louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01085929: Incision and Drainage Versus Needle Aspiration in Soft Tissue Abscesses
Official title: Ultrasound Guided Needle Drainage Versus Formal Incision and Drainage of Superficial Soft Tissue Abscesses in the Emergency Department Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abscess
Cellulitis
Keywords: abscess
infection
ultrasound guidance
incision and drainage
needle aspiration
skin
ultrasound
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2010-03-12
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The incidence of skin and soft tissue infections has increased dramatically over the last decade, in part due to increased prevalence of community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA). Incision and drainage (I\&D) is considered the primary intervention, however some clinicians prefer ultrasound guided needle aspiration (US Asp). The investigators performed a randomized trial comparing US Asp to I\&D for uncomplicated skin and soft tissue abscesses, with a subgroup analysis of patients with CA-MRSA.


Eligibility criteria: Inclusion Criteria:

* presenting to emergency department with skin abscess
* abscess required surgical drainage
* healthy appearing

Exclusion Criteria:

* pregnant
* unable to give consent
* abscess located in oral cavity
* abscess located on genitalia
* abscess located intra-gluteal at coccyx

Primary outcomes:
measure: Successful drainage of abscess
timeFrame: 7 days
Secondary outcomes:
measure: Successful drainage of abscess
timeFrame: 2 days
measure: Ability to evacuate purulence from abscess
timeFrame: Day 1
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Romolo Gaspari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376229: Proton Radiation Therapy Registry
Official title: Proton Radiation Therapy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer, Therapy-Related
Keywords: proton therapy
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients with proton therapy

Brief summary: The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.

Detailed description: Proton based radiation therapy has considerable dosimetric advantages over the standard photon based radiation therapy, with a significantly higher cost. The clinical advantages, however, may not be realized for all patient populations, even with the improved dose distributions. Establishing the clinical efficacy of proton therapy requires years of experience treating patients. The goal is to accelerate the knowledge gain through the use of the registry that allows for detailed information to be captured and is inclusive of every patient treated.

Eligibility criteria: Inclusion Criteria:

* All patients treated at the proton center.

Exclusion Criteria:

* Any other than what is supplied in the inclusion criteria

Primary outcomes:
measure: Research registry of cancer patients receiving proton radiation therapy
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Washington
country: United States
facility: Suburban Hospital
state: District of Columbia
city: Baltimore
country: United States
facility: Bayview Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Curtiland Deville, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05495529: Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors
Official title: Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiology, Interventional
Liver Neoplasm
Carcinoma, Hepatocellular (RENI)
Neoplasm Metastasis
Ablation Techniques
Radiofrequency Ablation
Microwaves
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with single malignant liver tumor with high iatrogenic risk treated by thermal ablation with biliary or digestive protection by room air interposition, in Nice CHU, between January 2013 and December 2021.

Brief summary: This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.

Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.

The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.

Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.


Eligibility criteria: Inclusion Criteria :

* Patients with single malignant primary or secondary liver tumor
* Thermal ablation area located within 1 centimeter from central biliary tree or gut
* Thermal insulation using room air interposition
* Follow-up of at least 2 months

Primary outcomes:
measure: Feasability
timeFrame: 1 day
measure: Security
timeFrame: 2 months
measure: Efficacity
timeFrame: 2 months
measure: Clinical success
timeFrame: 2 months
Secondary outcomes:
measure: Local and distant recurrence
timeFrame: 2 months
measure: Local tumorous recurrence free survival
timeFrame: 2 months
measure: Progression free survival
timeFrame: 2 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: GARGIULO Manuel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06406829: Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
Official title: Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Analgesia
Supratentorial Brain Tumor
Keywords: multimodal analgesia
Postoperative acute pain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

Detailed description: The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 65 years
* American Society of Anesthesiologists physical status I to III
* Scheduled to undergo elective supratentorial tumor resection

Exclusion Criteria:

* Incision-area skin infection
* A history of previous craniotomy
* Allergy to study medications
* A history of preoperative change in consciousness or cognitive function
* Severe hepatic or renal dysfunction
* Severe bradycardia (heart rate\<40 beats/min)
* Sick sinus syndrome or second- to-third degree atrioventricular block

Primary outcomes:
measure: Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.
timeFrame: 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yuming Peng, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02092129: Pituitary Histopathology and Hyperprolactinaemia and Risk of Glucose Metabolic Disturbances in Acromegaly.
Official title: Prognostic Value of Pituitary Histopathology and Plasma Hyperprolactinaemia in Predicting the Risk of Glucose Metabolic Disturbances in Patients With Acromegaly.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Surgery
Keywords: Acromegaly, surgery, histopathology, hyperprolactinaemia,
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acromegaly treated with surgery

Brief summary: Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. The study population include 79 patients who have all undergone surgical treatment for acromegaly.

Detailed description: Acromegaly is frequently associated with impaired glucose tolerance and diabetes. We hypothesise that pituitary histopathology and plasma hyperprolactinaemia could have prognostic value in predicting the risk of glucose metabolic disturbances in acromegalic patients. The aim of this study is to examine glucose metabolic outcome in acromegalic patients with and without histologically verified prolactin and growth hormone (GH) co-secreting adenomas. 79 patients who have all undergone surgical treatment for acromegaly are included. Clinical and biochemical baseline data are collected from medical records. Patients are divided into two groups based on histopathological evaluation of pituitary adenomas;

1. pure GH secreting adenomas or
2. GH and prolactin co-secreting adenomas.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acromegaly, and treated at the department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Denmark (tertiary referral hospital), surgical treatment of acromegaly

Exclusion Criteria:

* no surgical treatment performed

Primary outcomes:
measure: Evaluate glucose metabolic outcome related to pituitary histopathology and plasma hyperprolactinaemia in patients with acromegaly
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National University Hospital, Department of Medical Endocrinology
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulla Feldt-Rasmussen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04195529: Genetic Polymorphisms Associated With Vertebral Osteochondrosis
Official title: Evaluation of Polymorphisms in the Vitamin D Receptor and Involved in Inflammation Associated With Vertebral Osteochondrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Osteochondrosis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70-100 adult male and female patients suffering from osteochondrosis and disc degeneration evidenced by MRI will be enrolled, after signing the informed consent, at the Galeazzi Orthopedic Institute.

Brief summary: The present study is proposed for the identification of phenotype, biochemical and genetic markers in adult symptomatic spinal osteochondrosis to promote the early diagnosis of this pathological condition and to establish possible therapeutic targets that favor a conservative approach aimed at treating patients.

Detailed description: The primary outcome is to determine the association between specific phenotypic characteristics of osteochondrosis, in particular linked to osteo-cartilaginous degeneration, with the identified vitamin D receptor genotypes.

The secondary outcomes are to evaluate the circulating levels of the osteo-cartilage degradation markers, of the vitamin D and to evaluate the association of the osteochondrosis phenotype with variants in genes involved in inflammatory processes.

Eligibility criteria: Inclusion criteria

* males and females
* 18≤age ≤ 65 years old
* patients with adult spinal osteochondrosis Exclusion criteria
* age \< 18 or \> 65 years old
* chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies

Primary outcomes:
measure: association of spinal osteochondrosis with specific VDR genotypes
timeFrame: 1st year
Secondary outcomes:
measure: association of spinal osteochondrosis with specific biochemical markers
timeFrame: 2nd year
Other outcomes:
measure: association of spinal osteochondrosis with specific inflammatory genotypes
timeFrame: 1st year
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto ortopedico Galeazzi
state: Milan
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Alessandra Colombini
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03138629: Expanded Access to VAL-083
Official title: Expanded Access to VAL-083
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Lead sponsor: Kintara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Patient has relapsed/refractory disease and exhausted all standard treatments.

Exclusion Criteria:

* Patient is eligible for a VAL-083 clinical trial.
* Patient has previously received VAL-083 for the same disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03572829: Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC
Official title: A Prospective, Open-label, Single-arm Study for Efficacy and Safety of Three-drug Antiemetic Regimen to Prevent the Emesis During Radiotherapy With Concurrent Chemoradiotherapy in Locally Advanced HNSCC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vomiting
Nausea Post Chemotherapy
Head Neck Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-06-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of aprepitant combined with ondansetron and dexamethasone to prevent nausea and vomiting induced by Intensity-modulated Radiotherapy (IMRT) cisplatin-chemotherapy regimen in locally advanced squamous cell carcinoma of head and neck

Detailed description: To evaluate the complete response rate, nause-free rate, vomiting-free rate, and the quality of life of aprepitant combined with ondansetron and dexamethasone for the nausea and vomiting induced by chemoradiotherapy in HNSCC.

Eligibility criteria: Inclusion Criteria:

Pathology confirmed squamous cell carcinoma. The primary sites included nasopharynx, mouth, oropharynx, hypopharynx, larynx, nasal cavity and paranasal sinuses; Aged 18 to 70 years old; Stage III-IVB diseases; Eastern Cooperative Oncology Group Performance Status 0-1; Normally functioning of liver, kidney, bone marrow; Concurrent chemoradiotherapy is recommended after multi-disciplinary team discussion; Must be able to swallow tablets; At least 12 weeks lifetime was expected; Fertile male or female patients volunteered to use effective contraception within 90 days of the study period and at the end of study.

Exclusion Criteria:

Nausea and vomiting occurred 24 hours before the start of the chemotherapy; Corticosteroid or benzodiazepines used; Combination Medicine which metabolism through drug-metabolizing enzyme CPY3A4 and CYP2D6; Serious cardiovascular, pulmonary, diabetes, mental and other diseases; Perinatal women or refused to take contraception during treatment; Other induced vomiting factors. (The transfer of the central nervous system, intestinal obstruction or hypocalcemia, and so on)

Primary outcomes:
measure: Complete response rate
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Complete response rate
timeFrame: up to 3 weeks
measure: Complete response rate
timeFrame: up to 6 weeks
measure: European Organization for Research on Treatment of Cancer Quality of life questionnaire
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
Study officials:
affiliation: National Cancer Center/ Cancer Hospital, Chinese Academy of Medcal science and Peking Union Medical College
name: Junlin Yi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302129: Ultrasound Guided Erector Spinae Plane Block Combined With General Anaesthesia Versus Conventional General Anaesthesia in Lumbar Spine Surgery
Official title: ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANAESTHESIA VERSUS CONVENTIONAL GENERAL ANAESTHESIA IN LUMBAR SPINE SURGERY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anaesthetic Drugs, Hypotensive Drugs, Perioperative Analgesia
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: University of Alexandria
First posted: 2020-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.

Detailed description: Primary outcomes:

• Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.

Secondary outcomes:

* Stress response measurement based on serum cortisol and blood glucose levels
* Controlled hypotensive anaesthesia: various drugs required and doses given
* Intraoperative and postoperative analgesia.
* Postanaesthesia care unit data concerning recovery.

Eligibility criteria: Inclusion Criteria:

patients undergoing lumbar spine surgery

Exclusion Criteria:

* Coagulation disorders.
* BMI \> 30 or \< 18.5.
* Patients with surgical site infection.
* Patients with unstable spine integrity like fractures or scoliosis.
* Hypertensive ,cardiac and diabetic patients.

Primary outcomes:
measure: Anaesthetic requirements:
timeFrame: the surgery period
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria faculty of medicine
Study officials:
References:
Clinical trial NCT01969929: Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Official title: Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Hole
Macular Pucker
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.


Eligibility criteria: Inclusion Criteria:

age \> 18 years macular hole macular pucker willing to perform follow up written signed consent

Exclusion Criteria:

other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery

Primary outcomes:
measure: Alteration of aqueous flare between preoperative and 3-week-postoperative time point
timeFrame: 3 weeks
Secondary outcomes:
measure: Visual acuity change
timeFrame: 3 weeks
measure: Closure of Macular hole
timeFrame: 3 weeks
Other outcomes:
measure: Patient satisfaction
timeFrame: 3 weeks
Locations:
city: Cologne
country: Germany
facility: Center of Ophthalmology, University of Cologne
state: NRW
Study officials:
References:
citation: Scholz P, Muther PS, Schiller P, Felsch M, Fauser S. A Randomized Controlled Clinical Trial Comparing 20 Gauge and 23 Gauge Vitrectomy for Patients with Macular Hole or Macular Pucker. Adv Ther. 2018 Dec;35(12):2152-2166. doi: 10.1007/s12325-018-0826-6. Epub 2018 Nov 17.