louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00971035: A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids (MOLLY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: MILR1444A
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.


Eligibility criteria: Inclusion Criteria:

* Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
* Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
* Stable asthma

Exclusion Criteria:

* Asthma exacerbation during screening
* Known malignancy
* Known immunodeficiency
* Pre-existing lung disease other than asthma
* Uncontrolled clinically significant medical disease
* Current smoker
* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
* Prior allergic reaction to a monoclonal antibody
* Patients (men and women) of reproductive potential who are not willing to use contraception
* Pregnancy

Primary outcomes:
measure: Change in forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in pre-bronchodilator FEV1
timeFrame: Baseline to Week 24
measure: Change in quality of life and symptom scores
timeFrame: Baseline to Week 12
measure: Change in peak flow
timeFrame: Baseline to Week 1
measure: Rate of asthma exacerbations
timeFrame: During the 24-week treatment period
measure: Change in rescue medication use
timeFrame: From baseline to Week 1
measure: Frequency and severity of adverse events
timeFrame: From the first study-specific procedure through the last observation visit
measure: Incidence of human anti-therapeutic antibodies (ATA)
timeFrame: Baseline to Week 32
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Michelle Freemer, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04907435: Comparison of Simultaneous Laparoscopic and Open Operations for Synchronous Liver Metastases With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optimization of Treatment
Lead sponsor: Federal State Budgetary Institution Russian Scientific Center of Roentgenoradiology of the Ministry
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with synchronous metastatic liver lesions with colorectal cancer

Brief summary: retrospective analysis of medical records of patients with synchronous liver metastatic colorectal cancer, who underwent simultaneous operations on the intestine and on the liver, from January 2011 to November 2020 at the Russian Scientific Center for Roentgenoradiology. 2 groups of 21 patients each were formed: group 1 included a patient with simultaneous laparoscopic operations, group 2 included a patient with simultaneous open operations.


Eligibility criteria: Inclusion Criteria:

* patients with synchronous metastatic liver lesions with colorectal cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01450735: Evaluation of the MANOS Carpal Tunnel Release System in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Thayer Intellectual Property, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The MANOS device is a carpal tunnel blade used to perform carpal tunnel release (CTR). CTR is indicated for the treatment of Carpal Tunnel Syndrome when conservative therapy fails. This study is being conducted to evaluate the safety and effectiveness of CTR with the MANOS device.


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled to undergo carpal tunnel release surgery.
* Patient has chronic Carpal Tunnel Syndrome with persistent symptoms despite non-operative treatment, or refusal of non-operative treatment, with one or more of the following: splinting, NSAIDs or corticosteroid injections.
* Carpal Tunnel Syndrome must be confirmed by positive results of Electromyography (EMG) and Nerve Conduction Velocity (NCV) tests.
* Patient is a male or non-pregnant, non-lactating female.
* Patient is 18-75 years of age, inclusive.
* Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
* Patient must voluntarily provide written, informed consent.

Exclusion Criteria:

* Patient has a prior or current musculoskeletal or neurologic condition that limits strength, motion, or sensation in the affected hand.
* Patient has a medical condition that precludes the use of anesthetic required for surgery.
* Patient has an ipsilateral injury or other conditions affecting hand function.
* Patient has acute CTS resulting from an injury (e.g., fracture).
* Patient has had previous CTR surgery on the affected hand.
* Patient has psychiatric history, head injury or any other condition which, in the Investigator's opinion, would prevent patient from complying with post-operative hand therapy or follow-up visits.

Primary outcomes:
measure: Gather clinical outcome data on the safety and efficacy of the MANOS Carpal Tunnel Release System.
timeFrame: Baseline throughout 12 weeks post-operatively
Secondary outcomes:
measure: Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events.
timeFrame: Baseline throughout 12 weeks post-operatively
Other outcomes:
Locations:
city: Hayward
country: United States
facility: The Hand Treatment Center
state: California
city: San Francisco
country: United States
facility: Neurospine Institute Medical Group
state: California
city: Willits
country: United States
facility: William Bowen, MD Orthopedic Surgery
state: California
Study officials:
References:
Clinical trial NCT06190535: Can Administration of Etamsylate Reduce Postpancreatectomy Hemorrhage
Official title: Doses Systematic Per Oral Administration of Etamsylate Can Reduce Postpancreatectomy Hemorrhage From Pancreatic Stump in Pancreatogastrostomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpancreatectomy Hemorrhage
Lead sponsor: University of Sfax
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS.

In this way we try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Detailed description: Whipple procedure is usually performed for periampullary malignancies. If the mortality of this intervention has been markedly decreased, it persists a morbid one. Morbidity is mainly due to postoperative leak of the pancreato-digestive anastomosis or postoperative pancreatic fistula (POPF), but also to postpancreatectomy hemorrhage (PPH). In several studies comparing the tow types of pancreato-digestive anastomosis: pancreatogastrostomy (PG) and pancreatojejunostomy (PJ), authors concluded that PG exposed to more postpancreatectomy hemorrhage (PPH) especially early, digestive and moderate hemorrhage classified as type A according to the classification of the ISGPS. In this case of hemorrhage, blood generally comes from pancreatic stump which is anastomosed or telescoped in the stomac. Incomplete hemostasis , soft pancreatic tissue and vascular fragility can help PPH to occur.

Etamsylate is an antihemorrhagic agent which works by increasing the resistance in the endothelium of capillaries and stimulating platelet adhesion. It also inhibits synthesis and action of prostaglandins causing platelet disaggregation, vasodilation and increased capillary permeability.

In this way, the investigators try to test the ability of the enteral administration through the nasogastric tube of Etamsylate for 48 hours after Whipple to reduce the rate of digestive PPH and mortality.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing Whipple procedure regardless the type of pathology and in which a PG is performed.

Exclusion Criteria:

* Patients undergoing Whipple procedure regardless the type of pathology and in which a PJ is performed.

Primary outcomes:
measure: Rate of postoperative early (24-48 hours) digestive hemorrhage
timeFrame: 24-48 hours, postoperative day Day 1, Day 2
Secondary outcomes:
measure: Operative mortality
timeFrame: 30 day
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Ali Kchaou
Study officials:
References:
Clinical trial NCT00391235: White Matter in Pediatric Bipolar Disorder: A DTI Study
Official title: White Matter Connectivity in Pediatric Bipolar Disorder: A Diffusion Tensor Imaging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: bipolar disorder
magnetic resonance imaging
white matter
diffusion tensor imaging
children
adolescents
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: American Academy of Child Adolescent Psychiatry.
name: Eli Lilly and Company
First posted: 2006-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bipolar Disorder

Brief summary: Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.

Detailed description: We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.

Eligibility criteria: Inclusion Criteria:

* Age 6 to 13
* Male or female
* Right-handed

Exclusion Criteria:

* IQ less than 70
* Learning disabilities
* History of autism, schizophrenia, anorexia or bulimia nervosa
* Substance abuse
* Claustrophobia
* Metal in body
* Pregnancy or lactation

Primary outcomes:
measure: Fractional anisotropy in brain white matter
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Medford
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Jean A Frazier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04816435: Airway Ultrasound Assessment in the Prediction of Difficult Airway
Official title: Review of Classical Predictors and Role of Airway Ultrasound in the Prediction of Difficult Airway
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Complication of Anesthesia
Anesthesia Intubation Complication
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients under general anesthesia with orotracheal intubation

Brief summary: To assess whether the thickness of pre-tracheal fat, greater than 28 mm, and measured by ultrasound, constitutes a reliable parameter in the prediction of a difficult airway.


Eligibility criteria: Inclusion Criteria:

* Patients risk ASA I-IV
* Non-urgent surgery under general anesthesia with orotracheal intubation
* Acceptance to participate and grant written consent

Exclusion Criteria:

* Urgent surgery
* Patients with a history of craniocervical pathology (trauma, tumor, malformations)
* Pregnancy
* Patient Refusal

Primary outcomes:
measure: Pretracheal fat thickness for intubation complexity
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Díaz
Study officials:
References:
Clinical trial NCT01897935: Flare Photometry in Uveitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: Uveitis
Lead sponsor: ChromoLogic, LLC
Sponsor class: INDUSTRY
Collaborators: name: UW Medicine Eye Institute
First posted: 2013-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with uveitis seen in the uveitis clinic at the UW Medicine Eye Institute would be eligible for participation in the uveitis arm of the study (n ≤ 50). Patients with other, non-inflammatory forms of eye disease will be eligible for the non-inflammatory arm of the study (n ≤ 50).

Brief summary: This is a cross sectional study of a novel non-invasive optical flare photometer (OFAM). Patients meeting the inclusion/exclusion criteria will receive a standard eye examination including a slit lamp examination to collect ocular flare data. In addition to the standard eye examination, subjects will receive flare measurements using the OFAM device.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Ability to understand and willingness to sign a written informed consent document.
* To be eligible for the uveitis arm of the study subjects must have active anterior chamber uveitis in one or both eyes as determined by a physician
* To be eligible for the non-inflammatory arm of the study the study subjects must have no ocular inflammation in either eye as determined by a physician.

Exclusion Criteria:

* Inability to give informed consent
* Exclusion criteria for the uveitis arm: no active disease
* Exclusion criteria for the non-inflammatory arm: Signs of uveitis

Primary outcomes:
measure: Establish OFAM algorithms for quantitation of ocular flare
timeFrame: 3 months
Secondary outcomes:
measure: Determine the impact that various potential confounders such as age and sex have on OFAM Measurements
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine Eye Institute
state: Washington
Study officials:
affiliation: UW Medicine Eye Institute
name: Deborah Lam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UW Medicine Eye Institute
name: Russell Van Gelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02455635: Lower Abdominal Pain During Office Hysteroscopy Can Assess Tubal Patency in Infertile Women
Official title: Lower Abdominal Pain During Office Hysteroscopy As A Guide In The Assessment Of Tubal Patency In Infertile Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Office Hysteroscopy
tubal patency
infertility
Lower Abdominal Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic with saline distension medium. The presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas. Then, laparoscopy with tubal chromopertubation was done.

Detailed description: Office hysteroscopy through vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath \& 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure. Meanwhile, the presence or absence of lower abdominal pain and the side of pain were recorded. Then, transvaginal sonography within 20 minutes was done to detect the presence of free fluid in the pouch of Douglas.Then, laparoscopy with tubal chromopertubation was done.

Eligibility criteria: Inclusion Criteria:

* Infertile women normal semen analysis

Exclusion Criteria:

* Ladies with evidence of upper or lower genital tract infections,
* presence of free fluid in the pouch of Douglas before hysteroscopy or pelvic pathology or those with cervical stenosis that required cervical dilatation prior to hysteroscopy

Primary outcomes:
measure: lower abdominal pain as measured by Visual Analog Scale
timeFrame: at time of hystroscopy till 15 minutes after end of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00482235: A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.


Eligibility criteria: Inclusion Criteria:

* You are between the ages of 40 and 75
* You have had a history for at least a year of COPD symptoms
* You have a history of smoking one pack of cigarettes per day for 10 years

Exclusion Criteria:

* You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
* You have donated blood in the last 4 weeks.
* You have been hospitalized or had major surgery in the last 4 weeks
* You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
* You have a history of heart problems in the last 6 months
* You have a history of stomach problems
* You are unwilling to avoid grapefruit juice throughout the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.
Clinical trial NCT03114735: Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia
Official title: The Effects of Preoperative Anxiety and Pain Sensitivity on the Intraoperative Hemodynamics, Consumption of Propofol and Postoperative Recovery in Cases of Endoscopic Ultrasonography (EUS) Received Sedoanalgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sedoanalgesia
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled for elective endoscopic ultrasonography with deep sedation

Brief summary: The objective of this study was to detect whether preoperative anxiety and pain sensitivity had effects on the consumption of anesthetics, time to achieve desired level of sedation, patient and endoscopist satisfaction, and postoperative recovery time and pain in deep sedation.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2 category
* between the ages of 20 and 65
* patients who has an education level and mental state to complete the scale and questionnaire provided for assessment

Exclusion Criteria:

* patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake

Primary outcomes:
measure: consumption of propofol(mg)
timeFrame: 1-3 hours
measure: the heart rate(n/min)
timeFrame: 1-3 hours
measure: arterial pressure(mmHg)
timeFrame: 1-3 hours
measure: peripheral oxygen saturation(%)
timeFrame: 1-3 hours
measure: postoperative nausea and vomiting (Numeric Rank Score)
timeFrame: 1-3 hours
measure: Post-procedure pain(Visual Analog Score)
timeFrame: 1-3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Yilmaz Inal F, Yilmaz Camgoz Y, Daskaya H, Kocoglu H. The Effect of Preoperative Anxiety and Pain Sensitivity on Preoperative Hemodynamics, Propofol Consumption, and Postoperative Recovery and Pain in Endoscopic Ultrasonography. Pain Ther. 2021 Dec;10(2):1283-1293. doi: 10.1007/s40122-021-00292-7. Epub 2021 Jul 22.