bioihbjkbjnl/mcl2 huggingface dataset:
Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute
      treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally
      advanced NPC. Three hundreds and twenty patients will be recruited into this study.
    

Detailed description: 
      Scheme:

      Eligible stage III and IVA/B NPC patients will first be stratified by institution, then
      randomized to 2 arms at 1:1 ratio.

      - Arm Cisplatin:

      Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3
      weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

      - Arm nimotuzumab:

      Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3
      weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT
    

Intervention name(s): TPF neoadjuvant chemotherapy; Concurrent chemotherapy with cisplatin during radiotherapy; Concurrent nimotuzumab during radiotherapy; Radical radiotherapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Nimotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasopharyngeal carcinoma; Neoadjuvant chemotherapy; Concurrent chemotherapy; Nimotuzumab
Measuring the Peripheral Optical Quality of The Eye
Condition: Nearsightedness
MeSH terms: Myopia
Study type: Observational

Summary: 
      The goal of the study is to quantify wavefront aberration profiles of the eye with and
      without contact lens across the visual field. This will enable us to investigate the impact
      of the aberration on retinal image quality.
    

Detailed description: 
      The goal of this study is to investigate the effects of monofocal and bifocal soft contact
      lenses in the changes of peripheral optical quality and through-focus visual performance on
      real eyes. The goal will be accomplished by performing optical measurements using
      Shack-Hartmann wavefront sensor with and without the use of single vision and bifocal soft
      contact lenses.
    

Intervention name(s): Monofocal Contact Lens; Bifocal Contact Lens
Intervention type(s): Device; Device
Intervention description(s): A monofocal contact lens will be used for this measurement.; A bifocal contact lens will be used for this measurement.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with no ocular pathology and uses contact lenses.
Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.
Condition: Sensorineural Hearing Loss; Long QT Syndrome
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Long QT Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large
      cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing
      loss.
    

Detailed description: 
      The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large
      cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing
      loss.

      The goal of this study is to answer the following questions:

        1. What is the incidence of an abnormal ECG (QTc > 450 msec) in neonates greater than a
           week of age with either unilateral or bilateral Sensorineural hearing loss?

        2. What percentage of neonates greater than one week of age with either bilateral or
           unilateral sensorineural hearing loss and an abnormal ECG have an identifiable genetic
           mutation?

        3. What is the incidence of an abnormal genetic mutation consistent with long QT regardless
           of the ECG in neonates with bilateral sensorineural hearing loss?
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn infants
      
Keywords: Sensorineural hearing loss; Long QT Syndrome
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an
      antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a
      form of a mental disorder.
    

Detailed description: 
      There is evidence that some of the symptoms of psychosis may be related to past infection
      with common viruses.

      Researchers are looking to recruit a total of 100 subjects with evidence in the past, of
      exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes
      cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2
      which causes genital sores, and has affected less than 1/10 people in Vancouver) and
      cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver).
      People who have been infected with these viruses in the past develop antibodies in the blood.
      The antibodies can be measured in blood, and are a test of whether or not there was infection
      in the past, and possibly affecting the symptoms of psychosis.
    

Intervention name(s): Valacyclovir (Valtrex)
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychosis; early psychosis; first episode psychosis; schizophrenia; schizoaffective; schizophreniform; bipolar disorder; valtrex; valacyclovir.
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a prospective, multi-center, open label, randomized; two-arms cross over study.

      This is the test protocol for the InsuPatch device, whose purpose is to improve insulin
      delivery into the blood when the insulin is infused using an insulin-infusion pump by
      controlled heating of the area surrounding the point of infusion.
    

Detailed description: 
      Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin
      pump, meeting the inclusion/exclusion criteria as outlined below and who provide written
      Informed Consent will be enrolled in the study.

      The study will be done with subjects randomized into one of two procedure sequences. Each
      subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the
      InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be
      randomized into one sequence or the other. The order of the procedures will be selected
      randomly and will be performed both within one month.

      There will be six Device visits starting with a screening and randomization visit, 3 clamps
      and a completion visit.
    

Intervention name(s): InsuPatch
Intervention type(s): Device
Intervention description(s): the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MiniMed paradigm insulin pumps; insulin Lispro; Insulin Asprt.
Effects of Omega-3 Fatty Acids and Menaquinone-7 on Thrombotic Tendency
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Omega-3 fatty acids are notably present in fish oil and krill oil, and are known to have
      beneficial effects on the vasculature. Vitamin K2 is known for preventing vascular
      calcification. In this study we investigate a potential synergy between the effects of either
      fish or krill oil and menaquinone-7, which is one of K2 vitamins.
    


Intervention name(s): menaquinone-7; fish oil; krill oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): capsule consisting of 10, 20 or 45 µg menaquinone-7 per day during 8 weeks; 9 fish oil capsules equivalent to 3 gram per day of n-3 polyunsaturated fatty acids during 12 weeks; 9 krill oil capsules, equivalent to 1,5 gram per day of n-3 polyunsaturated fatty acids (PUFA) during 12 weeks
Other intervention name(s): MenaQ7
Intervention MeSH terms: Vitamin K 2; Vitamin K; Menaquinone 7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular; Calcification
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Stage III or Stage IV Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Vaccines may make the body build an immune response to kill tumor
      cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim
      following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's
      lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a
      specific immune response against the B cell idiotype of the malignant clone that constitutes
      the tumor in patients with previously untreated stage III or IV indolent non-Hodgkin's
      lymphoma. II. Determine the safety and toxicity of this treatment regimen using Genitope
      Corporation's molecular rescue technology in this patient population.

      OUTLINE: Patients receive induction chemotherapy consisting of oral cyclophosphamide,
      vincristine, and prednisone (CVP). Treatment repeats every 3 weeks until the maximal clinical
      response is achieved followed by 2 additional courses of consolidation therapy for up to a
      maximum of 10 courses. Patients not achieving adequate response receive up to 6 courses of
      alternate chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and
      prednisone. At 3 months or up to 1 year following completion of chemotherapy, patients
      achieving adequate disease response receive vaccination consisting of recombinant tumor
      derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ)
      at 2 sites immediately followed by sargramostim (GM-CSF) SQ on day 1. Patients receive GM-CSF
      alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 12 weeks later by
      the fifth and final dose. Patients are followed every 3 months for 2 years, every 6 months
      for 2 years, and then annually thereafter until disease progression.
    

Intervention name(s): keyhole limpet hemocyanin; sargramostim; tumor cell-based vaccine therapy
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Sargramostim; Keyhole-limpet hemocyanin; Vaccines
Primary purpose: Treatment
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma
Intrauterine Contraceptive Device (IUD) Placement at Time of C-Section
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study of up to 10 women, which will test the hypothesis that the placement of
      copper IUDs through the uterine incision at the time of uncomplicated elective C-section is
      technically feasible and acceptable to women seeking long-term contraception.
    

Detailed description: 
      Women will be enrolled in this study during late prenatal care. Consent for placement of the
      IUD will be verified prior to elective C-section. After removal of the placenta, the copper
      IUD will be placed through the incision at the fundus and the tail strings will be delivered
      through the cervix. Data will be collected about patient bleeding and possible infection
      during the immediate postoperative period. The visibility of the strings will be verified at
      discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by
      ultrasound at the patient's last visit.
    

Intervention name(s): Copper IUD ( ParaGard Intrauterine Contraceptive Device)
Intervention type(s): Device
Intervention description(s): Intraoperative placement of copper IUD at time of C-section
Other intervention name(s): ParaGard Intrauterine Contraceptive Device
Intervention MeSH terms: Copper; Contraceptive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postpartum contraception; Copper IUD
First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine seizure control and tolerability of Topiramate after
      either transitioning from previous antiepileptic drug (AED) or adding on to previous AED.
    

Detailed description: 
      This is a multicenter, randomized (treatment is assigned by chance), open-label (everyone who
      is involved in the trial knows the study drug), parallel group trial. The study has three
      phases: a retrospective baseline assessment of patients (4 weeks), titration period (8 weeks)
      and maintenance period (8 weeks). After qualifying for trial entry in the retrospective
      baseline phase, eligible patients will be randomized in 1:1 ratio to receive either
      topiramate add-on therapy or topiramate monotherapy. During the titration period (period in
      which the dose of the study drug is increased or decreased at the discretion of
      investigator), topiramate, given as morning doses, will be started with daily doses of 25
      mg/day for one week. After that, topiramate will be given as morning and evening doses, and
      the doses will be gradually increased every week to reach the initial target dose of 200
      mg/day at the end of titration period. During the maintenance period, the dose of topiramate
      could be increased or decreased according to the investigator's judgment. Patients should
      keep seizure diaries during the 16 weeks of topiramate treated period and are followed with
      once monthly visits to the clinic, at which safety will be evaluated.
    

Intervention name(s): Topiramate add-on therapy; Topiramate monotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.; Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Topiramate; Neuro-surgical patients; Nervous disorder; Seizures
Effects of Intravenous Lidocaine During Sedation for Colonoscopy.
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assesses the benefits of continuous intravenous lidocaine administration during
      sedation for colonoscopy.

      Sedation will consist of propofol infusion titrated to provide adequate working conditions to
      the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine
      infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same
      volume of placebo (normal saline)
    

Detailed description: 
      The potential benefits of lidocaine infusion will be tested on:

        -  propofol consumption (primary outcome)

        -  intraoperative respiratory depression

        -  time for patient recovery

        -  postoperative fatigue

        -  postoperative pain

        -  postoperative cognitive dysfunction
    

Intervention name(s): Lidocaine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness; Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness
Other intervention name(s): XYLOCAINE ; (NDA) 006488
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: colonoscopy; lidocaine; propofol; sedation
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides
      protection that is non-inferior to the protection afforded by vaccination with Havrix 720
      Junior.
    


Intervention name(s): HAVpur Junior; Havrix 720 Junior
Intervention type(s): Biological; Biological
Intervention description(s): ≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months; ≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A; Vaccination; Immunity
Epidemiology of Rotavirus Infection in North India Community
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      This study was designed to support site preparation and to conduct a disease burden study for
      the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
    

Detailed description: 
      Field workers conducted weekly surveillance in areas allocated to them and identified
      pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for
      participation through criteria for inclusion and exclusion in the trial were enrolled. Two
      cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly
      till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and
      followed up till 24 months of age (cohort 2=100).

      Weekly contact were made by field workers for both the cohorts. At each contact cases of
      gastroenteritis were identified. All infants with gastroenteritis were assessed by a field
      worker/clinical coordinator. The child was assessed for presence of dehydration, danger
      signs. The field worker/clinical coordinator ensured that at least one diarrheal stool
      specimen was collected for each episode of gastroenteritis. Infants were treated at the study
      clinic or escorted to one of the identified hospitals, if required.

      Caregivers of the enrolled infants were explained the signs and symptoms of suspected
      intussusception, dehydration and danger signs that require hospital referral and were given
      the option to seek care from the study clinic or from one of the identified hospitals in the
      vicinity.

      Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who were
      identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were
      collected in order to assess duration of shedding of rotavirus during a natural infection.

      The study was also designed to collect information on data essential for planning and
      implementation of phase III trials pertaining to trial logistics, data collection tools and
      validity of questions including those in the Vesikari score.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study was conducted in Delhi at Govindpuri-Tigri-Dakshinpuri, Tuglakabad and Sangam
        Vihar.
      
Keywords: Disease burden; Rotavirus gastroenteritis
Pediatric Anxiety Intervention With an Entertaining Video Game: Feasibility Study
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This research study aims to test the feasibility and effectiveness of using an entertaining
      video game as an addition to traditional therapy for the treatment of anxiety disorders in
      youth, particularly those youth who may have limited access to mental health treatment in the
      traditional clinical setting.
    

Detailed description: 
      The purpose of this research is to learn whether or not youth with social anxiety find a
      therapeutic video game engaging and useful. Children between the ages of 7 & 17 who have been
      diagnosed with a social anxiety disorder will be invited to participate in this study.
    

Intervention name(s): Entertaining Video Game
Intervention type(s): Device
Intervention description(s): Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anxiety; Social Phobia; Separation Anxiety; Generalized Anxiety; GAD; Phobia; video game; teen; youth; child; adolescent
At-home Transcranial Alternating Current Stimulation During Multitasking
Condition: Multitasking Behavior
Study type: Interventional

Summary: 
      The goal is to replicate in-lab results from transcranial alternating current stimulation
      (tACS) with at-home tACS.
    

Detailed description: 
      Participants will be assessed in-lab on multitasking and sustained attention abilities.
      Participants will be sent home with a tACS device to be used at-home for five days while
      engaged in a multitasking paradigm that is different from the multitasking outcome measure
      used pre/post tACS. After the at-home stimulation is complete, participants return to UCSF
      for a final in-lab assessment of multitasking and sustained attention ability.
    

Intervention name(s): Transcranial alternating current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial alternating current stimulation across the prefrontal cortex using electrodes F3 and F4.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science