louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06070259: Insights Into Participating in Studies for Bone Cancer
Official title: Examining Patient Involvement Patterns and Trends in Participation in Bone Cancer Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bone Cancer
Keywords: Bone Cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bone cancer patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Clinical studies, with a distinct focus on bone cancer, play a crucial role in evaluating the safety and effectiveness of novel treatments for this disease. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption.

The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of bone cancer
* No prior treatment for bone cancer

Exclusion Criteria:

* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Enrolled in another research study
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a bone cancer clinical research.
timeFrame: 3 months
measure: Number of bone cancer study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Ventura C, Nunez SV, Goncalves A, Abreu C, Costa L. Bone Health in Metastatic Cancer. Semin Oncol Nurs. 2022 Apr;38(2):151278. doi: 10.1016/j.soncn.2022.151278. Epub 2022 Apr 15.
citation: Porta-Sales J, Garzon-Rodriguez C, Llorens-Torrome S, Brunelli C, Pigni A, Caraceni A. Evidence on the analgesic role of bisphosphonates and denosumab in the treatment of pain due to bone metastases: A systematic review within the European Association for Palliative Care guidelines project. Palliat Med. 2017 Jan;31(1):5-25. doi: 10.1177/0269216316639793. Epub 2016 Jul 10.
citation: Niiyama Y, Kawamata T, Yamamoto J, Furuse S, Namiki A. SB366791, a TRPV1 antagonist, potentiates analgesic effects of systemic morphine in a murine model of bone cancer pain. Br J Anaesth. 2009 Feb;102(2):251-8. doi: 10.1093/bja/aen347. Epub 2008 Nov 26.
Clinical trial NCT03792659: The EXPLORE MG Registry for Myasthenia Gravis
Official title: Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.

Brief summary: The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.

Detailed description: This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered.

Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data.

Exclusion Criteria:

* Failure to meet the Inclusion Criteria.

Primary outcomes:
measure: The number of successful blood draws will be reported at the conclusion of the sample collection
timeFrame: 8 years
Secondary outcomes:
measure: The number of stool samples collected will be reported at the conclusion of the sample
timeFrame: 8 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Assistant Professor, Yale University
name: Richard Nowak, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16.
Clinical trial NCT06833359: Validity, Reliability of Neck Disability Index in Albanian
Official title: Adaptation, Translation, and Cross-cultural Validation of the Cervical Disability Index (NDI) for Use in the Albanian-speaking Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Pain Dysfunction Syndrome
Trigger Point Pain, Myofascial
Keywords: Validity
cross-cultural adaptation
Albanian Neck Disability index
Translation
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults with cervical pain

Brief summary: To translate and validate the Cervical Disability Index (NDI) into Albanian for use in the Albanian-speaking population

Detailed description: The cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis.

Psychometric properties will be assessed by administering the questionnaire to approximately 400 participants. Reliability will be estimated by assessing stability and homogeneity.

Eligibility criteria: Inclusion Criteria:

* Myofascial syndrome
* Headache
* muscular pain
* articular pain
* arthirtis

Exclusion Criteria:

* contraindications to manual therapy
* severe trauma
* tumor
* metabolic disease

Primary outcomes:
measure: Albanian Neck Disability Index
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Jasemin Todri
Study officials:
affiliation: UCAM Universidad Catolica San Antonio de Murcia
name: Jasemin Todri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06198959: Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices
Official title: Heat Loss in Humans Covered With Full-Body Blankets Connected to Different Warming Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heat Transfer by Clinical Warming Devices
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Surgical Company
First posted: 2024-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators propose a single-center multiple crossover randomized trial to determine cutaneous heat transfer with four warming devices and five blankets. Cutaneous heat loss/ gain will be measured with thermal flux transducers in unanesthetized volunteers.
Primary purpose: OTHER

Brief summary: The investigators propose a single-center multiple crossover randomized trial to determine the efficacy of four warming devices and five warming blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.

Detailed description: The investigators propose a single-center, assessor-Blinded, multiple crossover randomized trial to determine the efficacy of four warming devices and five blankets. The investigators will measure cutaneous heat loss/ gain using thermal flux transducers in unanesthetized volunteers.

American Society of Anesthesiologists (ASA) physical status 1 and 2 adults with body-mass index 20-33 kg/m2 will be included in this study. Volunteers will be excluded if they have serious skin lesions, history of allergy or skin sensitivity to tape or adhesive materials, serious vascular disease in the arms including Raynaud's Syndrome, or a history of recent fever or infection.

20 volunteers will be randomized to one of 5 different sequence groups: 1. Mistral Air, Blower MA1200-PM. plus the Adult Blanket plus, MA2220, 2. Mistral Air, Blower MA1200-PM plus the Premium Adult Blanket, 3320, 3. 3M, Bair Hugger, Blower 775 plus Blanket full body, 30000, 4. Smiths Medical, Blower L1-CW-100V, plus Blanket full body SWU-2001, 5. Care Essential, Cocoon, Blower CWS5000 plus Blanket Full Body blanket (CLM0101).

Eligibility criteria: Inclusion Criteria:

* Body-mass index 20-33 kg/m2
* Age 18-40 yrs.
* ASA Physical Status 1-2.

Exclusion Criteria:

* Serious skin lesions
* History of allergy or skin sensitivity to tape or adhesive materials
* History of serious vascular disease in the arms, including Raynaud's Syndrome
* History of recent fever or infection

Primary outcomes:
measure: Heat transfer, thermal flux
timeFrame: 30 minutes
Secondary outcomes:
measure: Thermal comfort
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: sessled@ccf.org Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492400: Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 363
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 safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 or 2 diabetes mellitus
* Diagnosis of macular edema
* Visual acuity between 20/200 to 20/40

Exclusion Criteria:

* Eye surgery to the study eye within 3 months
* Use of Ozurdex® within 9 months
* Any active ocular inflammation and infection
* Diagnosis of glaucoma
* Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months

Primary outcomes:
measure: Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, 12 Months
Secondary outcomes:
measure: Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye
timeFrame: Baseline, Month 12
measure: Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Arlington
country: United States
state: Texas
city: Brussels
country: Belgium
city: Copenhagen
country: Denmark
city: Glostrup
country: Denmark
city: Paris
country: France
city: Ahaus
country: Germany
city: Tel Aviv
country: Israel
city: Udine
country: Italy
city: Nijmegen
country: Netherlands
city: Coimbra
country: Portugal
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: London
country: United Kingdom
state: England
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Callanan DG, Loewenstein A, Patel SS, Massin P, Corcostegui B, Li XY, Jiao J, Hashad Y, Whitcup SM. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017 Mar;255(3):463-473. doi: 10.1007/s00417-016-3472-1. Epub 2016 Sep 8.
citation: Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
citation: Chakravarthy H, Devanathan V. Molecular Mechanisms Mediating Diabetic Retinal Neurodegeneration: Potential Research Avenues and Therapeutic Targets. J Mol Neurosci. 2018 Nov;66(3):445-461. doi: 10.1007/s12031-018-1188-x. Epub 2018 Oct 6.
Clinical trial NCT05768100: Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
Official title: Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 12
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: Heart Failure (HF) is a major public health issue affecting 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is high. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

In a first-in-man study we have recently discovered that 3-OHB-infusion increases cardiac output by 2 L/min (40% relative increase) and left ventricular (LV) ejection fraction (LVEF) by 8% in absolute numbers in patients with HF and reduced LVEF (HFrEF).

1,3-Butanediol (BD) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. Whether BD provides similar hemodynamic effects as ketone monoester remains unknown.

Hypothesis Oral BD increases cardiac output and LV function in patients with HFrEF.

Aims To investigate the acute hemodynamic effects of weight-adjusted oral BD supplements in patients with HFrEF.

Design In a randomized, single-blind, placebo-controlled, crossover design, 12 patients with HFrEF are studied following overnight fast on 2 separate visits in random order: 1) during intake of BD (HVMN, San Francisco, California, USA) and during placebo.

Methods Transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 minutes from baseline until 6 hours following BD ingestion.


Eligibility criteria: Inclusion Criteria:

* Chronic HF: NYHA class II-III, LVEF \<40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.

Exclusion Criteria:

* Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent.

Primary outcomes:
measure: Cardiac output
timeFrame: 6 hours
Secondary outcomes:
measure: Stroke volume
timeFrame: 6 hours
measure: Heart rate
timeFrame: 6 hours
measure: LVEF
timeFrame: 6 hours
measure: Changes in circulating 3-OHB
timeFrame: 6 hours
measure: Changes in FFA
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Cardiology, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT05345600: MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery
Official title: A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Perineal Scars
Delivery Complication
Episiotomy
Pain
Treatment
Keywords: Perineal scars
Delivery Complication
episiotomy
Pain
treatment
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.

The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.

This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.


Eligibility criteria: Inclusion Criteria:

* vaginal delivery less than 24h before inclusion
* perineal scar with pain assessed as \> 3/10 with a numerical scale
* 18-years-old or older
* registration to the French medical system
* speaking and writing French
* written informed consent signed

Exclusion Criteria:

* woman under 18-years-old
* woman under law liberty restriction
* women unable to understand the written informed consent
* no written informed consent signed
* previous perineal surgery
* delivery with a caesarian section
* vaginal delivery with no perineal scar
* vaginal delivery with infected perineal scar
* women with restrictions for the use of level 1 analgesic
* women requiring level 2 or 3 analgesics for other reasons

Primary outcomes:
measure: pain level
timeFrame: day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT02515500: Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial
Official title: Cigarette Reduction Using the Quitbit Digital Lighter and Mobile Application for Smoking Cessation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: cigarette reduction
digital health
mobile health
technology
Quitbit
mHealth
smoking cessation
quit smoking
self-regulation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Quitbit, Inc.
First posted: 2015-08-04
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the efficacy of a cigarette reduction intervention using a novel device called the Quitbit, a digital lighter paired with a smartphone mobile application, to enhance self-regulatory techniques for reducing cigarettes smoked per day toward cessation.


Eligibility criteria: Inclusion Criteria:

* 18 years of age
* cigarette smoker
* wanting to quit in the next 30 days
* preference to quit gradually (vs. abruptly) or having no preference
* access to an iPhone (iOS only)
* completion of a run-in period

Exclusion Criteria:

* no major change in number of cigarettes per day in the past month (+/- 20%)
* no major health diagnoses that could impact study attrition

Primary outcomes:
measure: Saliva cotinine level
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT01874600: Seizure Detection and Warning System for Epilepsy Patients
Official title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 239
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.

Brief summary: The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.


Eligibility criteria: Inclusion Criteria:

1. Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 13-21.
4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Is able to read, speak, and understand English or has a LAR that does so.
8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria:

1. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
2. Intracranial EEG electrodes are being used.
3. The subject is allergic to adhesives or any component of the electrode patch assembly

Primary outcomes:
measure: Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.
timeFrame: less than 1 month
Secondary outcomes:
measure: Comparison of study device to self reporting of seizures using a seizure diary.
timeFrame: Less than 1 month
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brain Sentinel
state: Texas
Study officials:
affiliation: Brain Sentinel
name: Jose' E Cavazos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Dennis Dlugos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Jonathan Halford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Dileep Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: