TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01038323

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: CBT and milnacipran
Description: Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week starter pack. Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: CBT with a placebo
Description: Participants will receive a series of eight telephone sessions of CBT along with a 21-week regimen of a placebo. Dosing for the placebo begins with a one week starter pack. Dosage: 12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Educational with milnacipran
Description: Participants will receive a series of eight telephone sessions of fibromyalgia related education along with a 21-week regimen of milnacipran. Dosing for milnacipran begins with a one week starter pack. Dosage:12.5 mg on day 1,12.5 mg twice daily on days 2 and 3, then 25 mg twice daily on days 4,5,6,and 7. On day 8 participants will begin taking 50 mg twice daily for the balance of the study.
Study: NCT02613078

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Self-Monitoring
Description: Use of symptom diary that questions about main bowel complains (including pain or discomfort) during the day. Applied on a daily basis (about 2 min in the evening)
Study: NCT03705949

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Hyaluronate 0.1% drops
Description: Patients will be administered Drops of Sodium Hyaluronate 0.1% quid

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Sodium Hyaluronate 0.2% drops
Description: Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
Study: NCT00871949

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 300 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 300 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 35 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 100 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 35 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 1000 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 1500 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: Fed conditions, 600 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 1500 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 600 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: Fed conditions, 600 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 1000 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: 600 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PNU-100480
Description: Fed conditions, 600 mg oral suspension given once

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: placebo to match oral suspension given once
Study: NCT04190264

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Thermal Rehabilitation Machine
Description: The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Cold Water Immersion
Description: Whole-body immersion in cold water.
Study: NCT04651192

Intervention type: OTHER
Intervention: Combat Exposure
Description: Soldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat.
Study: NCT04787770

Intervention type: OTHER
Intervention: non-intervention
Description: non-intervention

Intervention type: OTHER
Intervention: non-intervention
Description: non-intervention

Intervention type: OTHER
Intervention: non-intervention
Description: non-intervention
Study: NCT03103971

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fludarabine
Description: Given IV
Study: NCT00047034

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: eribulin mesylate
Description: Given IV
Study: NCT01771315

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Telephone follow-up
Description: The consultation is structured by predefined themes relevant for identifying health related problems in regard to illness to give adequate education and counseling. The form of each consultation will vary according to the individual needs of the patients.
Study: NCT03103971

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Laboratory Biomarker Analysis
Description: Correlative studies

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Leukapheresis
Description: Undergo leukapheresis

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Pharmacological Study
Description: Correlative studies
Study: NCT02248480

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Duloxetine
Description: Administered orally

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Administered orally
Study: NCT00920881

Intervention type: DEVICE
Intervention: FreeStyle Navigator Continuous Glucose Monitoring System
Description: Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.
Study: NCT02525510

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pump Eligible - Normothermia - Pump Both Kidneys
Description: Normothermia and Machine Perfusion Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Recovered kidneys will receive machine perfusion prior to implantation.OPO's protocol

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pump Eligible - Hypothermia and Pump Right Kidney
Description: Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Right Kidney will receive machine perfusion prior to implantation and the Left Kidney will receive cold storage.~Recovered kidneys will be placed in University of Wisconsin for cold storage until reimplantation.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Pump Eligible - Hypothermia and Pump Left Kidney
Description: Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Left Kidney will receive machine perfusion prior to implantation and the Right Kidney will receive cold storage.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Not Pump Eligible - Normothermia
Description: Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery.~Pulsatile Perfusion of kidney grafts based on the respective OPO's protocol

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Not Pump Eligible - Hypothermia
Description: Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.
Study: NCT01595321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Cyclophosphamide (Cy) 200 mg/m\^2 administered one day prior to GVAX (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GVAX Pancreas Vaccine
Description: GVAX administered one day after Cy (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional CY/GVAX boosts may be given every 6 months thereafter until disease recurrence.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation
Description: Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple).~Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.
Study: NCT00047034

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: pharmacological study
Description: Correlative studies

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: laboratory biomarker analysis
Description: Correlative studies
Study: NCT02083978

Intervention type: OTHER
Intervention: MRI scanning

Intervention type: OTHER
Intervention: MRI scanning
Study: NCT01595321

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation
Description: Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple).~Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Stereotactic Body Radiation
Description: Cohort 1 and 2: SBRT (6.6 Gy per day, 33 Gy total dose) will be administered over 5 days within 6-10 weeks of pancreas surgery (Whipple).~Cohort 3: SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first dose of CY/GVAX.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRINOX
Description: FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT.~FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle:~Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours);~modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m\^2 Fluorouracil bolus.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRINOX
Description: FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT.~FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle:~Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours);~modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m\^2 Fluorouracil bolus.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: FOLFIRINOX
Description: FOLFIRINOX is given over six 28-day cycles, starting at least 1 weeks after SBRT.~FOLFIRINOX consists of the following drugs given IV on days 1 and 15 of each cycle:~Oxaliplatin (85 mg/m\^2), Irinotecan (180 mg/m\^2), Leucovorin (400 mg/m\^2), Fluorouracil (400 mg/m\^2 bolus followed by 2,400 mg/m\^2 continuous infusion over 46-48 hours);~modified FOLFIRINOX consists of the same regimen described above but without the 400 mg/m\^2 Fluorouracil bolus.
Study: NCT04263545

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Group session with smoking cessation counsellor
Description: Group session with smoking cessation counsellor

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Standard Care
Description: standard care arm will receive very brief advice (VBA) and signposting to local organisations to support a quit.
Study: NCT04789798

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: TeleDiab (Telemedicine)
Description: TeleDiab program components consist of:~1. Electronic transmission of capillary blood glucose measurement results~2. Electronic transmission of blood pressure measurements~3. Synchronized video-conferencing, secure messaging~4. Access to clinical data from patient files when necessary~5. Reminding of routine follow-up tests and examinations~6. Providing web-based educational materials to patients.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Usual care
Description: Usual diabetes care, as provided by primary care providers
Study: NCT00515450

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: GB-0998 (Intravenous immunoglobulin)

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Plasmapheresis
Study: NCT00824369

Intervention type: DRUG
Group type: NO_INTERVENTION
Intervention: No drug will be administered
Description: No drug will be administered.
Study: NCT03163433

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Feedback in the consultation
Description: Patients will complete electronic Patient Reported Outcome Measures (PROM) before the consultation at the hospital. The results are fed back to physicians. In the consultation patients will systematically participate in a dialogue with their physician about issues that are most important for the patients.
Study: NCT03766711

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical Therapy
Description: Repetitive bimanual task training for upper limb motor function recovery.
Study: NCT04661527

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sarilumab
Description: Treatment with Sarilumab 200 mg IV x 2 doses 24 hours apart for first 5 patients. If no severe AE and no significant improvement within 48 hours, the dose will be increased for subsequent patients to 400 mg IV for the first dose and 200 mg or 400 mg IV for the second dose 24 hours later. Te second dose will be decided at the investigators discretion.
Study: NCT00410579

Intervention type: OTHER
Intervention: Telephone interview
Description: Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)
Study: NCT04010448

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: TV P2-VP8
Description: 90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Rotarix
Description: Rotarix® PO plus IM placebo administered on study days 1, 29 and 57
Study: NCT03750942

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Adhesix® monofilament polypropylene mesh (Bard Davol)
Description: The intervention group will receive preventive mesh placement and in the control group no mesh is placed, the stoma is closed according to standard practise.
Study: NCT01334320

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: elective neck dissection
Description: patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor
Study: NCT02156609

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Percutaneous ventricular support with the HeartMate PHP
Description: The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,
Study: NCT02430740

Intervention type: DRUG
Group type: OTHER
Intervention: recFSH

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: recFSH
Study: NCT00270803

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Tetra Hydro Cannabinol (THC)
Description: Oral THC 13mg and 17mg smoked in low nicotine cigarettes
Study: NCT03207568

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Thoracic Endovascular Aortic Repair (TEVAR)
Description: thoracic endovascular repair (TEVAR) with a thoracic stent-graft
Study: NCT02750800

Intervention type: BIOLOGICAL
Intervention: Adalimumab
Description: Pre-filled syringe or pen, administered by subcutaneous injection
Study: NCT04016025

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Adherence to topical standard therapy assessed
Description: Adherence defined as percentage of patients applying at least aimed daily dose

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Adherence to topical standard therapy assessed
Description: Adherence defined as percentage of patients applying at least aimed daily dose
Study: NCT02008084

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TRIA-662
Description: Following Baseline randomized to active TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then active TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: TRIA-662
Description: Following Baseline randomized to active TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then active TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Following Baseline randomized to placebo TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then placebo TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.

Intervention type: DRUG
Group type: SHAM_COMPARATOR
Intervention: Placebo
Description: Following Baseline randomized to placebo TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then placebo TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.
Study: NCT02881944

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Low FODMAP Diet
Description: Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: High FODMAP Diet
Description: Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
Study: NCT02621424

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: RTMS
Description: stimulation of the brain with magnetic pulses

Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: sham
Description: sham noise to block the sound of stimulation
Study: NCT00786942

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: high tibial osteotomy
Description: addition of bone graft to fill the osteotomy gap

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: higi tibial osteotomy
Description: the gap of the tibia is unfilled
Study: NCT00327665

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: 11-valent pneumococcal vaccine GSK513026
Description: Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Study: NCT02750800

Intervention type: BEHAVIORAL
Intervention: AbbVie Care 2.0
Description: Supportive services provided to participants included reminder calls, emails, text messages, nursing services, dietician, and psychological support. An adalimumab starter pack, injection guide, digital and print educational materials were also provided.
Study: NCT00142519

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Methadone
Description: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methadone and morphine
Description: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 1 mg and methadone 1 mg
Study: NCT00620321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: LY2181308 sodium
Description: 750 milligrams (mg) is administered as a 3-hour intravenous infusion on Days 1, 2, 3, 8, 15, 22 of Cycle 1 (28 days) and Days 1, 8, 15, 22 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: 1.5 grams per square meter (g/m²) will be administered as a 4-hour intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: idarubicin
Description: 12 milligrams per square meter (mg/m²) will be administered as a 30-minute intravenous infusion on Days 3, 4, 5 of Cycle 1 (28 days) and on Days 1, 2, 3 of Cycle 2 (28 days) until disease progression or unacceptable toxicity develops.
Study: NCT00606762

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Laparoscopic cholecystectomy
Description: Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure
Study: NCT00632463

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RI-001
Description: Dose 1

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: RI-001
Description: Dose 2

Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: RI-001
Description: Placebo
Study: NCT03010995

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Prazosin
Description: Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prazosin
Description: Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Prazosin
Description: Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes