louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804609: Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery
Official title: A Study to Evaluate the Effects of Epidural Lidocaine Administration on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® (Morphine Sulfate Extended-release Injection) in Patients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Analgesia, Obstetric
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space.

Detailed description: To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space. Specifically, we are looking at pregnant women undergoing cesarean delivery who will be receiving these medications. A secondary objective is to evaluate how well DepoDur® works for pain control, as well as its safety, when it is given either alone or following a dose of epidural lidocaine.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)
timeFrame: a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05652309: Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?
Official title: Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obturator Nerve Block
Ultrasound Guided Nerve Block
Complications Neurological
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will undergo transurethral resection of the bladder

Brief summary: Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach


Eligibility criteria: Inclusion Criteria:

* age between 18-75
* ASA1, ASA2, ASA 3 physical status

Exclusion Criteria:

1. The patient's refusal
2. Active infection in the area to be blocked
3. Kidney failure
4. Liver failure
5. Heart failure
6. BMI less than 18 and a BMI greater than 40

Primary outcomes:
measure: pin prick test
timeFrame: postoperatively 2nd hour
measure: bromage score
timeFrame: postoperatively 2nd hour
measure: pin prick test
timeFrame: postoperatively 5th hour
measure: bromage score
timeFrame: postoperatively 5th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Serap Diker
state: Çankaya
Study officials:
References:
Clinical trial NCT00634309: Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)
Official title: Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Depressed Left Ventricular Systolic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Atacand
Candesartan
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-13
Enrollment: 597
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 or above
* Congestive Heart Failure with symptoms for more than 4 weeks before starting study
* Provision of informed consent

Exclusion Criteria:

* Current low blood pressure with symptoms
* Liver disease considered significant by the study doctor
* Pregnant or lactating females

Primary outcomes:
measure: Cardiovascular mortality or hospitalisation due to congestive heart failure
timeFrame: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
Secondary outcomes:
measure: Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI
timeFrame: 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months
Other outcomes:
Locations:
Study officials:
name: Prof. JJV McMurray
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund LH, Claggett B, Liu J, Lam CS, Jhund PS, Rosano GM, Swedberg K, Yusuf S, Granger CB, Pfeffer MA, McMurray JJV, Solomon SD. Heart failure with mid-range ejection fraction in CHARM: characteristics, outcomes and effect of candesartan across the entire ejection fraction spectrum. Eur J Heart Fail. 2018 Aug;20(8):1230-1239. doi: 10.1002/ejhf.1149. Epub 2018 Feb 12.
citation: Desai AS, Claggett B, Pfeffer MA, Bello N, Finn PV, Granger CB, McMurray JJ, Pocock S, Swedberg K, Yusuf S, Solomon SD. Influence of hospitalization for cardiovascular versus noncardiovascular reasons on subsequent mortality in patients with chronic heart failure across the spectrum of ejection fraction. Circ Heart Fail. 2014 Nov;7(6):895-902. doi: 10.1161/CIRCHEARTFAILURE.114.001567. Epub 2014 Oct 17.
citation: Preiss D, Zetterstrand S, McMurray JJ, Ostergren J, Michelson EL, Granger CB, Yusuf S, Swedberg K, Pfeffer MA, Gerstein HC, Sattar N; Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity Investigators. Predictors of development of diabetes in patients with chronic heart failure in the Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM) program. Diabetes Care. 2009 May;32(5):915-20. doi: 10.2337/dc08-1709. Epub 2009 Feb 5.
Clinical trial NCT01663909: Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion
Official title: The Efficacy of Guided Imagery on Pain, Anxiety, and Coping for Adolescents Post-spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Scoliosis
Keywords: Pain
Scoliosis
Rehabilitation
Cognitive-behavioral interventions
Adolescents
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2012-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. Several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. The investigators developed a DVD on guided imagery, customized for teenagers, to help them cope better with their pain. The investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Aged between 11 and 20 years old
* Have undergone a posterior/anterior arthrodesis surgery for idiopathic scoliosis
* Able to write and understand French
* Requires a computer or DVD player at home.

Exclusion Criteria:

* Diagnosed with a moderate cognitive deficit or severe mental retardation

Primary outcomes:
measure: Level of pain intensity
timeFrame: Level of pain intensity at two weeks after the surgery
Secondary outcomes:
measure: Level of anxiety
timeFrame: Level of anxiety from 24-hrs before the surgery, to two weeks and to one month after the surgery
measure: Level of coping
timeFrame: Level of coping from Baseline (pre-operative), to two weeks and to one month after the surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Ste-Justine Hospital
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Sylvie Le May, RN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01082809: Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma
Official title: Phase II Study of Sunitinib as Second-line Treatment in Advanced Biliary Tract Carcinoma: Multicenter, Multinational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Biliary Tract Adenocarcinoma
Keywords: advanced biliary tract carcinoma
Sunitinib
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sunitinib as second-line treatment in advanced biliary tract carcinoma

Detailed description: Phase II study of sunitinib as second-line treatment in advanced biliary tract carcinoma: multicenter, multinational study

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18
2. histologically or cytologically confirmed adenocarcinoma of biliary tract
3. unresectable or metastatic
4. ECOG performance status of 0\~2
5. measurable or evaluable lesion per RECIST criteria
6. adequate marrow, hepatic, renal and cardiac functions
7. One prior treatment of cytotoxic chemotherapy (including adjuvant treatment within 12 months)
8. provision of a signed written informed consent

Exclusion Criteria:

1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. active CNS metastases not controllable with radiotherapy or corticosteroids
4. known history of hypersensitivity to study drugs

Primary outcomes:
measure: Time to progression
timeFrame: 12months
Secondary outcomes:
measure: Safety profile
timeFrame: 12 months
measure: Response rate
timeFrame: 12 months
measure: Duration of response
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Correlative analyses: EGFR mutational analysis, EGFR immunohistochemical staining, RAS mutational analysis, KIT, PDGFRA, PDGFRB, Beta-Catenin (CTNNB1) mutations
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Ho yeong Lim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi JH, Thongprasert S, Lee J, Doval DC, Park SH, Park JO, Park YS, Kang WK, Lim HY. A phase II study of sunitinib as a second-line treatment in advanced biliary tract carcinoma: a multicentre, multinational study. Eur J Cancer. 2012 Jan;48(2):196-201. doi: 10.1016/j.ejca.2011.11.017. Epub 2011 Dec 14.
Clinical trial NCT03715309: R2 in the Treatment of Follicular Lymphoma
Official title: R2 in the Treatment of Follicular Lymphoma Grade 1-3A
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 115
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lenalidomide Based Immunotherapy in the Treatment of FL

Detailed description: Lenalidomide Based Immunotherapy efficacy related molecular biomarker in follicular lymphoma

Eligibility criteria: Inclusion Criteria:

Patients diagnose as de novo or relapse refractory FL grade 1-3A .

No history of stem cell transplantation.

Written informed consent.

Exclusion Criteria:

Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.

Clinically significant active infection.

Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.

Patients who are pregnant or breast-feeding.

HIV infection.

Primary outcomes:
measure: CR
timeFrame: 12 weeks
Secondary outcomes:
measure: PFS
timeFrame: 1 year
measure: OS
timeFrame: 1 year
measure: ORR
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06129409: Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease
Official title: A Randomized, Double -Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: NodThera Limited
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug vs Placebo
Primary purpose: TREATMENT

Brief summary: This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease.

Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment.

For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.

Detailed description: The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or older.
2. Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
3. Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease:

   * History of controlled hypertension
   * History of hypercholesterolemia
   * History of high-density lipoprotein levels
   * Controlled Type 1 or Type 2 Diabetes mellitus

Exclusion Criteria:

1. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
2. History of acute coronary syndrome (ACS)
3. Stable angina.
4. Diagnosis of congestive heart failure
5. Evidence of past or current infection with Hepatitis B or Hepatitis C

Primary outcomes:
measure: Change in hsCRP levels
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change in Body weight (kg)
timeFrame: Change from baseline to Day 28
measure: Body composition
timeFrame: Change from baseline to Day 28
Other outcomes:
measure: Clinical laboratory values
timeFrame: Change from baseline to Day 28
measure: Vital signs
timeFrame: Change from baseline to Day 28
Locations:
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Austin
country: United States
facility: Investigative Site
state: Texas
Study officials:
References:
Clinical trial NCT02180009: Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis
Official title: Dynamic Changes of Tim-3 on Monocytes and Soluble Tim-3 in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Severe Sepsis
Septic Shock
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Institute of Basic Medical Science
First posted: 2014-07-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with sepsis

Brief summary: In this study, the investigators will dynamically detect the expression of an immune regulator- T cell Ig and mucin domain protein 3 (Tim-3) in patient with sepsis.

Detailed description: In this study, we will collect the peripheral blood of 1,3,5,7,10,14 day after diagnose of sepsis.All the patients rolled in this study will be divided into three groups which is sepsis, severe sepsis and septic shock group according their severity. Then,the flow cytometry will be used to detect the express of Tim-3 on monocyte and ELISA will be used to exam the plasm soluble Tim-3.IL-6,IL-10,IL-12 and TNF-αin the peripheral blood will also be detected. We would like to find a new marker to predict the severity and prognosis of sepsis patients.

Eligibility criteria: Inclusion Criteria:

* More than one of the following:

clinical manifestations: (1) a body temperature greater than 38℃ or less than 36℃; (2) a heart rate greater than 90 beats/minute; (3)tachypnea, manifested by a respiratory rate greater than 20 breaths per minute, or hyperventilation, as indicated by a PaCO2 of less than 32 mmHg; and (4)an alteration in the white blood cell count, such as a count greater than 12×10\^9/L, a count less than 4×10\^9/L, or the presence of more than 10 percent immature neutrophils

Exclusion Criteria:

* (1)patients younger than 18 years of age; (2)agranulocytosis (granulocyte counts,0.5×10\^9/L); (3) those discharged within 24 h; (4) those diagnosed with HIV infection or cancer; and (5) patients who refused to participate.

Primary outcomes:
measure: all cause mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Head of Department of Respiratory Medicine,Chinese PLA Gerneral Hospital
name: Lixin Xie, PhD & MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; International Sepsis Definitions Conference. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med. 2003 Apr;29(4):530-8. doi: 10.1007/s00134-003-1662-x. Epub 2003 Mar 28.
Clinical trial NCT01548209: Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery
Official title: Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 97
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine was reported to a reduced PONV due to opioid-sparing effect. It is not clear if dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study: intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than placebo for reducing of PONV and improve postoperative quality of recovery score within 48 postoperative hours.

Detailed description: This study was approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System. After written informed consent was obtained from all patients, aged 20-75 years with ASA physical status class I-II who were scheduled breast cancer surgery under general anaesthesia were enrolled in this study All the patients were randomly assigned to receive dexmedetomidine or placebo during surgery. The primary outcome was quality of recovery determined by QOR-40 in the first 24h after surgery.The secondary outcome measure was PONV assessed by visual analogue scale every 6 hours within 48 postoperative hours.

Eligibility criteria: Inclusion Criteria:

* ASA I, II
* aged 20-70 years
* Undergoing breast cancer surgery

Exclusion Criteria:

* CAOD
* Bradycardia
* QT prolongation

Primary outcomes:
measure: Quality of Recovery 40 (QoR-40)
timeFrame: 24 postoperative hours
Secondary outcomes:
measure: Change from preoperative baseline in PONV within 48 postoperative hours
timeFrame: every 6 hours within 48 postoperative hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu
Study officials:
References: