louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04844788: A Consensus on Opioid Prescription for Oncologic Patients in Latin America - A DELPHI Study.
Official title: A Consensus on Opioid Prescription for Oncologic Patients in Latin America - A DELPHI Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Patients
Cancer-related Pain
Keywords: opioids
cancer-related pain
end-of-life
opioid abuse
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The experts assessed in this study will be the heads of anesthesia, pain management and palliative care of leading cancer hospitals of Latin America countries. For each Latin America country will be assessed 3 experts maximum.

Brief summary: As seen worldwide, cancer incidence is increasing in Latin America achieving an amount of 1.3 million new cases annually.1 In addition, it is expected that up to 70% of patients with cancer will experience pain2, one of the most distressing symptoms in patients with advanced cancer.

And despite of advances in cancer therapies, opioids remain the mainstay treatment of cancer-related moderate-to-severe and end-of-life pain.3 However, concerns regarding opioid prescriptions have emerged for reasons like the risk of misuse and the possibility of cancer progression.

In the last decades, an increase in consumption of opioids as well as in opioids-related deaths generating the so called 'opioid crisis'. This rise is mainly due to abuse / addiction of opioids. Consequently, oncologic patients are at risk for abuse, as well as for aberrant use, which can complicate the course of cancer treatment.4 5 Another feature of opioids use in cancer patients is that it may contribute to disease progression. Experimental studies suggest that opioids can may lead to immunosuppression and tumor progression or recurrence.6-8 On the other hand, retrospective analysis of clinical data shows conflicting results and trials are lacking.


Eligibility criteria: Inclusion Criteria:

* Head of anesthesia, Pain management and palliative care departments of cancer hospitals in Latin America.

Exclusion Criteria:

* Surveys not answered.

Primary outcomes:
measure: Survey answers
timeFrame: Up to 3 (three) months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Felipe Porto Rangel
state: SP
Study officials:
affiliation: MD Anderson
name: Felipe P Rangel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Juan P Cata, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06727188: Atypical Pneumonia
Official title: Clinico Laboratory Study of Unresolving Pneumonia in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Unresolving Pneumonia in Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children included in the definition of unresolving pneumonia

Brief summary: The goal of this observational study is to learn about causes of unresolved pneumonia in children who take appropriate antimicrobial therapy.

Detailed description: Recurrent pneumonia is defined as two episodes of pneumonia in 1 year or three episodes over any time frame. Non resolving pneumonias are characterized by the persistence of symptoms and roentgenographic abnormalities for more than 1 month. The key step in evaluating the patient referred for recurrent or persistent pneumonia is to review the clinical and radiographic features of the episodes to determine if there is adequate documentation to proceed with treatment. After deciding that a patient has had a persistent episode of pneumonia or the requisite number of recurrent episodes of pneumonia (accompanied by radiographic evidence of pulmonary infiltrates), it is essential to classify the episodes into those involving single or multiple lobes. On the basis of this classification.

Eligibility criteria: Inclusion Criteria:

* Patients with incomplete resolution by 4 weeks despite appropriate antimicrobial therapy.

  * From the age of one month to the age of 6 years old.

Exclusion Criteria:

* \*Age of the patient below one month and above 6 years old.

  * Patients with chronic lung diseases.
  * Patients with immunodeficiency.
  * Patient with aspiration pneumonia.

Primary outcomes:
measure: studying the prevalence of unresolving pneumonia and determining the underlying ateology .
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Pediatrics hospital AssiutUniversity
Study officials:
affiliation: AssiutUniversity
name: Maher Mokhtar Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: AssiutUniversity
name: Ahlam Badawi Ali, Doctor
role: STUDY_DIRECTOR
References:
citation: de Silva GD, Lamabadusuriya SP, Abeywickrema R. Unresolving pneumonia in a child? Look for an aspirated foreign body. Ceylon Med J. 1996 Dec;41(4):159. No abstract available.
Clinical trial NCT04878588: The Correlation Between the Barium Examination and High Resolution Impedance Manometry
Official title: The Correlation Between High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function After Patients Undergoing Esophagectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: the Correlation Between the Barium Examination and High Resolution Impedance Manometry
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving elective esophagectomy

Brief summary: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.

Detailed description: In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry (HRIM) could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.

In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.

For the patients and method decription, consecutive patients who will fulfill the criteria of elective esophagectomy patients aged \>= 20 will be enrolled. After got the inform consent, these patients receive the swallowing function by barium examination and HRIM.

Eligibility criteria: Inclusion Criteria:

* patients receiving elective esopagectomy

Exclusion Criteria:

* patients with major organ disease, such as heart, lung, or liver disease
* patients with coagulopathy

Primary outcomes:
measure: the contractility of the muscle at the upper gastrointestinal tract
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00127088: Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients
Official title: A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years and less than 70 years
* Histologically-proven Gleason 7 adenocarcinoma of the prostate
* pT2a or pT2b disease based on biopsies of the prostate
* More than 2/3 of positive biopsies or 15 ≤ serum PSA \<20
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* Contra-indication to general anesthesia or surgery
* Patients who do not fit inclusion criteria

Primary outcomes:
measure: Complete prostate specific antigen (PSA) response rate
Secondary outcomes:
measure: Toxicity
measure: Pathological response rate
measure: Progression free survival
measure: Overall survival
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02760888: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:
Official title: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Procedure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.

Detailed description: This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite \[ECDU\].

Patients fulfilling inclusion and exclusion criteria will be divided into three groups.

Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.

Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.

Group C (control group) Include 34 patients who will receive a placebo.

Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Eligibility criteria: Inclusion Criteria:

* BMI raging between (18.5 - 30 ).
* Scheduled for diagnostic hysteroscopy only.
* All of them should have given informed written consent.

Exclusion Criteria:

* Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection).
* Receiving any other form of analgesia.
* Patients with known cervical stenosis, polyps and ulcers.
* Previous cervical surgery.
* Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
* known sensitivity to non-steroidal anti-inflammatory and opioids drugs.
* Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.
* Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study

Primary outcomes:
measure: Pain during the procedure
timeFrame: intraoperative
measure: pain after the procedure
timeFrame: 15 minutes after completing the procedure
Secondary outcomes:
measure: Adverse effect and difficulties
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT00288288: Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures
Official title: Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2006-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Center

Brief summary: The primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads.

Detailed description: The purpose of this study is to: a) examine the usefulness of placing an epicardial LV lead at the time of open chest surgery in patients who are likely to benefit from a CRT system following their surgery; b) compare differences between patients who receive LV leads using the transvenous approach and those patients who receive LV leads using the epicardial approach; and c) assess the cost effectiveness of placing the LV lead via the transvenous versus the epicardial approaches.

Eligibility criteria: Inclusion Criteria:

1. Left ventricular ejection fraction \< or = 35%
2. QRS duration greater than or = to 120ms
3. NYHA Functional Class 3 or 4
4. Age \> or = to 18 years

Exclusion Criteria:

1. No previous pacemaker or ICD implant
2. No permanent atrial fibrillation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Loren Berenbom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00137488: Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)
Official title: Angiogenic Profile and Non-invasive Imaging May Predict Tumor Progression of High Risk Group Low Grade Glioma (LGG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Keywords: non-enhancing lesion
low grade glioma
high risk group selection
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred to Cross Cancer Institute between 2004 and 2005

Brief summary: The low grade glioma (LGG) is a type of brain tumor which is generally more common in younger age group patients. Most patients with LGG undergo surgery which is mostly incomplete due to concern about loss of function. This is an incurable disease. More than half of these patients progress to a higher grade with a worse outcome within five years of their diagnosis and only one-third survive for up to ten years. Post-operative radiation treatment improves local control without survival advantage. Efforts are being made without great success to select the patients with a higher risk of progression based on physical characteristics and histological features.

Tumor vascularity is thought to be the key element in tumor progression. Tremendous progress has been made in functional imaging by using magnetic resonance imaging (MRI) 3-Tesla (3T) and in biotechnology which can be used to investigate angiogenic gene profiles in order to identify gene signature for these tumors. In this study the investigators are proposing that patients of LGG with a higher risk of tumor progression may be selected by functional imaging and angiogenic profiles. These higher risk patients may be candidates for post-operative radiation in the future with a potential survival benefit.

Detailed description: Summary: Comprehensive analysis of the angiogenesis-related gene expression profiles and tumor perfusion of patients with LGG will provide a novel understanding of subgroup (low and high-risk) of LGG. Thus, this study will allow identifying clinically relevant factors predictive for tumor progression and to select patients in high-risk group for adjuvant radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Brain tumor with no contrast enhancement on conventional MRI and confirmed histological of LGG
* No adjustment treatment
* Consent to participate in study
* No contra-indication for dynamic contrast-enhanced (DCE)-MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Bassam Abdulkarim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864588: Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist
Official title: A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Satisfaction
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Sharpe-Strumia Research Foundation
First posted: 2019-03-06
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
* ASA I - III
* Spinal anesthesia
* All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
* Patients must be between 18 and 80 years of age.
* Active and valid email address for the participant.

Exclusion Criteria:

* Allergy to anesthetics or study analgesic medications.
* Contraindication to regional anesthesia
* Non-english speaking
* ASA IV or greater
* Renal insufficiency with Cr \> 2.0 or hepatic failure
* General or epidural anesthesia
* Sensory/motor disorder involving the operative limb
* Patients who consume preoperative opioids for pain control.
* Pregnant women
* Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
* Prisoners

Primary outcomes:
measure: Change in visual analog scale pain score
timeFrame: Up to 6 weeks post-surgery
Secondary outcomes:
measure: Change in range of motion
timeFrame: up to 6 weeks post-surgery
measure: Change in timed up and go
timeFrame: up to 6 weeks post-surgery
measure: Change in daily opioid consumption
timeFrame: up to 6 weeks post-surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00758485: Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)
Official title: A Randomized, Safety-assessor Blinded Trial Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in Adult Subjects Scheduled for Surgery Requiring Profound Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Neuromuscular Blockade
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 140
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: The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants.


Eligibility criteria: Inclusion Criteria:

* Male or female participants
* American Society of Anesthesiologists (ASA) class 1, 2 or 3
* Age \>=18 years
* Scheduled to undergo a surgery requiring profound NMB such as cardiovascular, gynaecologic, neurologic and thoracic surgical procedures under general anesthesia requiring neuromuscular relaxation with rocuronium for endotracheal intubation and if applicable maintenance of NMB in a position allowing neuromuscular monitoring
* Given written informed consent

Exclusion Criteria:

* Participants known or suspected to have neuromuscular disorders affecting NMB

Primary outcomes:
measure: Time From Start of Administration of Investigational Medicinal Product (IMP, Sugammadex or Placebo) to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
timeFrame: From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from ~2 minutes up to ~90 minutes)
Secondary outcomes:
measure: Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7
timeFrame: From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.7 (estimated from ~1 minute up to ~70 minutes)
measure: Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.8
timeFrame: From Start of IMP Administration to Recovery of the T4/T1 Ratio to 0.8 (estimated from ~2 minutes up to ~80 minutes)
Other outcomes:
Locations:
Study officials:
References:
citation: Rahe-Meyer N, Berger C, Wittmann M, Solomon C, Abels EA, Rietbergen H, Reuter DA. Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. Anaesthesist. 2015 Jul;64(7):506-12. doi: 10.1007/s00101-015-0048-0. Epub 2015 Jul 1.