louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01727570: Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
Official title: Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer
Colon
Rectum
Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Immunotec Inc.
First posted: 2012-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the impact of nutritional supplementation with whey protein on postoperative functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized that, compared with a control group receiving nutrition counselling only, patients receiving nutritional counselling along with preoperative and postoperative nutritional supplements will have a significantly improved change in functional walking capacity from baseline to 8 weeks after surgery.

Detailed description: The aims of this research project are the following:

1. Determine to what extent a nutritional prehabilitation regimen, which includes whey protein, initiated before surgery and continued after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.
2. To understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Eligibility criteria: Inclusion Criteria:

* +18 years of age
* referred electively for resection of malignant, non metastasized, colorectal lesions
* French or English speaking

Exclusion Criteria:

* ASA class 4-5
* co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic and neuromuscular disease, psychosis)
* cardiac abnormalities
* severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine \> 1.5 mg/dl, and hepatic failure ALT and AST \>50% over the normal range)
* sepsis
* morbid obesity (BMI \>40)
* anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl).

Primary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: up to 8 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillis C, Nguyen TH, Liberman AS, Carli F. Nutrition adequacy in enhanced recovery after surgery: a single academic center experience. Nutr Clin Pract. 2015 Jun;30(3):414-9. doi: 10.1177/0884533614562840. Epub 2014 Dec 29.
Clinical trial NCT01745770: TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
Official title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Ulcerative Colitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2012-12-10
Enrollment: 306
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: The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Men or women aged 18 to 75 years
* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis)
* Toxic megacolon
* Screening stool positive for germs causing bowel disease
* Malabsorption syndromes
* Celiac disease
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding

Primary outcomes:
measure: Rate of clinical remission
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of stools per week
timeFrame: 8 weeks
measure: Number of bloody stools per week
timeFrame: 8 weeks
measure: Time to first resolution of clinical symptoms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Med. Klinik 1 - Markus-Krankenhaus
state: Hessen
Study officials:
References:
Clinical trial NCT03704870: Outcomes Following Omission of Daily Routine Chest Radiographs Following Pulmonary Resection
Official title: A Randomized Controlled Feasibility Study Looking at Differences in Hospital Stay Variables Following Omission of Daily Routine Chest Radiographs After Pulmonary Resection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lung Diseases
Lung Cancer, Nonsmall Cell
Surgery
Lung Adenocarcinoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, it is the standard of care practice to perform daily routine CXR when a chest tube is in situ following pulmonary resection. However, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. Eliminating daily routine CXR for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.


Eligibility criteria: Inclusion Criteria:

* Adult males or females who plan to receive VATS pulmonary resections confined to lobectomies, segmentectomies and wedge resections.
* Willingness to adhere to randomized treatment.
* Ability to answer self- and interviewer- administered questions in English
* Understand and sign a written informed consent form in English

Exclusion Criteria:

* Previous thoracic surgery history in the same side.
* Exploration, biopsy, lung volume reduction surgeries (LVRS), bilobectomies, sleeve resections or pneumonectomies performed.

Primary outcomes:
measure: Number of total chest xrays performed per subject
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: UHN
name: Gail Darling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563470: Bleeding, Cardio- and Cerebrovascular Complications in Head and Neck Surgery
Official title: A Retrospective Registry of Bleeding, Cardio- and Cerebrovascular Complications in Patients Treated for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
First posted: 2015-09-30
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: head and neck cancer patients

Brief summary: In this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

Detailed description: Inclusion criteria consisted of all the consecutive patients (n=456) diagnosed with head and neck cancer at Turku University Hospital between 1999 and 2008. Patients receiving palliative procedures were also included. Patients whose treatment had started in other institute or whose treatment was not finished in the investigators institute and patients with primary diagnosis of skin cancer were excluded from this study. All head and neck surgery operations (n=591) were assessed. Information was collected by the first author of this article from referral letters, patient files, anesthesiology reports, intensive care unit reports, laboratory database, radiology database, electrocardiograms and pathology reports. Death was certificated from national authority for collecting and compiling statistics on various fields of society and economy.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with head and neck cancer in Turku University hospital between 1999-2008

Exclusion Criteria:

* skin cancer, treatment started in other institute or not finished in our institute

Primary outcomes:
measure: all cause mortality
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
measure: bleeding
timeFrame: 30 days
measure: decompensated heart failure
timeFrame: 5 years
measure: new onset atrial fibrillation
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Turku University Hospital
name: Tuomas Kiviniemi, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03966170: Citicoline as Neuroprotector in Preterm
Official title: Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pre-Term
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Citicoline as neuroprotector in preterm

Detailed description: Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Preterm on CPAP or ventilator

Exclusion Criteria:

* Multiple congenital anomalies

Primary outcomes:
measure: Number of children with affection of the brain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: May R Elsheikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kafr-Elsheikh University - Faculty of Medicine
name: Abeer Salamah, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00257270: The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Official title: The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinnitus
Keywords: Chronic
Tinnitus
Acoustic trauma
Psychophysics
Loudness match
gabapentin
Lead sponsor: Tinnitus Research Consortium
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.'

Detailed description: Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day).

Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.

Eligibility criteria: Inclusion Criteria:

* non-pulsatile tinnitus present \> 1 year
* Tinnitus Handicap Questionnaire score \> 30
* ability to perform psychophysical matching procedure

Exclusion Criteria:

* evidence of depression
* renal insufficiency
* conductive hearing loss

Primary outcomes:
measure: Psychophysical loudness match of tinnitus to broad band noise and pure tones.
measure: Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
measure: The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
Secondary outcomes:
measure: Quality of Life survey (SF36-QOL)
Other outcomes:
Locations:
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Carol Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526370: Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
Official title: Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Uterine Cervical Cytology
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Keywords: self test
PAP smear
tampon test
E6/E7
mRNA
HPV
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 72
Sex: FEMALE
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 women in out-patient gynecological ward in account of cervical cell changes and 50 women in the national screening program for cervical cancer, included by their G.P.

Brief summary: The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses.

Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.


Eligibility criteria: Inclusion Criteria:

* Women with cervical dysplasia been referred to conisation.
* Women invited to cervical screening program and with only normal smear and normal smears in their history.

Exclusion Criteria:

* Women not performing the tampon self-test before conisation.
* Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.

Primary outcomes:
measure: Sensitivity and specificity of the HPV test of the material from the tampon self-test
timeFrame: Spring 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Region Hospital Randers
Study officials:
affiliation: Region Hospital, Department of Pathology
name: Hans Svanholm, Head of department
role: STUDY_DIRECTOR
References:
Clinical trial NCT00704470: Performance and Stress During Full Scale Simulator Training
Official title: Excellence in Performance and Stress Reduction During Two Different Full Scale Simulator Training Courses: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance in Simulated Emergencies
Stress During Simulator Scenario
Behaviour of Physicians in Simulated Emergencies
Keywords: Patient Simulation
Education, Medical, Continuing
Education, Medical, Graduate
Stress
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-06-25
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In Intensive Care Medicine, critical incidents are not rare and may result in fatal outcome. High fidelity patient simulators are commonly used in training curricula for healthcare professionals especially in anesthesiology, emergency medicine, and intensive care medicine. Several different course concepts have previously been published. As we know from recently published data, up to 80% of all critical incidents in the field of medicine are caused by human error. The authors of the present study aimed to investigate the effects of two different course concepts (one addressing technical skills in intensive care medicine and on addressing non-technical skills) on stress and performance. Stress and performance are measured in a pre-intervention and a post-intervention testing scenario.


Eligibility criteria: Inclusion Criteria:

* Physician with experience in intensive care medicine.

Exclusion Criteria:

* No experience in intensive care medicine
* previously taken part in simulator training

Primary outcomes:
measure: Performance in simulated emergencies (medical performance and non-technical skills)
Secondary outcomes:
measure: Stress in simulated emergencies (measured by salivary amylase and cortisol levels)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Interdisciplinary Medical Simulation Centre, University Hospital Dresden
Study officials:
affiliation: Director of Simulation Centre, Dept. of Anesthesiology, University Hospital Dresden
name: Michael P Mueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller MP, Hansel M, Stehr SN, Fichtner A, Weber S, Hardt F, Bergmann B, Koch T. Six steps from head to hand: a simulator based transfer oriented psychological training to improve patient safety. Resuscitation. 2007 Apr;73(1):137-43. doi: 10.1016/j.resuscitation.2006.08.011. Epub 2007 Jan 22.
Clinical trial NCT02517658: Adenotonsillectomy Postoperative Parental Teaching Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 99
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will involve parents filling out a survey before \& after watching a teaching tool video (https://www.youtube.com/watch?v=rIH63jqvlio) in addition to standard post-op teaching. The parents randomized to the video arms will watch the video while their child is in the OR and then either take the post survey immediately after or wait to take the survey until just prior to discharge. Parents not in the video arms of the study will also be asked to complete a survey pre and post standard pain management teaching.


Eligibility criteria: Inclusion Criteria:

* Parent or caregiver of any child having either adenotonsillectomy or tonsillectomy.

Exclusion Criteria:

* Non-english speaking families that require an interpreter.
* Any parent/family/caregiver that declines to be part of the study.

Primary outcomes:
measure: Difference in Answers to Pre & Post Teaching Questionnaires
timeFrame: approx. 1 - 2 hrs post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Sarah Khan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651858: Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Official title: Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 52
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy and male subjects aged 20 to 45 years
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

Exclusion Criteria:

* A subject with sign or symptoms or previously diagnosed disease of liver

Primary outcomes:
measure: to Assess Pharmacokinetics
timeFrame: 24h after drug administration
Secondary outcomes:
measure: to Assess Safety
timeFrame: 24h after administration
Other outcomes:
Locations:
Study officials:
References: