louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06286657: Xanthohumol and Viral Infections (XL)
Official title: Xanthohumol in the Prevention of Virus-mediated Upper Respiratory Tract Infections in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection Viral
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.

Detailed description: In this placebo-controlled study, blood is taken on the first day of the study, followed by a 90-day intervention with xanthohumol or a placebo, which is taken twice daily. Blood samples will be taken on day 0, day 45 and day 90. Should the study participants develop a respiratory infection during the study, they will be asked to perform a self-test.

Eligibility criteria: Inclusion Criteria:

* healthy
* BMI \>18 kg/m² or \< 28kg/m²

Exclusion Criteria:

* food intolerances
* food allergies
* chronic inflammatory diseases
* metabolic diseases
* viral or bacterial infections within the last 3 weeks of inclusion
* intake of immunosuppressive medication
* severe acute respiratory syndrome coronavirus type 2-infection in the last 4 months
* influenza infection in the "current" flu season

Primary outcomes:
measure: Changes in severity and duration of viral infections
timeFrame: 90 days
Secondary outcomes:
measure: Changes in blood lipid levels
timeFrame: 90 days
measure: Changes in cognitive skills
timeFrame: 90 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT06373757: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect
Official title: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chitosan
Nano-hydroxyapatite Hydrogel
Intrabony Defect
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

Detailed description: Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.

Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.

Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.

HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.

Eligibility criteria: Inclusion Criteria:

* Age from 25 to 55 years.
* Both sexes.
* Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.

Exclusion Criteria:

* Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
* Smokers.
* Pregnant and lactating females.
* Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.

Primary outcomes:
measure: Gingival index
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Plaque index
timeFrame: 6 months after treatment
measure: Clinical attachment level
timeFrame: 6 months after treatment
measure: Periodontal probing depth
timeFrame: 6 months after treatment
measure: Acrylic stent for pocket assessment
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References:
Clinical trial NCT01454557: The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)
Official title: The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Acquired Brain Injury
Heart Rate Variability (HRV)
Auditory Stimuli
Physical Activity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an external stimuli. The aim of this system is to maintain homeostasis.The variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be a damage to the Central Nervous System (CNS) function. The damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. The autonomic system can influence the ability of patient with ABI to participate in the rehabilitation program. The aim of this work is to investigate the activity of the autonomic system activity as manifested by HRV among patients with ABI in different conditions: resting, during activity and while listening to different auditory stimuli.


Eligibility criteria: Inclusion Criteria:

* 2-4 months from acceptance to rehabilitation medical stable

Exclusion Criteria:

* medical unstable a significant hearing deficit premorbid neurological or mental condition

Primary outcomes:
measure: Heart Rate Variability
timeFrame: first measurement: 2 weeks to 2 months from hospitalization to the department: 24 hours EKG follow up for HRV base line. Last measurement: before the release from rehabilitation (up to 12 months).
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Ofer Keren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031857: Comparison of Kinesio Tape and Dry Needling for the Management of Rotator Cuff Tendinopathy: A Randomized Control Trial
Official title: Comparison of Kinesio Tape and Dry Needling for the Management of Rotator Cuff Tendinopathy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tendinopathy
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
Collaborators: name: Rawal General and Dental hospital, Islamabad
First posted: 2023-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind RCT
Primary purpose: TREATMENT

Brief summary: Its a single blind RCT

Detailed description: Kinesio tape and dry needling were compared for the management of rotator cuff tendinopathy

Eligibility criteria: Inclusion Criteria:

* age between 25-50 years old
* Both genders
* Not any comorbidity

Exclusion Criteria:

* Parkinson disease
* DM
* HTN

Primary outcomes:
measure: PNS
timeFrame: will be used to assess at baseline after 3 weeks
measure: SF-36
timeFrame: will be used to assess at baseline after 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: The Neurocouncil Clinic
state: Federal
Study officials:
References:
Clinical trial NCT06090357: Biomechanical Functional Evaluation of Plantar Pressures After Foot and Ankle Surgeries
Official title: Biomechanical Functional Evaluation of Plantar Pressures After Foot and Ankle Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Pressure
Keywords: foot
ankle
Post-operative
plantar pressure
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The described surgical techniques for the treatment of foot and ankle pathologies are numerous. In order to objectively assess the outcomes of these procedures, evaluation methods are typically used, primarily considering pain symptoms, residual functionality, the correction of any deformities achieved, and radiographic parameters. Conversely, assessments of plantar pressures, as a potential indicator of functional and biomechanical recovery, are still not widely utilized. Biomechanical functional assessments examine specific variables, including gait analysis, stabilometry, kinematics and kinetics of joint movements, and the activation and strength of particular muscle groups. These assessments can be conducted by specialized personnel using dedicated equipment such as a baropodometric platform and inertial sensors.

This study aims to, for the first time in the literature, present the results related to plantar pressures from different surgical treatments of the foot and ankle


Eligibility criteria: Inclusion Criteria:

* Patients who need to undergo surgical intervention
* Patients of both sexes aged between 18-75 years
* Patients who have provided their written informed consent to participate in the study
* Patients who have expressed their willingness to attend the Institute for the 6-month follow-up

Exclusion Criteria:

* Patients with severe postural instability
* Patients with cognitive deficits

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: At baseline (day 0)
measure: Visual Analogue Scale
timeFrame: After 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Giannini S. Kenneth A. Johnson Memorial Lecture. Operative treatment of the flatfoot: why and how. Foot Ankle Int. 1998 Jan;19(1):52-8. doi: 10.1177/107110079801900111. No abstract available.
Clinical trial NCT05744557: Vapocoolant Analgesia for Breast Lymphoscintigraphy
Official title: Vapocoolant Analgesia for Breast Lymphoscintigraphy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Gilero, LLC
First posted: 2023-02-27
Enrollment: 30
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: To learn if applying vapocoolant anesthetic spray ("Nüm") on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.

Detailed description: Primary Objectives:

1. Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy.
2. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy.

Secondary Objectives:

1. To assess patient pain intensity associated with the performance of breast lymphoscintigraphy.
2. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

Eligibility criteria: Inclusion Criteria:

* Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible.
* Age ≥18 years old
* Ability to understand and the willingness to sign a written informed consent document.
* Childbearing potential, lactating, pregnant women will be included.

Exclusion Criteria:

* Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane.
* Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes)
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sanjit Tewari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04751357: Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test
Official title: Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heparin-induced Thrombocytopenia
Keywords: Argatroban
ECA-Test
Ecarin
Clot-Pro
Thrombelastometry
ROTEM
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients at the Intensive Care Unit who receive a continuous infusion of argatroban are eligible for inclusion.

Brief summary: Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.


Eligibility criteria: Inclusion Criteria:

* Continuous infusion of Argatroban in routine clinical use according to local standard of care
* Expected length of stay at ICU \> 4 days
* 18 years

Exclusion Criteria:

* Heparin infusion in the last fourhours

Primary outcomes:
measure: Correlation of ECA-Test CT with Argatroban Plasma Concentration
timeFrame: ECA-Test CT and Argatroban Plasma Concentration will be measured on five consecutive days starting with inclusion in the study on day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, General Hospital
Study officials:
References:
Clinical trial NCT04110457: Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH
Official title: Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Metastases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with spinal metastases

Brief summary: To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .

Detailed description: this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Patient with tissue proven dx of cancer

Exclusion Criteria:

* Patient younger 18 years old
* CNS or spinal 1ry tumor

Primary outcomes:
measure: Evaluate quality of life after surgery
timeFrame: baseline
Secondary outcomes:
measure: to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university
city: Assuit
country: Egypt
facility: Assuit university
Study officials:
affiliation: lecturer
name: Essam El morshidy, PHD
role: STUDY_DIRECTOR
References:
citation: Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039.
citation: Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.
Clinical trial NCT06839157: Artificial Intelligence - Assisted Model for Optimal Timing of Surgery in Advanced Ovarian Cancer
Official title: An Artificial Intelligence - Assisted Model for Predicting Optimal Timing of Surgery in Advanced Ovarian Cancer: the Combined Study of the SUNNY Trial and the Real World Data
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian, Fallopian, and Primary Peritoneal Cancer
Artificial Intelligence (AI)
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
Collaborators: name: Shanghai Zhongshan Hospital
name: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
name: Sun Yat-sen University Cancer Centre
name: Fudan University
First posted: 2025-02-21
Enrollment: 4489
Sex: FEMALE
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: Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)

Brief summary: This study integrates data from the randomized controlled SUNNY trial (RCT) and real-world (RWD) data, and employs multimodal data fitting to construct a medical artificial intelligence model to identify the clinical characteristics of patient subgroups suitable for primary debulking surgery (PDS) or interval debulking surgery (IDS), and the cutoff values for selecting different timings of surgery for advanced ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients who were included in the SUNNY study or who were newly diagnosed with stage IIIC or IV primary epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer during the SUNNY study period (2015-2023)
* Underwent primary debulking surgery or interval debulking surgery
* Data avaliable on first-line treatment and follow-up

Exclusion Criteria:

* Non-epithelial ovarian cancer or borderline tumors.
* Low-grade tumors.
* Mucinous ovarian cancer.
* Missing data on first-line treatment and follow-up

Primary outcomes:
measure: The accuracy of predicting the 3-year overall survival (OS) difference between primary debulking surgery (PDS) and interval debulking surgery (IDS).
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05770557: Survey on Attitudes About COVID-19 Vaccinations in Italian HCW
Official title: Survey on Attitudes About COVID-19 Vaccinations in a Survey of Italian Healthcare Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination Hesitancy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 385
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthcare workers residing in Italy, of any age and gender

Brief summary: The Project is aimed at analyzing the perceptions, knowledge, attitudes and intentions of the population towards the anti-SARS-CoV-2 vaccine in order to identify the determinants of vaccine refusal/hesitancy, and to guide specific activities aimed at updating and the implementation of institutional communication strategies on the vaccine, involving health professionals and targeting the general population.


Eligibility criteria: Inclusion Criteria:

* healthcare workers residing in Italy

Exclusion Criteria:

* healthcare workers not residing in Italy

Primary outcomes:
measure: KAB factors
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli
state: RM
Study officials:
References: