louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03327584: Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
Official title: Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effusion Joint
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. Ultrasound (US) and landmark (LM) small \& medium joint arthrocentesis are both performed within the clinical setting. Both techniques are considered standard of care. Selection of which technique to use is dependent upon the physician's preference. There is currently limited data comparing the two methods. The investigators hope to determine if one modality is more effective in terms of success rate, number of attempts, and time to complete the procedure.

Detailed description: Patients presenting to the Emergency Department who are 18 years old or older, who do not belong to a vulnerable group, requiring small or medium joint arthrocentesis will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts to tap the joint, success rate, and time for procedure to be completed. The arthrocentesis will be performed by PGY-3 residents only. A 21 gauge needle will be used for the arthrocentesis.

Eligibility criteria: Inclusion Criteria:

* All patients who require an arthrocentesis of a small and/or medium joint (defined previously)

Exclusion Criteria:

* Coagulopathic patients
* Patients on anticoagulants
* Patients with cellulitis overlying the joint.
* Patients with artificial joints
* Adults Unable to Consent
* Vulnerable Populations

Primary outcomes:
measure: Superiority of Method of arthrocentesis
timeFrame: 1 day
Secondary outcomes:
measure: Success of method
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple University
state: Pennsylvania
Study officials:
affiliation: Lewis Katz School of Medicine at Temple University
name: Ryan C Gibbons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbons RC, Zanaboni A, Genninger J, Costantino TG. Ultrasound-versus landmark-guided medium-sized joint arthrocentesis: A randomized clinical trial. Acad Emerg Med. 2022 Feb;29(2):159-163. doi: 10.1111/acem.14396. Epub 2021 Oct 23.
Clinical trial NCT01733784: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
Official title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea
Keywords: Sleep Apnea
Pathophysiology
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-11-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The investigators will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.

Detailed description: In obstructive sleep apnea, the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test how the viscoelastic properties of the airway influence PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. Pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.

Eligibility criteria: Inclusion Criteria:

* Normal subjects or patients with OSA

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy

Primary outcomes:
measure: Upper airway elasticity
timeFrame: 10 - 40 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: David A Wellman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04250584: Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
Official title: Investigation of the Substantial Equivalence of a Novel Mandibular Advancement Device, iSlpr™, With SomnoDent® Classic, in a Non-inferiority Study, in the Treatment of Snoring and Mild to Moderate Obstructive Sleep Apnoea.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Snoring
Lead sponsor: BioAnalytics Holdings Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study.

The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.

Detailed description: The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment of snoring and mild to moderate Obstructive Sleep Apnoea.

The target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea.

Participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks.

This study includes -

* a screening period of up to 28 days
* a 2 week device initiation period
* a 24 week treatment period

Eligibility criteria: Inclusion Criteria:

* 18 years or older and younger than 75 years at time of screening
* Snoring and mild to moderate sleep apnoea ( AHI \> 5 and \< 30 per hr)
* Written informed consent
* Able to complete the study procedures within the study timeline.

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* Central sleep apnoea
* Severe respiratory disorders
* Loose teeth or advanced periodontal disease
* Lateral bruxers
* Full or partial dentures
* Temporomandibular Joint (TMJ) abnormalities, pain or dysfunction
* Other teeth, jaw or gum disorders would preclude use of the device
* Cardiovascular comorbidities or stroke/heart attack in past 12 months
* Drug-addiction
* Major Depressive Disorder or psychosis
* Undergoing concomitant therapy for OSA/Snoring
* current or previous therapy with SomnoDent Classic
* Professional drivers or machine operators required to be undertaking CPAP

Primary outcomes:
measure: AHI
timeFrame: 24 weeks
measure: ODI
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03435484: Using RCT to Increase Completion Rates of the Health Assessment Questionnaire.
Official title: Using Rapid Cycle Randomized Controlled Trials to Increase Completion Rates of the Patient-Reported Health Assessment Questionnaire During Outpatient Visits at NYU Langone Orthopedic Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-reported Outcomes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 27263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study aims to examine several iterations of instructions/reminders that patients receive for completing the Health Assessment Questionnaire (self-reported health outcomes) for their outpatient visit at NYU Langone Orthopedic Center. The goal is to increase the completion rates of patient-reported health outcomes.


Eligibility criteria: Inclusion Criteria:

* All patients who are eligible to receive the Health Assessment Questionnaire in preparation for and during their outpatient visit to the NYU Langone Orthopedic Center.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Questionnaire Completion Rate (number of times patients complete or partially complete the questionnaire).
timeFrame: Duration of the study, up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498784: HR-QoL and Sexuality in Mirena Inserted Contraception Users
Official title: A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: Intra-uterine contraception
Intrauterine Devices
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-07-10
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.


Eligibility criteria: Inclusion Criteria:

* Healthy woman willing to, or having to switch from her OC to another contraceptive method

Exclusion Criteria:

- Any contraindication to Mirena insertion/use

Primary outcomes:
measure: Health-related QoL score
timeFrame: 1 year
Secondary outcomes:
measure: Sexuality Index, treatment satisfaction, usual safety outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
state: Gironde
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05017584: ED90 of 0.75% Bupivacaine for Bilateral Tubal Ligation (BTL)
Official title: Determining the ED90 for Intrathecal 0.75% Hyperbaric Bupivacaine for Bilateral Tubal Ligation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: Tubal ligation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ED90) of patients undergoing bilateral tubal ligation. This will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. The goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* American Society of Anesthesiology class II or III
* bilateral tubal ligation

Exclusion Criteria:

* patient refusal
* BMI ≥ 50 kg/m2
* American Society of Anesthesiology class IV or above
* contraindication to neuraxial anesthesia
* allergy to bupivacaine

Primary outcomes:
measure: Dose (in mg) of intrathecal 0.75% hyperbaric bupivacaine that provides effective analgesia in 90% of patients undergoing bilateral tubal ligation as measured by patient reported effectiveness.
timeFrame: End of study, up to 2 years
Secondary outcomes:
measure: Numerical Pain Rating Scale (NPRS) during surgery
timeFrame: End of study, up to 2 years
measure: Side effects
timeFrame: End of study, up to 2 years
measure: Nausea
timeFrame: End of study, up to 2 years
measure: Vomiting
timeFrame: End of study, up to 2 years
measure: Itching
timeFrame: End of study, up to 2 years
measure: Vasopressor use
timeFrame: End of study, up to 2 years
measure: Patient satisfaction
timeFrame: End of study, up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Cameron Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02576184: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
Official title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia After Diverting Stoma Closure
Keywords: Incisional hernia
Stoma
rectal cancer
synthetic mesh
biologic mesh
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Biologic mesh Synthetic mesh
Primary purpose: PREVENTION

Brief summary: This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

Detailed description: This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.

Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.

Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
* Signed consent
* Affiliation to the French social security system

Exclusion Criteria:

* Emergency surgery
* History of laparotomy before ileostoma closure.
* Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
* Lactating or pregnant woman
* Allergy to porcine product or collagen-based product. Allergy to polypropylene.
* Participation to another protocol focusing on ileostoma closure

Primary outcomes:
measure: radiological incisional hernia rate
timeFrame: up to 36 months
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days
measure: Postoperative pain
timeFrame: 36 months
measure: Postoperative rehospitalization
timeFrame: 36 months
measure: Postoperative reintervention
timeFrame: 36 months
measure: Quality of life (The Short Form (36) Health Survey score)
timeFrame: 12 months
measure: Clinical incisional hernia rate
timeFrame: 36 months
Other outcomes:
Locations:
city: Clichy
country: France
facility: Service de Chirurgie Colorectale - Hôpital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Leon Maggiori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540084: Cocktail Sedation Containing Propofol Versus Conventional Sedation for Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: Cocktail Sedation Containing Propofol Versus Conventional Sedation for ERCP: a Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorders of Gallbladder, Biliary Tract and Pancreas
Keywords: Cocktail sedation
ERCP
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2012-02-28
Enrollment: 205
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: Endoscopic retrograde cholangiopancreatography (ERCP) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. The investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP.

Detailed description: ERCP patients were prospectively randomized into 2 groups; the cocktail group and the controls. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for ERCP

Exclusion Criteria:

* Age under 18 years
* American Society of Anesthesiologists' (ASA) physical classification IV - V
* History of sulfite, egg or soy bean allergy
* Emergency need for ERCP
* Informed consent could not be obtained

Primary outcomes:
measure: procedure related time
timeFrame: participants will be followed for the duration of procedure, an expected average of 1.5 hours
Secondary outcomes:
measure: Cardiopulmonary complications
timeFrame: participants will be followed for the duration of procedure, an expected average of 1.5 hours
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: Gastroenterology Unit, King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
affiliation: Gastroenterology unit, King Chulalongkorn Memorial Hospital
name: Rungsun Rerknimitr, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Angsuwatcharakon P, Rerknimitr R, Ridtitid W, Kongkam P, Poonyathawon S, Ponauthai Y, Sumdin S, Kullavanijaya P. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study. BMC Anesthesiol. 2012 Aug 9;12:20. doi: 10.1186/1471-2253-12-20.
Clinical trial NCT01455584: Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors
Official title: Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignancies
Keywords: HM781-36B
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

Detailed description: Besides the main objective, there are 4 other objectives as follows:

1. To determine dose-limiting toxicity (DLT) of HM781-36B
2. To determine Maximum Tolerated Dose (MTD) of HM781-36B
3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously
4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed advanced solid tumor
2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
3. Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
4. Aged ≥19
5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
6. A life expectancy greater than 12 weeks
7. Adequate bone marrow, renal and liver function.
8. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

1. Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
3. Patients who have GI malabsorption or difficulty taking oral medication
4. Patients who have psychiatric or congenital disorder
5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Primary outcomes:
measure: MTD determination
timeFrame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: