louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01301261: Sugammadex: Effect on the Awareness Monitoring and Hemodynamics
Official title: The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: Sugammadex
entropy
bispectral index
blood pressure
heart rate
oxygenation
end-tidal CO2
hemodynamics
general anesthesia
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Detailed description: Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied.

Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium.

Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Eligibility criteria: Inclusion Criteria:

* patients ASA I-III scheduled for elective major surgery
* both sexes

Exclusion Criteria:

* patients hypertensive
* treated with antihypertensive drugs

Primary outcomes:
measure: Entropy
timeFrame: every three minutes
Secondary outcomes:
measure: hemodynamics
timeFrame: every three minutes
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Anesthesiology, Aretaieio Hospital
Study officials:
References:
Clinical trial NCT03296761: Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury
Official title: Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population admitted to ICU of Zhongda hospital ，diagnosed of ARDS

Brief summary: To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.

Detailed description: 70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h
2. Patients age between 18 years old and 80 years.

Exclusion Criteria：

1. Pregnant women,
2. Patients with malignant tumor,
3. Immunosuppression or immunocompromised patients.

Primary outcomes:
measure: mortality
timeFrame: 28-day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Zhongda Hospital, School of Medicine, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhong-Da Hospital, School of Medicine, Southeast University,
name: Haibo qiu
role: STUDY_CHAIR
References:
Clinical trial NCT06493461: A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults
Official title: Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension (PAH)
Lead sponsor: 35Pharma Inc
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

Detailed description: Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy

Eligibility criteria: Inclusion Criteria:

1. Male and female patients, 18 years of age and older.
2. Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
3. Documented diagnostic RHC at any time prior to screening.
4. Diagnosis of WHO PAH Group 1.
5. Symptomatic PAH classified as WHO FC II to IV.
6. Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn・sec・cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
7. On stable doses of at least 2 background PAH therapies.

Exclusion Criteria:

1. Left ventricular ejection fraction \< 50% at screening.
2. Any symptomatic coronary disease events within 6 months of the screening visit.
3. Uncontrolled systemic hypertension.
4. History of restrictive, constrictive or congestive cardiomyopathy.
5. History of atrial septostomy.
6. Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
7. Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 \< 60% predicted at the screening visit or within 6 months prior to the screening visit.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to 24 weeks
measure: Change from Baseline in Physical Examination
timeFrame: Up to 24 weeks
measure: Change from Baseline in Clinical Laboratory Parameters
timeFrame: Up to 24 weeks
measure: Change from Baseline in Blood Pressure
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Site-501
state: Alberta
city: Greifswald
country: Germany
facility: Site-202
Study officials:
affiliation: VP, Clinical Operations
name: Monique Champagne, M.Sc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06434961: The Trial of SHR6508 in Secondary Hyperparathyroidism
Official title: A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 498
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 study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa

Exclusion Criteria:

1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
8. Subjects with a treatment history of similar drugs
9. Allergic to a drug ingredient or component
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Subject with a history of alcohol abuse and drug abuse
13. Participated in clinical trials of other drugs
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
timeFrame: efficacy assessment period, defined as Week 20-27
Secondary outcomes:
measure: Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
timeFrame: efficacy assessment period, defined as Week 20-27
measure: Incidence of nausea and vomiting events
timeFrame: Day1 to End of Treatment, End of Treatment is about Week 27
measure: Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline
timeFrame: efficacy assessment period, defined as Week 20-27
measure: Change From Baseline in serum cCa and P
timeFrame: efficacy assessment period, defined as Week 20-27
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day1 to End of Study, End of Study is about Week 31
measure: Participants with Anti-SHR6508 Antibody at baseline and postbaseline
timeFrame: Day1 to End of Study, End of Study is about Week 31
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01400061: Relation of Blood-boron Levels With Body Mass Index
Official title: Phase 1 Study of Blood Boron Levels According to Body Mas Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: obesity, etiology, pathogenesis, treatment
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Normal: 19-24 Overweight: 25-29 Obes: 30-40 Morbid Obes: \>40

Brief summary: According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.

Detailed description: In the results of our experimental study on mices we revealed that low dose oral boric acid intake cause seriously body mas reducing. Although blood and urine analyses support high glucose, lipid and middle protein catabolisms, but the mechanism was unclear. There are some diseases according to blood elementary deficiencies, like hypothyroidi in hypoiyodinemia, hiperparathyroidi in hypocalcemia, etc. We hypothesised that hypoboronemia may be corralated to body mass index level.

Eligibility criteria: Inclusion Criteria:

* body mas index levels in over 19 peoples

Exclusion Criteria:

* known chronic, morbid and malign diseases

Primary outcomes:
measure: blood boron level
timeFrame: 6 months
Secondary outcomes:
measure: body mass index
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: rector
name: adnan yuksel, prof
role: STUDY_CHAIR
References:
citation: Aysan E, Bektas H, Ersoz F, Sari S, Kaygusuz A. A novel colonic anastomosis technique involving fixed polyglycolic acid mesh. Int J Clin Exp Med. 2010 Oct 24;3(4):341-6.
Clinical trial NCT00621361: Phase I Safety and Tolerability Study of Cediranib (RECENTIN™, AZD2171) in Combination With Chemo in First Line Lung Cancer Patients
Official title: A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: Lung Cancer
AZD2171
cediranib
RECENTIN
etoposide
cisplatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.


Eligibility criteria: Inclusion Criteria:

* Cancer diagnosis and stage (histological or cytological confirmed extensive stage lung cancer, which EP would be considered a standard therapy, required at the time of diagnosis.)
* No prior chemotherapy or immunotherapy for advanced stage lung cancer (prior radiotherapy will be permitted if it is outside of the measurable field and greater than or equal to 2 weeks prior to entry to the study.)
* WHO performance status 0-2

Exclusion Criteria:

* Untreated unstable brain or meningeal metastases
* Patient with inappropriate laboratory tests values
* Inadequate bone marrow reserve.

Primary outcomes:
measure: Assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171) in combination with etoposide and cisplatin (EP).
timeFrame: From date of consent through to data cut-off, 7th August 2009.
Secondary outcomes:
measure: Preliminary efficacy assessment of Cediranib in combination with etoposide & cisplatin using available tumor assessment data to assess response rate,duration of response,change in tumor size(only those with measurable disease)& progression free survival
timeFrame: From date of randomisation through to data cut-off, 7th August 2009.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Kansas City
country: United States
facility: Research Site
state: Kansas
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: John Heymach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01424761: Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA) indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes of this study are going to investigate the relation of coenzyme Q10 with other antioxidant vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD) patients during Statin therapy. The study is going to design a placebo-controlled study. The investigators will recruit coronary artery disease (CAD) patients who are identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery, and healthy subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements (150 mg/bid = 300 mg/d) groups. Intervention is going to administration for three months. Fasting blood will be obtained in each month and determine the concentration of antioxidant vitamins, lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the investigators will measure the level of inflammatory markers in all subjects of this study. Hopefully, the results of this study could provide information of coenzyme Q10 supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.


Eligibility criteria: Inclusion Criteria:

CAD patients is identified by cardiac catheterization as having at least 50% stenosis of one major coronary artery and under statin therapy.

Exclusion Criteria:

* age \< 18 years old
* pregnancy women
* taking antioxidant vitamins supplements

Primary outcomes:
measure: Antioxidant and inflammation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital
Study officials:
References:
citation: Lee BJ, Tseng YF, Yen CH, Lin PT. Effects of coenzyme Q10 supplementation (300 mg/day) on antioxidation and anti-inflammation in coronary artery disease patients during statins therapy: a randomized, placebo-controlled trial. Nutr J. 2013 Nov 6;12(1):142. doi: 10.1186/1475-2891-12-142.
Clinical trial NCT05063461: Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
Official title: Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Detailed description: General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.

Eligibility criteria: Inclusion Criteria:

* Age between 18- 65 years
* ASA physical status I or II
* Elective surgery in general anesthesia planned
* Written informed consent

Exclusion Criteria:

* Use of CNS-active medication or abuse of alcohol
* Presents of any neuromuscular or neurologic disease
* History of cardiac arrhythmia
* Pregnancy or using a pacemaker

Primary outcomes:
measure: To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
timeFrame: Change from Baseline ANI that 2 minutes after applied tetanic stilumation
Secondary outcomes:
measure: The ANI predictability for tetanic noxious stimuli
timeFrame: Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation
measure: The heart rate predictability for tetanic noxious stimuli
timeFrame: Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation
measure: The Bispectral Index predictability for tetanic noxious stimuli
timeFrame: Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05822661: Impact of Black Seed Oil on Hemodialysis Patients
Official title: Evaluation of the Impact of Black Seed Oil on Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: black seed oil
nigella sativa
hemodialysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug vs placebo
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of black seed oil on endothelial dysfunction, oxidative stress and quality of life in hemodialysis patients.

Detailed description: Evaluation of the effect of black seed oil in hemodialysis patients via:

* Evaluation of serum Endothelin-1 levels
* Evaluation of serum Malondialdehyde (MDA) levels
* Evaluation of serum Total Antioxidant Capacity (TAC) levels
* Evaluation of Quality of Life (QOL)
* Evaluation of fatigue scale

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years old
* Three to four times per week hemodialysis
* Being on hemodialysis for at least 6 months
* Ability and willingness to cooperate in the study

Exclusion Criteria:

* Pregnancy or lactation
* Cigarette smoking or substance/alcohol abuse
* Having active infectious diseases
* Receiving steroidal or nonsteroidal anti-inflammatory drugs
* Using Nigella sativa oil regularly
* Changes in treatment methods (dialysis) or medications during the supplementation

Primary outcomes:
measure: serum Endothelin-1 (ET-1) level
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum malondialdehyde (MDA) and total antioxidant capacity (TAC)
timeFrame: 8 weeks
measure: Quality of life questionnaire
timeFrame: 4 weeks and 8 weeks
measure: Fatigue severity
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
affiliation: Faculty of pharmacy - Ain Shams University
name: May A Shawki, PHD
role: STUDY_DIRECTOR
affiliation: Faculty of pharmacy - Ain Shams University
name: Areej M Ateya, PHD
role: STUDY_DIRECTOR
References: