louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00346788: The Subvastus Approach in Total Knee Arthroplasty
Official title: The Subvastus Approach in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2006-06-30
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.


Eligibility criteria: Inclusion Criteria:

* You are willing to take part in the study, including signing this form after carefully reading it.
* You are available for follow-up for a minimum of 24 months (2 years).
* You have no medical conditions that prevent you from having surgery.
* This is the primary (first) knee replacement for this knee
* You are fluent in English and are able to understand your responsibilities in this study.

Exclusion Criteria:

* Active, local or systemic infection
* Fibromyalgia or other chronic pain syndrome
* Inability to follow the study requirements
* Had this knee replaced before
* Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty)
* Body Mass Index (BMI) \> 35, as you would not be eligible for the MIS approach.

Primary outcomes:
measure: Length of hospital stay
timeFrame: Post Operative
measure: Range of motion at discharge and six weeks post-operatively
timeFrame: Discharge and six weeks post operative
Secondary outcomes:
measure: Wound complications
timeFrame: post operative until wound healed
measure: Post-operative narcotic use
timeFrame: 24 months post operative
measure: Post-operative blood loss
timeFrame: Post operative
measure: The ability to straight-leg raise at two and twenty-four hours post-operatively
timeFrame: 2 and 24 hours post operative
measure: Knee Society Clinical Rating Scale
timeFrame: pre-op, 6 months, 12 months, and 24 months post operative
measure: SF-12
timeFrame: pre-op, 6 months, 12 months, and 24 months post operative
measure: WOMAC.
timeFrame: pre-op, 6 months, 12 months, and 24 months post operative
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Ross K Leighton, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953988: Technology and System for Minimally Invasive TKA Surgery Robot
Official title: Technology and System for Minimally Invasive TKA Surgery Robot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: KOA
TKA
robotic surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Detailed description: 1. For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
2. To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Eligibility criteria: Inclusion Criteria:

1. No surgery on the knee joint.
2. Age\>55

Exclusion Criteria:

1. Knee surgery history.
2. Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
3. Severe flexion contracture deformity.
4. Revision and replacement surgery for knee joints.

Primary outcomes:
measure: Full-length radiography of both lower limbs
timeFrame: Before and two days after the operation
measure: Conventional anteroposterior radiograph of Both Lower Extremities
timeFrame: Before and two days after the operation
measure: computed tomography
timeFrame: Before and two days after the operation
measure: Magnetic Resonance Imaging
timeFrame: Before and two days after the operation
measure: Range of motion
timeFrame: Before and two days after the operation
measure: Operation time
timeFrame: During the operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01390688: Brain-derived Neurotrophic Factor and Cogntive Function
Official title: Brain-derived Neurotrophic Factor: A Link to Obesity, Insulin Resistance and Cognitive Dysfunktion?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Dysfunction
Glucose Metabolism
Low-grade Inflammation
Bodycomposition
Keywords: Brain-derived Neurotrophic factor
Low-grade inflammation
Cognitive dysfunction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from newspapers.

Brief summary: Individuals with type 2 diabetes have an increased risk of developing cognitive dysfunction followed by dementia in late life. Obesity, physical inactivity and "systemic low-grade inflammation" are strong risk factors and play a crucial role in this network of diseases.

Brain-derived Neurotrophic factor (BDNF) is produced in brain as well as several tissues outside brain eg muscle cells. Low BDNF are associated with cognitive dysfuction, obesity and type 2 diabetes.

The investigators include 200 individuals divided into three groups: 80 individuals with type 2 diabetes, 80 age and BMI-matched controls and 40 individuals with impaired glucose tolerance.

The project will test the hypothesis, that low systemic BDNF are associated with accumulation of abdominal fat, cognitive dysfunction and insulin resistence with different effect in men and women.

Detailed description: Methods:

200 individuals in age 40-65 years are recruited and categorized into 3 groups: 1. Type 2 Diabetes, 2. Impaired glucose Tolerance and 3. Normal Glucose Tolerance. Groups are supposed to be age and BMI-matched.

Measurements of systemic BDNF, cogntive function (memory, attention and langue), fitness, bodycomposition, glucose metabolism and systemic inflammation are done.

Multiple regression analysis are perfomed to explain variablity in cognitive function, with age, visceral fat and BDNF as explanotory varibales.

Eligibility criteria: Inclusion Criteria:

* 40-65 years of age

Exclusion Criteria:

* Chronic inflammatory diseases or infectious diseaases within 3 month prior to visit
* Fasting glucose \> 12 mmol/l
* Hypertension: systolic \>180 mmHg and Diastolic \>110 mmHg
* Intake of more than 2 oral antidiabetic drugs or any TZD drung within 3 months before recruitment

Primary outcomes:
measure: Systemic Brain derived neurotrophic factor
timeFrame: Baseline
Secondary outcomes:
measure: Cognitive function and bodycompisition
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre of Inflammation and Metabolism
Study officials:
References:
Clinical trial NCT01497288: A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects
Official title: An Open Label, Randomised, Single-centre, Two Sequence, Cross-over Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects Using a Population PK Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Intranasal fentanyl spray
Population PK
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.


Eligibility criteria: Eligibility Criteria:

Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]
timeFrame: Blood sampling for PK will be performed until 72 hours after the first treatment administration
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Nycomed Investigational Site
Study officials:
References:
Clinical trial NCT01533688: Study of Efficacy and Tolerability of Various Bowel Preps in Diabetic Patients
Official title: Efficacy and Tolerability of Various Bowel Preparations in Diabetic Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 212
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: DIAGNOSTIC

Brief summary: Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.


Eligibility criteria: Inclusion Criteria:

* adult diabetic outpatients referred for elective colonoscopy

Exclusion Criteria:

* patients \< 18 years of age or \> 75 yrs of age,
* known or suspected pregnancy,
* known or suspected renal failure,
* unstable angina,
* acute coronary syndrome,
* decompensated congestive heart failure,
* decompensated liver failure,
* known or suspected bowel obstruction,
* major psychiatric illness,
* solid organ transplant patients,
* known allergies to PEG-ELS or bisacodyl,
* prior alimentary tract surgery or refusal to consent to the study.

Primary outcomes:
measure: Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.
timeFrame: Day 1
Secondary outcomes:
measure: Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma VA Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Science Center
name: Mohammad Madhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00358488: Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Official title: A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Safety
Asthmatic patients
GSK159797
Efficacy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.


Eligibility criteria: Inclusion criteria:

* Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
* Female subjects only using acceptable birth control method
* Non-smokers
* FEV1 between 60 and 90% predicted
* Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

* Past or present disease conditions
* Normal screening Holter ECG
* Respiratory tract infection within 4 weeks of screening
* History of life threatening asthma
* Previous use of COA

Primary outcomes:
measure: Mean change from baseline in trough FEV1
timeFrame: after 14 day repeat doses
Secondary outcomes:
measure: Mean change from baseline in trough FEV1
timeFrame: after a single dose
measure: Mean change from baseline in trough FEV1
timeFrame: after 7 days repeat dosing
measure: Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02743988: Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Official title: Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Hypoxemia
Apnea of Prematurity
Keywords: cerebral oxygenation
NIRS
near-infrared spectroscopy
bradycardia
hypoxemia
cerebral perfusion
cardiac output
apnea
desaturation
oxygen saturation target range
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation \< 80%.


Eligibility criteria: Inclusion Criteria:

* preterm infant \< 29 weeks gestation
* at least 8 hypoxemic events during 8 hours
* requires supplemental oxygen to achieve high SpO2 target range
* parental consent given

Exclusion Criteria:

* congenital life-threatening malformation
* fatal outcome expected
* airway malformation
* higher grade intraventricular bleeding (grade III or IV according to LA Papile)
* posthaemorrhagic hydrocephalus
* life-threatening disease at the time of study entry

Primary outcomes:
measure: Duration SpO2 < 80%
timeFrame: during 16 hours of measurement
Secondary outcomes:
measure: Cerebral tissue oxygen saturation as measured by NIRS
timeFrame: during 16 hours of measurement
measure: Arterial SpO2 as measured by pulse oxymetry
timeFrame: during 16 hours of measurement
measure: Heart rate as measured by ECG
timeFrame: during 16 hours of measurement
measure: cerebral and visceral fractional oxygen extraction as measured by NIRS
timeFrame: during 16 hours of measurement
measure: Cardiac output as measured by Cardiovelocimetry
timeFrame: during 16 hours of measurement
measure: Number of hypoxemic and / or bradycardic events
timeFrame: during 16 hours of measurement
measure: Visceral tissue oxygen saturation as measured by NIRS
timeFrame: during 16 hours of measurement
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University Medical Center, Ulm University
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT06763588: Diet Quality Before and After Metabolic Bariatric Surgery (Eetscore Study)
Official title: Changes in Diet Quality After Bariatric Surgery Measured With the 'Eetscore' Screener.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity and Overweight
Bariatric Surgery
Nutrition Assessment
Diet Quality
Keywords: Screener
Diet quality
Obesity
Metabolic bariatric surgery
Weight loss surgery
Validity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Wageningen University & Research
First posted: 2025-01-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe obesity who were eligible and scheduled for metabolic bariatric surgery at Vitalys Obesity Clinic, part of Rijnstate hospital (Arnhem, the Netherlands), were asked to participate in this prospective cohort study. Participants were included approximately 6 weeks pre-surgery and followed up until 5 years post-surgery.

Brief summary: The aim of this study was to learn more about the use of a short screener for diet quality (Eetscore FFQ) in bariatric patients and about changes in diet quality before and after the bariatric procedure.


Eligibility criteria: Inclusion Criteria:

* Approved for (primary) bariatric surgery
* Aged 18-65 years
* Following the standard care pathway

Exclusion Criteria:

* Previous bariatric procedure other than adjustable gastric banding
* Non-Dutch eating pattern
* Active eating disorders
* Inability to fill in questionnaires or food records

Primary outcomes:
measure: Dutch Healthy Diet index score
timeFrame: Before surgery and at 6 mo after surgery
Secondary outcomes:
measure: Macro- and micronutrient intake
timeFrame: Before surgery and at 6 mo after surgery
measure: Dietary intake at 3 and 5 years post-surgery
timeFrame: 3 y and 5 y after surgery
Other outcomes:
Locations:
city: Elst
country: Netherlands
facility: Vitalys/Rijnstate
state: Gelderland
Study officials:
References:
citation: Heusschen L, Berendsen AAM, Balvers MGJ, Deden LN, de Vries JHM, Hazebroek EJ. Changes in nutrient composition and diet quality in the first 6 months following bariatric surgery: An observational cohort study. J Hum Nutr Diet. 2024 Feb;37(1):365-376. doi: 10.1111/jhn.13258. Epub 2023 Nov 14.
citation: Heusschen L, Berendsen AA, Balvers MG, Deden LN, de Vries JH, Hazebroek EJ. Relative validity of a short screener to assess diet quality in patients with severe obesity before and after bariatric surgery. Public Health Nutr. 2022 Jul 4;25(10):1-11. doi: 10.1017/S1368980022001501. Online ahead of print.
Clinical trial NCT03821688: SAS-J Compared to OAGB and LSG as a Treatment for Morbid Obesity
Official title: Single Anastomosis Sleeve Jejunal Bypass Compared to One Anastomosis Gastric Bypass and Sleeve Gastrectomy as a Treatment for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 210
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: 150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities.

Detailed description: 150 morbidly obese patients divided into to equal groups, group A underwent single anastomosis sleeve jejunal bypass and group B underwent mini gastric bypass, group C underwent sleeve gastrectomy. All patients were followed for at least one year. all cases were evaluated as regard BMI, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: percentage of excess weight loss
timeFrame: 12 months
Secondary outcomes:
measure: the incidence of nutritional deficiency
timeFrame: 2 years
measure: the rate of improved co morbidity
timeFrame: 2 years
measure: the incidence of early operative complications
timeFrame: one month
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Minia University
name: Alaa M Sewefy, MD
role: PRINCIPAL_INVESTIGATOR
References: