louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02604979: The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were undergoing robot- assited laparoscopic gastrectomy

Brief summary: Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which is performed in a head up position under CO2 pneumoperitoneum.

Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.

Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc interval) during robotic-assisted laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy.

Exclusion Criteria:

1. emergency operation
2. cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
3. ventricular conduction abnormality
4. prior pacemaker insertion
5. abnormal electrolyte values
6. patients who take antiarrythmic agent
7. hepatic or renal failure
8. drug hyperactivity
9. neurological or psychiatric illnesses

Primary outcomes:
measure: Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy
timeFrame: through study completion, an average of 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Kim NY, Bai SJ, Kim HI, Hong JH, Nam HJ, Koh JC, Kim HJ. Effects of long periods of pneumoperitoneum combined with the head-up position on heart rate-corrected QT interval during robotic gastrectomy: an observational study. J Int Med Res. 2018 Nov;46(11):4586-4595. doi: 10.1177/0300060518786914. Epub 2018 Jul 20.
Clinical trial NCT05958979: Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 1
Official title: Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Cigarette Smoking
Cigarette Use, Electronic
Vaping
Keywords: vaping
e-cigarette
vape
nicotine
tobacco
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 601
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to use a varying number of e-liquids with differing marketing strategies.
Primary purpose: OTHER

Brief summary: This study assess the ways in which e-cigarette product characteristics, such as marketing strategies, impact user experience to inform potential regulations.

Detailed description: There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile.

Eligibility criteria: Inclusion Criteria:

Vapers/E-cigarette Users

* Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

- Regular use of cigarettes containing nicotine

Exclusion Criteria:

* Pregnant or planning to become pregnant

Primary outcomes:
measure: Subjective Appeal Rating Measure
timeFrame: 1 hour
measure: Sensory Attributes
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT06580379: Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery.
Official title: Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spine Fusion
Spine Injury
Spine Degeneration
Navigation, Spatial
Keywords: Imaging
Depth Imaging
Spine Surgery
Intraoperative Registration
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2024-08-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult spine surgery candidates treated within the Imperial College Healthcare NHS Trust , with the capacity to consent (non-vulnerable)

Brief summary: The primary study objective is to build a video dataset, consisting of both colour and depth information, of spine surgery that includes both 'open' and 'minimally invasive' (MIS) surgeries. Using accompanying preoperative CT scans of the patient's spine, we aim to develop a markerless tracking system for spine surgery, which the collected dataset will be used to both train, and then benchmark against.


Eligibility criteria: Inclusion Criteria:

* Candidate surgeries include all spine surgeries taking a posterior approach. This includes both 'open' and 'minimally invasive' surgeries, provided some portion of vertebrae bone is exposed.

Exclusion Criteria:

* Candidate surgeries will be excluded if the patient is under the age of 18 or the clinical lead feels the patient lacks capacity to consent.

Primary outcomes:
measure: Number of Data Collection completed
timeFrame: 3 years (initial recording duration)
measure: Number of Data points collected containing a variety of exposed spine anatomy
timeFrame: 3 years (initial recording duration)
measure: Patient diversity in Ethnicity
timeFrame: 3 years (initial recording duration)
measure: Patient diversity in Age
timeFrame: 3 years (initial recording duration)
Secondary outcomes:
measure: Usefulness for training navigation system
timeFrame: 4 years (initial recording duration + 1)
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College Healthcare Trust
name: Salvatore Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03609879: Effect of Cervical Collar on Intracranial Pressure
Official title: Effect of Cervical Collar on Optic Nerve Sheath Diameter Measured Sonographically. A Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Ultrasonography
Keywords: cervical collar
sonography
adult patients
Optic nerve sheath diameter
Ultrasonography
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: The Cleveland Clinic
First posted: 2018-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The routine use of cervical collar in emergency medical conditions has recently been questioned. The application of cervical collars, as their opponents point out, results in deterioration of intubation conditions, intensification of pain in the region of mastoid processes, and impaired venous outflow from the head.


Eligibility criteria: Inclusion Criteria:

* voluntary participation in the study

Exclusion Criteria:

* head or the spine injury in the last 3 months
* eye injuries in the last 3 months
* amputation of the eyeball
* Headache

Primary outcomes:
measure: Optic nerve sheath diameter 5 minutes after collar placement
timeFrame: 1 day after
measure: Optic nerve sheath diameter 20 minutes after collar placement
timeFrame: 1 day after
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Faculty of Medicine, Lazarski University
state: Masovian
city: Warsaw
country: Poland
facility: Lazarsku University
state: Masovian
Study officials:
affiliation: Lazarski University
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szarpak L, Truszewski Z, Kurowski A, Samarin S, Evrin T, Adamczyk P, Czyzewski L. Knowledge, attitude, and practices of paramedics regarding optic nerve sheath diameter ultrasonography. Am J Emerg Med. 2016 Jun;34(6):1160-1. doi: 10.1016/j.ajem.2016.02.063. Epub 2016 Mar 3. No abstract available.
citation: Ladny M, Smereka J, Ahuja S, Szarpak L, Ruetzler K, Ladny JR. Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial. Medicine (Baltimore). 2020 Apr;99(16):e19740. doi: 10.1097/MD.0000000000019740.
Clinical trial NCT06031779: Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer
Official title: Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: serum bile acid
biomarker
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending Xijing Hospital and Patients included in the biospecimen bank

Brief summary: In this study, the composition and level of serum bile acids in patients with gastric cancer and non-gastric cancer were analyzed by detecting the serum bile acid profile, so as to develop new serological diagnostic methods for early diagnosis and treatment of gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age between 18-70, both gender;
2. The gastric cancer group was early gastric cancer or advanced gastric cancer diagnosed by endoscopic examination and pathological biopsy. The non-gastric cancer group included patients without gastric lesions, superficial gastritis, chronic atrophic gastritis, intestinal metaplasia or dysplasia diagnosed by gastroscopy or pathological biopsy;
3. Informed consent was obtained.

Exclusion Criteria:

1. The patients have diseases that affect bile acid metabolism, such as liver cirrhosis, gallstones or inflammatory bowel disease, Behcet's disease, etc;
2. Due to other diseases, the patient took drugs affecting bile acid metabolism, such as cholestyramine, anti-inflammatory Lidan tablets, Danshu capsules, ursodeoxycholic acid, obticholic acid, Schisandrin B, tanshinone ⅡA, Yinzhihuang, etc;
3. Pregnant women;
4. Primary tumors of other systems were diagnosed;
5. Those with poor physiopathological conditions, such as chronic kidney disease requiring long-term dialysis;
6. Patients with mental illness;
7. Patients who have received radiotherapy or surgery previously;
8. Those with poor adherence or difficult to follow up.

Primary outcomes:
measure: serum bile acid profile before treatment
timeFrame: 1 month
Secondary outcomes:
measure: concentration of serum tumor markers before treatment
timeFrame: 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hosipital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Xijing Hpsipital of Digestive Disease
name: Yongquan Shi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01784484: Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes
Official title: Screening for Liver Fibrosis by Using Non-invasive Methods ( Fibro Scan) in Patients With Elevated Liver Enzymes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elevated Liver Enzymes
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-02-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abnormal liver enzymnes who attend the liver clinic

Brief summary: BACKGROUND: Fibrosis assessment by Transient Elastography or Fibro scan is validated in chronic hepatitis C, however limited data are available in chronic hepatitis B and in non alcoholic fatty liver disease (NAFLD). AIMS: Document the prevalence and severity of fibrosis in patients with different chronic liver disease (elevated liver enzymes) who are being followed up in the liver unit and to find associated factors with significant fibrosis and cirrhosis at ziv medical center, Safed,Bar Ilan University. Israel. METHODS: Fibro scan will be performed to all patients with abnormal liver enzymnes who attend the liver clinic. Liver stiffness measurement, age, gender, BMI, will be measured. Questionaire on soft drink consumption, Coffee drinking, use of herbs, and a history of cancer or heart disease will be distributed. Expected RESULTS: we expect that the liver stiffness (normal 1-6 Kpa) will be higher in NAFLD patients than in viral hepatitis patients for the same age ,same BMI, and the same duration of disease. More over, we expect serum aspartate aminotransferase (AST) values will emerge as the most important independent predictive variable of fibrosis and not serum ALT. A significant correlations between soft drink and coffee consumption with the extent of liver fibrosis is also expected. CONCLUSIONS: This prospective study will confirm that screening patients with elevated liver enzymes is beneficial and detect earlier the presence of liver fibrosis mainly in patients with NAFLD.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects
* More than 18 years of age
* Patients with elevated liver enzymes
* Written informed consent

Exclusion Criteria:

* Patients refusing to participate to the study and to provide written informed consent
* clotting disorder
* ongoing treatment with anti-coagulant or anti-aggregant
* advanced or decompensated cirrhosis (Child-Pugh class C)
* hepatocellular carcinoma
* other cancer
* history of surgery for brain aneurysm
* pace maker or defibrillator
* ocular metal foreign body

Primary outcomes:
measure: liver stiffness
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT04138784: Individualized Comprehensive Rehabilitation Program in Chronic Knee Osteoarthritis
Official title: Effectiveness of an Individualized Comprehensive Rehabilitation Program in Disabled Chronic Knee Osteoarthritis Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 38
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis is a common condition characterized by pain and functional disability in older people. Prevalence increases with age and is more frequent in older women. The aim of this study was to assess the effects of an 8-weeks individualized comprehensive rehabilitation program with elastic bands on pain and functional disability in chronic knee osteoarthritis.

Detailed description: The main symptoms of knee osteoarthritis are pain and functional disability. These symptoms are caused by a progressive loss and deterioration of articular cartilage with reactive new bone formation at the joint's surface and margins involving articular cartilage, soft tissues, and bone damage. Many treatment programs have been developed, including medication with nonsteroidal anti-inflammatory drugs, physical modalities, and therapeutic exercises. It is hypothesized that an individualized comprehensive rehabilitation program uring 8 weeks would benefit women with knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary symptomatic KOA according to the criteria of the American College of Rheumatology
* Women aged older than 65 years
* Pain predominantly over the last 3 months
* Kellgren and Lawrence score ≥2.

Exclusion Criteria:

* Ankle, hip or foot severe disorders
* Chronic back pain
* Alzheimer's disease, Parkinson's disease, motor neuron disorders.
* Diabetes mellitus
* Cardiac or respiratory insufficiency
* Inability to understand the procedure

Primary outcomes:
measure: Changes in Functionality
timeFrame: Baseline, 8 weeks, 3 months
measure: Changes in Physical Performance
timeFrame: Baseline, 8 weeks, 3 months
measure: Changes in Physical Performance
timeFrame: Baseline, 8 weeks, 3 months
measure: Changes in Perceived Health Status
timeFrame: Baseline, 8 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lopez LL, Benitez PO, Lopez JC, Martos IC, Torres JR, Santiago MG, Valenza MC. Effectiveness of an individualized comprehensive rehabilitation program in women with chronic knee osteoarthritis: a randomized controlled trial. Menopause. 2022 Jun 1;29(6):687-692. doi: 10.1097/GME.0000000000001959.
Clinical trial NCT01039584: A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations
Official title: A Randomized Study Evaluating the Therapeutic Equivalence and Safety of Butoconazole Nitrate Vaginal Cream, 2% and Gynazole 1 (Butoconazole Nitrate) Vaginal Cream, 2%, Against a Vehicle Control in the Treatment of Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Candidiasis
Keywords: bioequivalence
butoconazole
vulvovaginal
candidiasis
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 611
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.


Eligibility criteria: Inclusion Criteria:

* Female subjects, at least 18 years of age
* Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
* Signed and dated informed consent

Exclusion Criteria:

* Were pregnant, nursing, or planning a pregnancy within the study participation period
* Had evidence of any bacterial, viral, or protozoal infection
* Had hypersensitivity or allergy to the imidazoles, their analogues, and/or any of the Test Product ingredients
* Had any medical condition, or used any medication which, in the opinion of the investigator, could have interfered with the conduct of the study

Primary outcomes:
measure: The Test of Equivalence Between the Test and Reference Products Was Based on the Therapeutic Cure Rates at Visit 3/Test-of-Cure.
timeFrame: Visit 3: Day 22-31
Secondary outcomes:
measure: Clinical Cure
timeFrame: Visit 3: Day 22-31
measure: Mycological Cure
timeFrame: Visit 3: Day 22-31
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: PharmaNet, Inc. (PharmaNet)
state: North Carolina
Study officials:
References:
Clinical trial NCT04437784: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia
Official title: Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Inguinal Hernia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of bilateral primary inguinal hernia

Detailed description: This prospective study included 180 patients with bilateral primary inguinal hernia; randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.

.

Eligibility criteria: Inclusion Criteria:

* Patients with painless uncomplicated primary bilateral inguinal hernias

Exclusion Criteria:

* Immune compromised patients
* Coagulopathy
* Chronic liver or renal disease
* High-risk patients unfit for major surgery (ASA III or IV),
* Massive scrotal hernias, Recurrent or Complicated hernias
* Groin pain due to any other pathology
* Previous infra-umbilical surgery

Primary outcomes:
measure: Operative time
timeFrame: From skin incision until incision closure at the end of surgery
measure: Postoperative pain after 24 hours
timeFrame: 24 hours after surgery
measure: Postoperative pain after 7 days
timeFrame: 7 days after surgery
measure: Early postoperative complications
timeFrame: Within 30 days after the surgery
Secondary outcomes:
measure: Chronic Groin pain
timeFrame: After 3 months postoperatively
measure: 3 years hernia recurrence rate
timeFrame: within 3 years after surgery
measure: Patient's satisfaction score
timeFrame: within 3 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor of Surgery
name: Mohamed Elmessiry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.
citation: Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.