louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03082820: Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries
Official title: Evaluation of Pain-related Evoked Potentials (PREP) for the Objectivization of Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Injuries
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.

Brief summary: The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve injuries. Since previous studies found altered latencies and amplitudes of PREP in generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study investigates if these alterations are detectable in unilateral peripheral nerve injuries as well.


Eligibility criteria: Inclusion Criteria:

* Peripheral Nerve Injury

Exclusion Criteria:

* Polyneuropathy
* Contralateral peripheral nerve injury
* Severe psychiatric disorders
* Disorders affecting central nervous system

Primary outcomes:
measure: N1-latency
timeFrame: 1 day
Secondary outcomes:
measure: N1P1-amplitude
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Bergmannsheil Bochum
name: Christoph Maier, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04362020: Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants
Official title: Strategies to Maintain Radial Artery Patency Following Diagnostic Coronary Angiography - Subgroup of Patients on Oral Anticoagulants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Undergoing Diagnostic Coronary Angiography
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether omitting systemic anticoagulation during transradial coronary angiography and/or a distal radial access reduce the risk of postprocedural radial artery occlusion


Eligibility criteria: Inclusion Criteria:

* Clinical indication to perform diagnostic coronary angiography
* Pretreatment with oral anticoagulants (phenprocoumon or direct oral anticoagulants \[dabigatran, apixaban, rivaroxaban, or edoxaban\])
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Already administered additional anticoagulation prior to coronary angiography
* Planned coronary intervention
* Preexisting radial artery occlusion or missing pulse at the potential puncture sites
* Allergy / intolerance to anticoagulants
* Active bleeding or comorbidity with elevated bleeding risk
* Pregnancy
* Inability to sign informed consent
* Participation in another trial

Primary outcomes:
measure: Occurrence of postprocedural radial artery occlusion
timeFrame: Day 1
Secondary outcomes:
measure: Sonographic characteristics of radial artery occlusion
timeFrame: 3 Month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01902082: Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Official title: Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: ARDS
Keywords: ARDS
mesenchymal stem cells
Safety
Cytokines
Lead sponsor: Shaoxing Second Hospital
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.


Eligibility criteria: Inclusion Criteria:

1. ARDS diagnosed using Berlin definition
2. Eligible patients were at least 18 years of age had acute onset of ARDS.
3. Bilateral opacities in chest radiography
4. No cardiac failure
5. PaO2/FiO2 ratio \< 200

Exclusion Criteria:

1. 72 hours after all inclusion criteria met
2. Pre-existing severe diseases of any major organs
3. Pregnancy
4. Pulmonary hypertension
5. Malignant diseases
6. HIV infections.

Primary outcomes:
measure: Compare the adverse events between mesenchymal stem cell treatment and placebo groups
timeFrame: From day 0 at the start of treatment to day 28.
Secondary outcomes:
measure: Hospital indices by treatment group
timeFrame: From admission to discharge
Other outcomes:
measure: cytokines
timeFrame: Day 0 to day 7
Locations:
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
Study officials:
References:
citation: Zheng G, Huang L, Tong H, Shu Q, Hu Y, Ge M, Deng K, Zhang L, Zou B, Cheng B, Xu J. Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study. Respir Res. 2014 Apr 4;15(1):39. doi: 10.1186/1465-9921-15-39.
Clinical trial NCT06398782: Prognostic Effect of Body Composition in Cancer Survivors
Official title: The Impact of DXA-Based Body Composition Phenotypes on the All-cause Mortality Among the US Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Composition
Morality
Cancer Survivor
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 1500
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: The data were extracted from National Health and Nutrition Examination Survey (NHANES) 1999 to 2006 and 2011 to 2018.

Brief summary: This study aims to evaluate the association between body composition and mortality risk among the US population based on data from the National Health and Nutrition Examination Survey (NHANES), a nationally representative cohort.


Eligibility criteria: Inclusion Criteria:

* Participants with cancer diagnosis beyond 18 years old.

Exclusion Criteria:

* Participants with missing cancer investigations and incomplete DXA body composition data were excluded from the study.

Primary outcomes:
measure: Rate of all-cause mortality
timeFrame: Jan 1 1999 to Dec 31 2019
measure: Rate of all-cause mortality
timeFrame: Jan 1 1999 to Dec 31 2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01655082: Nicotine Patch Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smokers
Keywords: Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-08-01
Enrollment: 160
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 safety profile of a repeated application of a new transdermal patch compared to a reference product during 3 weeks, in a large population.


Eligibility criteria: Inclusion Criteria:

* Male or female aged more than 18 years
* Regular smoker motivated to stop tobacco consumption
* Current smoker of \> or = 20 cigarettes/day and \< or = 25 cigarettes/day or Fagerström score \> or = 5 (for smokers between 10 to 20 cigarettes/day)

Exclusion Criteria:

* Any visible skin disorder, abnormal skin pigmentation or other dermatologic disease which, in the opinion of the investigator would interfere with the assessment of the different parameters
* Current or past serious chronic cardiovascular, renal, hepatic, gastrointestinal (including duodenal or gastric ulcer), endocrine, hematological, neuropsychiatric, immunosuppressive condition or allergic disease, myopathies, epileptic seizures, bleeding tendency, cancer
* History of angina pectoris, myocardial infarction or stroke in the previous 3 months, coronary artery vasospasm, cardiac arrhythmia, acute stroke
* Clinically relevant abnormal findings on the physical examination (e.g large scars on the application zone)

Primary outcomes:
measure: Safety
timeFrame: up to Day 22
Secondary outcomes:
measure: Sensory profile
timeFrame: Day 22
measure: Global assessment by the patient
timeFrame: Day 22
measure: Subject behaviours
timeFrame: up to Day 22
Other outcomes:
Locations:
city: Gières
country: France
city: Pierre - Benite
country: France
city: Rennes
country: France
city: Rueil - Malmaison
country: France
Study officials:
References:
Clinical trial NCT06085482: A Phase I Study of LY3502970 in Healthy Participants
Official title: A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 9 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation
* Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study

Exclusion Criteria:

* Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
* Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
* Participants who regularly use known drugs of abuse or show positive findings on drug screen

Primary outcomes:
measure: Pharmacokinetics (PK): Absolute bioavailability of LY3502970
timeFrame: Predose up to 16 days postdose
Secondary outcomes:
measure: PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of Total Radioactivity
timeFrame: Predose up to 16 days postdose
measure: PK: AUC [0-∞] of [14C]-LY3502970
timeFrame: Predose up to 16 days postdose
measure: PK: AUC [0-∞] of LY3502970
timeFrame: Predose up to 16 days postdose
measure: PK: Maximum Concentration (Cmax) of Total Radioactivity
timeFrame: Predose up to 16 days postdose
measure: PK: Cmax of [14C]-LY3502970
timeFrame: Predose up to 16 days postdose
measure: PK: Cmax of LY3502970
timeFrame: Predose up to 16 days postdose
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Inc
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01125982: Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
Official title: Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fatigue
Nausea
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2010-05-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to establish validated outcome measures for Postoperative Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms during first week after Propofol or Desflurane based anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for day-surgery laparoscopic cholecystectomy
* The patient is able to read and comprehend Norwegian language
* The patient is cognitive adequate and able to fill in survey forms
* The patient has read and signed patient information form

Exclusion Criteria:

* Serious illness (ASA 3-4)
* Pregnancy or suspected pregnancy
* Breastfeeding women
* Contraindications to use of NSAIDs
* Serious allergic reaction to anaesthetics
* Allergy towards egg, soya or peanuts
* Known or suspected Malignant Hyperthermia or Porphyria
* Fatigue-related diagnosis
* Recently received adjuvant therapy (chemotherapy, radiotherapy)
* Severe chronic pain

Primary outcomes:
measure: Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
timeFrame: Within the first week postoperatively
Secondary outcomes:
measure: Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane
timeFrame: Within the first week postoperatively
measure: Fatigue scale validation
timeFrame: See under "Description":
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Telemark Hospital
state: Telemark
Study officials:
References:
Clinical trial NCT06609382: Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
Official title: Prognostic Value of Left Ventricular Mass Index in Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
Keywords: left ventricular mass index
all-cause death
survival
obstructive hypertrophic cardiomyopathy
septal myectomy
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: oHCM who underwent septal myectomy and had at least one CMR image before surgery.

Brief summary: In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival.

Detailed description: This retrospective study aimed to determine the prognostic value of left ventricular mass index in predicting clinical outcomes, including all-cause death, new-onset or recurrent atrial fibrillation, and a composite endpoint of all-cause death, heart failure,permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.

Eligibility criteria: Inclusion Criteria:(1) Difficulty in relieving symptoms with medication or recurrent syncope. (2) Left ventricular outflow tract (LVOT) pressure gradient ≥ 50 mmHg at rest or with provocation and the maximum thickness of the septum is ≧ 15 mm.

Exclusion Criteria:

* (1) Combined right ventricular outflow tract obstruction requiring right ventricular outflow tract dissection. (2) Combined mitral or aortic valve organic lesions requiring valve replacement surgery. (3) Apical ventricular aneurysm formation requiring ventriculotomy. (4) Previous septal reduction therapy, including alcohol ablation or septal myectomy. (5) patients did not undergo cardiac magnetic resonance examination.

Primary outcomes:
measure: All-cause death
timeFrame: One month after discharge
Secondary outcomes:
measure: composite endpoint
timeFrame: One month after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00704782: Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
Official title: An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease
* On donepezil (Aricept)
* Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

* Unstable medical illnesses or significant hepatic or renal disease
* Other primary psychiatric or neurological disorders

Primary outcomes:
measure: To assess the safety of Dimebon in combination with donepezil (Aricept)
timeFrame: week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
Study officials:
References:
Clinical trial NCT05959382: Evaluation of Clinical Success of Restorations Using Different Magnification Aids
Official title: Evaluation of Clinical Success of Restorations Using Different Magnification Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental loupe
restoration success
FDI criteria
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It has 4 groups in total. The treatments were carried out

* with no magnification aid
* with x2 loupe
* with x5 loupe
* with Dental operation microscope
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of using a loupe and dental operating microscope with different magnifications on the success of class II direct composite restorations.

Detailed description: A total of 130 class II, D2 deep caries teeth of 85 patients were randomly distributed to the naked eye, 3x magnification loupe, 5x magnification loupe, 8.5x magnification dental operating microscope (DOM) groups, and direct composite restorations were made with these magnification aids. carried out. Clearfil SE Bond 2 and Clearfil Majesty Posterior composite were used in all restorations. The restorations were evaluated using FDI criteria at 1,6 and 12-month periods, and restorations were scored between 1 and 5 for all criteria.

Eligibility criteria: Inclusion Criteria:

* Good oral and dental care of the patient,
* The need for at least 1 Class II restoration at a depth of D2 in the posterior group teeth,
* No crowding in the tooth to be restored, tooth contact and antagonist,
* The relevant tooth is vital,
* Absence of pain on percussion and palpation of the tooth.
* Absence of any pathology in the periapical tissues in radiographic evaluation,
* The patient was informed about the study and accepted the study,
* Having agreed to attend 1 month, 6 month and 12 month control sessions,
* The patient has no systemic disease,

Exclusion Criteria:

* Presence of severe periodontal disease,
* Teeth that cannot be insulated, malposed or overloaded or not loaded at all,
* Periodontal and endodontic removal of the relevant tooth is healthy,
* the patient is undergoing orthodontic treatment,
* Recording of dry mouth is set,
* Severe bruxism habit,
* Smoking

Primary outcomes:
measure: Evaluation of Restoration Success using FDI Criteria
timeFrame: a week after dental treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT05400382: Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression
Official title: Optimizing Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression, Unipolar
Pain, Postoperative
Keywords: postpartum
depression
pain
cesarean
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
name: Southern Illinois University
name: Arrowhead Regional Medical Center
name: Northwestern University Feinberg School of Medicine
First posted: 2022-06-01
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Detailed description: This clinical trial will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Eligibility criteria: Inclusion Criteria:

* 18-45 years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish

Exclusion Criteria:

* Women who screen 10 or higher on the EPDS

Primary outcomes:
measure: Postpartum depression
timeFrame: 4 weeks - 6 months
Secondary outcomes:
measure: Post-operative pain
timeFrame: 4 weeks - 6 months
Other outcomes:
Locations:
Study officials:
References: