AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT01662115 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Nicotine gum
Description: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
Study NCT01662115 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Regular chewing gum
Description: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Study NCT02009995 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Aerobic Training (AT)
Description: All subjects will participate in a 10-week ramp-in period with the goal of achieving 150 minutes of moderate-to-vigorous physical activity per week. Walking and jogging will be the primary modes of achieving the prescribed aerobic activity as these are the modes of aerobic exercise that are most accurately recorded by an accelerometer. Subjects will use the Rate of Perceived Exertion (RPE) to guide aerobic exercise intensity. Aerobic activity will be objectively monitored by the Technogym MyWellness Key (MWK) accelerometer, which is a lightweight device worn on the waistband.
Study NCT02009995 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Aerobic Training (AT)
Description: All subjects will participate in a 10-week ramp-in period with the goal of achieving 150 minutes of moderate-to-vigorous physical activity per week. Walking and jogging will be the primary modes of achieving the prescribed aerobic activity as these are the modes of aerobic exercise that are most accurately recorded by an accelerometer. Subjects will use the Rate of Perceived Exertion (RPE) to guide aerobic exercise intensity. Aerobic activity will be objectively monitored by the Technogym MyWellness Key (MWK) accelerometer, which is a lightweight device worn on the waistband.
Study NCT02009995 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: AT plus Primarily Home-Based Resistance Band Training
Description: The bands + AT group will engage in RBT 3 times per week, progressing to 3 sets of 10-15 repetitions of 12 exercises. The exercises will be: chair squat, sitting chest press, seated rear fly, seated row, overhead press, lateral raise, biceps curl, triceps extension, leg extension, hamstring curl, gluteal extension, and abdominals. The resistance band exercise sessions will be between 25-60 minutes.~Participants in this group will attend supervised group sessions weekly in weeks 1-4, every 2 weeks in weeks 5-8, and every 4 weeks thereafter to ensure proper form and appropriate progression. Participants in this group will be responsible to complete all remaining sessions (a total of 3 per week, including supervised sessions) at home on their own time.
Study NCT01679353 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: caudal block
Description: After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.
Study NCT01679353 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: normal saline 0.5ml
Study NCT01978262 — intervention group
Intervention type: BIOLOGICAL
Group type: OTHER
Intervention: Seasonal Inactivated Influenza Vaccine
Description: Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Study NCT01548157 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HCP1007 / omarco and crestor
Description: HCP1007 / Rosuvastatin plus Omega-3
Study NCT01548157 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: HCP1007 / omarco and crestor
Description: HCP1007 / Rosuvastatin plus Omega-3
Study NCT04103697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: 2000 mg/m2, bid, per os, days 1-14, 4 cycles
Study NCT04103697 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Capecitabine
Description: 2000 mg/m2, bid, per os, days 1-14, 4 cycles
Study NCT04103697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin
Description: 130 mg/m2 iv day 1, 4 cycles
Study NCT04103697 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxaliplatin
Description: 130 mg/m2 iv day 1, 4 cycles
Study NCT04103697 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Capecitabine
Description: 825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
Study NCT04103697 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Radiotherapy
Description: Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
Study NCT04103697 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Rectal cancer surgery
Description: Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)
Study NCT04103697 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Rectal cancer surgery
Description: Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)
Study NCT03622554 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Adapted Physical Activity (APA)
Description: 12 APA sessions of 60 minutes
Study NCT03622554 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Therapeutic Patient Education (ETP)
Description: Personalized ETP with 3 group sessions (1h30) and one at the end of the course (1h) and educational follow-up by phone at 3, 6 and 12 months
Study NCT00828841 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cetuximab
Description: Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Study NCT00828841 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Paclitaxel
Description: Paclitaxel 200 mg/m2 Day 1 every 21 days
Study NCT00828841 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Carboplatin
Description: Carboplatin AUC 6 Day 1 every 21 days
Study NCT00828841 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Gemcitabine
Description: Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Study NCT00828841 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cisplatin
Description: Cisplatin 75 mg/m2 Day I every 21 days
Study NCT04147650 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.05% Voclosporin Ophthalmic Solution (VOS)
Description: 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Study NCT04147650 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.10% VOS
Description: 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Study NCT04147650 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 0.20% VOS
Description: 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Study NCT04147650 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Vehicle Ophthalmic Solution
Description: Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
Study NCT01694355 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vitamin D
Study NCT04747782 — intervention group
Intervention type: OTHER
Intervention: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
Description: no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
Study NCT01306487 — intervention group
Intervention type: PROCEDURE
Intervention: Vitrectomy
Description: Macular hole surgery
Study NCT02376075 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Linagliptin
Description: Intake of tablets containing 5 mg Linagliptin, administered once daily as add on to pre-existing antihypertensive treatment for 6 weeks
Study NCT02376075 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Intake of Placebo, administered once daily as add on to pre-existing antihypertensive treatment for 6 weeks
Study NCT03227796 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LEVI-04
Description: LEVI-04 intravenous infusion
Study NCT03227796 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo intravenous infusion
Study NCT01388790 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cetuximab
Description: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m\^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Study NCT01388790 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cisplatin 60 mg/m\^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent
Study NCT01388790 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: S-1
Description: S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Study NCT02203292 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Liberal transfusion strategy
Description: Patients will have red blood cells transfused only if Hb \< 9.0 g/dL
Study NCT02203292 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Restrictive transfusion strategy
Description: Patients will have red blood cells transfused only if Hb \< 7.0 g/dL
Study NCT01734408 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: alum-adjuvant 160U /0.5ml
Description: inactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine
Study NCT01734408 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: alum-adjuvant 320U /0.5ml
Description: inactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine
Study NCT01734408 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: alum-adjuvant 640U /0.5ml
Description: inactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine
Study NCT01734408 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: adjuvant-free 640U /0.5ml
Description: inactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine
Study NCT01734408 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: 0/0.5ml placebo
Description: 0/0.5ml placebo
Study NCT01148966 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: aminolevulinic acid
Description: Given PO
Study NCT01148966 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study NCT01148966 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: therapeutic conventional surgery
Description: Standard brain tumor surgery with intra-operative frameless MRI stereotactic guidance and intra-operative ultrasound guidance
Study NCT04487574 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: XC221
Description: Participants will receive XC221 100 mg 2 times a day during 14 days
Study NCT04487574 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Participants will receive Placebo 2 times a day during 14 days
Study NCT01728532 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Pulp Canal Sealer (Kerr)
Description: permanent obturation of the root canal space with the aid of obturating points
Study NCT01728532 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: PA0903
Description: Sealing performed by the dentist , coronal obturation placed after the canal obturation
Study NCT01462838 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: P16_37-63
Description: 100 ug per application subcutaneously, mixed with 0.3 ml Montanide ISA-51 VG; once a week for four weeks, followed by a 4 week rest period (1 cycle), up to 3 cycles
Study NCT03639233 — intervention group
Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: YESS!
Description: Web based self-management education
Study NCT02940938 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Applying pulse oximeter sensor
Description: During general anesthesia, pulse oximeter sensor is applied with gradually increased contact force, from 0 to 1.5N (increase by about 0.2N), at an index finger and POP waveform is obtained for 60 seconds.
Study NCT06406556 — intervention group
Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Pegaspargase combined with concurrent radiotherapy.
Description: Patients receive CCRT (radiation 50 Gy and two cycles of pegaspargase 2500 unit/m2 every 3 weeks). 4 courses of pegaspargase were performed after CCRT.
Study NCT00973362 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: APTIMA HPV Assay
Description: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
Study NCT00973362 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: FDA-Approved HPV DNA Test
Description: A FDA-Approved HPV DNA Test is used as the comparator assay.
Study NCT04261023 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Orencia 125 MG Per 1 ML Prefilled Syringe
Description: Abatacept sub-cutaneous injection 125mg at week 0 and once weekly thereafter for a maximum of 48 weeks
Study NCT01917513 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: G-EYE™ colonoscopy
Description: G-EYE™ colonoscopy
Study NCT01917513 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Standard Colonoscopy
Description: Standard Colonoscopy
Study NCT03514212 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: ProActiveS
Description: A 12-week behaviour change intervention, during which time participants met with the researcher weekly and used a pedometer to measure step count and completed an activity diary to monitor progress, set goals and plan how to cope with identified barriers.
Study NCT02844881 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apatinib
Description: Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Study NCT02844881 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: MASCT
Description: Dendritic cells(DC) loaded with 17 antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Study NCT00887679 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Escitalopram
Description: 10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
Study NCT04494581 — intervention group
Intervention type: OTHER
Intervention: questionnaire
Description: Questionnaire survey
Study NCT02573454 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: App assignment
Description: Under-active undergraduates are assigned to use a GPS exercise app that is prosocial (i.e., allows the user to raise money for charities) or personal (does not allow the user to raise money for charities) in nature
Study NCT02573454 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: App assignment
Description: Under-active undergraduates are assigned to use a GPS exercise app that is prosocial (i.e., allows the user to raise money for charities) or personal (does not allow the user to raise money for charities) in nature
Study NCT02683941 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lanreotide (Autogel formulation)
Description: 120mg every 28 days until disease progression, death, or unacceptable toxicity
Study NCT02683941 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Saline solution 0.9% administered via deep subcutaneous injection every 28 days until disease progression.
Study NCT02683941 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Best Supportive Care
Description: Best Supportive Care is best available therapy at the choice of the investigator
Study NCT02683941 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Best Supportive Care
Description: Best Supportive Care is best available therapy at the choice of the investigator
Study NCT02475174 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Without upper limb elevation
Description: Lymphatic drainage without elevation of the upper limb.
Study NCT02475174 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Upper limb elevation to 30º
Description: Lymphatic drainage with elevation of the upper limb to 30º.
Study NCT00892723 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZX100 Drug Product
Description: Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Study NCT00892723 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Study NCT00892723 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AZX100 Drug Product
Description: Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Description: Tablet, 2.5 mg, twice daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Description: Tablet, 5 mg, twice daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin
Description: Tablet, 100 mg, once daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Description: Tablet, 100 mg, once daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin placebo
Description: Aspirin matching placebo, once daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rivaroxaban placebo
Description: Rivaroxaban matching placebo, twice daily, oral
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pantoprazole
Description: Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pantoprazole
Description: Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Pantoprazole placebo
Description: Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Study NCT01776424 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Pantoprazole placebo
Description: Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Study NCT01060826 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: fisiologic serum
Description: 250 microgramos bolus intravenous during 3 minutes and continuous infusion for 4 hours after endoscopic procedure
Study NCT01060826 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: somatostatin, intravenous bolus
Description: 250 microgramos bolus intravenous in 3 minutes and continuous infusion for 4 hours after endoscopic
Study NCT01060826 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: somatostatin
Description: Intravenous bolus 250 micrograms
Study NCT02347033 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sertraline
Description: Sertraline will be prescribed by the patients' GP, starting at 25mg daily for 1-2 weeks and increasing to 50mg daily if tolerated. The GP should review the patient within the first 2 weeks, checking for acceptability, concordance and any side-effects, with further reviews at 6 and 12 weeks. We expect the usual treatment dose to be 50 to 100mg daily, although some may require 150mg.~We will suggest that the GPs use their usual procedures to review the patient's progress, asking about and noting functional change as well as clinical improvement. Minimal improvement after 12 weeks at a maximal tolerated dose should prompt consideration of change of treatment. If there has been an adequate therapeutic benefit there should be further review at 26 and 52 weeks.