louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06773351: A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane
Official title: A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane During Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Induction of General Anesthesia
Keywords: ciprofol
response surface analysis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Provincial People's Hospital
First posted: 2025-01-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. By employing response surface methodology, we constructed a three-dimensional pharmacodynamic interaction surface for various dose combinations of ciprofol and sevoflurane. This approach allows us to determine the nature of the interaction between the two drugs at any given level, thereby providing a ciprofol understanding of the dose-response relationship when ciprofol and sevoflurane are used in combination. This knowledge will serve as a theoretical basis for rational drug administration during surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective general anesthesia and non-cardiac surgery;
* Age 18-60 years old, gender is not limited;
* ASA I or II level;
* Body mass index (BMI) 18-30 kg/m2

Exclusion Criteria:

* Preoperative assessment of potential difficult airway risk;
* Airway hyperreactivity;
* There is disease of the central nervous system or cardiovascular system;
* Currently using drugs that may alter the pharmacokinetics and pharmacokinetics of the drug under study;
* Known or suspected allergy or contraindication to the components or regimens of the investigational drug;
* A history of drug or alcohol addiction;
* Patients with gastroesophageal reflux disease;
* Severe liver and kidney dysfunction.

Primary outcomes:
measure: Bispectral Index (BIS) value
timeFrame: Induction period of anesthesia
measure: The score of Observer's Assessment of Alertness/Sedation Scale
timeFrame: Induction period of anesthesia
measure: Numbers of of participants with laryngoscopy and tracheal intubation positive response
timeFrame: Induction period of anesthesia
measure: Numbers of participants with tracheal intubation stress positive respose
timeFrame: Induction period of anesthesia
measure: Blood plasma concentration
timeFrame: Induction period of anesthesia
Secondary outcomes:
measure: HR
timeFrame: Period of anesthesia
measure: MAP
timeFrame: Period of anesthesia
measure: Adverse reactions
timeFrame: Perioperative period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03355651: Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
Official title: Prospective Study for Assess Efficacy and Tolerability of an Oral Supplement Based on Collagen, HC-15 and Plasmatic Proteins, in the Recovery of ACL After Surgery: a Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Reconstruction
Keywords: Anterior Cruciate Ligament Tears
Dietary Supplementations
Plasma Rich Proteins
Collagen
Chondroitin Sulfate
Hyaluronic Acid
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.


Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 55 years with partial or complete anterior cruciate ligament (ACL) rupture, diagnosed clinically and by Magnetic Resonance Imaging (MRI), requiring reconstructive surgery.
* Patients with symptoms of acute or subacute ACL rupture (such as inflammation of the knee and pain with leg movement) or chronic ACL tear, including instability of the knee.
* Patients with ACL ruptures without osteochondral lesions requiring additional surgery.
* Patients with a medical history of therapeutic benefit using analgesic agents.

Exclusion Criteria:

* Patients with concomitant osteochondral pathology.
* Patients treated with intra-articular injections of corticosteroids and/or platelet-rich plasma, or with oral glucosamine, CS, HA or CH in the two months prior to surgery.
* Patients with systemic diseases, those treated with antibiotics or other drugs that might alter the healing process, and those who had undergone arthroscopic lavage in the 90 days prior to surgery.

Primary outcomes:
measure: Pain improvement
timeFrame: 90 days
Secondary outcomes:
measure: Knee function
timeFrame: 90 days
measure: Analgesic consumption
timeFrame: 90 days
measure: Number of rehabilitation sessions required
timeFrame: 90 days
measure: Maduration of the graft
timeFrame: Day 0, day 90
Other outcomes:
measure: Perceived efficacy and tolerability by both patients and physicians
timeFrame: 90 days
measure: Safety
timeFrame: 90 days
Locations:
Study officials:
References:
citation: Lopez-Vidriero E, Olive-Vilas R, Lopez-Capape D, Varela-Sende L, Lopez-Vidriero R, Til-Perez L. Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled Trial. Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb.
Clinical trial NCT06479954: Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use.
Official title: ELREXFIO SPECIAL INVESTIGATION- INVESTIGATION ON LONG-TERM TREATMENT -
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Relapsed and Refractory Multiple Myeloma (RRMM)
Keywords: RRMM
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 1
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All of the patients who satisfy all of the registration criteria in all the institutions to which elranatamab is delivered based on the conditions for approval are subject to this study.

registration criteria ;Patients who have received at least one dose of elranatamab.

Brief summary: To investigate the safety and efficacy in patients with relapsed and refractory multiple myeloma treated with elranatamab under the actual use.

Detailed description: The objective of this study is to assess the safety and efficacy in patients with relapsed and refractory multiple myeloma (RRMM) treated with elranatamab under the actual use.

* Primary objective: Confirm whether the onset status (the number of patients, incidence, grade, seriousness, timing of onset, duration, treatment and outcome) of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) is comparable to that in the clinical studies and whether adverse reactions were appropriately treated.
* Secondary objective: Confirm the onset status of any adverse reaction (including unknown adverse reaction) to long-term treatment with elranatamab and the overall response (ORR) as efficacy assessment and evaluate them in terms of benefit-risk.

Conditions for approval; Because of the extremely limited number of patients treated in Japanese clinical studies, a drug use investigation in all patients should be conducted to understand the background information of patients on elranatamab, early collect data on the safety and efficacy of elranatamab, and take measures necessary for the proper use of elranatamab until the data of a certain number of patients are accumulated.

Eligibility criteria: Inclusion Criteria:

Patients who have received at least one dose of elranatamab.

Primary outcomes:
measure: Incidence of CRS events in adverse drug reaction
timeFrame: up to 52 weeks
measure: Incidence of ICANS events in adverse drug reaction
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Proportion of patients with objective response rate (ORR)
timeFrame: up to 52 weeks
measure: Incidence of other adverse drug reactions (ADRs)
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03850054: AADI Glaucoma Shunt - a Quality Control Study
Official title: AADI Glaucoma Shunt - a Quality Control Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glaucoma
Keywords: AADI; glaucoma tube shunt
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational study, prospective, to evaluate the effect and safety of this new drainage device

Brief summary: To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital.

The device will be implanted in eyes instead of the Bearveldt drainage device. Patients and data are prospectively registered to evaluate the effect and safety of the AADI device.


Eligibility criteria: Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt

Primary outcomes:
measure: Change in IOP
timeFrame: Baseline and after 12 months
measure: The change in number of IOP lowering drugs
timeFrame: Baseline and after 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Dept. of Ophthalmology
Study officials:
References:
Clinical trial NCT00133354: Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
Official title: Double-blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypopituitarism
Keywords: Puberty
Growth hormone deficiency
aromatase inhibitors
estrogen
bone mineral density
short stature
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Genentech, Inc.
name: EMD Serono
First posted: 2005-08-23
Enrollment: 53
Sex: MALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.


Eligibility criteria: Inclusion Criteria:

* Growth hormone deficient by formal testing with two provocative agents.
* Treated with growth hormone for a minimum of 6 months prior to study entry.
* Growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol.
* Stable organic pathology
* Presence of puberty \[genital Tanner Stage \> II (\>4cc testicular volume)\]
* Bone age (BA) \> or = 11.5 years and \< 15 years

Exclusion Criteria:

* Participation in any other trial involving hormone therapy for at least 6 months prior.
* Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included).
* Hereditary disease diagnosed clinically.
* Moderate to severe scoliosis.

Primary outcomes:
measure: The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
timeFrame: 12months, 24months, 36months
Secondary outcomes:
measure: The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.
timeFrame: 12months, 24months, 36months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Nelly Mauras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709954: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
Official title: Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Sub-Study I
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cannabis
Alcohol Effect
Driving Under the Influence of Alcohol and Other Drugs
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

Detailed description: To study the effects of oral ethanol (a target BAC of \~0.04 g/dl; equivalent to consuming approximately 2 drinks over 1 hour) and vaporized THC (4 mg of THC dissolved in an ethanolic solution; equivalent to smoking approximately 1/4 of a marijuana cigarette, or "joint") on driving.

Eligibility criteria: Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Occasional current cannabis users.
* Experience with drinking 2 or more standard drinks of alcohol at least once in lifetime.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve.
* Alcohol naïve.
* Positive pregnancy screen
* Hearing deficits.

Primary outcomes:
measure: Road Tracking Error
timeFrame: baseline, +20, +50, +120, +180 mins after start of alcohol administration
Secondary outcomes:
measure: Biphasic Alcohol Effects Scale (BAES)
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Visual Analog Scale (VAS)
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Willingness to Drive Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Cognitive Test Battery
timeFrame: +40 mins after start of alcohol administration
measure: Number of Joints Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
measure: Number of Drinks Scale
timeFrame: baseline, +20, +50, +120, +180, +240 mins after start of alcohol administration
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit, VA Connecticut Healthcare System
state: Connecticut
Study officials:
References:
Clinical trial NCT01642654: Water Exercise and Vascular Function in Elderly
Official title: Nitrite Levels and Vascular Function in Elderly Women Submitted to Water Exercise: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Women
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives:

The purpose of this research was to assess modifications caused by a concurrent water exercise program on plasma nitrite (NO3), cerebral vascular resistance and cholesterol in the elderly and analyze the correlations between these variables after intervention.

Methods The sample was composed of 40 women mean age 69,21 ±5,27 years old, divided into an intervention (WG) and control group (CG). It was to measure nitrite concentration (NO3) by the Griess reaction; internal cerebral arteries were assessed by Doppler ultrasound to determine the resistivity index and Cholesterol was determined using the colorimetric enzymatic method and test kit. Intervention with water exercise program consisted of three weekly sessions for 16 weeks.


Eligibility criteria: Inclusion Criteria:

* older than 60 and lass than 80 years age;
* the elderly should be independent in their ADLs;
* be considered able for medical evaluation to participate in the intervention and testing protocols;
* still not be participating in regular systematized physical activity for at least six months.

Exclusion Criteria:

* subjects with any form of transmittable or uncontrolled disease or insulin-dependent hypertensive;
* unable to perform functional autonomy tests;
* women undergo hormonal replacement therapy

Primary outcomes:
measure: Determining modifications caused by this program on plasma nitrite concentration (NO3).
timeFrame: 16 weeks
Secondary outcomes:
measure: Cerebral artery assessment
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Teresina
country: Brazil
facility: Universidade Estadual do Piauí
state: PI
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Arméle Dornelas
role: STUDY_CHAIR
References:
citation: Cress ME, Buchner DM, Prohaska T, Rimmer J, Brown M, Macera C, Dipietro L, Chodzko-Zajko W. Best practices for physical activity programs and behavior counseling in older adult populations. J Aging Phys Act. 2005 Jan;13(1):61-74. doi: 10.1123/japa.13.1.61.
Clinical trial NCT06759454: Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Official title: Comparison of Mean Pain Score Using LASER Therapy and Desensitizing Agents in Patients With Dentinal Hypersensitivity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentinal Hypersensitivity
Lead sponsor: College of Physicians and Surgeons Pakistan
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of laser therapy versus desensitizing agents in reducing pain among participants with dentinal hypersensitivity conducted in Saidu College of Dentistry. Pain will be measured at baseline, immediately post-treatment, one week, and three months using the Visual Analog Scale (VAS)

Detailed description: This study examines dentinal hypersensitivity treatment modalities, including laser therapy and desensitizing agents. The study is conducted in compliance with regional ethical guidelines

Eligibility criteria: Inclusion Criteria:

* Participants aged 18-50 years with a preoperative VAS score of ≥2 for dentinal hypersensitivity.
* Participants with sensitivity due to gingival recession, cervical abrasion, or enamel erosion.
* Participants with good systemic health.
* Minimum of two hypersensitive teeth present in two different quadrants.

Exclusion Criteria:

* Teeth with caries, defective restorations, or cervical defects \> 2 mm (may affect sensitivity measurements).
* Periodontal surgery or deep periodontal pockets (\> 6 mm) within the past three months (potential influence on periodontal health and sensitivity).
* Participants using desensitizing toothpaste within the past three months (could interfere with study outcomes).
* Presence of gross oral pathology or systemic diseases (e.g., eating disorders, chronic diseases, uncontrolled metabolic conditions) (may alter oral health status).
* Pregnant or lactating women (hormonal changes can influence oral health).

Primary outcomes:
measure: Change in pain intensity: Visual Analog Scale
timeFrame: Immediately post-treatment, one week, and three months
Secondary outcomes:
Other outcomes:
Locations:
city: Swat
country: Pakistan
facility: Saidu College of Dentistry
state: KPK
Study officials:
affiliation: SAIDU COLLEGE of DENTISTRY
name: BREKHNA YOUSAFZAI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03506854: Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients
Official title: Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study Of ISIS 681257 Subcutaneous Injections In Male And Female Subjects With Normal And Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Akcea Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Ionis Pharmaceuticals, Inc.
First posted: 2018-04-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* BMI 18.5 to 42.0 kg/m2
* No known diseases or significant findings on physical exam (normal renal only)
* eGFR \>/= 90 mL/min/1.73m2 (normal renal only)
* Clinically stable (renal impaired only)
* eGFR 30-59 mL/min/1.73m2 (renal impaired only)

Exclusion Criteria:

* Females of childbearing potential
* Conditions or disease that may interfere with study drug
* Any significant diseases
* Hypersensitivity to any drugs or similar drugs to those used in the study
* Drug dependency or abuse
* Previous exposure to other investigational drug within 28 days
* Blood donations within 28 days

Primary outcomes:
measure: Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.
timeFrame: Day 31
Secondary outcomes:
measure: The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.
timeFrame: Day 31
measure: The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.
timeFrame: Day 1
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Clinical Site
state: Florida
city: Knoxville
country: United States
facility: Clinical Site
state: Tennessee
city: Québec
country: Canada
facility: Clinical Site
Study officials:
References: