TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01996787

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Air Optix Aqua
Description: Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Air Optix Aqua
Description: Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Clariti with Handling Tint
Description: Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Clariti with Handling Tint
Description: Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
Study: NCT03051633

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Be Under Your Own Influence
Description: School based anti-drug use communications campaign
Study: NCT01146470

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: RGC
Description: dosage of Red Grape Cells once a day, during 3 months

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: RGC
Description: dosage of Red Grape Cells once a day, during 3 months

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: dosage of Placebo once a day, during 3 months
Study: NCT02145962

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Forearm tissue exposure with ELF-MF
Description: The treatment was delivered 2 hours/day, 2 times/week and consisted of sinusoidal oscillating magnetic fields of 120 Hz using a solenoid, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the forearm device is approximately 30 ml/min or 3.6 lt/session.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Thorax tissue exposure with ELF-MF
Description: The treatment was delivered 25 minutes/day, 2 times/week and consisted of 120 Hz using a quasi-Helmholtz coil configuration, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the thorax device should be approximately 6,500 ml/min or 162.5 lt/session, which is approximately 45 times more blood volume stimulation per unit of time compared with the Forearm exposure system.
Study: NCT01035190

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Budesonide
Description: Inhalation, 200 µg/puff
Study: NCT01409928

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: LAP-BAND (Allergan, Inc.)
Description: Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Study: NCT03115996

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: REGN3918
Description: Intravenous (IV) or Subcutaneous (SC)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: REGN3918
Description: Intravenous (IV) or Subcutaneous (SC)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Matching Placebo

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Matching Placebo
Study: NCT03358914

Intervention type: OTHER
Intervention: No intervention
Description: Completion of surveys

Intervention type: OTHER
Intervention: No intervention
Description: Completion of surveys

Intervention type: OTHER
Intervention: No intervention
Description: Completion of surveys
Study: NCT02649257

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: cataract surgery

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: intraocular lens (MC 6125 AS)

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: capsular tension ring (CTR 13/11)
Study: NCT04315467

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SGM-101
Description: A one-time infusion of SGM-101

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Near infrared camera imaging system
Description: Near infrared camera imaging system
Study: NCT02051907

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: KAM1403 Gel

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: aloevera gel
Study: NCT03562767

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Group-based Cognitive Behavioral Intervention
Description: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Web-based Cognitive Behavioral Intervention
Description: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
Study: NCT04484350

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Labetalol
Description: 10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Labetalol
Description: 10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
Study: NCT02197156

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 20 mg HC-ER
Description: Single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 30 mg HC-ER
Description: Single dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 40 mg HC-ER
Description: Single dose
Study: NCT03562767

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Usual Care
Description: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
Study: NCT03893890

Intervention type: BIOLOGICAL
Intervention: Previously Treated with EN3835
Description: No treatment to be administered - Observational only
Study: NCT02204761

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Proton Beam Radiation Therapy
Description: Undergo proton beam re-irradiation therapy
Study: NCT00456144

Intervention type: DRUG
Intervention: Gonadotropin Releasing Hormone Agonist Therapy
Description: Given either for 24 months and 6 months

Intervention type: DRUG
Intervention: Gonadotropin Releasing Hormone Agonist Therapy
Description: Given either for 24 months and 6 months
Study: NCT01863589

Intervention type: DRUG
Intervention: Adefovir tablets
Description: Administered according to the prescribing information in the locally approved label by the authorities.
Study: NCT00927940

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MDT-4107 Drug Eluting Stent
Description: Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent
Study: NCT03007888

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sinemet
Description: Immediate Release Tablet containing carbidopa-levodopa flexible dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sinemet
Description: Immediate Release Tablet containing carbidopa-levodopa flexible dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IPX203
Description: Extended Release capsules containing carbidopa-levodopa flexible dosing

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IPX203
Description: Extended Release capsules containing carbidopa-levodopa flexible dosing
Study: NCT01658813

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 5-Fluorouracil and Interferon
Description: 5-Fluorouracil Interferon-alfa-2b
Study: NCT05270447

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Massage and patient education
Description: Connective tissue manipulation: The patients were informed about CTM and its mechanism of action before starting the CTM application. CTM was performed by a trained physiotherapist as the patient was in a sitting position.~Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Massage and patient education
Description: Connective tissue manipulation: The patients were informed about CTM and its mechanism of action before starting the CTM application. CTM was performed by a trained physiotherapist as the patient was in a sitting position.~Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Routine care and advising
Description: Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Routine care and advising
Description: Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Routine care and advising
Description: Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.

Intervention type: BEHAVIORAL
Group type: OTHER
Intervention: Routine care and advising
Description: Routine care and advising: In-bed activities were taught and recommended to the patients in both groups. In-bed activities; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities were recommended after the anesthetic effect wore off.
Study: NCT00528541

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: botulinum toxin type A
Description: 200 Units at Visit 1 (Day 1)

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: botulinum toxin type A
Description: 750 Units at Visit 1 (Day 1)
Study: NCT00471614

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: NucleomaxX (contains uridine)
Description: Escalated doses of NucleomaxX tid

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: NucleomaxX (contains uridine)
Description: Escalated doses of NucleomaxX tid
Study: NCT02285062

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lenalidomide

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Placebo

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Rituximab

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Rituximab

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Doxorubicin

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: prednisone

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: prednisone

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: vincristine

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vincristine
Study: NCT02858700

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Study: NCT01845623

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: QAB149 75 mg Concept 1
Description: QAB149 delivered via the concept 1 device.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: QAB149 75 mg Epic Test Fixture
Description: QAB149 delivered via the EPIC test fixture

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo Concept 1
Description: Placebo administered via the Concept 1 device.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Concept 1
Description: Placebo administered via the Concept 1 device.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Placebo EPIC Test Fixture
Description: Placebo administered via the EPIC Test Fixture.

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo EPIC Test Fixture
Description: Placebo administered via the EPIC Test Fixture.
Study: NCT02793622

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy
Study: NCT03337672

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexmedetomidine
Description: Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Midazolam
Description: Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery
Study: NCT02589600

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Zoledronic acid
Description: Annual intravenous 5.0 mg

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: vitamin D
Description: 800 IU daily

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: vitamin D
Description: 800 IU daily

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: calcium
Description: approximately 1200 mg (dietary and supplement)

Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: calcium
Description: approximately 1200 mg (dietary and supplement)

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Saline
Description: Annual intravenous saline placebo
Study: NCT02461472

Intervention type: OTHER
Intervention: not intervention
Description: This is a cross-sectional study, no intervention was performed.
Study: NCT02557074

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: IL2
Description: IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
Study: NCT00403169

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: lenalidomide
Description: drug
Study: NCT03189498

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-64041575
Description: All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-64041575
Description: All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-64041575
Description: All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-64041575
Description: All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: JNJ-64041575
Description: All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.
Study: NCT05349201

Intervention type: OTHER
Intervention: KYMRIAH
Description: Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse

Intervention type: OTHER
Intervention: KYMRIAH
Description: Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse

Intervention type: OTHER
Intervention: YESCARTA
Description: Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Study: NCT02990247

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: anharmonic morphological analysis of the respiratory signals (AMARS)
Study: NCT04268602

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: local anesthetic injection
Description: 1% lidocaine
Study: NCT01459289

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: leaflet

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: counseling and leaflet
Study: NCT01190735

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Caffeine alkaloid
Description: The following intervention will be provided for six consecutive weeks:~Week 1 (100 mg BID), Week 2 (200 mg BID), Week 3 (300 mg BID), Week 4 (400 mg BID), Week 5 and 6(500 mg BID). At the conclusion of the study, patients will decrease their dose by 100 mg BID every other day, until caffeine is stopped. This gradual reduction will be to prevent withdrawal symptoms. If a patient experiences a dose-limiting event, they will be terminated from the study, and will withdraw from the medication in the same manner. If dose-limiting events occur between visits, patients will be encouraged to decrease the caffeine dose back to the previously-tolerated dose until in-person assessment can be performed.
Study: NCT02030431

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Dynaloc

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Cancellous screws
Study: NCT02996058

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine 0.35µg/kg /h
Description: the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexmedetomidine 0.5µg/kg /h
Description: the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
Study: NCT02916121

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: folic acid 5 mg/cap
Description: the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: placebo
Study: NCT01908946

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: SMS reminders
Description: SMS reminders for vaccination visit at 6, 10 and 14 weeks of life.
Study: NCT05218954

Intervention type: DIAGNOSTIC_TEST
Intervention: Biomechanical analysis of risk fall
Description: Biomechanical analysis of risk fall in terms of balance

Intervention type: DIAGNOSTIC_TEST
Intervention: Biomechanical analysis of risk fall
Description: Biomechanical analysis of risk fall in terms of balance
Study: NCT01092832

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: voriconazole
Description: Subjects 12 - \<18 yrs (excluding subjects 12 - 14 yrs weighing \<50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.~Subjects 2 - \<12 yrs, and subjects 12 - 14 weighing \<50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).~Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days.
Study: NCT00133978

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Glutamine
Description: 0.35 gm/kg/day parenterally and 30 gms/day enterally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Antioxidants
Description: 500 micrograms of selenium/day parenterally and selenium 300 microgram, zinc 20 mg, beta carotene 10 mg, vitamine E 500 mg and vitamin C 1500 mg per day enterally

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Glutamine + Antioxidants
Description: 0.35 g/kg/day glutamine parenterally and 30 g/day of glutamine enterally. 500 mcg selenium parenterally plus the following administered enterally: selenium 300 mcg, zing 20 mg, beta-carotene 10 mg, vitamin E 500 mg and vitamin C 1500mg
Study: NCT03301948

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Energy Balance
Description: Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements