louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05532618: Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery
Official title: Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: adductor canal block
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

Detailed description: Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.

Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).

Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Undergoing anterior cruciate ligament surgery under general anesthesia
* ASA I-III

Exclusion Criteria:

* Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
* Neuromuscular disorders

Primary outcomes:
measure: Postoperative pain level
timeFrame: Within first 48 hours after surgery
Secondary outcomes:
measure: Opiate use
timeFrame: Within first 48 hours after surgery
measure: Nausea
timeFrame: Within first 48 hours after surgery
measure: Block result
timeFrame: within first 24 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: St. Antonius Hospital
name: Leon Timmerman, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.
citation: Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21.
Clinical trial NCT00044018: CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Revimid
CC5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2002-08-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.


Eligibility criteria: * Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
* Subject must understand and voluntarily sign an informed consent document.
* Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
* ECOG (Zubrod) performance status of 0 to 2.
* Subject must be able to adhere to the study visit schedule and other protocol requirements.
* Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Primary outcomes:
measure: Confirmed M-Protein Response During Single Agent CDC-501 Therapy
timeFrame: Response assessed every 4 weeks; up to 62 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffit Cancer Center
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: St Vincent's Cancer Center
state: New York
Study officials:
affiliation: Celgene Corporation
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
citation: Richardson PG, Blood E, Mitsiades CS, Jagannath S, Zeldenrust SR, Alsina M, Schlossman RL, Rajkumar SV, Desikan KR, Hideshima T, Munshi NC, Kelly-Colson K, Doss D, McKenney ML, Gorelik S, Warren D, Freeman A, Rich R, Wu A, Olesnyckyj M, Wride K, Dalton WS, Zeldis J, Knight R, Weller E, Anderson KC. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006 Nov 15;108(10):3458-64. doi: 10.1182/blood-2006-04-015909. Epub 2006 Jul 13.
Clinical trial NCT00151918: Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Official title: A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Failure, Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 48
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 purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride


Eligibility criteria: Inclusion Criteria:

* Patients receiving haemodialysis for ESRD
* Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

Exclusion Criteria:

* Pregnant or lactating women
* Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
* Patients who are HIV+
* Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months

Primary outcomes:
measure: Mean pre-dialysis serum phosphate level
timeFrame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary outcomes:
measure: Mean pre-dialysis serum calcium product
timeFrame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
measure: Mean pre-dialysis calcium-phosphate product
timeFrame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
measure: Average daily pill burden
timeFrame: Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
measure: Treatment emergent adverse events
timeFrame: Throughout the study period of approximately 7.5 months.
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01120418: Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
Official title: A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Endothelial cell density
screening
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes
* Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator
* Must be willing to discontinue contact lens wear for the duration of the study

Exclusion Criteria:

* Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study
* History of extended or continuous wear contact lens use other than silicone hydrogels
* History of intraocular surgery
* Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study
* Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study

Primary outcomes:
measure: Endothelial cell density change between treatment group.
timeFrame: Baseline, 5 days
Secondary outcomes:
measure: Endothelial cell density change within treatment group
timeFrame: Baseline, 5 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06553118: Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
Official title: Evaluation of the Effect of Central Sensitivity on Pain and Functional Status After Total Knee Joint Replacement Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Central Sensitisation
Postoperative Pain
Arthritis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of patients who were planned to have total knee arthroplasty for primary knee osteoarthritis

Brief summary: The study is a prospective observational study designed to determine the effects of central sensitization on pain and functional status of patients before and after total knee joint replacement surgery.

The aim of this study is to evaluate whether there is a difference in preoperative and postoperative pain and functional status between patients with and without central sensitization with knee osteoarthritis.

When the literature was reviewed, it was seen that central sensitization was one of the important mechanisms that caused pain in knee osteoarthritis, and it was determined that this had negative consequences in terms of postoperative pain and improvement in functional status. In this study, the effect of central sensitization on the results will be investigated by evaluating pain and functional status before and after knee total joint prosthesis in two groups of knee osteoarthritis patients, with and without central sensitization, and by comparing the groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary knee osteoarthritis
* Planning for total joint replacement surgery for the knee
* Being between the ages of 60-75

Exclusion Criteria:

* Having secondary knee osteoarthritis
* Planning for knee total joint prosthesis revision
* Having uncontrolled systemic disease (such as diabetes mellitus, hypertension, thyroid disease)
* Having neuromuscular disease
* Having a body mass index over 40

Primary outcomes:
measure: Knee pain
timeFrame: Preoperative, 1 month postoperative and 3 months postoperative
Secondary outcomes:
measure: Functional Status
timeFrame: Preoperative, 1 month postoperative and 3 months postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Faculty of Medicine
name: Fatma Merih Akpınar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203318: Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of Study
Keywords: cryptorchidism, undescended testis, hypertrophy of contralateral testis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 60
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24 children, normal control : 24 children

Brief summary: The aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. According to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but not normally descended testis group(group2) and control group(group3). The size of testis will be measured with Ultrasound and the length, width and the height will be measured before surgery at outpatient department. For the group 1 \& 2, the viability of the affected testis will be evaluated and compared after surgery. In addition the comparison with normal control group is also going th be conducted.


Eligibility criteria: Inclusion Criteria:

1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended testis.(group 1, 2) aged from 6months to 18months
2. neonates or Infants aged from 6months to 18months with normal testis (volunteers, Group3)

Exclusion Criteria:

1. previous history of hormonal therapy.
2. chromosomal abnormality
3. previous history of abdomen or inguinal area surgery
4. children diagnosed with epididymitis or orchitis
5. twin baby
6. infants with premature (\<37 weeks) birth history

Primary outcomes:
measure: Size of contralateral testis
timeFrame: 1 day of initial visit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00890318: A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.

Detailed description: Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072

Eligibility criteria: Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
  * If female, subject is postmenopausal for at least 2 years or surgically sterile.
  * If female, subject is not pregnant and is not breast-feeding.
  * Male or female between 18 and 55 years old, inclusive.
  * If male, subject must be surgically sterile or practicing at least 1 method of birth control.
  * Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

* Use of medications including over the counter and vitamines.
* Abuse of alcohol, drugs, or nicotine.
* Current diseases or disorders.
* History of cardiac disease.
* If after consideration by the investigator, for any reason, that you are unsuitable to receive ABT-072.

Primary outcomes:
measure: Analysis of pharmacokinetic results.
timeFrame: Study Days 1-13
measure: Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
timeFrame: Study Days -2 through 39
Secondary outcomes:
measure: Analysis of single dose administration of ketoconazole on steady state ABT-072 pharmacokinetics.
timeFrame: Study Day 11-13
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Abbott Clinical Pharmaceutical Research Unit
state: Illinois
Study officials:
affiliation: Abbott
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06499818: CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
Official title: Circumferential Pulmonary Vein Isolation Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yantai Yuhuangding Hospital
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.


Eligibility criteria: Inclusion Criteria:

1. Patients age is 18-80 years;
2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
3. Patients can sign the written informed consent for the study;
4. Patients can endure the required follow-up.

Exclusion Criteria:

1. Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
2. Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
3. Left atrial diameter \>55mm
4. Left ventricular ejection fraction \<35%
5. Left atrial thrombus
6. Postoperative cardiac surgery
7. After valve replacement
8. After permanent pacemaker implantation
9. hypertrophic cardiomyopathy
10. Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
11. Hemorrhagic stroke within 6 months
12. Transient ischemic attack or ischemic stroke within 1 month
13. Mental disorder or history of mental illness and inability to cooperate voluntarily
14. Breastfeeding, pregnancy and women planning or likely to become pregnant
15. Life expectancy \<12 months
16. Participating in other interventional clinical trials
17. The researchers judged that it was not suitable for inclusion in this study

Primary outcomes:
measure: The incidence of no atrial arrhythmias greater than 30 seconds
timeFrame: at least 18 months follow up
Secondary outcomes:
measure: No use of antiarrhythmic drugs and no occurrence of atrial fibrillation exceeding 30 seconds
timeFrame: at least 18 months follow up
measure: No use of antiarrhythmic drugs and no occurrence of atrial tachycardia/flutter exceeding 30 seconds
timeFrame: at least 18 months follow up
measure: Atrial fibrillation load
timeFrame: at least 18 months follow up
measure: Procedure time
timeFrame: Surgical procedure
measure: Ablation time
timeFrame: 1 week after patient enrollment
measure: Incidence of peri-procedural complications
timeFrame: at least 18 months follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00983918: Pain After Laparoscopic Cholecystectomy
Official title: Postoperative Pain After Laparoscopic Cholecystectomy After Anesthesia With Isoflurane, Desflurane, Sevoflurane or Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane.

PURPOSE

To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.


Eligibility criteria: Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Scheduled for ambulatory surgery
3. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
4. Allergy to any of the study medications or anesthetic agents
5. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
6. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
7. Patient or surgeon refusal

Primary outcomes:
measure: Pain Measured on Verbal Scale of 0-10
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Dept. of Anesthesiology
name: Jaime Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References: