louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03824496: Head Pulse for Ischemic Stroke Detection
Official title: Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 42
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: Patients who have been evaluated by a medical professional who feels the subject may be experiencing an acute stroke and has triggered the acute stroke algorithm within the medical center.

Brief summary: Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect LVO is needed. Using highly sensitive accelerometers, one can measure the "HeadPulse"- tiny forces exerted on the skull from the cardiac contraction. This study tests the hypothesis that LVO alters the HeadPulse characteristically. Analysis of these data along with the subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to create a model that can predict LVO status in suspect stroke subjects.

Detailed description: Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers. Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers.

EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or absence of LVO based on recordings from a consecutive series of patients undergoing CTA for suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during LVO.

Eligibility criteria: Inclusion Criteria:

* Suspected acute stroke
* CTA or MRA performed

Exclusion Criteria:

* Any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.

Primary outcomes:
measure: Cranial accelerometry model
timeFrame: Through study completion, likely 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
References:
Clinical trial NCT00764296: Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds
Official title: Collection of Samples for the Evaluation of Wound Biofilm in Acute and Chronic Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: acute wounds and chronic wounds
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 34
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 Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.

Brief summary: The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.

Detailed description: Characterizing the surface of the acute wound is important because the characterization can act as a control and can give a standard by which to judge the microscopic pathology observed in chronic wounds.

Eligibility criteria: Inclusion Criteria:

* The subject must be 18 years of age or older.
* The subject must have a full thickness acute or chronic wound. The sampling is restricted to subjects with the presence of a full thickness wound in order to reduce any risk for infection to the subject. Biopsying a wound that is already full thickness should not increase the subject's risk.
* The subject must have no history of coagulopathy
* If the subject's acute wound will be biopsied, the wound must be less than 48 hours old.
* The subject must be a candidate for sharp debridement

Exclusion Criteria:

* The subject may not have myelosuppression indicated by a CBC which may include a WBC less than 1500 cells per cubic millimeter, platelet count less than 125,000 per cubic millimeter, or hemoglobin less than 9 g/dL.
* The subject may not be on anticoagulation therapy because anticoagulation therapy increases the risk of bleeding.
* The subject may not have a TCpO2 less than 20 torr. Subjects with low tissue oxygenations may have some risk from biopsy due to their poor ability to heal and, therefore, are excluded.
* The subject may not be pregnant
* The subject's wound must not be in the region of the face, neck, or genitalia

Primary outcomes:
measure: The Specific Aim of examining wounds microscopically is to attempt to demonstrate the presence of biofilm in chronic wounds and to understand these populations on a cellular level.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Southwest Regional Wound Care Center
state: Texas
Study officials:
References:
Clinical trial NCT02848196: An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients
Official title: A Phase II Trial of Image-guided Stereotactic Body Radiation Therapy (SBRT) for Adrenal Gland Metastasis in Oligometastatic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adrenal Gland Metastases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.

Detailed description: This is a phase II, single arm, trial for testing efficacy of ablative high hypofractionated dose delivered with VMAT technique in oligometastatic patients with adrenal gland metastases. The potential advantages of this approach include the possibility to lead an increased local control in irradiated adrenal gland metastases. Other purpose of this study is to assess acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18years.
* WHO performance status ≤ 1 (ECOG - KPS).
* Histologically-proven of primary cancer disease
* Metastases at adrenal gland radiologically proven
* Written informed consent

Exclusion Criteria:

* Prior radiation to the interested adrenal gland.
* Patients allergic to contrast used in CT scans or who cannot be premedicated for the use of contrast.

Primary outcomes:
measure: Control of local disease
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of acute and late complications
timeFrame: 5 years
measure: Endocrine mechanisms of hormonal production
timeFrame: 5 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Humanitas Cancer Center
name: Ciro Franzese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03426696: Psychological Status and Related Factors of Thyroid Related Eye Disease
Official title: Psychological Status and Related Factors of Thyroid Related Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Related Eye Disease
Keywords: psychological status
Related Factors
Thyroid Related Eye Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in Sun Yat-sen University that diagnosed as Thyroid Related Eye Disease

Brief summary: The purpose of this study is to evaluate the psychological status of Thyroid Related Eye Disease.

Detailed description: The purpose of this study is to evaluate the psychological status of patients of Thyroid Related Eye Disease over 16 years old, and to analyze the related factors of them.

Eligibility criteria: Inclusion Criteria:

* over 16 years old
* diagnosed as Thyroid Related Eye Disease

Exclusion Criteria:

* any uncontrolled clinical problems

Primary outcomes:
measure: Quality of life questionnaire of patients of Thyroid Related Eye Disease
timeFrame: immediately
Secondary outcomes:
measure: Symptom checklist 90(SLC-90)
timeFrame: immediately
measure: Hamilton anxiety scale(HAMA)
timeFrame: immediately
measure: Somatic self-rating scale(SSS)
timeFrame: immediately
measure: Hamilton depression scale(HAMD)
timeFrame: immediately
measure: Young manic rating scale(YMRS)
timeFrame: immediately
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Ye, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180596: PACMAN - PAcing for CardioMyopathies, a EuropeAN Study
Official title: Pacing for Cardiomyopathies, a European Study- A Therapy Acceptance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication

Detailed description: Heart Failure is a syndrome that affects millions of patients in Europe with over half a million new cases reported annually. Drug therapy had been the conventional treatment of choice until the emergence of cardiac resynchronization therapy (CRT) where biventricular pacing can be delivered to the heart through a pacemaker or implantable cardioverter defibrillator. This study was designed to assess the effect of CRT on patients optimized on conventional heart failure medication including diuretics, beta blockers and ACE inhibitors. The effect of CRT was evaluated by comparison of 6 minute walk performance, Quality of Life and NHYA class after 6 months with CRT therapy either programmed ON or OFF. In addition, evaluation of the incidence of adverse events (predefined as ventricular arrhythmias, hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6 months. Patients were all programmed ON after 6 months and data was collected for an additional 6 months.

Eligibility criteria: Inclusion Criteria:

- NYHA Class III and IV with EF \< 35%; Optimal individual drug therapy in 2 weeks prior to enrollment including ACE inhibitors; beta blockers and diuretics unless not tolerated

Exclusion Criteria:

* Reduced life expectancy of \< 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter

Primary outcomes:
measure: Improvement in functional capacity as measured by a six-minute walk test at 6 months
Secondary outcomes:
measure: Improvement in Quality of Life at 6 months; Improvement in NHYA classification at 6 months; incidence of adverse events at 6 months
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Guidant Corporation, , , Belgium
city: Aachen
country: Germany
facility: Medizinische Klinik I, University RWTH Aachen
Study officials:
affiliation: Medizinische Klinik I, University RWTH Aachen, Pauwelsstr. 30, 52057 Aachen, Germany
name: P HANRATH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04475796: Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Official title: Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis With Cholecystitis
Keywords: Choledocholithiasis
Early
Delayed
Laparoscopic cholecystectomy
ERCP
Nassar scale
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 66
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones.

Detailed description: Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new parameters like Nassar scale.

Eligibility criteria: Inclusion Criteria:

* patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP

Exclusion Criteria:

* advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.

Primary outcomes:
measure: operative time
timeFrame: one day
Secondary outcomes:
measure: intraoperative difficulty and complications
timeFrame: one day
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafr Al Sheikh
Study officials:
affiliation: Kafrelsheikh University
name: Ahmed Aouf, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452696: Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate
Official title: Clinical Trial to Evaluate the Gastric Tolerability and Efficacy of the Food Supplement of Microencapsulated Calcium Carbonate vs Conventional Calcium Carbonate and Calcium Citrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypocalcemia; Dietary
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
Collaborators: name: Nexentia S.A.S.
First posted: 2018-03-02
Enrollment: 208
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman
* Low contribution of elemental calcium in the daily diet

Exclusion Criteria:

* Hypersensitivity to the active substances or to any of the excipients
* Renal insufficiency
* History of kidney or urinary stones
* Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones
* Use of any other drug or experimental device during the 30 days prior to the selection

Primary outcomes:
measure: Gastric symptoms
timeFrame: 1 month
Secondary outcomes:
measure: Changes in bone markers
timeFrame: Basal and 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Instituto Palacios
name: Santiago Palacios, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04649996: Variation in Acute Appendicitis During COVID-19 Pandemic in Italy
Official title: Variation of Incidence and Clinical Presentation of Acute Appendicitis During a Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 532
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in hospital for acute appendicitis

Brief summary: retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern Italy, compared with the same period in the previous 2 years.


Eligibility criteria: Inclusion Criteria:

* acute appendicitis

Exclusion Criteria:

* other diagnosis

Primary outcomes:
measure: complicated appendicitis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
state: BG
city: Lecco
country: Italy
facility: Ospedale Manzoni
state: LC
city: Monza
country: Italy
facility: ASST Monza
state: MB
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Mi
city: Lodi
country: Italy
facility: ASST Lodi
city: Pisa
country: Italy
facility: Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello
Study officials:
References:
citation: Ceresoli M, Coccolini F, Magnone S, Lucianetti A, Bisagni P, Armao T, Ansaloni L, Zago M, Chiarugi M, Catena F, Braga M; Appendicitis-COVID study group. The decrease of non-complicated acute appendicitis and the negative appendectomy rate during pandemic. Eur J Trauma Emerg Surg. 2021 Oct;47(5):1359-1365. doi: 10.1007/s00068-021-01663-7. Epub 2021 Apr 12.
Clinical trial NCT06987396: Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients
Official title: Clinical Investigation to Assess the Effect of Betaglucan Administration in HPV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV
Keywords: HPV
Betaglucans
Immunity
RNA
Lead sponsor: Vitae Health Innovation
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised, controlled clinical study to assess the efficacy and tolerability of an oral supplementation of 1000 mg daily of Betaglucans in the evolution of patients with Human Papilloma Virus (HPV). The improvement is measured by DNA PCR test, cytology and a specific RNA test.


Eligibility criteria: Inclusion Criteria:

* Women over 30 years old, whether or not they have been vaccinated against HPV
* Patients attending a visit with a routine cytological result of ASCUS or lSIL, or a normal result with a positive HPV test, no more than 3 months prior to be enrolled
* Patients who freely provide written informed consent
* Patients with a positive DNA PCR test

Exclusion Criteria:

* Patients who are participating in another clinical study about the same or different condition within the 30 days prior to inclusion.
* Any subject who, in the investigator's opinion, is unable to follow instructions or properly comply with the treatment.
* Subjects who do not provide written informed consent to participate in the study.
* Patients who are receiving any of the prohibited drugs or supplements, and for whom withdrawal of these medications/products is expected to pose a significant issue.
* Pregnant or breastfeeding women.
* Transplanted patients and/or patients taking immunosuppressive medication.
* Patients with autoimmune diseases.

Primary outcomes:
measure: RNA PCR Test result
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: DNA PCR Test result
timeFrame: From enrollment to the end of treatment at 6 months
measure: Citology Test result
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Gynaecology Department, Medical Service Ishtar
Study officials:
References:
Clinical trial NCT01158196: Safety and Efficacy of Infrared Diode Laser on Improvement of Scar and Prevention of Recurrence of Excised Keloid
Official title: Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Keloid
Surgical Scar
Keywords: laser
keloid
scar
Lead sponsor: Ekkyo
Sponsor class: INDUSTRY
First posted: 2010-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Skin type from I to VI (Fitzpatrick classification scale)
* Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients

Exclusion Criteria:

* Malignant tumor pathology
* Infectious or viral skin disease
* Immunosuppressive pathology and/or immunosuppressive treatment,
* Long-term corticosteroid treatment
* Pregnant woman

Primary outcomes:
measure: treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
timeFrame: 10 days after surgery or excision
Secondary outcomes:
measure: improvement of scarring for plastic surgery group
timeFrame: 12 months after surgery
measure: keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.
timeFrame: 12 months after excision
measure: quality of life assessment for keloid group
timeFrame: 12 months after excision
measure: Socio and medical economic evaluation for keloid group
timeFrame: 12 months after excision
Other outcomes:
Locations:
city: Marseille
country: France
facility: Magalon
Study officials:
affiliation: plastic and reconstructive surgey department, APHM
name: Guy Magalon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: