louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05415761: Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care
Official title: Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: tobacco use intervention
mobile health aids
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-06-13
Enrollment: 1332
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

Detailed description: The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.

Eligibility criteria: Inclusion Criteria:

* ≥21 years old
* Referred by the provider via Ask-Advise-Connect
* Receiving care at one of the participating clinics
* Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)
* No household members already enrolled

Exclusion Criteria:

* Unstable medical or psychiatric illness

Primary outcomes:
measure: Smoking Point-Prevalence Abstinence (PPA)
timeFrame: Month 6
Secondary outcomes:
measure: Smoking Point-Prevalence Abstinence (PPA)
timeFrame: Months 2 and 12
measure: Treatment Satisfaction
timeFrame: Month 12
measure: Quality of Life and Well-Being
timeFrame: Baseline, and month 6
measure: Self Efficacy
timeFrame: Baseline, and month 6
measure: Acceptance
timeFrame: Months 2 and 6
measure: Values
timeFrame: Months 2 and 6
measure: Motivation
timeFrame: Months 2 and 6
measure: Smoking Prolonged Abstinence
timeFrame: Months 6 and 12
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Jesse Dallery, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Ramzi Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05245461: Comparison of Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls
Official title: Comparison of Patients Who Had Remnant-Preserving Anterior Cruciate Ligament Reconstruction With Healthy Controls In Terms of Muscle Strength and Proprioception
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Acibadem University
Sponsor class: OTHER
Collaborators: name: Haydarpasa Numune Training and Research Hospital
name: Marmara University
First posted: 2022-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had remnant-preserving ACL reconstruction and healthy controls

Brief summary: Anterior cruciate ligament reconstruction stabilizes the knee joint biomechanically and returns the patients back to the sportive activities. Numerous techniques exist to perform an anterior cruciate ligament reconstruction surgery. Remnant- preserving reconstruction technique is performed to increase surgery success rates and to accelerate the post-surgical return to sport process. In general, there is no consensus regarding the clinical outcomes of remnant-preserving anterior ligament reconstruction over standart procedure. The purpose of this study is to compare the patients who had remnant-preserving anterior cruciate ligament reconstruction with healthy controls in terms of muscle strength and proprioception.


Eligibility criteria: Inclusion Criteria:

* Anatomical single-bundle ACL reconstruction with AM portal technique using hamstring autograft due to full-thickness ACL tear,
* Endobutton technique was used for femoral fixation,
* Not having any trauma or surgery on the opposite knee,
* Patients with a follow-up period of at least 12 months after surgery.

Exclusion Criteria:

* Fracture of lower extremity accompanying anterior cruciate ligament tear; posterior cruciate ligament, inner and outer lateral ligament tears,
* Patients who have undergone previous surgery on the knee to be evaluated,
* Cases with repeated anterior cruciate ligament reconstruction,
* Having a history of knee joint arthritis (osteoarthritis, inflammatory arthritis),
* Cases with neurological disease will be excluded from the study.

Primary outcomes:
measure: Isokinetic muscle strength
timeFrame: 1 day
measure: Proprioception
timeFrame: 1 day
Secondary outcomes:
measure: Kinesiophobia
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem Mehmet Ali Aydınlar University
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT03600961: BIOFLOW-SV Portugal Registry
Official title: BIOTRONIK - SaFety and Performance Registry for an Allcomers Patient Population With the SiroLimus Eluting Orsiro Stent Within Daily Clinical Practice in Small Vessels - Portugal Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Heart Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This registry will include subjects requiring a treatment of coronary artery disease with an Orsiro DES

Brief summary: Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

Detailed description: Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.

Eligibility criteria: Inclusion Criteria:

* Subject is ≥18 years of age
* Subject must sign a Patient Informed Consent (PIC) or a Patient Data Release Form (PDRF)
* Subject must agree to undergo all required follow-up visits

Exclusion Criteria:

* Pregnant and/or breast feeding females at the time of enrolment
* Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant

  /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated
* Currently participating in another study that has not yet reached the primary endpoint

Primary outcomes:
measure: Target Lesion Failure for the small vessel group
timeFrame: at 12 months
Secondary outcomes:
measure: TLF for the overall cohort
timeFrame: at 12 months
measure: Clinically driven Target Lesion Revascularization (TLR)
timeFrame: at 6 and 12 months
measure: Clinically driven Target Vessel Revascularization (TVR)
timeFrame: at 6 and 12 months
measure: Definite and probable stent thrombosis
timeFrame: at 6 and 12 months
measure: Procedure success
timeFrame: 12 months
measure: Device success
timeFrame: 12 months
Other outcomes:
Locations:
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz
city: Carnaxide
country: Portugal
facility: Hospital da Luz
city: Leiria
country: Portugal
facility: Centro Hospitaler de Leiria E.P.E.
city: Évora
country: Portugal
facility: Hospital Espirito Santo Evora
Study officials:
affiliation: Centro Hospitalar de Vila Nova de Gaia
name: Pedro Braga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407261: OHRQoL and Accelerated Orthodontics With Micro-osteoperforations
Official title: OHRQoL Assessment Between Sliding Anterior Retraction and Micro-osteoperforations for Accelerated Orthodontics in Patients Who Were Assigned for Pre-molar Extraction and Decompensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: OHRQoL assessment using OHIP-14 between sliding anterior retraction with self-ligating brackets and micro-osteoperforations for accelerated orthodontics in orthognathic surgery patients who were assigned for pre-molar extraction and decompensation

Detailed description: Our patients are participants in a randomized clinical trial, an ongoing study about the effectiveness of micro-osteoperforations to accelerate tooth movement. The study sample consisted of 22 consecutive subjects - 12 females and 10 males - between the ages of 18 and 35, who were selected for ortho-surgical treatment and pre-molar extraction assigned for decompensation. The participants were randomly allocated to two groups: control (anterior retraction was performed using implant-assisted sliding mechanics with self-ligating brackets) and experimental (micro-osteoperforations were performed in the activation appointments for anterior retraction using implant-assisted sliding mechanics). For immediate and follow-up assessment of patients' perceptions, comparing regular orthodontic activation and activation with Accelerated Orthodontics, subjects were asked to complete an electronic questionnaire OHIP-14, to assess the participants' comfort level, experiences, and QoL impact.

Eligibility criteria: Inclusion Criteria:

* maxillomandibular discrepancy indicative for orthognathic surgery, no previous dental extractions, good oral and general health, non-smokers, and no use of systemic corticosteroids or biphosphonates

Exclusion Criteria:

* any tooth absence/previous tooth extraction

Primary outcomes:
measure: Comparision of OHRQoL between groups - OHIP-14A
timeFrame: 4 days
measure: Comparision of OHRQoL between groups - 7 domains
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: FOUSP
Study officials:
References:
Clinical trial NCT02896361: Burst Optimized Stimulation Study
Official title: Burst Optimized Stimulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Medizinische Einrichtungen der Universität Düsseldorf
name: Klinikum Duisburg GmbH
name: NKO Sint-Augustinus Antwerpen
First posted: 2016-09-12
Enrollment: 29
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: This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.

Detailed description: This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.

Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

Eligibility criteria: Inclusion Criteria:

* Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
* Subject has been exclusively using burst stimulation for at least three months;
* Subject is 18 years of age or older;
* Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
* Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;

Exclusion Criteria:

* Subject is currently participating in a clinical investigation study that includes an active treatment arm;
* Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
* Subject has a non SJM neuromodulation device

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: assessed every 2 weeks after each intervention, for a total of 6 weeks
Secondary outcomes:
measure: EQ-5D
timeFrame: assessed every 2 weeks after each intervention, for a total of 6 weeks
measure: Subject Preference
timeFrame: assessed 6 weeks after baseline at the last follow up visit
measure: Subject Satisfaction
timeFrame: assessed every 2 weeks after each intervention, for a total of 6 weeks
measure: Percentage of Participants With Adverse Events
timeFrame: assessed over 6 weeks of study participation
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: NKO Sint-Augustinus
city: Duisburg
country: Germany
facility: Klinikum Duisburg GmbH
state: North Rhine-Westphalia
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: North Rhine-Westphalia
Study officials:
affiliation: Abbott Medical Devices
name: Lalit Venkatesan, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05140161: Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery
Official title: Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nails, Ingrown
Coagulation Defect; Bleeding
Keywords: collagen
nail
ingrown
bleeding
surgery
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 98
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the hemostatic capacity of two types of collagen hemostatic sponges in nail surgery.

It is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).

Detailed description: To evaluate bleeding, all patients with onychocryptosis will be operated on with the same technique.

In the experimental groups, once the surgical procedure has been completed on both edges of the nail, hemostatic collagen will be applied in the experimental groups (experimental group 1- medium porosity collagen and experimental group 2-high porosity collagen) In all groups, including the control, once the intervention was finished, the same bandage was performed with the same number of gauze pads.

At 72 hours, the gauze set will be removed to weigh it using a precision balance and quantitatively evaluate the amount of bleeding.

In this way, a comparative study can be carried out between the 3 groups and determine if there are statistically significant differences or not, and can determine if lyophilized hemostatic collagen is useful in nail surgery and if there are significant differences between both experimental groups, determining if the percentage of porosity in a hemostatic is relevant in the hemostatic effect.

Eligibility criteria: Inclusion Criteria:

* STADIUM I, II, or III (Kline classification) without infective onychocryptosis (cellulitis) on both edges of the Hallux
* Susceptible to phenol-alcohol technique with Suppan I modification

Exclusion Criteria:

* Platelet Antiplatelet Therapy
* Oral Anticoagulant Therapy
* History of congenital or acquired Hemorrhagic Syndrome
* Alteration in the following parameters (platelet count, prothrombin time, activated thromboplastin time, and plasma fibrinogen)

Primary outcomes:
measure: Bleeding
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 72 hours after surgery
measure: Postoperative inflammation
timeFrame: 72 hours after surgery
Other outcomes:
measure: Recovery time
timeFrame: 3 weeks after surgery
Locations:
Study officials:
References:
Clinical trial NCT01497561: Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 15
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: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Subjects treated with insulin for minimum 3 months
* Duration of diabetes for at least 12 months
* Body Mass Index (BMI) below 30 kg/m\^2
* HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

* Current treatment with insulin above 1.2 U/kg/day
* Current treatment with insulin glargine
* Current treatment with drugs known to interfere with glucose metabolism
* Current treatment with oral antidiabetic drugs

Primary outcomes:
measure: Area under the glucose infusion rate curve
Secondary outcomes:
measure: Maximum glucose infusion rate
measure: Time to maximum glucose
measure: Area under the curve
measure: Maximum concentration
measure: Time to maximum concentration
measure: Insulin clearance
measure: Mean residence time of insulin
measure: Terminal rate constant
measure: Terminal half-life
Other outcomes:
Locations:
city: Graz
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B; PREFER Study Group. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab. 2009 Jan;11(1):45-52. doi: 10.1111/j.1463-1326.2008.00915.x. Epub 2008 Jul 17.
Clinical trial NCT06834061: Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome
Official title: Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasonography
Diagnosis
Management
Follow-Up
Carpal Tunnel Syndrome
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study will be carried out on 60 patients with CTS admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.

Brief summary: This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).

Detailed description: Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.

The ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old.
* Both sexes.
* Patients with carpal tunnel syndrome.

Exclusion Criteria:

* History of wrist surgery (including carpal tunnel injection) or fracture.
* Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.
* History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.
* Electrodiagnostic findings suggestive of co-existing neurological disorders.
* Subclinical sensory polyneuropathy.

Primary outcomes:
measure: Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References: