louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06995326: A Study of SGB-3383 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3383 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Suzhou Sanegene Bio Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 37
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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3383 in healthy subjects. The study will be designed as a single ascending dose (SAD) phase, utilizing a double-blind, placebo-controlled approach.


Eligibility criteria: Inclusion Criteria:

* Weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), and Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m², inclusive
* Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to investigator's judgement.
* Participants must agree to use adequate contraception from signing the informed consent until 3 months after completion of the follow-up visit.
* Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

* A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
* History of meningococcal infection, or subjects from occupations or living environment at risk of Neisseria meningitidis exposure.
* Positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
* Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)\> 1.5 × ULN, and deemed clinically significant by the Investigators
* QTcF values \> 450 ms for male, and \> 470 ms for female

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: up to approximately 12 months
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of SGB-3383
timeFrame: Up to Day 3
measure: Area Under the Concentration-time Curve (AUC) of SGB-3383
timeFrame: Up to Day 3
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03149926: Emotional Reaction and Self Injury in Patients With Borderline Personality Disorder and Healthy Controls
Official title: Emotional Reaction of Patients With Borderline Personality Disorder (BPD)on Stimuli Connected to Self-injury - A Comparison Between Patients With BPD and a Healthy Control Group.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Borderline Personality Disorder
Emotions
Lead sponsor: University of Oldenburg
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Borderline personality disorder that are current in treatment in the inpatient dialectical behavioral therapy unit of the universityhospitel or have completed the treatment.

Matched, healthy controls without psychiatric disorders

Brief summary: The current study investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury.


Eligibility criteria: Inclusion Criteria:

* Patients that are able to use skills and have some therapy experiences.

Exclusion Criteria:

* Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality

Primary outcomes:
measure: Emotional reaction
timeFrame: one session of 90min
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Zwischenahn
country: Germany
facility: Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg
Study officials:
affiliation: Department of Psychiatry and Psychotherapy - University Hospital, University of Oldenburg, Oldenburg, Germany
name: Alexandra Philipsen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmann K, Schulze M, Soros P, Schmahl C, Philipsen A. Development and validation of an emotional picture set of self-injury (EPSI) for borderline personality disorder: protocol for a validation study. BMJ Open. 2019 May 22;9(5):e027063. doi: 10.1136/bmjopen-2018-027063.
Clinical trial NCT06178926: Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation
Official title: Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation: A Double-Blind, Randomized, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Ciprofol
Keywords: Radiofreqency ablation
Liver Cancer
Ciprofol
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Detailed description: Ciprofol was injected before ablation and sedation scores were measured to make sure certain sedation.

Eligibility criteria: Inclusion Criteria:

* Patients who intend to undergoing ultrasound-guided percutaneous radiofrequency ablation of liver tumors;
* Age: 18-75 years old;
* ASA grade I-III;
* Laboratory examination meets the following conditions: neutrophils \>1.5×109/L, platelet \>80×109/L, hemoglobin \>90g/L, aspartate transferase \<1.5×ULN, total bilirubin \<1.5×ULN, serum creatinine \<1.2 x ULN;
* Chemotherapy \< 4 times.

Exclusion Criteria:

* Patients who are known to be allergic to propofol, opioids, eggs, soy products, or patients who are contraindicated with these drugs or foods due to illness;
* serious organ dysfunction and other systemic diseases, such as liver dysfunction, renal dysfunction; Worsening congestive heart failure within the last 6 months resulting in hospitalization or adjustment of medication; Severe aortic or mitral stenosis; Heart surgery (heart valve replacement) within the last 6 months; Acute myocardial infarction in the last 6 months; Hemodynamic disturbance due to arrhythmia; Respiratory diseases; Cerebrovascular diseases; . Taking propofol, opioids or other analgesic and sedative drugs 72 hours before . Emergency surgery;
* Those who are unable to communicate with the researcher normally or who are deemed unsuitable by the researcher and refuse to participate in the study.

Primary outcomes:
measure: Sedation efficacy
timeFrame: From the start of propofol/ciprofol injection to 4 min after sedation.
Secondary outcomes:
measure: Respiratory depression
timeFrame: From the injection of propofol/ciprofol to the period patient return to the ward, an average of 2 hours.
measure: Injection pain
timeFrame: From the injection of propofol/ciprofol to the end of the surgery, an average of 1 hour.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Jiangling Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167826: Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate.
Official title: Oral Health Status and Diet History Analysis Among Orphan House Children From 10-14 Years in Cairo Governorate : A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gingival Disease Due to Bacteria
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 115
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will done for Orphan children in Resalaa charity organization in Cairo governorate in Egypt.

Brief summary: the purpose of study to determine oral health status and dietary habits among group of orphan children from 10-14 years in Cairo Governorate.

Detailed description: The study's investigators will record all data related to oral health status of orphan children from 10-14 years and their dietary habits to describe usual food intake and its variation over a long period of time . the OHI-S will also recorded which has 2 components the Debris index and Calculus index .

Eligibility criteria: Inclusion Criteria:

* Egyptian children aged from 10-14 years
* Cooperative children

Exclusion Criteria:

* Children with systemic disease , genetic disorders , or any disabilities

Primary outcomes:
measure: oral health status
timeFrame: 3 months
measure: oral health status
timeFrame: 3 months
measure: Diet history analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Sherine Ezz eldeen, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03597126: Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer
Official title: Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: Robotic
Intersphincteric Resection
rectal cancer
pelvic autonomic nerve anal function
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.


Eligibility criteria: Inclusion Criteria:

1. 18 years \< age \< 80 years
2. Matching the diagnostic criteria;
3. tumor located 3 cm from anal verge
4. Clinically diagnosed cT1-3N0-2 M0 lesions
5. Tumor size of 4 cm or less
6. ASA 1-3 scores;
7. ECOG score is 0-1;
8. Adequate preoperative sphincter function

Exclusion Criteria:

1. Requiring a Mile's procedure
2. Fecal incontinence;
3. Previous abdominal surgery
4. Severe mental disease.
5. Intolerance of surgery for severe comorbidities
6. Emergency operation due to complication
7. Pregnant woman or lactating woman

Primary outcomes:
measure: Change in urinary function
timeFrame: 6 months
measure: Change in International Index of Erectile Function [IIEF] score
timeFrame: 18 months
measure: Change in FIQL scores
timeFrame: 18 months
measure: Change in Female Sexual Function Index [FSFI]
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
References:
Clinical trial NCT00800826: The Combination Effect of Dexmedetomidine and Morphine in Postoperative Patient-Controlled Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia, Patient-Controlled
Analgesia, Postoperative
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study was designed to examine the analgesic and side effects of dexmedetomidine-morphine mixture for intravenous patient-controlled analgesia (PCA).

Detailed description: Patient-controlled analgesia (PCA) is a widely accepted method to control postoperative pain. Morphine is the commonest opioid for PCA, however its side effects are troublesome. Morphine-related side effects include pruritus, nausea, vomiting, constipation, urinary retention, respiratory depression, and sedation. Many studies had been conducted to reduce the side effect of morphine. The current trend of reducing morphine side effect is direct combination of other drugs and morphine in PCA. The advantages of this method are convenient in clinical use and preventive for side effects. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist that has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. The main advantage of this drug is that it does not cause serious respiratory side effects. The analgesic, sedative/hypnotic and anxiolytic prop¬erties of dexmedetomidine make this drug potentially useful for postoperative sedation and analgesia. No previous study had investigated the effect of direct combination of dexmedetomidine and morphine in PCA. The goal of this study is to investigate the combination effect of dexmedetomidine and morphine in postoperative patient-controlled analgesia.

Eligibility criteria: Inclusion Criteria:

1. Patients who sign informed consent to receive general anesthesia and postoperative analgesia with a PCA device
2. Age between 18-65 y/o
3. ASA physical status I-III
4. Scheduled surgical procedures: gynecological surgery (vaginal or abdominal total hysterectomy), general surgery (gastrectomy, hepatectomy, colon cancer) , orthopedic (spinal fusion or total knee placement), or neurosurgical (cervical decompression)

Exclusion Criteria:

1. Patients with a definite diagnosis of chronic pain syndrome, psychiatric disorders, or drug abuse (include opioids, NSAIDs, sedatives, antidepressants).
2. Use of sedatives, analgesics, antiemetics, or antipruritics within 24 hours before operation.
3. Patients with definite diagnosis of esophageal reflux syndrome.
4. Patients with the probability to be pregnant.
5. Intraoperative fentanyl use \> 6 μg/kg.
6. Patients with significant bradycardia (HR \< 60/min) and hypotension (SBP \< 90mmHg) after the surgery.
7. The duration of surgery is longer than 6 hours.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01123226: Trigger Point Therapy Versus Manipulation Correcting Thoracic Manipulable Lesion
Official title: Relative Effectiveness of Trigger Point Therapy Compared to Spinal Manipulation in Correcting a Thoracic Spinal Manipulable Lesion in Subjects With Mechanical Thoracic Back Pain: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Manipulable Lesion
Somatic Dysfunction
Lead sponsor: Anglo-European College of Chiropractic
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be no difference between trigger point therapy and spinal manipulation in correcting a spine joint dysfunction in the back


Eligibility criteria: Inclusion Criteria:

* mechanical thoracic back pain
* age 18-64
* presence of at least one spinal manipulable lesion
* presence of a trigger point associated with the spinal manipulable lesion
* able to lie prone on a treatment table for 15 minutes

Exclusion Criteria:

* absolute contraindications to spinal manipulation
* specific thoracic back pain
* bleeding diathesis, use of anticoagulants, long-term corticosteroid use
* involved in litigation for thoracic back pain
* inability to read or write English fluently
* treatment with manipulation or myofascial therapy within past three days

Primary outcomes:
measure: Correction of spinal manipulable lesion
timeFrame: Immediate effect of one treatment
Secondary outcomes:
measure: Change in pressure pain threshold over the involved spinous process
timeFrame: Immediate effect of one treatment
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Anglo-European College of Chiropractic
state: Dorset
Study officials:
References:
Clinical trial NCT00172926: Study on the Relationship Between Physical Constitution and Diseases
Official title: Cross Sectional Study on Relationship Between Physical Constitution and Diseases in the Integrative Chinese Medicine and Western Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Diseases
Keywords: Physical Constitution
Disease Pattern
Laboratory Data
Integrative Chinese Medicine and Western Medicine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Physical constitution is an important factor for the development and outcome of diseases according to the theory in traditional Chinese medicine.

The purpose of the study is to find the correlation between physical constitution and clinical characteristics (age, sex, symptoms, physical signs, life style, laboratory results and image findings) through the questionnaire and results of health examination.

Detailed description: It is difficult to predict the process or outcome of disease for individuals who expose to the same pathogen or condition. But according to the Traditional Chinese Medicine, physical constitution is an important factor for disease pattern, severity and response to the treatment. So it is paid more and more attention in Western Medicine to study the variation of individualized susceptibility to diseases.

There have been some researches to investigate the relationship between physical constitution and disease pattern. Before further studies, we need to obtain more information about physical constitution and clinical characteristics. Therefore we design a comprehensive questionnaire to survey the types of physical constitution. And we plan to collect the data from health reports of candidates after their medical tests at Health Examination Center in National Taiwan University Hospital Yu-Lin Branch. We focus on the relationship between clinical characteristics (age, sex, symptoms, physical signs, laboratory results and image findings) of Western Medicine and the physical constitutional types of Chinese Medicine. Then we will try to find the correlation and significance between them.

The study will conclude the constitutional characteristics in general population of Taiwan and the distribution tendency of physical constitution for the common diseases. The result can serve as a stepping stone for integration of the Traditional Chinese Medicine and Western Medicine.

Eligibility criteria: Inclusion Criteria:

* candidates with healthy report on health exam

Exclusion Criteria:

* acute infection
* chronic disease with acute exacerbation
* unstable disease status or medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: China Medical University, China
name: Yi-Chang Su, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01687426: Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official title: A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma and Ocular Hypertension
Lead sponsor: Eye Therapies, LLC
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
* Be willing and able to provide written informed consent prior to any study procedures being performed.
* Be willing and able to follow all instructions and attend all study visits.
* Be willing to discontinue use of disallowed medication
* Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
* Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.

Primary outcomes:
measure: IOP
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: For up to 8 weeks
Locations:
city: Winchester
country: United States
facility: Clinical Site
state: Massachusetts
Study officials:
References: