louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06905314: A Single Ascending Dose of HRS-4029 in Healthy Subjects
Official title: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HRS-4029 Following a Single Dose in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 55 years.
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
4. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria:

1. Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
2. Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
3. Subjects with positive tests for infectious diseases.
4. Female who are pregnant or breastfeeding.
5. Unable to tolerate venipunctures or have a history of fainting needles and blood.
6. Historic abuse of alcoholic beverages
7. Smoke ≥5 cigarettes per day within 3 months prior to the study
8. History of drug abuse.
9. Other reasons that the investigator consider it inappropriate to participate in the trial.

Primary outcomes:
measure: The incidence and severity of adverse events
timeFrame: From ICF signing date to Day15
Secondary outcomes:
measure: Maximum observed concentration of HRS-4029 (Cmax)
timeFrame: 0 hour to 48 hour after administration
measure: Area under the serum concentration time curve (AUC) of HRS-4029
timeFrame: 0 hour to 48 hour after administration
measure: Time to maximum observed concentration (Tmax) of HRS-4029
timeFrame: 0 hour to 48 hour after administration
measure: Half-life (T1/2) of HRS-4029
timeFrame: 0 hour to 48 hour after administration
measure: Clearance (CL) of HRS-4029
timeFrame: 0 hour to 48 hour after administration
measure: Volume of distribution (Vz) of HRS-4029
timeFrame: 0 hour to 48 hour after administration
measure: Number of subjects who developed HRS-4029 antidrug antibodies (ADA)
timeFrame: Baseline to Day15
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03605914: Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Official title: Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 100
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 compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.


Eligibility criteria: Inclusion Criteria:

* english speaking
* candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
* scheduled for surgery at Texas Sinus Institute

Exclusion Criteria:

* allergy to either NSAIDs or opioids
* contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
* surgical plan exceeding basic endoscopic sinus surgery
* use of anticoagulation
* the presence of any pain disorder
* the current usage of any analgesic medication
* history of opioid addiction
* pregnancy
* history of chronic pain or fibromyalgia
* current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)

Primary outcomes:
measure: Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
timeFrame: 24 hours (day 1 after operation)
Secondary outcomes:
measure: Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
timeFrame: 48 hours (day 2 after operation)
measure: Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
timeFrame: 72 hours (day 3 after operation)
measure: Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
timeFrame: 120 hours (day 5 after operation)
measure: Number of Participants With Bleeding Complications
timeFrame: 5 days after operation
measure: Number of Participants With Constipation
timeFrame: 5 days after operation
measure: Number of Participants With Nausea or Vomiting
timeFrame: 5 days after operation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Martin Citardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228914: Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
Official title: Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endoscopic Sinus Surgery
Nasal Polyps
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 20
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 compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.

Exclusion Criteria:

* pregnancy
* known coagulopathy
* an international normalized ratio greater than 1.3
* a partial thromboplastin time greater than 50 seconds
* use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
* use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
* poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
* having any adverse reaction to topical epinephrine or oxymetazoline.

Primary outcomes:
measure: Surgical Field Visualization During Sinus Surgery as Indicated by Score on Boezaart Grading Scale
timeFrame: during surgery approximately 2-3 hours
Secondary outcomes:
measure: Amount of Blood Loss in mL
timeFrame: immediately at the completion of surgery (surgery lasts about 2-3 hours, and the suctioning stops immediately following the completion of the case)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: William C Yao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05522114: Accuracy of Patient Specific Guide for TMJ Injection
Official title: Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMD
Keywords: virtual planning
3D printing
TMD
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

Detailed description: The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
* Patients who would not respond to conservative treatment as the first line of treatment.

Exclusion Criteria:

* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Primary outcomes:
measure: Angle of deviation
timeFrame: 1 month
measure: Vertical displacement of needle tip
timeFrame: 1 month
measure: Overall needle tip dislocation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Al-Azhar University.
Study officials:
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: AbdElKader A Hyder, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: Wael A ElMohandes, PhD
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
name: Bahaa El-Din A Tawfik, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02421614: Enteral Feeding Composition and Acute Respiratory Failure
Official title: Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Respiratory Failure
Keywords: acute respiratory failure
lung
enteral feeding
feeding composition
olive
high fat
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.


Eligibility criteria: Inclusion Criteria:

* enrolled in ICU
* age older than 18 years old
* need to be mechanically ventilation
* have enteral feeding
* no previous diabetes
* no previous HIV infection
* no previous nervous system
* no previous liver failure
* no previous nephrotic syndrome
* not passed more than 48 hours from diagnose of acute respiratory failure

Exclusion Criteria:

* death at less than three days of enteral feeding administration
* extubation at less than three days of enteral feeding administration

Primary outcomes:
measure: length of ventilation
timeFrame: The number of days at least 3, to which days that patient extubated
Secondary outcomes:
measure: Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood
timeFrame: 10 days
measure: Levels of Total Antioxidant Capacity (TAC) in patient's vein blood
timeFrame: 10 days
measure: Levels of uric acid in patient's vein blood
timeFrame: 10 days
measure: Levels of Interleukin 6 (IL-6) in patient's vein blood
timeFrame: 10 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition Sciences and Food Technology
Study officials:
References:
Clinical trial NCT04068714: Open Versus Endovascular Repair of Abdominal Aortic Aneurysms
Official title: Retrospective Cohort Study of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm Without Rupture
Lead sponsor: Hospital Sao Joao
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 125
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: This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015. The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.

Brief summary: This is an observational retrospective cohort study of all patients consecutively submitted to elective abdominal aortic aneurysm surgery repair at a tertiary referral centre between 2009 and 2015. Patients were excluded if they were non-elective cases or had complex aortic aneurysms (juxta-renal, thoraco-abdominal or thoracic). Differences between both groups of repair were assessed, as well as short- and long-term complications including medical complications, duration of hospital stay, major cardiovascular events, mortality and vascular reintervention.


Eligibility criteria: Inclusion Criteria:

* This is an observational retrospective cohort study of all patients consecutively submitted to elective AAA surgery repair at a tertiary academic referral center from south Europe, between January 2009 and December 2015.

Exclusion Criteria:

* The exclusion criteria were non-elective cases, aortic intervention due to diagnosis other than infrarenal AAA and complex aortic aneurysms such as juxta-renal, thoraco-abdominal or thoracic aneurysms.

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: 12 months
Secondary outcomes:
measure: Death
timeFrame: 12 months
measure: Medical complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário de São João
Study officials:
References:
Clinical trial NCT05276414: Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag
Official title: Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Schistosomiases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Samples will be collected from outpatient children aged between 5 - 16 years from Pediatric outpatient Clinics in Sohag hospitals.

Brief summary: Schistosomiasis is a chronic infection endemic in 74 tropical and sub-tropical countries. Sub-Saharan Africa carries the highest burden (90%) of schistosomiasis which caused by both Schistosoma mansoni and Schistosoma haematobium. The prevalence of Schistosomiasis should be assessed to control of the infection. This is usually achieved through surveys based on the use of traditional parasitological methods as urine filtration for S. haematobium. However, these traditional methods are time consuming, require an experienced technician and multiple samples due to light-infection and irregular shedding. Therefore, the point-of-care Circulating Cathodic Antigen (POC-CCA) urine test has been developed for the diagnosis of S. haematobium infection which is simple, rapid, sensitive and specific assay.


Eligibility criteria: Inclusion Criteria:

* 100 outpatient children aged between 5 - 16 years

Exclusion Criteria:

* Outpatient children should not have received schistosomiasis treatment (within the past 6 months) prior to the study

Primary outcomes:
measure: to evaluate the accuracy of rapid immunochromatographic assay (POC-CCA) compared with traditional microscopic examination for diagnosis of Schistosoma haematobium infection
timeFrame: 16 weeks following the startpoint of the study.
Secondary outcomes:
measure: to estimate the prevalence of Schistosoma haematobium infection in outpatient children in Sohag
timeFrame: 16 weeks following the startpoint of the study.
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine,Sohag University
Study officials:
affiliation: Medical Parasitology, Faculty of Medicine, Sohag University
name: Asmaa K Abd Ellah, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04162314: Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis
Official title: The Role of β-1,3/1,6-D-Glucan From Extract of Indonesian Ganoderma Lucidum Mycelium as a Combination Therapy With Methylprednisolone for Treatment of Non-infectious and Idiopathic Uveitis: A Double-blind Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Uveitis
Keywords: non-infectious uveitis
idiopathic uveitis
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis

Detailed description: Patients with non-infectious and idiopathic uveitis will receive standard treatment with methylprednisolone, but will be randomized to receive either Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum or placebo. Follow up will be performed on week-2, week-4, week-6, month-2, and month-3. Outcomes measured are anterior chamber cells, visual acuity, and serum TNF-alpha levels.

Eligibility criteria: Inclusion Criteria:

1. Patients with non-infectious and idiopathic uveitis.
2. Indicated to receive oral steroid and have signs of anterior segment inflammation.
3. Anterior chamber inflammation \>= +2 according to SUN criteria.
4. Age between 18 and 65 years old, good general condition, consented to be involved in the research, and are willing to come regularly according to follow up schedule.

Exclusion Criteria:

1. Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial.
2. Received antibiotics one week before the start of the trial.
3. Contraindicated to oral steroid.
4. Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others.
5. Pregnant and nursing women.
6. Patients with history of hypersensitivity/ allergy to Ganoderma species or other fungi.

Primary outcomes:
measure: Change in anterior chamber inflammatory cells grading
timeFrame: Baseline, week-2, week-4, week-6, month-2, month-3
measure: Change of serum TNF-alpha level
timeFrame: Baseline, week-6, month-3
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSCM Kirana
state: DKI Jakarta
Study officials:
affiliation: FKUI/RSCM
name: Lukman Edwar, SpM(K), Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05914714: Ruxolitinib as GVHD Prophylaxis in AA Patients
Official title: Ruxolitinib as Graft-versus-Host Disease Prophylaxis for Allogeneic Stem Cell Transplantation in Aplastic Anemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: The Prophylactic Value of Ruxolitinib for aGVHD in HSCT Recipients of AA
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 46
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our study aimed to determine the prophylactic value of ruxolitinib for aGVHD in HSCT recipients of AA.Ruxolitinib was initiated at the beginning of conditioning regimen at 5 twice daily until 3 months post-transplantation. The cumulative incidence of aGVHD within 6 months after HSCT will be the primary observation item.


Eligibility criteria: Inclusion Criteria:

* (1) diagnosed as aplasitic anemia, including V/SAA,CAA and HAAA. (2) Age elder than or equal to 14 years; (3) Informed consent may be signed by themselves. (4) HIV negative, HBV, HCV negative; (5) Informed consent must be signed before the start of the study procedures, and informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member

Exclusion Criteria:

* (1) received a previous allogeneic HSCT; (2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment; (3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 xthe upper limit of normal (ULN) or serum total bilirubin \> 2.5 x ULN.

  (4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.

  (5) has both moderate hepatic insufficiency AND moderate renal insufficiency; (6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments; (7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).

  (8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring; (9) unable or unwilling to sign the consent form; (10) patients with other special conditions assessed as unqualified by the investigator

Primary outcomes:
measure: cumulative incidence of aGVHD
timeFrame: 6 months post-HSCT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: