louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05877677: The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Official title: The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 50
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue


Eligibility criteria: Inclusion Criteria:

* Healthy male aged 30-60 years old
* Must read and sign the informed consent form
* During the experiment, do not change the lifestyle and eating habits
* Cooperate not to engage in high-intensity exercise 48 hours before each experiment

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients
* People who have undergone surgery within 6 months or have lower limb injuries
* People who are allergic to Polygonatum kingianum extract
* Participate in other clinical trials related to anti-fatigue within four weeks of the trial
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: The change of aerobic endurance
timeFrame: Day 0, day 14, day28
measure: The change of continuous attention performance
timeFrame: Day 0, day 14, day28
measure: The change of concentration of testosterone in blood
timeFrame: Day 0, day 14, day28
measure: The change of blood PDE5 gene expression
timeFrame: Day 0, day 14, day28
Secondary outcomes:
measure: The change of blood nitric oxide (NO)
timeFrame: Day 0, day 14, day28
measure: The change of self-assessment fatigue condition
timeFrame: Day 0, day 14, day28
Other outcomes:
measure: The change of concentrations of liver function biomarkers (AST, ALT) in blood
timeFrame: Day 0, day 14, day28
measure: The change of concentrations of renal function biomarkers (BUN, creatinine) in blood
timeFrame: Day 0, day 14, day28
measure: The change of concentrations of blood lipid profiles (total cholesterol, LDL-C, HDL-C, triglyceride)
timeFrame: Day 0, day 14, day28
Locations:
city: Pingtung
country: Taiwan
facility: National Pingtung University of Science and Technology
Study officials:
affiliation: National Pingtung University of Science and Technology
name: Bo-han Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02677753: Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Official title: InterStim Implantation Rates Following Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Urinary Incontinence
Fecal Incontinence
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.

Detailed description: Sacral nerve stimulation (SNS) is a well-established treatment for refractory urinary urgency, frequency, retention and urge incontinence as well as fecal incontinence. Patients whose symptoms are refractory to more conservative therapies such as behavioral modification and/or medications are candidates for SNS. The InterStim system consists of a permanent tined lead and implantable pulse generator (IPG) or battery that delivers the sacral neuromodulation. This device is typically implanted after patients have a successful response to a trial of sacral neuromodulation with a temporary lead and external battery. The temporary lead placement is known as a Percutaneous Nerve Evaluation (PNE) and is typically done in as an outpatient procedure using local anesthetic. It is standard practice to use fluoroscopy intraoperatively to confirm correct placement of the permanent lead. Additionally, some physicians also use fluoroscopy to confirm correct placement of temporary lead during PNE while others place the lead based on anatomical landmarks and expected elicited responses for S3 stimulation.

The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following (PNE) performed with or without fluoroscopic guidance.

Eligibility criteria: Inclusion Criteria:

* Women age \>18
* English speakers
* Patients with urinary urgency, frequency, or urge incontinence refractory to at least 1 other intervention who elect to undergo PNE

Exclusion Criteria:

* Patients in whom bilateral leads cannot be placed
* Pregnant women
* Prisoners
* Less than 18 years of age

Primary outcomes:
measure: Number of Participants With InterStim Implantation Following PNE With or Without Use of Fluoroscopy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Physicians
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Sean L Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767853: Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells. Phenotype for Precision Medicine in Patients With SARS-Cov-2 Infection
Official title: Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells Phenotype Associated With Severe Lung Manifestations and Cytokines Storm for Precision Medicine in Patients With SARS-Cov-2 Infection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Keywords: bronchoalveolar lavage fluid
peripheral blood
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospedalized for Covid-19 pneumonia.

Brief summary: We hypothesise that patients with SARS-Cov-2 infection are characterized by progressive changes in distribution of distinct lung macrophages populations mediated by influx of circulating monocytes into the lungs . Moreover, we also hypothesise that patients with higher rate of MerTKpos alveolar macrophages in the lung lavage will have the lowest rate of lung complications and the best recovery outcome in terms of clinical outcome and need of assisted ventilation supporting the use of macrophage phenotyping as novel prognostic biomarker in patients with SARS-Cov-2 infection. Finally, the definition of the transcriptomic signature of peripheral blood and tissue-derived myeloid cell subtypes will offer new therapeutic target of this uncurable newly discovered infection.


Eligibility criteria: Inclusion Criteria:

- Patients with COVID-19 pneumonia

Exclusion Criteria:

* Other infections rather than Covid-19
* Patients with concomitant treatment with prednisone ≥10 mg daily
* Patients under therapy with immunosuppressants

Primary outcomes:
measure: Clinical improvement as shown by PaO2/FiO2>200
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Division of Rheumatology
state: Lazio
city: Glasgow
country: United Kingdom
facility: School of Infection and Immunity
Study officials:
References:
Clinical trial NCT05960253: Peroperative Effect of Regional Anesthesia in Hip Surgery
Official title: Comparison of the Peroperative Efficacy of Pericapsular Nerve Group Block and Lumbar Erector Spina Plan Block Applied Preoperatively in Patients Undergoing Hip Fracture Operation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A total of 120 patients scheduled for surgical operation due to hip fracture were divided into two randomized groups. The first group received pericapsular nerve group (PENG) block, while the second group received lumbar erector spinae plane (L-ESP) block prior to the surgery. Subsequently, all patients were positioned in the lateral decubitus position before spinal anesthesia and compared in terms of anesthesia effectiveness through pain scores.


Eligibility criteria: Inclusion Criteria:

- American Society of Anesthesiologists(ASA) 2-3 patients undergoing surgery due to hip fracture.

Exclusion Criteria:

* Patients in whom regional anesthesia is contraindicated.
* Patients who are unable to communicate.
* Patients with a known allergy to local anesthetics.
* Patients with organ failure.

Primary outcomes:
measure: Analgesia
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
Clinical trial NCT05945953: Incentive Spirometer as a Visual Feedback in Children With Spastic Cerebral Palsy
Official title: Comparison of Incentive Spirometer as a Visual Feedback Versus Deep Breathing Via Mirror Mediated Therapy on Pulmonary Function in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: To compare the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on pulmonary function in children with spastic cerebral palsy. To determine the effects of incentive spirometer as a visual feedback versus deep breathing via mirror mediated therapy on sleep and quality of life in children with spastic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Spastic diplegic, age above 5.
* According to modified Ashworth scale, moderate spasticity 1 to 3.
* Adequate cognition (will be assessed by using MMSE scale) in order to follow the instructions to use Incentive Spirometry and also able to comprehend single verbal command for breathing.
* Able to attend all sessions. (mentally and physically capable of attending session).
* Able to sit with support.

Exclusion Criteria:

* Participant falling in this category would be excluded of the study.
* Patients with any respiratory or cardiac disease that can affect their respiratory function.
* Patients with beta blockers or bronchodilators.
* Children with any cognitive impairment who are unable to follow instructions.
* Children with bone deformities, such as scoliosis or kyphosis.
* Children with any sort of auditory and visual defects.

Primary outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 6 weeks
measure: Forced vital Capacity (FVC)
timeFrame: 6 weeks
measure: Peak Expiratory Flow (PEF)
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of life questionnaire for children (CPQOL-Child)
timeFrame: 6 weeks
measure: Sleep (Sleep Disturbance Scale-SDSC)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: NIRM (National Institute of Rehabilitation Medicine
state: Federal
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04098653: Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT
Official title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Myeloid Tumors Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Conditioning
Myeloid Tumors
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhujiang Hospital
First posted: 2019-09-23
Enrollment: 196
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.

Detailed description: Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in myeloid tumors undergoing allo-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* Myeloid tumors undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: relapse rate
timeFrame: 1 year
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 1 year
measure: disease-free survival (DFS)
timeFrame: 1 year
measure: transplant-related mortality (TRM)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05878353: Influence of Local Doxycycline on the Outcomes of Periodontal Regeneration
Official title: Influence of Local Doxycycline on the Inflammatory Status of Intrabony Defects and Clinical Outcomes of Periodontal Regeneration: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 60
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: In this double-blinded randomized clinical trial, patients presenting periodontal intrabony defects requiring regenerative surgery and showing BoP will be included. Experimental sites at T-0 will be randomly treated with gentle debridement and administration of local DOX (test group) or with debridement alone (control group). After 2 weeks (T-1), defects will be treated by means of minimally invasive surgical technique. 14 days after the surgery (T-2) the EHI will be evaluated by a blinded examiner. Patients will be recalled each 2 months up to 12 months (T-3). At T-0, T-1 and T-3 periodontal examination and radiographic analysis will be done.


Eligibility criteria: Inclusion Criteria:

* 1) diagnosis of Stage III or IV periodontitis (Tonetti et al. 2018);
* 2) FMPS and FMBS \< 15% at the time of enrollment;
* 3) etiological periodontal therapy completed at least 3 months prior to screening;
* 4) presence of one natural tooth having a vertical defect with residual PPD ≥ 6 mm and a radiographic intrabony component ≥ 3 mm and BoP + requiring periodontal regenerative surgery.

Exclusion Criteria:

* 1) age \< 18 years;
* 2) smoking habits (\> 10 cigarettes/day);
* 3) contraindications for periodontal surgery;
* 4) systemic diseases affecting periodontal healing;
* 5) pregnancy and lactation;
* 6) history of periodontal surgery at the experimental teeth;
* 7) allergies to doxycycline and tetracyclines;
* 8) assumption of antibiotics in the last 3 months.

Primary outcomes:
measure: Clinical attachment level change
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic bone level change
timeFrame: 12 months
measure: Probing pocket depth change
timeFrame: 12 months
measure: Bleeding on probing reduction
timeFrame: 12 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: CIR Dental School
Study officials:
References:
Clinical trial NCT00302653: Rasburicase in Tumor Lysis Syndrome
Official title: Program of Rasburicase in the Treatment of Hyperuricemia in Children and Adolescent Patients With or at Risk of Tumor Lysis Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperuricemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 33
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether rasburicase is effective and safety in correcting hyperuricemia.


Eligibility criteria: List of inclusion Criteria:

* Acute hyperuricemia patients(uric acid\>8.0 mg/dl) before/during chemotherapy for hematologic malignancies.

List of exclusion Criteria:

* Hypersensitivity to uricases or any of the excipients.
* Known history of hemolytic anemia (G6PD deficiency).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
timeFrame: 24-48 hours after last dose of rasburicase
measure: Percentage of patients with uric acid greater-than-normal laboratory levels (hyperuricemia)
timeFrame: 28 (+- 3) days after the last dose of rasburicase
measure: Adverse events occurrence
timeFrame: During the study
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05548153: An Observational Study on the Relationship Between Tear Metabolomics and POD
Official title: An Observational Study on the Relationship Between Tear Metabolomics and POD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the elderly patients who underwent abdominal surgery under general anesthesia, there were no serious systemic diseases and severe cognitive impairment before operation.

Brief summary: To explore the correlation between tear metabolomics and POD. The purpose of this study was to compare the results of tear metabolomics between POD and non-POD elderly patients undergoing abdominal surgery, to clarify the correlation between tear metabolomics and POD, and to find tear markers related to POD.


Eligibility criteria: Inclusion Criteria:

* age 65-90 years old;
* ASA I-III;
* patients who plan to undergo elective abdominal surgery under general anesthesia;
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* patients with known mental illness or lack of communication or cognitive impairment before operation;
* severe vision, hearing, language impairment or other reasons unable to communicate with visitors;
* severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;
* long-term use of sedatives, antidepressants or alcoholism;
* patients with severe postoperative complications and admitted to intensive care unit;
* patients who refused or failed to complete the cognitive function test.
* patients who could not cooperate with the study for any other reason

Primary outcomes:
measure: Postoperative delirium during the 3 adys-follow-up after anesthetic resuscitation
timeFrame: From ending of the surgery to 3 days after anesthetic resuscitation
Secondary outcomes:
measure: Postoperative delirium in the postanesthesia care unit
timeFrame: From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes.
measure: Postoperative delirium on the first day after operation
timeFrame: 9：00-10：00 and 15：00-16：00 on The first day after operation
measure: Postoperative delirium on the second day after operation
timeFrame: 9：00-10：00 and 15：00-16：00 on The second day after operation
measure: Postoperative delirium on the third day after operation
timeFrame: 9：00-10：00 and 15：00-16：00 on The third day after operation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
name: Huang He, MD
role: STUDY_DIRECTOR
References: