louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01316679: An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423
Official title: An Analysis of Urinary Proteases as Biomarkers for Hepatocellular Carcinoma-101423
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Liver Disease
Keywords: HCC
Liver Disease without HCC
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from Vanderbilt internal medicine, hepatology, hepatobiliary surgery, and general surgery clinics.

Brief summary: Specific urine proteases or groups of these enzymes can be reliable biomarkers and an effective gauge of response to therapy in patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to provide written informed consent
* Must be between 18-90 years of age at the time of consent
* Ability to provide urine specimen at protocol-defined timepoints
* Must have treatment interventions planned that are directly related to liver disease (excluding those assigned to group 3-Controls)

Exclusion Criteria:

* Suspected inability, e.g. unwillingness to comply with study procedures or unwillingness to provide written consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00526279: COmpliance and Efficacy in Mono and Combination Tablet Study ATacand/Atacand Plus
Official title: A Prospective, Non-interventional, Observational, Multi-center Trial to Evaluate Compliance and Efficacy in Mono and Combination Treatment of Candesartan Cilexetil(Atacand)/ Candesartan Cilexetil 16mg, Hydrochlorothiazide 12.5mg(Atacand Plus) in Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Atacand/Atacand plus
COMBAT
Compliance
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 9000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care

Brief summary: To evaluate compliance and patients' satisfaction in mono and combination treatment of Candesartan cilexetil (Atacand)/ Candesartan cilexetil 16mg, hydrochlorothiazide 12.5mg (Atacand plus) in hypertension.


Eligibility criteria: Inclusion Criteria:

1. Patients who have consented to participation/data release in this study
2. Patients diagnosed with hypertension and prescribed with atacand/atacand plus by the physician based on clinical decision

Exclusion Criteria:

1. Secondary hypertension requiring therapy other than antihypertensive medication
2. Patients not prescribed with atacand/atacand plus based on safety reasons or any other reason as determined by the physician
3. Women in pregnancy or lactation
4. Patients enrolled in any other studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Jongro-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Kangnam-gu
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Songpa-gu
Study officials:
affiliation: AstraZeneca Korea
name: Hyunah Caroline Choi
role: STUDY_DIRECTOR
References:
Clinical trial NCT04857879: Implementation of GLA:D Program in West Virginians With Osteoarthritis of the Knee
Official title: A Pilot Randomized Controlled Trial to Assess the Implementation and Outcomes of Good Life With Osteoarthritis (GLA:D) Program in West Virginians Suffering From the Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: knee arthritis
Good Life with Osteoarthritis in Denmark
neuromuscular exercises
Lead sponsor: Marshall University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: University of Southern Denmark
First posted: 2021-04-23
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine feasibility of implementing Good Life with Osteoarthritis in Denmark (GLA:D) program in West Virginians with osteoarthritis of the knee

Detailed description: Using West Virginia (WV) as an implementation site, this study will examine the feasibility of process implementation and effectiveness of the Good Life with Osteoarthritis in Denmark (GLA:D) program in individuals with osteoarthritis of the knee (KOA). Specifically, the study will examine the feasibility and acceptability of the GLA:D program in individuals with KOA. This study will also assess the magnitude of changes in self-reported knee pain and functional impairments as well as physical performance in individuals who receive GLA:D compared to those who receive control interventions consisting of disease-specific education and exercises for KOA.

Eligibility criteria: Inclusion Criteria:

1. Between 45 to 90 years of age,
2. Osteoarthritis of the knee (KOA) (Kellgren and Lawrence grade 2, 3, or 4) confirmed by an orthopedic surgeon based on plain film radiographs and symptoms, and
3. Recommendation by an orthopedic surgeon to pursue conservative management of KOA.

Exclusion Criteria:

1. Prior joint replacement surgery in the ipsilateral knee,
2. Known history of cognitive impairments or any neurodegenerative disease,
3. Any other neurological or musculoskeletal pathologies that have resulted in permanent mobility deficits or functional impairments,
4. Medical conditions that would preclude them from participating in exercise programs, and
5. Inability to read and comprehend English.

Primary outcomes:
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later
timeFrame: 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington
country: United States
facility: School of Physical Therapy, Marshall University
state: West Virginia
Study officials:
References:
Clinical trial NCT03716479: Gum Acacia and Blood Glucose
Official title: The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: subjects will consume 0, and 2 doses of acacia gum
Primary purpose: PREVENTION

Brief summary: This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.

Detailed description: This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.

Eligibility criteria: Inclusion Criteria: BMI between 18 and 29 kg/m2

Exclusion Criteria:

* distaste for bagels and cream cheese, orange juice or cheese pizza;
* current smoker;
* restrained eating habits;
* recent weight change;
* any history of disease or significant past medical history;
* are vegetarian;
* do not normally eat breakfast or lunch;
* pregnant or lactating;
* irregular menstrual cycles.

Primary outcomes:
measure: Blood glucose levels
timeFrame: 0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
measure: Appetite Sensation
timeFrame: 15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
References:
Clinical trial NCT02936479: C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
Official title: Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antibody Mediated Rejection of Kidney Transplant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2016-10-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant with acute antibody mediated rejection refractory to standard therapy

Exclusion Criteria:

* Patients with known intolerance of or anaphylaxis to Berinert

Primary outcomes:
measure: Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Robert Montgomery, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06874179: Oropharyngeal Vs Intravenous Lidocaine Effects on Optic Nerve Sheath Diameter After Intubation
Official title: Effects of Oropharyngeal-topical and Intravenous Lidocaine on the Optic Nerve Sheath Diameter Changes After Endotracheal Intubation: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endotracheal Intubation During Surgery
Optic Nerve Sheath Diameter
Keywords: endotracheal intubation
optic nerve sheath diameter
lidocaine
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 190
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: DIAGNOSTIC

Brief summary: This study aims to evaluate the effects of pre-intubation oropharyngeal topical lidocaine on optic nerve sheath diameter (ONSD) post-endotracheal intubation. The study will measure the ONSD using ultrasonography before intubation, and at 1, 5, and 10 minutes post-intubation. The results will be compared between patients receiving %10 lidocaine topically and %2 intravenous lidocaine.

Detailed description: Increased intracranial pressure (ICP) is a critical condition that requires early and accurate assessment. Traditional invasive ICP monitoring techniques, such as lumbar puncture and intracranial pressure monitoring devices, carry significant risks. Optic nerve sheath diameter (ONSD) measurement via ultrasonography is a non-invasive method that reflects increased ICP.

Patients will be divided into two groups: Group A will receive %10 topical oropharyngeal lidocaine, and Group B will receive %2 intravenous lidocaine. The primary aim of the study is to evaluate the impact of lidocaine on ONSD at 1, 5, and 10 minutes post-intubation and to compare the effects on the two groups.

Eligibility criteria: Inclusion Criteria:

* ASA class I or II
* Age 18-65 years
* BMI 18-30
* No history or expected difficult intubation
* No glaucoma or ocular pathology
* No intracranial pressure increase

Exclusion Criteria:

* ASA class III and above
* Obesity (BMI \> 30)
* Difficult intubation history or risk
* Glaucoma or other ophthalmic pathology
* History of intracranial pressure increase or prior ophthalmic/intracranial surgery
* Preoperative sedation
* Active malignancy or ongoing radiotherapy/chemotherapy

Primary outcomes:
measure: Optic nerve sheath diameter 0
timeFrame: Before intubation
measure: Optic nerve sheath diameter 1
timeFrame: 1 minute after intubation
measure: Optic nerve sheath diameter 2
timeFrame: 5 minutes after intubation
measure: 0ptic nerve sheath diameter 3
timeFrame: 10th minutes after intubation
Secondary outcomes:
measure: Postoperative sore throat
timeFrame: 1 hour after recovery room admission
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: İsmail Aytaç, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06978179: Ultrasound-Guided QL Block Versus TAP Block For Post-Operative Pain In Lower Abdominal Surgeries
Official title: Ultrasound-Guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block For Post-Operative Pain In Lower Abdominal Surgeries In Adult Patients, Prospective, Comparative Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 50
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: TREATMENT

Brief summary: This study aims to compare the efficacy of ultrasound-guided QL block and TAP block for postoperative pain management following lower abdominal surgeries.


Eligibility criteria: Inclusion Criteria:

* patients aged from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Patients scheduled for elective lower abdominal surgery.

Exclusion Criteria:

* Patient refusal.
* Patients with BMI (body mass index) \> 35 kg.m-2 , \[morbid obesity\].
* Patients with significant neurological, psychatric or neuromascular disease.
* Patients had local skin infection at the block injection site.
* Patients who operated under epidural and patient-controlled analgesia \[PCA\].
* Sensitivity to prescribed analgesia.
* Coagulopathies or those who had uncontrolled chronic medical disease \[e.g. diabetes mellitus, hypertension, or cardiac diseases\].

Primary outcomes:
measure: efficacy of ultrasound-guided QL block and TAP block for postoperative pain management following lower abdominal surgeries.
timeFrame: 48 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Borglum J, Gogenur I, Bendtsen TF. Abdominal wall blocks in adults. Curr Opin Anaesthesiol. 2016 Oct;29(5):638-43. doi: 10.1097/ACO.0000000000000378.
citation: Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
citation: Chen Q, Beal EW, Okunrintemi V, Cerier E, Paredes A, Sun S, Olsen G, Pawlik TM. The Association Between Patient Satisfaction and Patient-Reported Health Outcomes. J Patient Exp. 2019 Sep;6(3):201-209. doi: 10.1177/2374373518795414. Epub 2018 Aug 27.
Clinical trial NCT05480579: A Study of IBI311 in Healthy Volunteers
Official title: A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female subjects with age of 18\~45 yrs.
3. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.

Exclusion Criteria:

1. Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
2. Have received prior treatment with another anti-IGF-1R monoclonal antibody.
3. History of drug, alcohol, or chemical abuse within 6 months prior to screening.
4. History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
5. Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
6. History of recurrent significant infection or history of recurrent bacterial infections.
7. Must not have a history of tinnitus or hearing impairment.
8. Must not have received an investigational agent for any condition within 90 days.
9. Female volunteers must not be pregnant or lactating.

Primary outcomes:
measure: Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: maximum concentration (Cmax）
timeFrame: Up to 16 weeks.
measure: area under the curve (AUC)
timeFrame: Up to 16 weeks.
measure: half-life (t1/2)
timeFrame: Up to 16 weeks.
measure: the incidence of ADA
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Yongfang Yuan, Ph D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452179: Safety and Efficacy Study of APD125 in Patient With Insomnia
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: Sleep maintenance
Insomnia
Sleep Consolidation
Sleep
Insomnia, primarily sleep maintenance
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.


Eligibility criteria: Inclusion Criteria:

* Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
* PSQI \>/= to 5
* Qualifying screening PSG parameters
* Generally good health

Exclusion Criteria:

* History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
* Any clinically significant medical condition, laboratory finding, or ECG finding
* Pregnant and/or lactating females
* History of substance abuse within 2 years or positive urine drug screen
* Positive Hepatitis B/C results or HIV markers
* Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) \> 10 as determined by screening PSG
* History of treatment with an investigational drug within the last month
* Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study

Primary outcomes:
measure: Conventional PSG parameters
Secondary outcomes:
measure: Patient reported subjective sleep parameters
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Arena Pharmaceuticals
name: Warren A Prosser
role: STUDY_DIRECTOR
References:
Clinical trial NCT05574179: Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA
Official title: Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.

Detailed description: a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.

Eligibility criteria: Inclusion Criteria:

* ASA I and II Age 6 to 12 years Any gender

Exclusion Criteria:

* ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug

Primary outcomes:
measure: Dexmedetomidine is better sedative agent than midazolam in pediatric population
timeFrame: 25 minutes
Secondary outcomes:
measure: Midazolam is better sedating agent than dexmedetomidine in pediatric population
timeFrame: 25 minutes
measure: Midazolam and dexmedetomidine are equally good sedating agents in pediatric population
timeFrame: 25 minutes
Other outcomes:
Locations:
Study officials:
References: