle ear during myringotomy were revised as having tympanosclerosis and were
      excluded from the study. Children with craniofacial abnormities (Down syndrome, Treacher
      Collins syndrome, clefts etc.) were excluded from the study, as well. Demographic data and
      symptoms of EER disease were provided by parents, who were particularly inquired regarding
      the hoarseness, recurrent lower respiratory infection (bronchitis, pneumonia) and bronchial
      asthma of their child.

      Myringotomy using microscope was done in anterior inferior part of the tympanic membrane.
      Type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected by
      special suction device with collecting bottle and ventilation tube was inserted in the
      tympanic membrane. In case of bilateral OME, effusion was collected and analysed separately.
      Specimen was first standardized. An amount of 0.1 ml of 10 % citric acid was added, specimen
      was centrifuged for 10 minutes and subsequently original migration reagent was added.
      Afterwards, specimen was examined using Peptest, which contains monoclonal antibodies
      targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1
      line) and invalid (no line). Peptest detection limit is 16ng/ml of pepsin. Statistical
      analysis was done using MS Excel.
    

Intervention name(s): Peptest
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: otitis media with effusion; Laryngopharyngeal Reflux
U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM
Condition: Injection Site Haematoma; Local Anesthetic Toxicity
MeSH terms: Pain, Postoperative; Hematoma
Study type: Interventional

Summary: 
      The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane
      block versus conventional IV analgesics in postoperative pain management in modified radical
      mastectomy (MRM)
    

Detailed description: 
      All patients undergoing modified radical mastectomy were assigned to one of the following two
      groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20
      patients who received ultra sound guided serratus anterior plane block just after induction
      of anesthesia and Group B: IV analgesics group (control group): this group consists of 20
      patients who did not receive any type of block.Further evaluations were carried out by a
      different investigator who was unaware of the patients' grouping. The degree of
      post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours
      using the VAS score and the haemodynamic data and respiratory rate were measured during the
      first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in
      both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.

      Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood
      pressure, heart rate or respiratory rate >20% from the baseline, were given Pethidine (50 mg
      IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial
      blood pressure, heart rate or respiratory rate >20% from the baseline but still complaining;
      Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.
    

Intervention name(s): ultrasound guided serratus anterior plane block
Intervention type(s): Procedure
Intervention description(s): the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, randomized, controlled clinical trial.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: "SAPB"; "MRM"; "pain management"
A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)
Condition: Subcutaneous Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The
      primary objectives are to evaluate the safety and tolerability of injection lipolysis with
      CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.
    


Intervention name(s): CBL-514
Intervention type(s): Drug
Intervention description(s): CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ATRA, Celecoxib, and Itraconazole as Maintenance
Condition: Relapsed Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability associated with the
      combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous
      stem cell transplant in relapsed multiple myeloma patients.
    

Detailed description: 
      Primary objective:

      To evaluate safety and tolerability associated with the combination of ATRA/
      celecoxib/itraconazole given after a salvage transplant for relapsed myeloma in 25 patients
      in a cycle schedule consisting of three weeks of treatment followed by a rest period of two
      weeks for a total of five cycles. Subjects will be evaluable only if they have received at
      least one dose of maintenance treatment. The salvage transplant is not part of this study.

      Secondary objective:

      To explore changes in frequency and molecular signature in the multiple myeloma stem cell
      (MMSC) fraction based on flow-cytometric assays and gene expression profiling before and
      after the experimental treatment and to correlate outcome with expression levels of RARα2 at
      time of relapse.
    

Intervention name(s): ATRA; Celecoxib; Itraconazole
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): All-Trans-Retinoic Acid; tretinoin; Celebrex; Sporanox; Onmel
Intervention MeSH terms: Itraconazole; Celecoxib; Tretinoin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed multiple myeloma
Trabectedin in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
Condition: Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma; Peripheral Primitive Neuroectodermal Tumor
MeSH terms: Sarcoma; Rhabdomyosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Rhabdomyosarcoma, Embryonal; Neuroectodermal Tumors, Primitive, Peripheral; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial is studying how well trabectedin works in treating young patients with
      recurrent or refractory soft tissue sarcoma or Ewing's family of tumors. Drugs used in
      chemotherapy such as trabectedin use different ways to stop tumor cells from dividing so they
      stop growing or die.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the response rate in pediatric patients with recurrent or refractory soft tissue
      sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743 (trabectedin).

      II. Determine the toxicity of this drug in these patients. III. Determine the
      pharmacokinetics of this drug in these patients.

      OUTLINE:

      Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 21days for up
      to 26 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for up to 5 years.
    

Intervention name(s): trabectedin; pharmacological study
Intervention type(s): Drug; Other
Intervention description(s): Given IV; Correlative studies
Other intervention name(s): Ecteinascidin; ET 743; Yondelis; pharmacological studies
Intervention MeSH terms: Trabectedin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.

      The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics
      of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in
      adults with distal subungual onychomycosis of the toenails.
    


Intervention name(s): ME1111 solution; Vehicle Solution
Intervention type(s): Drug; Drug
Intervention description(s): Once a day for 28 days; Once a day for 28 days
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment