louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06344325: ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia
Official title: 90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Elective Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia

Detailed description: As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.

Eligibility criteria: Inclusion Criteria:

* Aged 18-80 years old, elective surgery under general anesthesia.
* ASA I-II;
* Surgical duration\>30 minutes;
* Sign an informed consent form.

Exclusion Criteria:

* American Society of Anesthesiologists(ASA)≥ III;
* Body mass index (BMI)\<18 kg/m2 or\>30 kg/m2;
* Individuals with a history or potential history of drug abuse or alcohol dependence;
* Preoperative use of sedative or analgesic drugs;
* Individuals with severe liver and kidney dysfunction;
* Individuals who are allergic or potentially allergic to propofol and lipids;
* The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
* Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
* Participants in other clinical studies within the past 3 months;
* researchers deemed it inappropriate for participants to participate in this study.

Primary outcomes:
measure: Sedation score
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative adverse reactions
timeFrame: 1 day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: aihua Du, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04303325: Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Official title: Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Depression
Keywords: depression
sleep deprivation
gut microbiota
bispectral index
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.

Detailed description: For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline

Eligibility criteria: Inclusion Criteria:

* At least18 years and pre-menopausal;
* scheduled to undergo elective breast cancer operation;
* American Society of Anaesthesiologists (ASA) risk classification I-II.
* Montgomery-asberg Depression Rating Scale (MADRS) score ≥22

Exclusion Criteria:

* Cognitive difficulties
* Partial or complete gastrectomy
* Previous esophageal surgery
* Inability to conform to the study's requirements
* Ongoing participation or participation in another study \<1 month ago

Primary outcomes:
measure: Montgomery-asberg Depression Rating Scale score
timeFrame: from baseline to postoperative 24 hours
Secondary outcomes:
measure: Bispectral index
timeFrame: from 8pm to 6am on the first postoperative night
measure: Gut microbiota
timeFrame: from baseline to postoperative 72 hours
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT05592925: Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study
Official title: Association Between Multiple Coagulation-related Factors and Lymph Node Metastasis in Patients With Gastric Cancer: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer Stage
Lymph Node Metastasis
Keywords: gastric cancer
lymph node metastasis
maximum amplitude
prognostic factor
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-25
Enrollment: 516
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with primary gastric cancer

Brief summary: We initially selected a total of 1128 patients with primary gastric cancer who presented at Shandong Provincial Hospital between January 2018 and October 2022, and retrospectively collected their clinical and pathological data. And retrospectively analyzed preoperative baseline characteristics, preoperative laboratory tests, and postoperative pathological results for these patients


Eligibility criteria: Inclusion Criteria:

1. patients with primary gastric malignant tumors,
2. patients who underwent radical resection of gastric cancer,
3. patients with a postoperative pathology of adenocarcinoma or signet ring cell carcinoma according to the WTO pathological classification,

Exclusion Criteria:

1. patients who have distant metastases, such as liver or lung metastases, were found on preoperative ultrasound and computed tomography (CT) examinations,
2. patients who have received preoperative neoadjuvant chemotherapy,
3. patients who take anticoagulant drugs (such as aspirin) prior to surgery,
4. patients who had any previous coagulation disorder.

Primary outcomes:
measure: Preoperative coagulation-related factors (MA values) of patients
timeFrame: Three years
measure: Preoperative coagulation-related factors (platelet counts) of patients
timeFrame: Three years
measure: Preoperative coagulation-related factors (fibrinogen levels) of patients
timeFrame: Three years
measure: Preoperative coagulation-related factors (D-dimer) of patients
timeFrame: Three years
measure: Postoperative pathological results of tumor T stage.
timeFrame: Three years
measure: Postoperative pathological results of tumor N stage.
timeFrame: Three years.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Feng Tian, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06497725: Teleguidance-facilitated Airway Management
Official title: Remote Teleguidance-facilitated Airway Management in Prehospital Emergency Medical Services: A Randomized Controlled Simulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Intubation; Difficult or Failed
Emergencies
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The advent of telemedicine has introduced teleguidance as a promising support to enhance endotracheal intubation skills among inexperienced operators. Several studies showed the effectiveness of supervisor assisted ETI using the various VL devices and commercial videoconferencing softwares. However, recent developments in VL technologies introduced the VL integrated videoconferencing features for this purpose. Scoper VL device (Technomedicare Inc, Turkiye) developed a real-time teleconsultation feature for difficult airway scenarios to be assisted by experts during the procedure. However, the literature is very limited about the effectiveness and feasibility of teleguidance-facilitated airway management.

This high-fidelity simulation study aims to assess impact of teleguidance-facilitated airway management on the success of ETI performed by inexperienced operators in a mobile ambulance.


Eligibility criteria: Inclusion Criteria:

* All paramedic students who completed their airway management training

Exclusion Criteria:

* The trainees who did not consent to participate
* The trainees who did not complete the VL training

Primary outcomes:
measure: Rate of first attempt success (n,%)
timeFrame: Measured at the 60-second mark.
Secondary outcomes:
measure: Intubation duration (seconds)
timeFrame: procedure (Measured at the confirmation of the tube passed between vocal cords.)
measure: Operator confidence assessed by Likert Scale.
timeFrame: At the end of the procedure
measure: Feasibility of intubation assessed by Likert Scale.
timeFrame: At the end of the procedure
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty Emergency Medicine Department
Study officials:
affiliation: Kocaeli University
name: Ibrahim Ozturan
role: STUDY_CHAIR
References:
Clinical trial NCT00139425: Osteoporosis Disease Management Demonstration Project (0000-037)
Official title: Osteoporosis Prevention and Treatment Program: A Disease Management Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the impact of disease management interventions on bone mineral density (BMD) screening rates and osteoporosis treatment rates in women age 65 years or older.


Eligibility criteria: Inclusion Criteria:

* Members of the Henry Ford Health System

Exclusion Criteria:

* Individuals who are not members of the Henry Ford Health System

Primary outcomes:
measure: Bone mineral density (BMD) testing rates
Secondary outcomes:
measure: Osteoporosis medication treatment rates
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lafata JE, Kolk D, Peterson EL, McCarthy BD, Weiss TW, Chen YT, Muma BK. Improving osteoporosis screening: results from a randomized cluster trial. J Gen Intern Med. 2007 Mar;22(3):346-51. doi: 10.1007/s11606-006-0060-9.
Clinical trial NCT02697825: Intraocular Pressure Versus Optic Nerve Sheath Diameter
Official title: Correlation Between Intraocular Pressure and Optic Nerve Sheath Diameter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Pressure
Optic Nerve Sheath Diameter
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study involves observing and comparing Intraocular Pressure and Optic Nerve Sheath Diameter in steep trendelenburg position. Both observations will be done in same patient over the surgical duration.

Detailed description: Steep trendelenburg position is required for various robotic surgical procedures like hysterectomy, radical prostatectomy etc. Both Intraocular Pressure and Optic Nerve Sheath Diameter are found to get increased while in this position.

Intraocular Pressure will be measured by schiotz tonometer over an hourly interval whereas Optic nerve sheath diameter will be measured with use of ultrasound using a probe of 7.5 Mega hertz. Both values will be measured in both the eyes and will be compared statistically to find any correlation which may exist between the two.

Eligibility criteria: Inclusion Criteria:

* robotic surgeries
* surgical duration upto 4 hours
* american society of anaesthesiologists 1 to 3

Exclusion Criteria:

* any history of opthalmic intervention
* patient suffering from glaucoma
* patients taking any diuretics for cardiac problems

Primary outcomes:
measure: correlation between rise of intraocular pressure and optic nerve sheath diameter
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Centre
state: Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute & Research Centre
name: Nitesh Goel, MBBS,DA, DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05104125: Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris
Official title: A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-dose Study to Evaluate Safety and Efficacy of ASC40 Tablets in Subjects With Moderate to Severe Acne Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
ASC40
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2021-11-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel controlled design. The subjects in the study group were given double-blind drugs, and they were taken (orally) after dinner every day according to the requirements of clinical trial scheme.


Eligibility criteria: Key Inclusion Criteria:

* 18-40 years old (including 18 and 40 years old);
* Investigator's Global Assessment of subject at baseline period was at 3-4.
* Facial skin lesions of subject need counting as follows: 30 \~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 \~ 75, including no more than 2 nodules), 30 \~ 100 non-inflammatory lesions (the total number of open and closed comedones is 30 \~ 100);

Key Exclusion Criteria:

* Known to be allergic or hypersensitive to ASC40 tablets;
* Facial nodules of subject is more than 2 facial nodules
* The subject with cystic acne
* Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs);
* Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range

Primary outcomes:
measure: Percentage change of total lesion count compared with baseline and week 12.
timeFrame: Baseline to week 12
measure: Ratio of subjects, whose IGA grades was decreased by ≥2 grades compared with baseline at week 12.
timeFrame: Baseline to week 12
Secondary outcomes:
measure: The changes status and changes of average percentage of inflammatory skin lesions count, non-inflammatory skin lesions count and total skin lesions count compared with baseline.
timeFrame: Baseline to week 2, 4, 8 and 12
measure: Ratio of subjects, whose GA grades was 1 or 0, or GA grades was decreased y ≥2 grades compared with baseline and Improvements in classification
timeFrame: Baseline to week 2, 4, 8 and 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03047525: Study of DC-CTL Combined With CIK for Advanced Solid Tumor
Official title: The Opening and Negative Controlled Clinical Study of Autologous Multiple Targets DC-CTL Combined With CIK for Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Renal Cell Carcinoma
Nasopharyngeal Carcinoma
Lung Cancer
Keywords: cytokine-induced killer cell
dendritic and cytokine-induced killer cells
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Combinations of Dendritic and Cytokine-induced Killer Cells (DC-CIK) and Cytokine-induced Killer Cells (CIK) treatment may enhance the immune response and stop cancer cells from growing. The investigators suppose that DC-CIK combined with CIK treatment will improve the prognosis of advanced solid tumors.

Objective: Phase II clinical trial to investigate the efficacy of concurrent chemotherapy with DC-CIK and CIK treatment in patients with treatment-refractory solid tumors.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments and 4 cycles of DC-CIK treatments within 8 months. Patients in group B will have no immunotherapy . chemotherapy are available in both groups.


Eligibility criteria: Inclusion Criteria:

1. Patients with treatment-refractory advanced colorectal cancer can not accept operation .
2. Age 18 to 75 years.Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months;
3. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
4. Without any other malignant disease;
5. With more than one scalable lesions
6. Patients Voluntary attempt, and informed consent.
7. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus.

Exclusion Criteria:

1. Patients who do not conform to the inclusion criteria;;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening(such as uncontrolled brain metastasis ); Patients who were pregnant or lactating;
3. ECOG perform status ≥ 2;
4. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.)..

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
Study officials:
References:
Clinical trial NCT00385125: Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL
Official title: Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma, High-Grade
Keywords: relapsed
refractory
CD 20 positive
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 30
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: Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation.

Detailed description: Phase II study for treatment of patients with relapsed or primary refractory aggressive B- cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for autologous stem cell transplantation. Aim is to find response rates and duration of combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD 20 positive B cell NHL.

Eligibility criteria: Inclusion Criteria:

* Histologically proven high grade B-NHL (CD 20 \>= 20 % positive)
* Age \>= 18 years
* At least one pretreatment with anthracycline polychemotherapy +/- radiatio:
* first relapse nad contraindication for aggressive salvage therapy e.g. high dose therapy with autologous stem cell transplantation
* second relapse (after aggressive salvage therapy)
* patient's refusal of aggressive salvage therapy in first relapse
* informed consent

Exclusion Criteria:

* untreated patients
* pretreatment with bendamustine
* primary CNS- lymphoma
* Karnofsky index \< 50 (except caused by lymphoma)
* HIV positive, hepatitis B or C
* serious concurrent disease
* non-compensated heart failure (\>=NYHA 3)
* non-compensated hypertension
* renal insufficiency (creatinine \> 2.0 mg/dl), not related to lymphoma
* hepatic insufficiency with transaminase values greater than 3-fold of normal values and/or bilirubin levels \> 200 µmol/l, not related to lymphoma
* missing compliance respective incapability to comply (e.g.cerebral dysfunction
* pregnancy
* hematopoetic insufficiency not lymphoma related (leucocyte count \<= 2500/µl, granulocyte count \<= 1000/µl, platelet count \<= 80000/µl)

Primary outcomes:
measure: response rate
measure: response duration
Secondary outcomes:
measure: overall survival
measure: toxicity
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University of Magdeburg, departement of Hematology and Oncology
Study officials:
affiliation: University of Magdeburg, Department of Hematology and Oncology
name: Martin Mohren, PD
role: PRINCIPAL_INVESTIGATOR
References: