louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01335542: Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Official title: Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Readiness to Discharge
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.


Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
* Age 18 to 85 years old
* Planned use of regional anesthesia
* Ability to follow study protocol
* Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus

Exclusion Criteria:

* Patients younger than 18 years old and older than 85
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with insulin-dependent diabetes
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with any prior major ipsilateral open knee surgery.
* Patients with flexion contracture of knee \> 15 degrees
* Patients with varus deformity \> 15 degrees
* Patients with valgus deformity \> 15 degrees
* Patients with a contraindication to use of epinephrine

Primary outcomes:
measure: The Primary Outcome is Time Until a Patient is "Ready for Discharge."
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798142: Analysis of Risk Factors Associated With the Development of Toxic Encephalopathy in Acute Diquat Poisoning
Official title: Analysis of Risk Factors Associated With the Development of Toxic Encephalopathy in Acute Diquat Poisoning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poisoning
Toxic Encephalopathy
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: history of acute diquat poisoning

Brief summary: This study aims to analyze the risk factors associated with the development of toxic encephalopathy in acute diquat poisoning.


Eligibility criteria: Inclusion criteria:

1. history of oral exposure to DQ solution reported by patient or proxy;
2. a specimen for the DQ plasma concentration collected immediately upon admission;
3. documentation that patients or, in case of unconsciousness of the patient, legal proxies were aware of and agreed to treatment plans.

Exclusion critera:

1. they had ingested other toxicants in addition to DQ;
2. DQ was not detected in biological samples;
3. patients with over half of incomplete information;
4. patients with an exposure time (time from exposure to presentation at ED) longer than 48 hours.

Primary outcomes:
measure: Survival outcome
timeFrame: 28 days within the index date of presentation at emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05563142: Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation
Official title: Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation - the Style-AF Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 125
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: Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).

Detailed description: The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.

Eligibility criteria: Inclusion Criteria:

* Patients age \>18
* Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites

Exclusion Criteria:

* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Platelet count \< 100,000 cells/mm3
* BMI \> 45 kg/m2 or \< 20 kg/m2
* Attempted femoral arterial access or inadvertent arterial puncture
* Procedural complications that interfered with routine recovery, ambulation, or discharge times
* Incorrect sheath placement
* Intraprocedural bleeding or thrombotic complications
* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath

Primary outcomes:
measure: Time to ambulation
timeFrame: 6 hours
Secondary outcomes:
measure: total post procedure time
timeFrame: 6 hours
measure: time to hemostasis
timeFrame: 6 hours
measure: time to discharge eligibility
timeFrame: 3 days
measure: time to discharge
timeFrame: 3 days
measure: time to closure eligibility
timeFrame: 6 hours
measure: Incidence of major adverse events
timeFrame: 30 days
measure: Incidence of minor adverse events
timeFrame: 30 days
measure: Time to final hemostasis
timeFrame: 3 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Klinik für Innere Medizin III
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: Klinik für Rhythmologie
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT00365742: Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
Official title: Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Keywords: red yeast rice
pharmaceutical grade fish oil
simvastatin
primary prevention
Lead sponsor: Chestnut Hill Health System
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized trial in a primary prevention population

* all participants have high LDL cholesterol

Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil

Detailed description: This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling

Eligibility criteria: Inclusion Criteria:

* Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study

Exclusion Criteria:

* No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP\>190 or DBP\>100), cannot have known intolerance to one of the study drug

Primary outcomes:
measure: LDL-c cholesterol
Secondary outcomes:
measure: total cholesterol
measure: HDL
measure: Triglycerides
measure: cardiac CRP
Other outcomes:
Locations:
Study officials:
name: David Becker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02207842: The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
Official title: The Determination of the Effect of Volatile Anesthetics on Leukocyte Function ex Vivo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukocyte Function
Anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients greater than or equal to 12 months of age, who present for a cardiac catheterization, cardiac surgery, or cardiac MRI at Boston Children's Hospital.

Brief summary: One of the most common side effects of a surgical procedure is infection. In order to lower the number of infections that occur after surgery, it is important for physicians to know how medications used during surgery affect the way the body fights infection. Often, when anesthesiologists are helping people go to sleep before surgery they give people medications known as "volatile anesthetics". Volatile anesthetics are medications that can change from a liquid or solid to a gas very easily. Some studies suggest that these types of medications may change the way white blood cells work in the body. Changing the way white blood cells work could possibly increase the person's risk of infection after their surgery or weaken their body's ability to fight infections. The goal of this research study is to learn about how volatile anesthesia medications change the way white blood cells work in people having anesthesia for cardiac procedures. To do this, investigators will examine the function of while blood cells in the laboratory based setting.


Eligibility criteria: Inclusion Criteria:

* Male and female patients
* greater than or equal to 12 months of age
* scheduled for a cardiac catheterization, cardiac surgery, or cardiac MRI

Exclusion Criteria:

* known underlying hematological disorder
* known oncological disorder
* patients who do not require preoperative laboratory testing

Primary outcomes:
measure: Leukocyte function under anesthesia
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Koichi Yuki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04324242: Activating Transversus Abdominis Muscle
Official title: Activating Transversus Abdominis Muscle: A Comparison Of Two Different Feedback Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Rehabilitative Ultrasound
Spinal Stabilization
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers between ages of 18-25 with no spinal problems.

Brief summary: Transversus abdominis (TrA) is an important muscle for spinal stabilization. Abdominal draw-in maneuver (ADIM) is a method that selectively activates TrA without activating external oblique (EO) and internal oblique (IO) muscles. Individuals with low back pain may have some troubles to understand proper contraction of TrA. Therefore, to contract the TrA, two different feedback techniques have been used to instruct. In this observational study we aim to investigate the effects of two different biofeedback methods to teach patients the proper activation of TrA muscle using ADIM. We aim to find out the differences between visual and traditional tactile biofeedback and decide which one is practical and easy to teach the patients in clinical environment.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers between ages of 18-25

Exclusion Criteria:

* Volunteers excluded if they had (1) history of LBP, (2) spinal or abdominal surgeries, (3) neuromusculer or romatologic diseases. Each volunteer gave their informed consent.

Primary outcomes:
measure: thickness change in TrA muscle
timeFrame: 1 month
Secondary outcomes:
measure: thickness change in EO muscle
timeFrame: 1 month
measure: thickness change in IO muscle
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Çankaya
Study officials:
affiliation: Hacettepe University
name: Sevil Bilgin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813306: 14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
Official title: A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Reflux Episodes
Keywords: GERD
TLESR
reflux
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of written consent prior to any study specific procedures.
* Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.
* Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.
* A measured LES pressure of \< 5mm Hg.
* History of previous or ongoing psychiatric disease/condition.

Primary outcomes:
measure: Manometry
timeFrame: 3.45 hours each study period
Secondary outcomes:
measure: pH
timeFrame: 3.45 hours each study period
measure: Impedance
timeFrame: 3.45 hours each study period
measure: Pharmacokinetic variables
timeFrame: 3.45 hours each study period
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research site
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Marie Sundin
role: STUDY_DIRECTOR
affiliation: Motiliteitscentrum (C2-310)Department of Gastroenterology,Academic Medical Centre
name: Guy E Boeckxstaens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05466006: Peri-implant Soft Tissue Volume Changes at Small Buccal Dehiscences
Official title: Peri-implant Soft Tissue Volume Changes After Treatment of Small Buccal Dehiscence With Volume-stable Collagen Matrix or Connective Tissue Graft: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to assess peri-implant soft tissue health, volume and marginal stability at implants sites which presented small buccal bone dehiscences (\<3mm evaluated in a vertical direction) at the time of insertion. Patients will be then randomly allocated to receive grafting with connective tissue graft or volume stable collagen matrix and evaluated at 3 months after surgery and at 12 months of follow up after crown placement.


Eligibility criteria: Inclusion Criteria:

* Single tooth edentulous space
* Expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) assessed according to the prosthetically guided position of an implant of 4 mm in diameter planned using the pre-surgical CBCT
* Completed non-surgical periodontal therapy (if needed)
* FMPS and FMBS \< 20%

Exclusion Criteria:

* Age \< 18 years old
* Pregnancy or lactation
* Heavy smokers (\> 10 cigarette/day)
* Conditions or diseases contraindicating surgical interventions
* Absence of the expected small buccal bone dehiscence (≤3mm evaluated in a vertical direction) verified after implant placement
* Need for bone regeneration at the implant site

Primary outcomes:
measure: Volumetric buccal soft tissue changes (-5 to +5 mm with positive values representing an increase in volume)
timeFrame: 12 months
measure: Change in Buccal Probing Pocket Depth (PD) at implant site (0-15 mm with higher values representing worse outcomes)
timeFrame: 12 months
measure: Mucosal recession at the buccal aspect of the implant site (0-15 mm with higher values indicating worse outcomes)
timeFrame: 12 months
measure: Pain (VAS scale)(0-10 with higher values indicating worse outcomes)
timeFrame: 12 months
measure: Bleeding on probing (0 no bleeding, 1 presence of bleeding)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
References:
Clinical trial NCT05152706: Parkinson´s Disease, Aerobic Exercise and Photobiomodulation
Official title: Parkinson´s Disease, Aerobic Exercise and Photobiomodulation: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to assess the effects of a combined therapy of aerobic exercise and transcranial photobiomodulation upon the cardinal motor sympomts of Parkinson´s disease of a group of Parkinson´s disease patients. It was hypothesized that aerobic exercise and transcranial photobiomodulation would yield significant benefits in the cardinal motor sympomts of the illness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis with idiopathic PD and rated 1-2 on the Hoehn and Yahr Scale.
* No type of dementia as assessed by the mini-mental state examination.
* Able to stand for 2 min without assistance.
* Able to walk 10 m without assistance.

Exclusion Criteria:

* Individuals were excluded if they suffered a neurological disease other than PD, if the subject has an implant of any kind in the head (e.g., stent, clipped aneurysm, embolized arteriovenous malformation, implantable shunt - Hakim valve) or if they did not meet the eligibility criteria.

Primary outcomes:
measure: MDS-UPDRS
timeFrame: 6 months
Secondary outcomes:
measure: DASH
timeFrame: 6 months
measure: Static posturography
timeFrame: 6 months
measure: TMWT
timeFrame: 6 months
measure: TUG
timeFrame: 6 months
measure: Grip strength
timeFrame: 6 months
Other outcomes:
Locations:
city: León
country: Spain
facility: Department of Physical Education and Sport, University of León
state: Castilla y León
Study officials:
References:
Clinical trial NCT04557306: Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
Official title: An Open, 3+3 Design With Dose De-escalation, Single-center, Phase 1 Trial to Evaluate Tolerabiility and Safety of Intravenously Administered CBT101, an Autologous Natural Killer Cell, in Patients Who Underwent Curative Surgery and Adjuvant Therapy for Solid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: CHABiotech CO., Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer


Eligibility criteria: Inclusion Criteria:

1. Male and female adults aged 19 years and older
2. Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy
3. Life expectancy 6 months
4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1

Exclusion Criteria:

1. History of leptomeningeal carcinomatosis or spinal cord compression
2. History of peritoneal carninomatosis
3. Hemoglobine less than 9.0g/dL
4. Absolute Neutrophil Count (ANC) less than 1.5x10\^3/mm\^3
5. Platelet count less than 75x10\^9/L
6. Total bilitbinn grater than 1.5 times te upper limit of normal
7. Alanine amino transferase (ALT) greater than 3 times the upper limit of normal
8. Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal
9. Uncontrolled hypertension
10. Intensive insuline therapy
11. Active infectious disease
12. Patients with hypersensitivity history or allergy to investigational product
13. Pregmant of lactating woman
14. Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial
15. Patients judged to be inappropriate for this study by the investigator with other reasons

Primary outcomes:
measure: Dose limiting toxicity (DLT)
timeFrame: 29 days
Secondary outcomes:
measure: Disease-free survival rate (DFS)
timeFrame: 6 months
measure: Oerall survival rate (OS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
affiliation: CHA Bundang Medical Center
name: Chan Kim
role: PRINCIPAL_INVESTIGATOR
References: