louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01785862: Ibuprofen Lozenge in Acute Sore Throat Pain
Official title: Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Sore Throat Pain
Keywords: sore throat pain
tonsillopharyngitis
upper respiratory tract infection
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 427
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 purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.


Eligibility criteria: Inclusion Criteria:

* male or female aged at least 18 years old
* patient with an acute sore throat

Exclusion Criteria:

* Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
* Oro-pharyngeal paresthesia or mycosis
* Severely traumatised and/or very severe oromucosal inflammation
* Tonsillopharyngectomy
* Peritonsillar abscess
* Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
* Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
* Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
* Any paracetamol intake within 6 hours before randomisation
* Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
* Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
* Heavy smokers (\>20 cigarettes/day)

Primary outcomes:
measure: Total Pain relief over 2 hours
timeFrame: 0-2 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Gières
country: France
city: Erfurt
country: Germany
city: Balvi
country: Latvia
city: Daugavpils
country: Latvia
city: Jekabpils
country: Latvia
city: Jelgava
country: Latvia
city: Kuldiga
country: Latvia
city: Liepaja
country: Latvia
city: Ogres Municipality
country: Latvia
city: Ogre
country: Latvia
city: Riga
country: Latvia
city: Saldus
country: Latvia
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
Study officials:
References:
citation: Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.
Clinical trial NCT02001662: Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders
Official title: The Analgesic Efficacy of the Adductor Canal Blockade in High Pain Responders After Arthroscopic Knee Surgery - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopic Knee Surgery
Keywords: Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft)
High pain responders
Adductore Canal Block
Analgesics
Ultrasound guided nerve block
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.


Eligibility criteria: Inclusion Criteria:

Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent

Exclusion Criteria:

Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)

Primary outcomes:
measure: Pain score during 45 degree flexion of the knee
timeFrame: 45 minutes after nerve block
Secondary outcomes:
measure: Pain score
timeFrame: 0-90 min. after first nerveblock
measure: muscle strength
timeFrame: 45 and 90 min after nerve block
measure: Opioid consumption
timeFrame: 0-90 min after nerve block
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager Hospital, University of Copenhagen, Denmark
state: Copenhagen, Amager
Study officials:
affiliation: Glostrup University Hospital, University of Copenhagen
name: Malene Espelund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04632862: The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.
Official title: A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 140
Sex: ALL
Minimum age (years): 19
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 determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 to 80 years
2. Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who have been on a stable diet and exercise program for at least 8 weeks
5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
4. eGFR \< 60 mL/min/1.73 m2
5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
6. Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)

Primary outcomes:
measure: HbA1c level at Week 24 after administration of the IP
timeFrame: at Week 24
Secondary outcomes:
measure: HbA1c level at Weeks 6, 12, and 18 after administration of the IP
timeFrame: at weeks 6, 12, and 18
measure: FPG level at Weeks 6, 12, 18, and 24 after administration of the IP
timeFrame: at weeks 6, 12, 18, and 24
measure: HbA1c level < 7% at Weeks 6, 12, 18, and 24 after administration of the IP
timeFrame: at weeks 6, 12, 18, and 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References:
Clinical trial NCT05744362: Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients
Official title: Outcome of Transanal Specimen Extraction Surgery for Elderly Colorectal Cancer Patients: a National Database Study in China of 1395 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: survival
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 1395
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly CRC patients with transanal-NOSES surgery

Brief summary: Retrospective analysis of a cohort of elderly CRC patients (aged ≥ 65 years) underwent transanal-NOSES between August 2008 and February 2022 was constructed. Data were obtained from China NOSES Database (CNDB). The primary outcomes included time to first flatus, postoperative hospital stays, 30-day postoperative complication and hospital mortality. The secondary outcomes were overall survival (OS) and disease-free survival (DFS).


Eligibility criteria: Inclusion Criteria:

patients diagnosed as T1-4N0-2M0 colorectal cancer pathologically

patients underwent transanal-NOSES

patients aged 65 years or older

Exclusion Criteria:

patients with multiple primary colorectal cancer

patients with total colectomy

patients without complete data

Primary outcomes:
measure: Overall survival
timeFrame: 4-year
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
References:
Clinical trial NCT04856462: The Alzheimer's Companion Engagement (ACE) Project.
Official title: The Alzheimer's Companion Engagement (ACE) Project.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress, Psychological
Adaptation, Psychological
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned to intervention groups where they will receive structured education and support.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Targeted, culturally responsive, health interventions that help Black ADRD caregivers to effectively manage their own health and use community preferenced ways of coping, can improve caregivers' overall health, perceived ability to provide care for a person with ADRD (self-efficacy), and increases the likelihood that they will experience benefits from caregiving. This clinical trial pilot will test the feasibility of a community based intervention designed to improve health outcomes for Black family caregivers of persons with ADRD.

Detailed description: The proposed intervention is a peer-supportive and facilitator-led video teleconference program that will engage small groups of caregivers weekly over 6 weeks. Each week participants (n = 36, 2-5/group) will receive a different culturally relevant caregiving or personal health strategy to practice. During the support calls, a facilitator will provide an overview of the content covered and each participant will have the opportunity to discuss their past week and how they engaged the weekly strategy, or challenges that came up for them during the week. The format will be structured to ensure that core content is reviewed, and everyone can be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken at weeks 1 and 8.

Eligibility criteria: Inclusion criteria for participation are as follows:

Self-identified as Black/ African American At least 18 years old Able to speak, understand, and hear spoken English Related to, or has a close personal relationship to a person over the age of 55 that has an ADRD diagnosis or evidence of cognitive impairment Regular access to a smartphone, tablet or computer with internet access that will allow video conferencing engagement.

Provides monitoring, and assistance in activities of daily living and or other care tasks for the care recipient.

-

Primary outcomes:
measure: Caregiver Self-efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Positive Aspects of Caregiving
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05320562: Effect of Kinesio Taping and Sham Taping in Knee Osteoarthritis
Official title: Effect of Kinesio Taping and Sham Taping on Knee Function in Patients With Knee Osteoarthritis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: kinesiotaping
functional mobility
physiotherapy
knee pain
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of knee osteoarthritis has been increasing in recent decades as the number of obese people has increased. Various interventions are used to improve the functional condition of patients, but it is still not clear which one is most effective. The primary aim of this study was to determine and compare the effects of kinesio taping and sham taping on the knee functional mobility.

Detailed description: The investigators assigned 30 adult participants (26 women, 4 men; mean age 58,1±3,9 yrs) from Lithuania. Participants were assigned to one of three groups: control group (CON) (n = 10), sham taping + exercise (STE) (n = 10), and kinesio taping + exercise (KTE) group (n = 10). Participants performed all necessary tests according to the study protocol one week before the intervention. A second set of tests was performed one week after the intervention. The intervention duration was 1 week. Exercise, sham and kinesio taping were applied by Physical Therapist. All the study groups did exercise training.

Eligibility criteria: Inclusion Criteria:

* clinical and radiography diagnosis of osteoarthritis of the knee joint
* patients with different degrees of severity of the knee osteoarthritis
* consent to participate in the study.

Exclusion Criteria:

* rheumatoid arthritis
* systemic connective tissue disease
* knee joint oedema
* surgery intervention in recent 6 months
* wearing of knee braces
* skin problems
* previous total or partial knee replacement surgery
* inability to perform physical examination tests
* oncology
* use of medications, infection
* previous experience of kinesio taping intervention.

Primary outcomes:
measure: Change from Baseline Knee Pain at 1 week
timeFrame: Baseline and after 7 days
measure: Change from Baseline Range of Motions at 1 week
timeFrame: Baseline and after 7 days
measure: Change from Baseline Muscle Strength at 1 week
timeFrame: Baseline and after 7 days
measure: Change from Baseline Walking Speed at 1 week
timeFrame: Baseline and after 7 days
measure: Change from Baseline Functional Mobility at 1 week
timeFrame: Baseline and after 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
References:
Clinical trial NCT00770562: A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Official title: A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 103
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: This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* untreated ITP.

Exclusion Criteria:

* ITP with relapse;
* positive test result for HIV or hepatitis B or C;
* active infection requiring systemic therapy;
* malignancy within 3 years before study.

Primary outcomes:
measure: Percentage of Participants With a Sustained Response
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With an Initial Response
timeFrame: Week 4
measure: Percentage of Participants With an Initial Complete Response
timeFrame: Week 4
Other outcomes:
Locations:
city: Bari
country: Italy
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Cagliari
country: Italy
city: Cuneo
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Pesaro
country: Italy
city: Pescara
country: Italy
city: Ravenna
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Taranto
country: Italy
city: Udine
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.
Clinical trial NCT04885062: Belun Ring Platform With an Improved Algorithm for OSA Assessment
Official title: Belun Ring Platform (BLS-100) Home Sleep Apnea Testing Device With an Improved Algorithm for Assessment of Obstructive Sleep Apnea: A Comparison to In-Lab Polysomnography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep-Disordered Breathing
Sleep Architecture
Keywords: Obstructive Sleep Apnea
Wearable
Home Sleep Apnea Testing
Photoplethysmography
Validation
Artificial Intelligence
Lead sponsor: Belun Technology Company Limited
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2021-05-13
Enrollment: 100
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: DIAGNOSTIC

Brief summary: OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Age 18-80
* Clinically assessed and suspicious for OSA

Exclusion Criteria:

* Full night PAP titration study
* On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
* Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
* Patients taking narcotics
* Recent hospitalization or recent surgery in the past 30 days
* Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician

An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.

Primary outcomes:
measure: REI parameters
timeFrame: 1 year
Secondary outcomes:
measure: Sleep stage parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Ambrose A Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651762: Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries
Official title: Ultra Sound Guided Genicular Nerves Cooled Radiofrequency Ablation in Total Knee Replacement Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total Knee Replacement surgery is common procedure that is usually done for patients suffering from persistent pain with limitation of movement. Unfortunately, they do suffer after the operation as it is associated still with significant pain that affect the rehabilitation plan, hospital length of stay, life style and patient satisfaction. New approaches are rising every day to add to the multimodal management plan. Genicular nerves cooled radiofrequency ablation is a new approach that can be simply done U.S. guided with little side effects, if any, and great results.

Detailed description: the study measures the efficacy of genicular nerves cooled radiofrequency ablation in enhancing quality of rehabilitation in patients undergoing total knee replacement

Eligibility criteria: Inclusion Criteria:• Undergoing a scheduled unilateral total knee replacement surgery

-

Exclusion Criteria:

* • Allergy to any of the drugs used in the study

  * Alcohol or drug abuse
  * Psychiatric disease

Primary outcomes:
measure: o Epidural rescue doses
timeFrame: 1st 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Ain Shams University
Study officials:
References: