louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01025206: A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma
Official title: A Phase I Dose-Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BI 505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
monoclonal antibody
safety
pharmacokinetic
Lead sponsor: BioInvent International AB
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.


Eligibility criteria: Inclusion Criteria:

* Advanced Myeloma with measurable disease after at least 2 previous regimens.
* Life expectancy \> 3 months.
* Performance status ECOG \< 2.

Exclusion Criteria:

* Prior antineoplastic therapy within 4 weeks prior to inclusion.
* No high dose steroids within 7 days prior to screening.
* Severe other conditions.

Primary outcomes:
measure: Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests
timeFrame: four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center, Department of Medicine, Division of Hematology, Utah Blood and Marrow Transplant and Myeloma Program
state: Utah
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Lund
country: Sweden
facility: Hematology Clinic Cancer Division, Skåne University Hospital
Study officials:
affiliation: University of Utah
name: Guido Tricot, MD, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansson M, Gimsing P, Badros A, Niskanen TM, Nahi H, Offner F, Salomo M, Sonesson E, Mau-Sorensen M, Stenberg Y, Sundberg A, Teige I, Van Droogenbroeck J, Wichert S, Zangari M, Frendeus B, Korsgren M, Poelman M, Tricot G. A Phase I Dose-Escalation Study of Antibody BI-505 in Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2015 Jun 15;21(12):2730-6. doi: 10.1158/1078-0432.CCR-14-3090. Epub 2015 Feb 24.
Clinical trial NCT02984306: Effect of Cherry Powder Supplementation on Vascular Function
Official title: Effect of Cherry Powder Supplementation on Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Examining the effect of four weeks of cherry powder supplementation on flow mediated dilatation


Eligibility criteria: Inclusion Criteria:

* physically inactive no prescription medications

Exclusion Criteria:

* physically active taking prescription medication

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: change from baseline to 4 weeks dietary supplementation
Secondary outcomes:
measure: Plasma nitrite concentration
timeFrame: change from baseline to 4 weeks dietary supplementation
measure: Plasma nitrate concentration
timeFrame: change from baseline to 4 weeks dietary supplementation
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences
state: Devon
Study officials:
References:
Clinical trial NCT02604706: Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
Official title: RCT of Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use and Use of Addiction Treatment Services. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Abuse
Anxiety
Sleep
Lead sponsor: Örebro Läns Landsting
Sponsor class: OTHER_GOV
First posted: 2015-11-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. Method. Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of two variants of auricular acupuncture - The National Acupuncture Detoxification Association protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index (ISI) with assessment before treatment and follow-ups after five weeks and three months. Secondary outcomes were drug use and addiction service utilization.


Eligibility criteria: Inclusion Criteria:

* Ongoing patients status at the clinic.

Exclusion Criteria:

* Nickel-allergy
* Ear infection
* Heart disease

Primary outcomes:
measure: Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
timeFrame: 5 weeks and 3 months
Secondary outcomes:
measure: Change in self rated sleep quality measured with Insomnia Severity Index (ISI).
timeFrame: 5 weeks and 3 months
measure: Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).
timeFrame: 5 weeks and 3 months
measure: Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).
timeFrame: 5 weeks ans 3 months
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Psychiatric Research Centre
Study officials:
affiliation: Örebro Läns Landsting
name: Rickard Ahlberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahlberg R, Skarberg K, Brus O, Kjellin L. Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Subst Abuse Treat Prev Policy. 2016 Jul 25;11(1):24. doi: 10.1186/s13011-016-0068-z.
Clinical trial NCT06496906: Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
Official title: Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction Status Nos
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 116
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 aim of the study is to compare the effectiveness of the vertical extraction system Benex and Physics forceps with the conventional extraction tools (extraction forceps and elevators) in the early wound healing period after tooth extraction, as means for minimally invasive tooth extraction.

All patients aged 18 years and over who require closed tooth extraction with good oral hygiene were eligible for participation.

Participants were randomly allocated to tooth extraction with either Benex, Physics forceps or conventional extraction tools using box randomization. Patients are followed up during the recovery period to assess pain and early wound healing, while at the time of extraction, success and buccal cortical plate fracture were evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with teeth indicated for closed extraction
* Teeth with at least 1mm of tissue above the bone level
* Patients without contraindications for surgical intervention (ASA 1 or 2)
* Patients with good oral hygiene

Exclusion Criteria:

* Patients with severe systemic conditions or immunosuppression
* Teeth with mobility greater than Grade 1
* Teeth indicated for open surgical extraction
* Patients with acute odontogenic infections
* Drug or alcohol abuse
* Patients with psychiatric conditions
* Patients on anticoagulant or antiaggregant drugs refusing to undergo prior tests and preparation for tooth extraction
* Patients on chemotherapy, radiotherapy, or oral bisphosphonate intake

Primary outcomes:
measure: Extraction success
timeFrame: From the beginning of the extraction to the completion of the procedure
measure: Alveolar bone buccal cortical plate preservation
timeFrame: From the beginning of the extraction to the completion of the procedure
measure: VAS pain score
timeFrame: 0, 1, 3, 7 day
measure: Early wound healing
timeFrame: 3, 7, 10 day
Secondary outcomes:
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Department of Oral Surgery, Faculty of Dental Medicine, Medical University - Plovdiv
state: Pl
Study officials:
References:
Clinical trial NCT05999006: Safety and Feasibility of the ELIOS System in POAG Patients
Official title: A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Lead sponsor: Elios Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 65
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate POAG
* Medicated IOP of \<=24 mmHg
* Shaffer angle grade of III or IV
* CD ratio \<=0.8
* At least 45 years old

Exclusion Criteria:

* Closed-angle and secondary glaucomas
* Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
* Cannot undergo medication washout in the study eye
* Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

Primary outcomes:
measure: Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
timeFrame: 12 Months
measure: Mean Change in DIOP from baseline on the same or fewer medications
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Elios Vision Clinical Site
state: Arizona
city: Largo
country: United States
facility: Elios Vision Clinical Site
state: Florida
city: Rock Island
country: United States
facility: Elios Vision Clinical Site
state: Illinois
city: Oklahoma City
country: United States
facility: Elios Vision Clinical Site
state: Oklahoma
city: Kenosha
country: United States
facility: Elios Vision Clinical Site
state: Wisconsin
Study officials:
affiliation: Prism Eye Institute
name: Iqbal (Ike) Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06698406: Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale
Official title: Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Chronic
Keywords: pain, chronic
patient education
self efficacy
bio-psycho-social model
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated by the ambulatory chronic pain clinic (consultation d'antalgie) of the HUG

Brief summary: We will validate the French version of the "Patients' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire

Detailed description: The primary objective is to validate the French version of the PEB scale, called "Echelle d'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".

The hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.

Consenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.

Eligibility criteria: Inclusion Criteria:

* - Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG
* French-speaking and able to understand the study information
* ≥18 years of age

Exclusion Criteria:

* - Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other de-pendent persons

Primary outcomes:
measure: incremental validity of the new ABDC scale
timeFrame: 1 day
Secondary outcomes:
measure: Reliability of the ABDC scale
timeFrame: 1 day
measure: Convergent validity
timeFrame: 1 day
measure: Discriminant validity
timeFrame: 1 day
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
Clinical trial NCT04931706: Nissen Sleeve by Single Port With Magnetic Assistance
Official title: Double Magnetic-assisted Single-port Nissen Sleeve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery Candidate
Obesity
GERD
Keywords: Bariatric Surgery
Magnetic assisted
Singe port
Nissen Sleeve
Lead sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the UICBM from Venezuela-Colombia

Brief summary: New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

Detailed description: A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.

Eligibility criteria: Inclusion Criteria:

* Any patient with controlled comorbidities suffering from obesity and GERD.

Exclusion Criteria:

* Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Primary outcomes:
measure: Surgical Complications
timeFrame: 1 month
measure: Surgical time
timeFrame: 30 minutes
measure: Weight loss follow up
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Maracaibo
country: Venezuela
facility: Unidad Internacional de Cirugia Bariatric y Metabolica
state: Zulia
Study officials:
affiliation: UICBM
name: Andres Maldonado, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792306: The Novel Electrolyzed Water Spray Treatment Discomfort, Redness and Swelling of the Skin Surrounding the Wound
Official title: A Novel Electrolyzed Water Spray Reduces Discomfort, Redness and Swelling of the Skin Surrounding the Wound Created by Skin Lasar Surgery: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Injury
Keywords: Electrolyzed water device
Hydroxyl radical
Tap water
Spray
Laser surgery wound
Discomfort of the skin
Redness of the skin
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An open label, two arm clinical study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether the reduction of the sense of discomfort and redness and swelling of the skin surrounding the wound of patients by use of the novel electrolyzed water spray will relieve the inflammation of the skin.

Detailed description: In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). In this study, this novel electrolyzed water device and the water spray are used to treat wounds created by skin laser surgery.

Eligibility criteria: Inclusion Criteria:

* Mild discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery
* Patient \> 18 years old.

Exclusion Criteria:

* Severe discomfort, redness and swelling of the skin surrounding the wound created by skin laser surgery.
* 80 years or older.
* Pregnant or breastfeeding women
* Systemically healthy individuals.

Primary outcomes:
measure: The sense of discomfort scale made by the Numeric Pain Rating Scale (NPRS).
timeFrame: 1 hour
Secondary outcomes:
measure: A skin signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
timeFrame: 3 hour
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT01300806: Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting
Official title: Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use
Keywords: HIV
harmful substance use
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic patients

Brief summary: The goal of this research is to assess the impact of the "screening, brief intervention, and referral to treatment" (SBIRT) intervention strategy for harmful substance use among HIV-positive people.

Detailed description: The specific aims of the study are:

1. To assess the feasibility of conducting SBIRT using (1) a patient self-administered intervention embedded in a web-based Personal Health Record (PHR) compared to (2) a provider-administered SBIRT intervention guided by the Electronic Medical Record (EMR) during clinic appointments.
2. To examine the acceptability of web-based PHRs to conduct and communicate SBIRT compared to EMR-activated SBIRT conducted by clinic staff, from the perspective of the patient and the provider.
3. To assess the impact of SBIRT on risky drug and alcohol use in an HIV/AIDS population and subsequent effects on sexual risk behaviors and antiretroviral therapy (ART) adherence.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* confirmed prior HIV+ serostatus
* ability to provide informed consent to be a participant over a 6 month period
* English or Spanish speaking

Exclusion Criteria:

Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.

Primary outcomes:
measure: reduced substance use among HIV-positive people
timeFrame: 6 months
Secondary outcomes:
measure: technological innovation to improve the quality of medical care
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Carol Dawson Rose, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson-Rose C, Draughon JE, Cuca Y, Zepf R, Huang E, Cooper BA, Lum PJ. Changes in Specific Substance Involvement Scores among SBIRT recipients in an HIV primary care setting. Addict Sci Clin Pract. 2017 Dec 12;12(1):34. doi: 10.1186/s13722-017-0101-1.