AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03081416 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Benadryl
Description: Standard therapy
Study NCT01100008 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Magnetic resonance imaging (MRI)
Description: MRI cardiac and pulmonary with gadolinium
Study NCT03661515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Selinexor
Description: According to escalation level:~* Level -1: Selinexor 40 mg/day, once weekly~* Level 1: Selinexor 60 mg/day, once weekly~* Level 2: Selinexor 80 mg/day, once weekly~* Level 3: Selinexor 100 mg/day, once weekly
Study NCT03661515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fludarabine
Description: fludarabine 30 mg/m2/day intravenously on days 1 to 4
Study NCT03661515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: idarubicin
Description: idarubicin 10 mg/m2/day intravenously on days 1 to 3
Study NCT03661515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: cytarabine 2 g/m2/day intravenously on days 1 to 4
Study NCT03661515 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: G-CSF
Description: G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5
Study NCT00261716 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: IPS
Description: Individual Placement and Support Evidence based supported employment
Study NCT00261716 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: IPS
Description: Individual Placement and Support Evidence based supported employment
Study NCT00261716 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: IE
Description: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
Study NCT00261716 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: VOMI
Description: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
Study NCT01800916 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Coloplast Adhesive baseplate A
Description: Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
Study NCT02012322 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Coenzyme Q10
Description: 300mg/day for three months
Study NCT01800916 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Coloplast Adhesive baseplate B
Description: Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
Study NCT01800916 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Coloplast Adhesive baseplate C
Description: Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
Study NCT01800916 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: SenSura 1-Piece
Description: SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
Study NCT06095843 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: placement of dental implants
Description: placement of dental implants in mandibular reconstruction.
Study NCT01514552 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Strawberry gummy
Description: Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this strawberry intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.
Study NCT01514552 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo control gummy
Description: Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this a placebo gummy intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.
Study NCT04820816 — intervention group
Intervention type: OTHER
Intervention: pelvic tilt effect on balance, sensory integration and risk of fall
Description: BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test
Study NCT03746821 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Biotin
Description: Biotin supplements (2) to be taken daily
Study NCT01988571 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Atorvastatin
Description: 40 mg tablet taken by mouth each morning for 24 months.
Study NCT01988571 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Atorvastatin
Description: 40 mg tablet taken by mouth each morning for 24 months.
Study NCT01988571 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: One placebo tablet taken each morning orally for 24 months.
Study NCT01416883 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ICI176,334-1
Description: Subject will receive single dose of ICI176,334-1
Study NCT02129361 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Adapted Screening and Brief Intervention (Adapted SBI)
Study NCT02129361 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Screening & Education Attention Control
Study NCT02128295 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Electric breast pump - A
Study NCT02128295 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Electric breast pump - B
Study NCT02151708 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
Study NCT02151708 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: motilitone
Description: Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
Study NCT02187302 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: CRLX101
Study NCT02187302 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bevacizumab
Study NCT02187302 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care (Investigator Choice)
Study NCT02493634 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: pressure gradient measurement
Description: A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.
Study NCT02493634 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: MRWire
Study NCT00805116 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Whale blubber oil
Description: 15 ml/day for 4 months, divided on dosage morning and evening, orally.
Study NCT00805116 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Cod liver oil
Description: 15 ml/day for 4 months, divided on dosage morning and evening, taken orally
Study NCT04194775 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Nofazinlimab (CS1003)+Lenvatinib
Description: Nofazinlimab (CS1003), intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
Study NCT04194775 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Nofazinlimab (CS1003) Placebo+Lenvatinib
Description: Nofazinlimab (CS1003) Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily
Study NCT00638703 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Oxalobacter formigenes
Description: NLT (not less than) 10\^7 CFU Oxalobacter formigenes twice daily for 24 weeks
Study NCT00638703 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo
Study NCT03456089 — intervention group
Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Urodynamics Testing
Description: Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance
Study NCT04114903 — intervention group
Intervention type: OTHER
Intervention: Study A: Single use of cannabis flower product
Description: Participants are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Study NCT04114903 — intervention group
Intervention type: OTHER
Intervention: Study B: Ad libitum cannabis use for four weeks or no cannabis use
Description: Participants choose whether to use a cannabis flower product ad libitum for four weeks or to not use cannabis for four weeks. Participants who choose to use cannabis are asked to purchase and use one of three cannabis flower strains with differing levels of THC and CBD: 1) CBD (\~14% CBD/0% THC), 2) THC (\~14% THC/0% CBD), or 3) THC+CBD (\~7% THC/7% CBD).
Study NCT01182506 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Cogmed Working Memory Training Program
Description: Women will be randomized to one of two 5-week rehabilitation software training programs that train working memory called Cogmed Working Memory Training Program.~The training software will be provided to each participant. For each group, training occurs for 30 minutes a day, 5 days a week for 5 weeks. As part of the set-up, training data is uploaded to the internet at a minimum of every 3 days. This function allows the coach (in this case, the PI and RSA) to review the training. A weekly coach phone call is made to review the training results, answer questions, troubleshoot, and motivate the participant. Participants can load the software onto multiple computers to provide flexibility for them to do training at home, after work, when they are away from home.
Study NCT02012322 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: OTHER
Intervention: Placebo
Description: Three month period
Study NCT03524027 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Posterior Vertebral Column Resection (PVCR)
Description: Posterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity
Study NCT01148953 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: ALN-TTR01
Description: Dose levels between 0.01 and 1.0 mg/kg by intravenous (IV) infusion
Study NCT01148953 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Sterile Normal Saline (0.9% NaCl)
Description: Calculated volume to match active comparator
Study NCT02719158 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6 mg ciprofloxacin
Description: Single administration of OTO-201
Study NCT02719158 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 12 mg ciprofloxacin
Description: Single administration of OTO-201
Study NCT02719158 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Sham
Study NCT02796807 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT
Study NCT00556595 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: primary electrophysiological approach
Description: primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
Study NCT00556595 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: primary anatomical approach
Description: primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps
Study NCT01234467 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bendamustine
Description: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Study NCT04019301 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Baduanjin Qigong, Community-based
Description: The Community-based Qigong group, will attend one 75 minute long Qigong class per week for 12 weeks. Additionally, participants practice Qigong at home for 20 minutes a day, 3 days a week. Printed materials will be provided to guide home practice.
Study NCT04019301 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Baduanjin Qigong, Internet-based
Description: The Internet-guided Qigong group will be given a computer tablet to access online Qigong classes. All participants assigned to this group will be provided with a tutorial to use the Qigong program by the research coordinator. Participants will be asked to follow a 40 minute long Qigong class twice a week for 12 weeks, and to practice an additional 20 minutes a day, 3 days a week. All sessions will be completed at home.
Study NCT01033123 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BSI-201
Description: IV infusion, 5.6 mg/kg
Study NCT02376062 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bundled Intervention
Description: The authors have designed continuing medical education curriculum to improve clinical capacity and competency about mental health for Nepali Primary Care Providers. Specifically:~* On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu~* Weekly case conferences~* Surveys of clinicians and clinical supervisors in accordance with CME curriculum
Study NCT01236144 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Plerixafor
Description: Fixed dose of Plerixafor (240mcg/kg) given by subcutaneous injection on each day of chemotherapy for up to 3 courses (depending on cohort). The three chemotherapy courses will be Daunorubicin/Clofarabine for courses 1\&2 and Daunorubicin/Ara-C for course 3. Each course will last 5 days, and Plerixafor will be given for 5 days.
Study NCT01236144 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AC220
Description: Each cohort of patients will receive three courses of chemotherapy approximately 4 to 5 weeks apart which will comprise of Daunorubicin/Ara-C/Etoposide in Courses 1\&2 and Daunorubicin/Ara-C in Course 3. Two days after the last day of each chemotherapy course, patients will receive AC220 orally for 7, 14 or 21 (depending on cohort) consecutive days. Depending on which cohort the patient enters, they will receive either 60mg, 90mg or 135mg of AC220 daily, with a provision to assess 40mg if necessary.
Study NCT01236144 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ganetespib
Description: Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.
Study NCT03807934 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
Description: Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
Study NCT03807934 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
Description: Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
Study NCT01234467 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
Study NCT01585142 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Test formula
Description: Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition
Study NCT04374175 — intervention group
Intervention type: BIOLOGICAL
Intervention: Blood sample
Description: Blood sample will be performed
Study NCT01525888 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
Description: stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker
Study NCT03199456 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Zip surgical skin closure device
Description: Zip surgical skin closure device manufactured by ZipLine Medical, Inc. is a CE-marked, non-invasive, single use device that is designated to provide closure of the skin layer for lacerations or surgical incisions.
Study NCT03199456 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Standard of Care sutures
Description: Standard of Care sutures according to the hospitals current clinical praxis.
Study NCT03890692 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: flexible nasoendoscopy
Description: nasopharyngeal endoscopy : After washing nasal cavities with a sterile physiologic solution to remove secretions or scabs, and decongesting them with an oxymetazoline solution in the subjects with turbinate hypertrophy,~* Endoscopy will be performed by passing the endoscope along either the floor of the nose or just under the middle turbinate. the condition of the nasal mucosa\\ septum\\ turbinates and the presence of discharge The postnasal space will be assessed . All abnormalities will be recorded .the images will be recorded and assessed separately by two independent otolaryngologists
Study NCT03490188 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Discharge Mentoring
Description: Phone Conversations on the importance of complying to discharge instructions delivered before discharge
Study NCT02074709 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Plain bupivacaine
Description: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn
Study NCT02074709 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Liposomal bupivacaine
Description: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Study NCT02301078 — intervention group
Intervention type: PROCEDURE
Intervention: Percutaneous Needle Aponeurotomy
Description: single procedure (day 0)
Study NCT02301078 — intervention group
Intervention type: DRUG
Intervention: Collagenase clostridium histolyticum
Description: Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)
Study NCT01280760 — intervention group
Intervention type: OTHER
Intervention: Device: Neurally Adjusted Ventilatory Assistance
Description: Device: Neurally Adjusted Ventilatory Assistance~In ICU following extubation NIV was performed as follows:~facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode
Study NCT02698319 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Copenhagen Triage Algorithm
Description: The Copenhagen Triage Algorithm is a new triage method for faster triage in the ED
Study NCT04195867 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Salmeterol Xinafoate
Description: Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).
Study NCT01502267 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: High dose IVIG and B cell depleting agents
Description: 1. IVIG(2g/kg two times on day 1, 30)~2. Rituximab(375mg/m2 on day 3)~3. Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)
Study NCT01603927 — intervention group
Intervention type: DEVICE
Intervention: Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus).
Description: Colonoscopists will narrow band imaging to provide an 'optical diagnosis' for colonic polyps found during routine colonoscopies performed for the diagnosis of symptoms or asymptomatic screening.
Study NCT01556659 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Absence of vitamin K antagonist
Description: Dual anti-platelet therapy
Study NCT03360721 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Abiraterone Acetate
Description: Given PO
Study NCT03360721 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Apalutamide
Description: Given PO
Study NCT03360721 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Prednisone
Description: Given PO
Study NCT01410149 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: PAV
Description: Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
Study NCT04066842 — intervention group
Intervention type: OTHER
Intervention: Observation
Description: Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
Study NCT01410149 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: PSV
Description: Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
Study NCT01410149 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: ACV
Description: Assist Control Ventilation will be used to ventilate the patient for a 24 hour period