louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01682707: Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
Official title: Randomized Clinical Trials to Compare the Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients Undergoing CABG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease Undergoing CABG
Keywords: intubation
coronary disease
hemodynamic response
anesthesia with tracheal intubation
assessment of hemodynamic response
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes.

In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.


Eligibility criteria: Inclusion Criteria:

* coronary disease ASA 2 e 3 using beta-blockers

Exclusion Criteria:

* emergency surgery arrythmia other antiarrythmic drugs

Primary outcomes:
measure: hemodynamic response
timeFrame: patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology / Ministry of Health
state: RJ
Study officials:
affiliation: Federal University of Juiz de Fora
name: Marcello F Salgado filho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.
citation: Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.
citation: Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.
Clinical trial NCT03245307: A Study To Test The Effect Of Apatinib On P450 Enzymes
Official title: A Single-center, Open-Label, Drug Interaction Study to Determine the Effects of Apatinib on the Metabolism of CYP3A4/5 and CYP2C9 Probe Drugs in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cytochrome P450 Interaction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2（VEGFR-2）, inhibits multiple cytochrome P450 (CYP450) enzymes in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib. The probes used included Nifedipine (CYP3A specific), warfarin (CYP2C9 specific).

Detailed description: This open-label study consists of a drug interaction phase that (part A) and a drug-continuation phase (part B). Patients will receive CYP450-probe drugs, and PK assessments will be performed before apatinib-administration and aſter once-daily administration of apatinib for 5 days (the predicted time point when steady-state plasma apatinib concentrations will have been achieved).

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumors.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal, lung, and liver function.
* A female subject must not be pregnant and will agree not to become pregnant during the trial

Exclusion Criteria:

* Primary carcinoma of liver
* Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days.
* Poorly controlled hypertension.
* A prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities, and corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 450 msec(male) or 470 msec(female).
* Arterial or venous thrombi (including cerebrovascular accident).
* Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents).
* Active brain metastases.
* A history of bleeding problems.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of warfarin or nifedipine
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Day 1 to 21 ( Phase A）
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Chinese Medical University First Hospital
state: Liaoning
Study officials:
References:
Clinical trial NCT05555407: Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
Official title: A Pilot Study to Assess the Feasibility of a Wireless Patch System (WPS) to Measure Gastrointestinal Motility and Gastric Emptying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Keywords: Scintigraphy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the utility of a new device - an external wireless patch system (WPS) - to measure gastric motility and to compare this external wearable device with the most commonly used test to measure stomach emptying, the nuclear medicine gastric emptying scan (also called gastric scintigraphy).


Eligibility criteria: Inclusion Criteria:

* Referred to the nuclear medicine department for a scintigraphic gastric emptying scan.

Exclusion Criteria:

* Have had prior gastric or esophageal surgery.
* Have had surgery to the GI tract within the last 60 days (e.g., appendectomy, cholecystectomy).
* Are on chronic opioids or other medications known to affect gastric emptying (e.g., GLP-1 agonists, high dose tricyclic agents).
* Have been recently hospitalized for complications of diabetes or have a HgbA1c \> 10.
* Have severe psychological distress preventing study participation.
* Unable to read or understand the consent form.

Primary outcomes:
measure: Subject willingness to wear a wireless patch system (WPS)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian Lacy, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570907: Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment for Bipolar I Disorder
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 25 mg Tablet under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to quetiapine or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
References:
Clinical trial NCT00225407: Processing and Effects of Cannabis
Official title: A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypotension
Tachycardia
Keywords: Cannabis
Tetrahydrocannabinol
Pharmacokinetics
Psychomotor tests
Event related potentials
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
First posted: 2005-09-23
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.

Detailed description: In Europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming "high" or "stoned"). The active compound in cannabis is THC (tetrahydrocannabinol). In recent years the strength of cannabis (marihuana) available on the market in the Netherland has increased (especially "netherweed"). The THC-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. Experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). However, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of THC. Information is lacking about the effects of cannabis at higher levels of exposure. Because of this, the Ministry of Health, Welfare, and Sports of the Netherlands ordered the investigators to perform a study to gain more insight in this issue.

Eligibility criteria: Inclusion Criteria:

* Cannabis users (2-9 joints per month)

Exclusion Criteria:

* Psychiatric illness
* Evidence of excessive alcohol abuse
* Use of other drugs

Primary outcomes:
measure: Serum concentration over time
measure: Physical parameters (heart rate, blood pressure)
measure: Psychomotor tests (such continuous attention)
measure: Event related potentials
Secondary outcomes:
measure: Self-reporting questionnaires
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: National Institute of Public Health and the Environment, the Netherlands
name: Tjeert T Mensinga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunault CC, Mensinga TT, Bocker KB, Schipper CM, Kruidenier M, Leenders ME, de Vries I, Meulenbelt J. Cognitive and psychomotor effects in males after smoking a combination of tobacco and cannabis containing up to 69 mg delta-9-tetrahydrocannabinol (THC). Psychopharmacology (Berl). 2009 May;204(1):85-94. doi: 10.1007/s00213-008-1440-0. Epub 2008 Dec 20.
Clinical trial NCT05898607: Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block
Official title: Continuous Ultrasound Guided Erector Spinae Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Patients Undergoing Thoractomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
Collaborators: name: Mohamed Emad Basune
name: Wesam Eldin Sultan
name: Rabab Mohammed Habeeb
First posted: 2023-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: in this study the investigators will investigate and compare the analgesic efficacy of two techniques (continuous TPVB and continuous ESPB) in relieving thoracotomy pain

Detailed description: General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98% and End tidal co2 Around 30-35 mmHg. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation after induction Group A: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous infusion U/S-Guided TPVB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative and Group B: Patients will receive Loading dose of 20 ml 0.25% bupivacaine then continuous U/S-Guided ESPB of 5 ml/h of 0.125% bupivacaine started through the catheter before the surgical procedure intraoperative.

Eligibility criteria: Inclusion Criteria:

- Eligible 40 patients will be older than 21 years old with American society of anesthesia physical status I\& II scheduled for elective thoracotomy

Exclusion Criteria:

* Patients who are:
* Uncooperative.
* Having allergy to any of the study drugs.
* Known abuse of alcohol or medication.
* Having Local infection at the site of injection or systemic infection.
* Pregnancy.
* With coagulation disorders or on anticoagulation therapy

Primary outcomes:
measure: Compare the VAS score postoperative of (U/S)-guided continuous (ESPB) to continuous (TPVB) following thoracotomy
timeFrame: 48 hours
Secondary outcomes:
measure: 1 st call analgesia
timeFrame: 1 hour
measure: Total rescue opioid dose used
timeFrame: 48 hour
measure: patient satisfaction at 24 hours
timeFrame: 24 hours
measure: occurrence of adverse events
timeFrame: 24hours
measure: hospital stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: Wesam Eldin Sultan, MD
role: STUDY_DIRECTOR
affiliation: Menoufia University
name: Mohamed Emad Basune
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014507: Protection of Ovarian Function in Female Patients With Hodgkin Lymphoma
Official title: Randomisierte Phase II Studie Zum Einsatz Von Goserelin Und Oralen Kontrazeptiva Zur Reduktion Ovarieller Toxizitäten während Zytostatischer Primärtherapie Bei Fertilen Patientinnen Mit Hodgkin Lymphom in Fortgeschrittenen Stadien
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkins Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to test the the protective capacity of Goserelin compared with oral contraceptive


Eligibility criteria: Inclusion Criteria:

* Advanced stage Hodgkins Lymphoma (histologically proven)
* Normal FSH-levels
* Written informed consent

Exclusion Criteria:

* Hodgkins Lymphoma as "composite lymphoma"
* Primary ovarial dysfunction
* Age \> 40

Primary outcomes:
measure: FSH level 6 month after end of treatment
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Behringer K, Wildt L, Mueller H, Mattle V, Ganitis P, van den Hoonaard B, Ott HW, Hofer S, Pluetschow A, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. No protection of the ovarian follicle pool with the use of GnRH-analogues or oral contraceptives in young women treated with escalated BEACOPP for advanced-stage Hodgkin lymphoma. Final results of a phase II trial from the German Hodgkin Study Group. Ann Oncol. 2010 Oct;21(10):2052-2060. doi: 10.1093/annonc/mdq066. Epub 2010 Mar 19.
Clinical trial NCT00296907: Psychological Interventions in Siblings of Children With Cancer
Official title: Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer
siblings
behavior
psychological adaptation
intervention
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.

Detailed description: Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.

Eligibility criteria: Inclusion Criteria:

brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level

Exclusion Criteria:

Primary outcomes:
measure: KIDSCREEN: health-related quality of life
timeFrame: baseline, 3 and 6 months post intervention
measure: UCLA Child PTSD Reaction Index
timeFrame: baseline, 3 and 6 months post intervention
measure: DIKJ (Depression-Inventory for Children and Adolescents)
timeFrame: baseline, 3 and 6 months post intervention
measure: Child Behavior Checklist
timeFrame: Baseline, 3 and 6 months post intervention
measure: Spence Children's Anxiety Scale
timeFrame: baseline, 3 and 6 months post intervention
Secondary outcomes:
measure: Posttraumatic Distress Scale
timeFrame: baseline, 3 and 6 months post intervention
measure: Symptom Checklist 27
timeFrame: baseline, 3 and 6 months post intervention
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich, Psychosomatic and Psychiatry
Study officials:
affiliation: University Children's Hospital Zurich, Psychosomatic and Psychiatry
name: Markus A Landolt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prchal A, Graf A, Bergstraesser E, Landolt MA. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial. Child Adolesc Psychiatry Ment Health. 2012 Jan 11;6(1):3. doi: 10.1186/1753-2000-6-3.
Clinical trial NCT02847507: Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb)
Official title: Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Hepatitis E
Keywords: HIV
Hepatitis E
Lead sponsor: Centre Hospitalier de la côte Basque
Sponsor class: OTHER
Collaborators: name: University Hospital, Toulouse
First posted: 2016-07-28
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seropositve for HIV and treated in the" Centre Hospitalier de la côte Basque" are considered for enrollment.

Patient must be \> 18 years, and followed or treated in the investigators institution

Brief summary: Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

Detailed description: Study of seroprevalence of hepatitis E among patient followed and treated in "centre Hospitalier de la Côte Basque" for HIV infections. Study of acquisition of hepatitis E , and determination of liver status using fibrotest in co-infected patients with hepatis C and / or B.

Eligibility criteria: Inclusion Criteria:

* HIV positive \> 18

Exclusion Criteria:

* patient refusal for participation

Primary outcomes:
measure: Prevalence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) for hepatitis E in blood sample of each patients. Positive sample for both IgM and IgG will be confirmed using polymerase chain reaction (PCR) techniques
timeFrame: 6 months time period
Secondary outcomes:
measure: fibrotest score
timeFrame: 6 months time period
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque
Study officials:
affiliation: centre hospitalier côte Basque
name: Marc-olivier Vareil, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784207: An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
Official title: An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Radiomics
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had HRCT and shown IPF/UIP in CT images, or patients who is suspected to have IPF based on MMD and proved by lung biopsy.

Brief summary: The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).


Eligibility criteria: Inclusion Criteria:

- the availability of non-contrast-enhanced HRCT

Exclusion Criteria:

* the use of contrast enhancement
* images containing metal or motion artifacts
* Images reconstructed with a slice thickness larger than 1.5 mm

Primary outcomes:
measure: The performance of Radiomics algorithm compared to the ground truth
timeFrame: May 2021
Secondary outcomes:
measure: Comparing the performance of the radiomics algorithm to that of physicians
timeFrame: June 2021
Other outcomes:
measure: Comparing the performance of radiomics algorithm to that of individual doctor
timeFrame: June 2021
measure: Comparing the reproducibility of diagnosis between the doctors
timeFrame: June 2021
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: