louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05936268: Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare
Official title: A Randomized, Open Lable, Multi-center, Active Competitor Phase 2 Study for Evaluating Efficacy and Safety of Genakumab for Injection as First Line Therapy in Patients With Gout Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Gout
Gout Flare
Keywords: Acute gout
Gout flare
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Huashan Hospital
First posted: 2023-07-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Acute gout patients with gout flare Group A: Genakumab 200mg single injection;Group B: Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days)
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Detailed description: Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.

Eligibility criteria: 1. Male or female, 18 years ≤ age ≤ 75 years;
2. BMI ≤ 40kg/m2
3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
4. Start of acute gout flare within 3 days prior to enrolled;
5. History of ≥2 gout flare within 12 months prior to study start;
6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)

Primary outcomes:
measure: 72hours target joint VAS change from baseline
timeFrame: 72h±2h
Secondary outcomes:
measure: Pain intensity
timeFrame: 6hours, 24hours, 48hours, 72hours, Day 8,
measure: Recurrence of flare
timeFrame: 12 weeks after the last dose
measure: Safety outcome
timeFrame: 12weeks
measure: immunogenic outcome
timeFrame: 12 weeks after the last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Affiliated Huashan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University Affiliated Huashan Hospital
name: Hejian Zou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02344368: The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants
Official title: The Effect of Sucrose on Pain Relief During Venous Blood Sampling in Preterm Infants: a Comparison of Two Different Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Sucrose
Anesthesia
Blood specimen collection
Injections, Intravenous
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Lower Umfolozi Regional War Memorial Hospital
First posted: 2015-01-26
Enrollment: 50
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Despite the fact that oral sucrose is the most frequently studied non-pharmacological intervention for procedural pain relief in infants, there is a paucity of data on the minimal effective dose. The aim of this study is to find the minimal effective dose of sucrose to reduce pain during a single venous blood sampling procedure.


Eligibility criteria: Inclusion Criteria:

* born preterm
* more than 1000 gram

Exclusion Criteria:

* severe intraventricular hemorrhage
* cerebral malformations
* other malformations requiring surgery
* medication that may impair pain expression (opioids, paracetamol, sedatives)

Primary outcomes:
measure: pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Empangeni
country: South Africa
facility: Lower Umfolozi Rigional War Memorial Hospital, NICU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Håkon Bergseng, MD PhD
role: STUDY_DIRECTOR
References:
citation: Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.
Clinical trial NCT03467568: Does Salt Intake Improve Mood
Official title: Do Humans Over-consume Salt to Improve Mood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mood
Salt Intake
Keywords: Mood Salt
Lead sponsor: Swansea University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has four arms. Salt alone; salt plus water; placebo alone, placebo plus water
Primary purpose: BASIC_SCIENCE

Brief summary: Humans display a preference for salt although the reasons remain unclear. The aim was to examine the hypothesis that salt may enhance mood. The study compares the drinking of water with and without electrolytes (either dissolved in water or by capsule). Mood was rated over a period of 155 minutes

Detailed description: Study 1. 120 young adults will be were recruited. They will arrive in the laboratory at 0900 having consumed their normal breakfast. Over the morning they will reported their mood by responding to one hundred millimetre visual analogue scales anchored with the words: Composed/Anxious; Hostile/Agreeable; Elated/Depressed; Unsure/Confident; Energetic/Tired; Confused/Clearheaded. These dimensions of mood came from the factor analysis that formed the basis of the Profile of Mood State questionnaire. An overall measure of mood will be calculated. .

Randomly they will receive either a 150ml glass of water, or an equivalent volume of water containing electrolytes (in total 150mg sodium chloride and 45mg potassium chloride (Gatorade G2 Low calorie (34 kcal) Thirst Quencher, Pepsico). This drink will be consumed for a first time after 50 minutes, and a second time after 140 minutes. A estimate of habitual salt preference will be gained by responding to questions concerning the adding of salt to meals and a preference for salty foods.

Study 2: One hundred and twenty young adults will be recruited. A second study attempts to replicate the first in a double-blind trial where the taste of salt was hidden by using a capsule. . Participants will be assigned to one of four experimental conditions; 1) swallowed placebo capsules; 2) swallowed capsules containing electrolyte (300mg sodium chloride); 3) received placebo capsules and plain water; 4) received capsules containing electrolyte and plain water. Each drink will be 150ml of water. The allocation of the type of capsule will be carried out double-blind, determined by computer generated random numbers.

Otherwise the procedure will be identical to study one.

Eligibility criteria: Inclusion Criteria: Self declared in good health -

Exclusion Criteria:

-

Primary outcomes:
measure: Mood ratings using visual analogue scales
timeFrame: Up to three hours
Secondary outcomes:
measure: Ratings of thirst
timeFrame: Up to three hours
measure: Body weight
timeFrame: Up to three hours
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Psychology, Swansea University
state: Wales
Study officials:
References:
Clinical trial NCT01219868: Physician-nurse Team to Reduce Emergency Department (ED) Overcrowding
Official title: Impact of Physician-nurse Team on ED Length of Stay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triage
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 8000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to explore the impact of a physician-nurse team supervising patient's flow on ED length of stay

Detailed description: A physician-nurse team will be in charge of patients flow in the ED during intervention periods. During control periods, no team will be present. The impact of this team on Ed length of stay will be assessed.

Eligibility criteria: Inclusion Criteria:

* all adult patients \> 16 years presenting to the ED

Exclusion Criteria:

* no

Primary outcomes:
measure: ED length of stay
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: ED of Geneva University Hospitals
Study officials:
affiliation: HUG
name: Olivier T Rutschmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084368: Application of Combined Lumbar Plexus and Sciatic Nerve Block
Official title: Application of Combined Lumbar Plexus and Sciatic Nerve Block in Unilateral Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: combined lumbar plexus and sciatic nerve block，
combined spinal and epidural anesthesia
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.


Eligibility criteria: Inclusion Criteria:

1. Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
2. Aged between 18 and 85 years
3. Undergoing elective total knee replacement.

Exclusion Criteria:

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired

Primary outcomes:
measure: Maintenance time of sensory and motor nerve block
timeFrame: up to 24h after operation
Secondary outcomes:
measure: The change of hemodynamics
timeFrame: 0, 5, 10, 20, 30, 60 min after injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
citation: Farny J, Girard M, Drolet P. Posterior approach to the lumbar plexus combined with a sciatic nerve block using lidocaine. Can J Anaesth. 1994 Jun;41(6):486-91. doi: 10.1007/BF03011542.
citation: de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14.
Clinical trial NCT04274868: Pediatric Hepatic Tumors
Official title: Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Tumor
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 600
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated after 01/01/1990 for a primary liver tumor before the age of 18.

Brief summary: Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.


Eligibility criteria: Inclusion Criteria:

1. - For inclusion in the clinical database:

   * Children and adolescents (≤18 years at diagnosis) suffering from a primary liver tumor diagnosed after 01/01/1990 and treated in France
   * Informed consent to the computerization of data signed by the patient or by parents or legal representatives if he is a minor.
2. - For inclusion in the biological collection (CRB Paris Sud):

   * Additional criteria:
   * Availability of biological samples (tumor tissue, healthy tissue, plasma and / or serum).
   * Informed consent to the use of biological remains signed by the patient or by parents or legal representatives if he is a minor.
3. - For the inclusion of deceased patients:

   * Obtaining consent or failing this, seeking non-opposition to the computerization of data (for inclusion in the database) and the use of biological remains (for inclusion in the biological collection) of the patient or both parents or the legal guardian if he is a minor.

Exclusion Criteria:

* None

Primary outcomes:
measure: Establish a national bank of rare biological material
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT02522468: A Trial of RSL Versus WL for Malignant Breast Disease
Official title: A Randomized Single-Center Superiority Trial of Radioactive Seed Localization Versus Needle Localization for Malignant Breast Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast- Female
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized trial is to determine the superiority of utilizing radioactive seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable malignant lesions in patients undergoing breast conservation surgery (BCS).

Detailed description: Consented and eligible subjects will be randomized to either radioactive seed localization or wire localization and stratified by surgeon and invasive versus DCIS prior to localization. Subjects on both arms will undergo breast conservation surgery including surgical specimen removal. Specimens will be grossed according to standard of care procedures. Localization, breast conservation surgery, and post-operative appointments will follow standard of care guidelines. Surveys will be administered according to the study calendar to the radiologist, surgeon, pathologist, and subject for data collection.

Eligibility criteria: Inclusion Criteria:

* Female
* 20 to 99 years of age
* Breast lesion necessitating image-guided excision
* Unifocal disease
* Breast-conservation candidate
* Biopsy-proven malignant breast lesion including by not limited to invasive ductal carcinoma, invasive lobular carcinoma, and ductal carcinoma in situ
* Signed written informed consent document by the subject and/or a LAR

Exclusion Criteria:

* Male
* Multifocal or multicentric disease
* Receiving neoadjuvant chemotherapy
* Pregnant or breastfeeding
* Locally advanced disease
* Breast conservation contraindication such as inability to receive whole breast radiation therapy, inability to tolerate localization procedure, inability to lay flat or prone for radiation, and undesirable tumor to breast ratio
* Prior breast cancer on ipsilateral side
* Unable or unwilling to adhere to post-localization instructions (e.g. timely seed removal)

Primary outcomes:
measure: Surgical Resection Margins
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lejla Hadzikadic-Gusic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03841968: Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization
Official title: Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgical Procedures
Central Venous Catheterization
Ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2019-02-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization.

SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel.

The aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.


Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery where central venous catheterization is required.

Exclusion Criteria:

* skin infection or trauma
* Shock
* Patients on ECMO or IABP support
* Morbid obesity
* Profound coagulopathy

Primary outcomes:
measure: First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
timeFrame: Intraoperative
Secondary outcomes:
measure: Total procedure time
timeFrame: Intraoperative
measure: Rate of posterior wall puncture_assessed by ultrasound
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01799668: Therapists' Preferences for Client Characteristics and Their Influence on the Therapeutic Alliance
Official title: Therapists' Preferences for Client Characteristics and Their Influence on the Therapeutic Alliance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diagnosis, Psychiatric
Outpatient Followup of Psychiatric Problem
Keywords: Psychotherapy
Preferences
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-02-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in the psychiatric department

Brief summary: The research will examine psychotherapists' preferences for theoretical client characteristics, such as age, gender, personality characteristics and symptoms. The research will also examine the preferences' influence on the therapeutic alliance, from the therapist's and the client's point of view.


Eligibility criteria: Inclusion Criteria:

* Outpatients over the age of 18,
* Hebrew speakers,
* Not in a psychotic state.

Exclusion Criteria:

* Psychotic state,
* Under the age of 18,
* Not qualified to answer the questions,
* Don't speak any Hebrew at all.

Primary outcomes:
measure: Positive correlation between preferences- characteristics match and therapeutic alliance.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ella Landa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689468: Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media
Official title: Echinacea Purpurea and Cranial Osteopathic Manipulative Treatment in Children With Recurrent Otitis Media: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Keywords: Otitis media
Echinacea
Osteopathic Medicine
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2008-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.

Detailed description: The use of complementary and alternative therapies by parents of young children remains common despite the lack of clinical trials demonstrating either the efficacy or safety of these treatments. Two of the more common complementary therapies used in young children with a history of recurrent otitis media are preparations of the herb Echinacea purpurea and cranial osteopathic manipulative treatment. This study represents one of the first double-blinded, placebo controlled trials of each approach in a population of young children who presented with three or more recent episodes of acute otitis media.

Eligibility criteria: Inclusion Criteria:

* 3 or more separate episodes of acute otitis media within a 6 month period, or
* 4 episodes of acute otitis media in one year,

Exclusion Criteria:

* Congenital malformations of the ears, nose, or throat
* Known or suspected allergy to echinacea
* Immune deficiency including HIV infection
* Tuberculosis
* Current use of prophylactic antibiotics
* Tympanostomy tubes in place
* Unwillingness of child to participate

Primary outcomes:
measure: The occurrence of a first episode of acute otitis media during the study period.
timeFrame: Six months
Secondary outcomes:
measure: The total number of episodes of diagnosed acute otitis media during the study period.
timeFrame: Six months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Pediatric Osteopathic Center
state: Arizona
city: Tucson
country: United States
facility: KateCare Osteopathic Center
state: Arizona
city: Tucson
country: United States
facility: Pediatric Clinic, Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Richard A Wahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Michael B Aldous, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mark JD, Grant KL, Barton LL. The use of dietary supplements in pediatrics: a study of echinacea. Clin Pediatr (Phila). 2001 May;40(5):265-9. doi: 10.1177/000992280104000505.