TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03855137

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atogepant 30 mg
Description: Tablets containing 30 mg atogepant

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atogepant 60 mg
Description: Tablets containing 60 mg atogepant

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: 30 mg/60 mg tablets containing atogepant-matching placebo

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: 30 mg/60 mg tablets containing atogepant-matching placebo

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 30 mg/60 mg tablets containing atogepant-matching placebo
Study: NCT02651194

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-493/ABT-530
Description: Tablet; ABT-493 coformulated with ABT-530
Study: NCT01212172

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Soprano/SHR
Description: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: LightSheer
Description: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.
Study: NCT00966758

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Computed Tomography
Description: 1 low dose CT scan is taken

Intervention type: PROCEDURE
Group type: OTHER
Intervention: Single Photon Emission Computed Tomography
Description: 1 SPECT scan is taken
Study: NCT03482219

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Home app intervention
Description: The app consists of videos depicting each exercise and ability to track adherence to exercises.
Study: NCT06490406

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Multimodal intervention (communication and education simulations) for EG1
Description: In summary, students in EG1 received the following multimodal intervention flow: 1) Health communication training, 2) Structured educational simulation using standardized patients (SPs), and 3) simulation feedback and self-assessment using a systematic guide that included the health literacy practices.
Study: NCT01745952

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: figure-of-eight active rTMS coil
Description: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: round active rTMS coil
Description: navigated rTMS over epileptogenic focus using round active rTMS coil

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: sham rTMS coil (figure-of-eight)
Description: commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
Study: NCT02972021

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: High-flow nasal cannula
Study: NCT03056040

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Ravulizumab
Description: All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilograms (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ravulizumab
Description: All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilograms (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
Study: NCT02972021

Intervention type: DEVICE
Group type: OTHER
Intervention: High-flow nasal cannula
Study: NCT02788513

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809 dose 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809 dose 2

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809 dose 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BI 425809 dose 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Study: NCT03056040

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Eculizumab
Description: All treatments were given as IV infusions. Participants received 900 mg of eculizumab q2w.
Study: NCT04163523

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanubrutinib
Study: NCT04799405

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: tDCS
Description: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:~1. First taper phase: three 30 minutes tDCS sessions applied every other day;~2. Second taper phase: three 30 minutes tDCS sessions applied one every third day;~3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.
Study: NCT01687738

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: communication intervention
Description: Because of the gaps between documented outcomes of lung cancer surgery and patient communication barriers identified in our recent work, our communication intervention will focus on improving presentation of risk information and confirmation of understanding of patient medical.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Real Time Registry and data feedback only
Description: This group of patients will not received the enhanced communication intervention
Study: NCT03982771

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bortezomib
Description: -Bortezomib: 1.3mg/m2 subcutaneous injection on Day 1,8,15,22 every month for 9 months; And maintained with 1.3mg/m2 subcutaneous injection every two weeks from Month 9 to 21;

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: -Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;
Study: NCT00610688

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prenatal Vitamin
Description: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prenatal Vitamin
Description: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prenatal Vitamin
Description: Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cholecalciferol (Vitamin D3)
Description: Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Study: NCT04163523

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanubrutinib

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zanubrutinib
Study: NCT00610688

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cholecalciferol (Vitamin D3)
Description: Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery
Study: NCT02228408

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydralazine/Isorsorbide Dinitrate
Description: Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.~Target Dose:~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day~Allowable Dosage Forms:~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day~Dose Titration:~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo
Description: Placebo titration will mimic titration of active study arm
Study: NCT00819442

Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: cardiobiopsy
Description: 5 samples will be taken from right ventricle by Cordis bioptome
Study: NCT02788513

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Study: NCT02418078

Intervention type: PROCEDURE
Intervention: local infiltration anesthesia and sedation
Description: the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents

Intervention type: PROCEDURE
Intervention: local infiltration anesthesia and sedation
Description: the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
Study: NCT03854110

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GP-2250
Description: GP-2250 monotherapy for pharmacokinetics and safety; GP-2250 plus gemcitabine for safety, tolerability, pharmacokinetics, and biomarker assessments
Study: NCT03098121

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: grazoprevir and elbasvir
Description: For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
Study: NCT02918201

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tranexamic Acid
Description: TXA 25 mg/ml applied topically to moisten the wound
Study: NCT00819442

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cardiobiopsy
Description: 5 samples will be taken from right ventricle by Cordis bioptome

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cardiobiopsy
Description: 5 samples will be taken from right ventricle by Cordis bioptome
Study: NCT03982771

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethason
Description: Dexamethasone: (oral) 40mg on Day 1,8,15,22 every month for 9 months; and maintained with 20mg (oral) every two weeks from Month 9 to 21.
Study: NCT02196051

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: one bout of 45 minutes exercise
Description: 45 minutes of exercise on an elliptical exercise machine
Study: NCT02918201

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: saline
Description: Saline solution (0.9% NaCl) applied topically to moisten the wound
Study: NCT00657358

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Lidocaine
Description: Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
Study: NCT02481583

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levosulpiride
Description: different formulations of levosulpiride

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Levosulpiride
Description: different formulations of levosulpiride
Study: NCT03596008

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Active drink
Description: The freeze-dried strawberry powder (25 g) in active drink

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo drink
Description: Placebo drink
Study: NCT04862117

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Description: Active Implantable Vagus Nerve Stimulation device.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Description: Active Implantable Vagus Nerve Stimulation device.
Study: NCT02444819

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: HM61713
Description: HM61713 will be administered to evaluate efficacy and safety of subjects.
Study: NCT02413125

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: ChitoRhino irrigation solution
Description: ChitoRhino irrigation solution has been developed with chitosan, a natural polysaccharide demonstrated to have antibacterial and antifungal properties. This polysaccharide has beneficial properties in multiple clinic applications including wound healing and post-operative sinus surgery. Chitosan's antimicrobial function develops from its polycationic structure. Chitosan interacts with the negatively charge bacterial wall, leading to disruption and cell lysis.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Normal saline
Description: Most nasal irrigations use normal saline (0.9% sodium chloride), which approximates the physiological concentration of plasma in the blood. The saline solution is used to flush the nose of mucous and allergens.
Study: NCT03631875

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ketamine
Description: use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Ketamine
Description: use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
Study: NCT02270008

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic floor training
Description: Baseline muscle strength will be measured with the modified Oxford scale. The intervention group will undergo an in-person standardized pelvic strength training session by a trained nurse practitioner.
Study: NCT02326792

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Exercise
Description: The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.
Study: NCT02364726

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Acupuncture
Description: Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Neuropathic Pain Scale (NPS) questionnaire
Description: It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: FACT/GOG-Ntx questionnaire
Description: It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion.
Study: NCT01742000

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Karinat

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Sugar pill manufactured to mimic Karinat 500 mg tablet
Study: NCT03941405

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Albumin treatment
Description: one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value \> 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
Study: NCT04279912

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis
Description: The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
Study: NCT00788775

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nilotinib
Study: NCT04629989

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Standard Oxygen Delivery System
Description: The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Double-Trunk Mask
Description: The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Surgical Mask
Description: The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
Study: NCT02481037

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Primary care clinical pathway
Description: Installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Asthma education
Description: Physicians will receive web-based education through an interactive learning module regarding best management for childhood asthma and use of the primary care clinical pathway. Chronic disease management (CDM) health professionals in practices will attend asthma education sessions delivered by an asthma educator. This training will be then used by the CDM professional to provide targeted and timely asthma education to parents and children with asthma.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: EMR embedded dashboard
Description: An EMR embedded dashboard will deliver real-time feedback to clinicians.
Study: NCT04584970

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Applied VR
Description: The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Apple iPad
Description: The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
Study: NCT01790854

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prasugrel dose 5 mg/day
Study: NCT01613287

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TheraSorb® - Ig flex
Description: TheraSorb® Treatment with one TheraSorb® Ig flex adsorber pair, used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy.~5 treatments performed over 5 to 8 consecutive days.
Study: NCT02708043

Intervention type: OTHER
Group type: OTHER
Intervention: Flexible-Laryngeal Mask Airway
Study: NCT03951961

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midostaurin
Description: 50mg Midostaurin bid for 12 months
Study: NCT02814357

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Control (market standard)

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: wheat flour

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: wheat flour
Study: NCT01790854

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prasugrel dose 10 mg/day
Study: NCT01514071

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Pop-up picture
Description: An animated picture depicting the key elements of the PECARN CT scan head injury rules will be explained. The picture will pop-up when a provider selects the order set for a CT scan due to head injury. Providers will need to select a box stating the patient either meets criteria or does not meet criteria in order to close the animated picture window.
Study: NCT02814357

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: wheat flour

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: chickpea flour
Study: NCT00133913

Intervention type: PROCEDURE
Intervention: Phlebotomy
Description: Peripheral blood draws for testing of circulating tumor cells
Study: NCT00844675

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: rabeprazole
Description: The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: placebo
Description: The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1).
Study: NCT04462770

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: EPX-100 (clemizole HCl)
Description: Daily dose of EPX-100

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Daily dose of placebo
Study: NCT02962388

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anagrelide
Description: Anagrelide in the study, according to the investigator decision fom day 1 to 48 months
Study: NCT02814357

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: chickpea flour

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: chickpea flour

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: guar gum

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: guar gum

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: guar gum

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: barley
Study: NCT02962388

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib (JAKAVI®)
Description: Ruxolitinib (JAKAVI®) - Novartis. Tablets 5 mg. Starting dose 10 mg BID, orally. To be increased or decreased (5 or 10 mg steps) per standardized dosing Maximum dose 25 mg BID. fom day 1 to 48 months

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: IFNα/ PegIFNα
Description: IFNα/ PegIFNα in the study, according to the investigator decision fom day 1 to 48 months