louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00799357: Utility of Bedside Ultrasound in the Prediction of Difficult Airway
Official title: Utility of Bedside Ultrasound in the Prediction of Difficult Airway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laryngoscopy
Keywords: ultrasound
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: The Association for Medical Ultrasound
First posted: 2008-11-27
Enrollment: 162
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-op patients

Brief summary: The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

Detailed description: A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for any surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Upper airway pathologies (facial fractures, tumours, etc)
* Cervical spine fractures
* Tracheostomy tube
* unable to give consent

Primary outcomes:
measure: Predictors of difficult laryngoscopy
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Srikar R Adhikari
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komatsu R, Sengupta P, Wadhwa A, Akca O, Sessler DI, Ezri T, Lenhardt R. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007 Feb;35(1):32-7. doi: 10.1177/0310057X0703500104.
citation: Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
citation: Chou HC, Wu TL. Large hypopharyngeal tongue: a shared anatomic abnormality for difficult mask ventilation, difficult intubation, and obstructive sleep apnea? Anesthesiology. 2001 May;94(5):936-7. doi: 10.1097/00000542-200105000-00043. No abstract available.
Clinical trial NCT04293757: Rotational Angiography in Cryoballoon Ablation
Official title: Preprocedural Imaging by Rotational Angiography in Cryoballoon Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: preprocedural imaging
Atrial Fibrillation
Rotational angiography
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is still unresolved question weather preprocedural imaging of left atrium and pulmonary veins is needed before the pulmonary vein isolation procedure for the treatment of atrial fibrillation. The investigators are conducting a randomized study to determine if 3D rotational angiography (as a mode of preprocedural imaging) performed before the cryoballoon ablation, facilitates the procedure and has positive impact on procedure characteristics and outcomes.

Detailed description: Around 50% of cardiac electrophysiology (EP) centers are using some kind of imaging to define left atrium and pulmonary vein anatomy before the pulmonary vein isolation (PVI) procedure. Most commonly, CT or MR are performed few days/weeks before the procedure. Three dimensional rotational angiography is least commonly used. However it has the advantage that it can be performed in the EP room just before the ablation procedure. There is still no consensus if any kind of imaging is really needed to perform safe and effective PVI.

The investigators want to determine if 3D rotational angiography (as a mode of preprocedural imaging) has positive impact on procedure safety and efficacy. Also the investigators want to compare the immediate procedure characteristics. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up.

Eligibility criteria: Inclusion Criteria:

* paroxysmal atrial fibrillation
* persistent atrial fibrillation
* scheduled for cryoballoon ablation

Exclusion Criteria:

* longstanding persistent atrial fibrillation
* renal failure
* contrast allergy

Primary outcomes:
measure: ablation success rates
timeFrame: 1 year
Secondary outcomes:
measure: procedure duration
timeFrame: 1 year
measure: radiation exposure
timeFrame: 1 year
measure: contrast expenditure
timeFrame: 1 year
measure: complication rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: KBC Zagreb
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Vedran Velagić, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876757: 5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BPH
Depression
Suicide
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 186394
Sex: MALE
Minimum age (years): 66
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All men \>66 years of age in Ontario between 2003-2013

Brief summary: In December 2015, Health Canada issued a warning about a potential relationship between suicide and finasteride use and called for further research. No population based studies have assessed the risk of suicide with finasteride use, and this risk is not currently part of the product monograph. Furthermore, the link between depression and finasteride has not been well studied in the older population who are the primary users of this medication.


Eligibility criteria: Inclusion Criteria:

* All men \>66 years of age in Ontario between 2003-2013

Exclusion Criteria:

* Non Ontario residents
* No prescriptions filled in prior 180 days
* Prior exposure to finasteride/dutasteride in the 2 years prior to study enrollment.
* Prescription initiated during hospital admission or ER visit.

Primary outcomes:
measure: Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)
timeFrame: Through study completition, an average of 18 months.
Secondary outcomes:
measure: Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)
timeFrame: Through study completition, an average of 18 months.
measure: Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)
timeFrame: Through study completition, an average of 18 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05485857: Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery
Official title: Influence of Arrangement of Small Intestine Order on the Recovery of Bowel Function After Laparoscopic Colorectal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The method of arranging and restoring the position of the small intestine under laparoscopy is used to determine whether it can promote the recovery of intestinal function after colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed colorectal cancer, patients undergoing colon cancer or radical resection of high rectal cancer；
* Tumor Stage (TNM): I-III；
* Age: \>18 years old; \<80 years old;
* ASA: I-III;
* Agree and sign the informed consent form.

Exclusion Criteria:

* Stoma patients；
* Patients with preoperative intestinal obstruction；
* Constipation patients (More than three days before the last bowel movement)；
* Combined other organ resection patients；
* Stroke or spinal cord injury patients；
* Long-term opioid use patients；
* Patients with a history of previous abdominal surgery；
* Patients refused entry into the trial；

Primary outcomes:
measure: First flatus time after surgery
timeFrame: 50 hours
Secondary outcomes:
measure: Time to liquid diet
timeFrame: 70 hours
measure: Postoperative hospital stay
timeFrame: 30 days
measure: Paralytic ileus time after surgery
timeFrame: 30 days
measure: First defecate time after surgery
timeFrame: 70 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Wei Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT02784457: Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome
Official title: Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Assisted Reproduction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer


Eligibility criteria: Inclusion Criteria:

* Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.

Exclusion Criteria:

* Women on short or antagonist protocols.
* Women who received GnRH agonist for triggering ovulation.
* Women who had embryo transfer.

Primary outcomes:
measure: Number of women who needed culdocentesis or paracentesis of the ascitic fluid
timeFrame: within 2 weeks of onset
Secondary outcomes:
measure: Number of women who needed hospitalization
timeFrame: within 2 weeks of onset of symptoms
measure: Time to regression of nausea/vomiting
timeFrame: within 2 weeks of onset of symptoms
measure: Time to regression of large ovarian size
timeFrame: within 4 weeks of onset of symptoms
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04825457: Comparative Study of Anchoring-tip vs. Conventional EMR of Colorectal Polyps
Official title: Comparative Study of Anchoring-tip vs. Conventional EMR of Intermediate-Size Colorectal Polyps: Multi-center, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Polyp
Lead sponsor: Kyungpook National University Chilgok Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 200
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: TREATMENT

Brief summary: Endoscopic mucosal resection (EMR) is an effective and has been widely used technique for the treatment of superficial colorectal neoplasms. Although, conventional EMR (CEMR) showed high efficacy for the management of colorectal superficial neoplasms, there is problematic limitation in this technique - incomplete resection. In literature, the anchoring-tip EMR (AEMR), named as "Tip-in EMR" was first introduced in 2016 from Japan. Recently, several retrospective studies have been suggested about the effectiveness of AEMR. However, there has been no prospective randomized controlled study to identify its advantage over CEMR. Therefore, the investigators performed a multicenter randomized controlled trial to estimate the effectiveness of AEMR compared with CEMR for the endoscopic treatment of intermediate-size (10 to 20 mm) colorectal polyps.

Detailed description: After injection of normal saline solution mix, snaring was tried for CEMR. In AEMR, the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.

Eligibility criteria: Inclusion Criteria:

* Intermediate-size (10 to 20 mm) colorectal polyps
* Morphologically sessile (Is), slightly elevated (IIa), flat (IIb), and slightly depressed (IIc) as Paris classification of superficial neoplastic lesions
* Laterally spreading tumor (granular and nongranular type) as Kudo classification.

Exclusion Criteria:

* Pedunculated or excavated/ulcerated polyps
* Polyps with features strongly suggestive of submucosal invasive carcinoma
* Polyps in patients with inflammatory bowel disease, familial polyposis, electrolyte abnormality, and coagulopathy
* Residual lesions after endoscopic resection or presence of severe submucosal fibrosis.

Primary outcomes:
measure: Primary outcome was comparing the R0 resection rate between Anchoring-tip EMR and Conventional EMR.
timeFrame: From EMR to reporting of histopathology, 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Joon Seop Lee
Study officials:
References:
Clinical trial NCT00374166: An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder
Official title: An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorders
Keywords: Anti-anxiety agents
antidepressive agents
controlled clinical trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder


Eligibility criteria: Inclusion Criteria:

* Diagnosis of generalized anxiety disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module.

Exclusion Criteria:

* Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine oxidase inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.
Clinical trial NCT03348566: Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes
Official title: Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Change
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 22000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Nurses' Health Study began in 1976, when 121,700 female registered nurses aged 30-55 y were recruited to complete a baseline questionnaire. the investigators included 11,323 women of European ancestry. Informed consent was obtained from all participants.

The Health Professionals Follow-up Study The HPFS was initiated in 1986, and was composed of 51,529 male aged 40-75 y at baseline. This study included 6,833 men whose genotype data were available. Informed consent was obtained from all participants.

The Women's Health Initiative (WHI) is a large, multiethnic, 40-center study that focuses on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. 6,254 Caucasians women with European ancestry were included.

The design of Singapore Chinese Health Study (SCHS): Between 1993 and 1998, 63,257 Chinese between 45 and 74 in Singapore were enrolled. 5,264 subjects with genotyping data were included in this analysis.

Brief summary: the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).


Eligibility criteria: Inclusion Criteria:

* 11,323 women of European ancestry.
* Informed consent was obtained from all participants. The DNA extraction methods, quality control measures,
* SNPs genotyping and imputation data are available .
* Both cases and controls with genotyping data are available based on GWASs

Exclusion Criteria:

* participants without genetic data

Primary outcomes:
measure: weight changes
timeFrame: 6-10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Heianza Y, Qi L. Gene-Diet Interaction and Precision Nutrition in Obesity. Int J Mol Sci. 2017 Apr 7;18(4):787. doi: 10.3390/ijms18040787.
citation: Qi Q, Chu AY, Kang JH, Huang J, Rose LM, Jensen MK, Liang L, Curhan GC, Pasquale LR, Wiggs JL, De Vivo I, Chan AT, Choi HK, Tamimi RM, Ridker PM, Hunter DJ, Willett WC, Rimm EB, Chasman DI, Hu FB, Qi L. Fried food consumption, genetic risk, and body mass index: gene-diet interaction analysis in three US cohort studies. BMJ. 2014 Mar 19;348:g1610. doi: 10.1136/bmj.g1610.
Clinical trial NCT00600366: Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen® in Insulin Naive Subjects With Type 2 Diabetes
Official title: Efficacy and Safety of Biphasic Insulin Aspart 30 in Insulin Naive Type 2 Diabetic Patients With Secondary OHA Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 71
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on blood glucose control in insulin naive type 2 diabetes failing on secondary oral hypoglycaemic agent (OHA).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insulin naive diabetes
* Current treatment with OHA, secondary failure
* Body mass index (BMI) below 40 kg/m2
* HbA1c over 8.5%
* Willing and able to start with insulin therapy and to perform self-blood glucose monitoring

Exclusion Criteria:

* History of drug or alcohol abuse
* Receipt of the investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products
* Severe uncontrolled hypertension
* Any disease or condition, which the Investigator feels, would interfere with the trial

Primary outcomes:
measure: HbA1c
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Blood glucose profiles
measure: Incidence of hypoglycaemic episodes
measure: Incidence of adverse events
Other outcomes:
Locations:
city: Belgrade
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Kragujevac
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Nis
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
city: Novi Sad
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lalic NM, Micic D, Antic S, Bajovic L, Pantelinac P, Jotic A, Kendereski A, Dimic D, Djukic A, Mitrovic M, Vujasin M. Effect of biphasic insulin aspart on glucose and lipid control in patients with Type 2 diabetes mellitus. Expert Opin Pharmacother. 2007 Dec;8(17):2895-901. doi: 10.1517/14656566.8.17.2895.