louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06987240: Landmark vs Ultrasound For Combined Spinal Epidural
Official title: Comparison Of Ultrasound-Assisted Combined Spinal Epidural Procedure With Anatomical Landmark Method In Obese Patients Undergoing Lower Extremity Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity (Body Mass Index &gt;30 kg/m2)
Ultrasonography
Combined Spinal Epidural Anesthesia
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery.

60 obese patients aged 40-80, ASA II-III, BMI\>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at Sakarya University Medical Faculty Education and Research Hospital will be included in the study.

General anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. When placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound.

Patients will be divided into two different groups as Anatomical Marking or Ultrasound.

Patients in the Ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with Ultrasound in the block room.

Patients in the Anatomical Marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination.

After determining the needle entry site, patients in both groups will undergo the Combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.


Eligibility criteria: Inclusion Criteria:

* ASA II-III
* BMI\>30
* Elective orthopedic lower extremity surgery
* Combined spinal epidural anesthesia (CSEA)

Exclusion Criteria:

* Patients with CSEA contraindication
* ASA IV-V
* Diagnosed with scoliosis
* Patients with anatomical disorders
* Patients who did not agree to participate in the study
* Patients for whom follow-up conditions could not be met

Primary outcomes:
measure: First attempt success rate
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Number of needle insertions
timeFrame: up to 20 weeks
measure: Time to determine the needle insert
timeFrame: up to 20 weeks
measure: Total procedure time
timeFrame: up to 20 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02068040: Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: with preserved ejection fraction of >55%
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the

1. structural and functional features of skeletal muscle (SkM)
2. exercise capacity (as assessed by VO2 max)
3. parameters of diastolic heart function (as assessed by echocardiography)

We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.

Detailed description: Patient Inclusion/Exclusion Criteria:

1. New York Heart Association Class II/III HF with preserved ejection fraction (EF) of \>50%.
2. Nonsmokers
3. Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
4. Ages between 40-65. We will exclude any women of child bearing potential

Eligibility criteria: Inclusion Criteria:

* Medically Diagnosed Heart Failure with Ejection Fraction of \>55%
* BMI 27-32
* No Significant HbA1C fluctuations in past 6 months

Exclusion Criteria:

* Smoking or quit smoking less than 1 year prior to enrollment
* Substance Abuse
* Taking Coudmadin or Pradaxa

Primary outcomes:
measure: Change from baseline in exercise capacity
timeFrame: Baseline and 3 months
measure: Change from baseline in skeletal muscle metabolism
timeFrame: Baseline and 3 months
measure: Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
Clinical trial NCT02034240: Neutrophil Gelatinase Associated Lipocalin (NGAL) in Urine: Can This Prove to be a Biomarker for Acute Kidney Injury in Patients With Sepsis?
Official title: Secretion of Neutrophil Gelatinase Associated Lipocalin in Septic Patients and the Development of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Acute Kidney Injury
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
Collaborators: name: Kolding Sygehus
First posted: 2014-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with no prior record of kidney failure

Brief summary: Patients with severe infection and sepsis are in high risk of hypo perfusion and therefore organ affection. Temporary or permanent kidney failure is a common complication in these patients. Today's golden standard for kidney failure detection is creatinine levels rising and / or oliguria. The investigators hypothesize that an even more sensitive biomarker; neutrophil gelatinase associated lipocalin(NGAL) in urine can predict kidney injury before creatinine levels rise. In recent studies NGAL in urine seem to be a sensitive biomarker in these patient to predict kidney injury, but the time factor for sampling optimally is not known. In this pilot study the investigators sample the urine at admission within the first hour of hospitalization to investigate if NGAL can be used as a predictor in an emergency setting.


Eligibility criteria: Inclusion Criteria:

* Severe sepsis
* Septic shock
* Patients must not be able to give consent

Exclusion Criteria:

* Underaged (18 years )
* known kidney injury
* Fully alert patients that can give consent

Primary outcomes:
measure: Development of Acute Kidney Failure
timeFrame: During hospitalization, anticipated approximately 5 weeks
Secondary outcomes:
measure: Levels of NGAL in patients with kidney failure compared to creatinine
timeFrame: During hospitalization, anticipated approximately 5 weeks
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Faelles Akut Modtagelse, Kolding Sygehus
Study officials:
affiliation: Odense University Hospital
name: Jannie Bisgaard Stæhr, PhD, M.D
role: STUDY_CHAIR
affiliation: Kolding Sygehus
name: Claes Falkenberg Elvander, M.D
role: STUDY_DIRECTOR
affiliation: Kolding Sygehus
name: Srishamanthi Sriskandarajah, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01697540: Management of Highly Active Anti-retroviral Therapy-related Hyperlipidemia Among HIV-infected Patients in Taiwan
Official title: Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/AIDS group

Brief summary: 1. Written informed consent must be obtained before any study specific procedures are undertaken.
2. The process of the experiment (brief describe) The patients must come back for follow during 4 to 12 weeks after starting the new therapy. The investigators will follow the patients' lipid profile and any side effects and stop the observation till 36 months after starting the new therapy. The serum level of HIV-VL, CD4, GOT, GPT, triglyceride, cholesterol, HDL-cholesterol, and LDL-cholesterol will be checked every 3 months. The patients' chart and all data will be delinked to protect the patients' right and privacy.


Eligibility criteria: Inclusion Criteria:

* HIV-infected patients who receive HAART therapy but have metabolic side effects.
* Age over 20 years old

Exclusion Criteria:

* Abnormal liver function: GOT or GPT 5 times over normal upper limit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Tropical medicine center
Study officials:
References:
Clinical trial NCT04136340: Supportive Care Delivered by Telemedicine to Cancer Patients at Home
Official title: Virtual Visits by Supportive Care Specialists to Cancer Patients at Home: A Randomized Controlled Pilot Noninferiority Trial of Video Telemedicine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Supportive Care
Keywords: Telemedicine
Virtual Visits
19-382
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Noninferiority, randomized, controlled trial (RCT) in which all patients will meet with a supportive care specialist in-person for the initial clinic visit, and then receive follow-up supportive care visits either in-person at clinic or via home video telemedicine.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test whether supportive care follow-up delivered to cancer patients at home by telemedicine ("virtual" medical visits using telecommunications technologies) is as effective as in-person supportive care visits in the clinic.

Detailed description: The protocol was developed and initially implemented when the standard of care for Supportive Care (and oncology) follow-up at MSK was in-person visiting and home telemedicine was only in an early stage of use at the institution. During the COVID-19 crisis, all outpatient Supportive Care visits and most oncology visits at MSK have been handled via telemedicine to protect patient (and staff) safety.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* solid tumor of any type
* completed an initial in-person clinic visit (i.e. an IR/NV or AFX visit) at Rockefeller Outpatient Pavilion with Dr. Saldivar, Dr. Martin, Supportive Care physicians, or Andrea Dolan, a Supportive Care nurse practitioner
* planned for Supportive Care Service follow-up visits, but none yet completed
* enrolled on the MyMSK secure online patient portal and have access to the portal off site of MSK campuses
* resident of New York or New Jersey or Connecticut (clinicians may not be licensed in other states, as would be required for televisits to patients there)

Exclusion Criteria:

* Patients and informal caregivers who cannot communicate with clinicians/respond to instruments in English without the use of an interpreter

Primary outcomes:
measure: Health-Related Quality of Life: FACT-G
timeFrame: Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Judith Nelson, MD,JD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02495740: E-Bike Versus Classic Bike Intervention Trial
Official title: E-Bike Study - Endurance Capacity Following 1 Month Training of Classic Bike Versus Electric-assisted Bike
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Obesity
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals.

Detailed description: Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase physical activity in daily life, to promote health, and to increase cardiorespiratory fitness in normal-weight individuals. The positive effect of commuting to work by a normal bike on cardiorespiratory fitness has been shown to be an important predictor of cardiovascular mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular events and all-cause mortality.

Eligibility criteria: Inclusion Criteria:

body mass index 25-35 kg/m2, and willingness to commute to work by e-bike or by normal bike at least 3 times per week with a one-way distance of ≥ 6 km.

Exclusion Criteria:

cycling as a leisure-time activity, active commuting to work or exercise training more than once per week within 4 weeks before the start of the study, uncontrolled cardiovascular diseases limiting cardiorespiratory fitness, stage II arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 95 mmHg), renal diseases, uncontrolled diabetes mellitus (HbA1c \> 6.5%), or active malignancy or chemotherapy during the past 6 months.

Primary outcomes:
measure: maximal oxygen uptake
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel
Study officials:
affiliation: University of Basel
name: Arno Schmidt-Trucksäss
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511640: Behavioral Effects of Pregabalin and Cannabis
Official title: Behavioral Effects of Drugs (Outpatient)(43)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis-use Disorders
Keywords: marijuana
addiction
treatment
pharmacotherapy
cannabinoid
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cannabis is the most commonly used illicit drug in the United States, and its use is associated with rates of development of abuse and dependence, treatment admission and relapse that are comparable to other illicit drugs. Currently there is no effective pharmacological treatment for cannabis-use disorders. The purpose of the present study is to evaluate the ability of pregabalin to reduce cannabis use thereby evaluating its effectiveness as a medication for cannabis-use disorders.


Eligibility criteria: Inclusion Criteria:

* regular cannabis use
* good health other than cannabis use
* willingness to attempt abstinence
* effective form of birth control in female subjects
* available for up to 6 hrs every day for two 2-week test periods with an intervening break of 7-10 days each
* located in close proximity to University of Kentucky

Exclusion Criteria:

* medical screening outcomes outside normal ranges or deemed clinically insignificant
* medical history that would contraindicate pregabalin administration

Primary outcomes:
measure: Number of Self-administered Puffs of Smoked Cannabis Containing Active THC Concentrations Compared to Placebo Under Controlled Laboratory Conditions
timeFrame: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joshua A. Lile, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02914340: REACH SVS Control Patient Cross-Over Study
Official title: REACH (Research to Assess SVS Safety and Effectiveness for the Treatment of Severe EmphysemA in China) SVS Control Patient Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.


Eligibility criteria: Inclusion Criteria:

* Patient was enrolled in the REACH SVS Study control group and has completed their participation in the Study including the 12 month follow-up visit.
* Patient has received standard-of-care medical management and it has been stable for 6 weeks.
* Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.

Exclusion Criteria:

* Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study.
* Patient has demonstrated unwillingness or inability to complete baseline data collection procedures.
* Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study.
* Patient is unable to provide informed consent.
* Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
* Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the prior 3 months.
* Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period
* Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.

Primary outcomes:
measure: Forced expiratory volume at 1 second
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
References:
Clinical trial NCT01072240: An Observational Study on Infusion-related Adverse Events at Administration of MabThera (Rituximab) in Patients With Chronic Lymphocytic Leukemia
Official title: An Observational Registration Study of Infusion-related Adverse Events at Administration of Mabthera (Rituximab) in the Treatment of Chronic Lymphocytic Leukemia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 92
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: CLL patients receiving standard of care rituximab infusions at haematological or medical clinics

Brief summary: This observational study will monitor and register infusion-related adverse events and their handling in patients with chronic lymphocytic leukemia on treatment with MabThera (rituximab). Data will be collected from patients receiving intravenous MabThera at a dose of 375mg/m2 in cycle 1 and 500mg/m2 in subsequent cycles at each treatment visit for up to 6 months. Target sample size is 100 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic lymphocytic leukemia treated with rituximab (MabThera)
* rituximab (MabThera) dosage 375 mg/m2 in cycle 1, 500 mg/m2 in subsequent cycles
* informed consent to data collection

Exclusion Criteria:

* participation in an interventional clinical study

Primary outcomes:
measure: infusion-related adverse events
timeFrame: data collection every 4-6 weeks for up to 6 months for each patient
Secondary outcomes:
measure: usage and applicability of 90-minute iv infusion in patients with CLL
timeFrame: data collection every 4-6 weeks for up to 6 months for each patient
Other outcomes:
Locations:
city: Gaevle
country: Sweden
city: Gothenburg
country: Sweden
city: Huddinge
country: Sweden
city: Jönköping
country: Sweden
city: Kalmar
country: Sweden
city: Karlstad
country: Sweden
city: Kristianstad
country: Sweden
city: Lidköping
country: Sweden
city: Linkoeping
country: Sweden
city: Luleå
country: Sweden
city: Mora
country: Sweden
city: Norrkoeping
country: Sweden
city: Oskarshamn
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Umea
country: Sweden
city: Visby
country: Sweden
city: Västervik
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: