louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02326870: Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
Official title: Evaluation of the Follow me Mode of the AutoLap System - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
Keywords: laparoscopic Cholecystectomy
laparoscope holder
gynecological laparoscopy procedures
fundoplication surgery
laparoscopic adnexal surgery
excision of endometriosis lesion
diagnostic laparoscopy procedures
right hemicolectomy
Diaphragmatic hernia
Lead sponsor: M.S.T. Medical Surgery Technology LTD.
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.


Eligibility criteria: Inclusion Criteria:

1. Signed and dated Informed Consent Form (ICF).
2. Patients over 18 years

Exclusion Criteria:

1. Pregnancy
2. Extensive adhesions that will preclude routine laparoscopic surgical approach.
3. American Society of Anesthesiologists' (ASA) classification\>2

Primary outcomes:
measure: Number of successful "Follow Me" movements
timeFrame: during surgery
measure: System set-up time
timeFrame: during surgery
measure: Length of procedure
timeFrame: during surgery
measure: Number of times that the laparoscope was removed for cleaning
timeFrame: during surgery
measure: AutoLap evaluation questionnaire
timeFrame: post surgery
Secondary outcomes:
measure: System repositioning
timeFrame: during surgery
Other outcomes:
measure: Surgeon's learning curve for the use of the AutoLap system
timeFrame: post surgery
Locations:
city: Haifa
country: Israel
facility: Assuta Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Meander Medisch Centrum
name: Ivo A. M. J. Broeders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02506270: Effect of Airseal System Valve-less Trocar on the Ventilatory Parameters During Robotic-assisted Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Pressure High
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the investigators' study is to investigate if the use of the AirSeal insufflation system impairs ventilatory parameters of patients less than a conventional system in patients undergoing robot-assisted laparoscopic cystectomy.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for robotic-assisted Radical Cystectomy
* Written informed consent
* - ≥ 18 years of age

Exclusion Criteria:

* Patients who refuse participating in the study
* ejection fraction \< 40%
* history of retinal vascular occlusion and ischaemic optic neuropathy

Primary outcomes:
measure: change of dynamic compliance during surgery
timeFrame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position
Secondary outcomes:
measure: change of peripheral oxygen saturation during surgery
timeFrame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position,1h after extubation
measure: change of Peak Pressure during surgery
timeFrame: 5min after induction,30min after trendelenburg position,1hours and 2hours after trendelenburg,30min and 1hour and 2hours after reduction Trendelenburg,5min after repositioning in supine position
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena CI
Study officials:
References:
citation: Herati AS, Andonian S, Rais-Bahrami S, Atalla MA, Srinivasan AK, Richstone L, Kavoussi LR. Use of the valveless trocar system reduces carbon dioxide absorption during laparoscopy when compared with standard trocars. Urology. 2011 May;77(5):1126-32. doi: 10.1016/j.urology.2010.06.052. Epub 2010 Oct 2.
Clinical trial NCT03860870: Response to Clenbuterol in Humans
Official title: Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dried blood spots
skeletal muscle biopsies
muscle strength
muscle signaling
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two phases:

First phase sequential Second phase crossover
Primary purpose: BASIC_SCIENCE

Brief summary: Due to the long half-life (\~36 hr) of clenbuterol, detection methods such as dried blood spots (DBS) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. If, and how long, the compound can be detected by DBS has not yet been investigated but is of interest due to its potential in doping-control. The aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using DBS and to assess the physiological response to clenbuterol in skeletal muscle..


Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* 18-40 years of age
* No known contraindications for anabolic drugs (e.g. cancer)

Exclusion Criteria:

* Abnormal ECG
* Steroid abuse
* Ongoing use of prescription medication
* heavy resistance training more than 2 times weekly
* Disease deemed by the MD to infer a risk to participate in the trial

Primary outcomes:
measure: Blood clenbuterol concentration
timeFrame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol
Secondary outcomes:
measure: Blood clenbuterol concentration
timeFrame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug
measure: Urine clenbuterol concentration
timeFrame: Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug
measure: Muscle strength
timeFrame: Before (baseline) and 2.5 hours after administration of study drug
measure: Muscle signalling
timeFrame: Before (baseline) and 2.5 hours after administration of study drug
measure: Plasma K+
timeFrame: Before (baseline) as well as 2.5 hours after administration of study drug
measure: Muscle mTOR signalling
timeFrame: Before (baseline) as well as 2.5 hours after administration of study drug
measure: Metabolic rate
timeFrame: Before (baseline) as well as 2.5 hours after administration of study drug
measure: Maximal voluntary strength
timeFrame: Before (baseline) and after two-week treatment of study drug
measure: Body composition
timeFrame: Before (baseline) and after two-week treatment of study drug
measure: Aerobic capacity
timeFrame: Before (baseline) and after two-week treatment of study drug
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT01289470: Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
Official title: Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Keywords: NIRS Technology
Cardiovascular surgery
valvular surgery with cardiopulmonary bypass
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass

Brief summary: An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.

Detailed description: See Eligibility Criteria section

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Weigh at least 40 kg
* Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure
* Willing and able to provide informed consent
* Able to communicate and read in English

Exclusion Criteria:

* Emergency procedure such that informed consent may not be obtained
* Known cognitive impairment, history of delirium or dementia
* Known hemodialysis or fistula graft
* Delirium Observation Score (DOS) Score of \>6 prior to surgery
* Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis)
* Any known contraindication or sensitivity to the cerebral oximeter sensor

Primary outcomes:
measure: Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.
timeFrame: Completion of cardiovascular surgery
Secondary outcomes:
measure: Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.
timeFrame: Patient discharge (on average 7 days)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Solomon Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618770: Triathlon PSR Outcomes Study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Total Knee System Using the Triathlon PSR Tibial Insert
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty
Knee
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.


Eligibility criteria: Inclusion Criteria:

1. Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.
3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for primary cemented total knee replacement.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) \> 45.
2. Patient is already participating in the study for a contralateral total knee replacement.
3. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
6. Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
8. Patient is diagnosed with lumbar radicular pain.
9. Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
10. Patient has a known sensitivity to device materials.
11. Patient is a prisoner.

Primary outcomes:
measure: Mean SF-36 Physical Component Score
timeFrame: pre-operative, 6 weeks, 1 year
Secondary outcomes:
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: PreOp, 6 week, 1 year
measure: Range of Motion
timeFrame: PreOp, 6 weeks, 1 year
measure: Survivorship of Triathlon PSR Insert
timeFrame: 1 Year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
Study officials:
References:
Clinical trial NCT03382470: Impact of Antimicrobial Stewardship Programs in the Global Setting
Official title: Partnership to Enhance Antimicrobial Use in Resource-Limited Settings (PEARL): An Assessment of Need and Feasibility of Antimicrobial Stewardship Programs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resistance Bacterial
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Moi University
name: Kilimanjaro Christian Medical Centre, Tanzania
name: Ruhuna University, Sri Lanka
First posted: 2017-12-26
Enrollment: 3115
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the adult medical wards at the three hospitals during the duration of the study will be eligible.

Brief summary: Antimicrobial resistance is one of the greatest threats to human health, and is driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials in hospitals. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania.

Detailed description: Antimicrobial resistance is one of the greatest threats to human health, and is driven by the inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania. The impact of creating a basic ASP will be assessed at each hospital.

Eligibility criteria: Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

-

Primary outcomes:
measure: Appropriate antimicrobial use, for example for urinary syndromes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Galle
country: Sri Lanka
facility: Teaching Hospital Karapitiya
Study officials:
affiliation: Assistant Professor of Medicine
name: Gayani Tillekeratne, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124475: Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Official title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hand Dermatoses
Keywords: Chronic Hand Dermatitis
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 1035
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 study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Detailed description: Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.

Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Eligibility criteria: Inclusion Criteria:

* Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
* Lasting for 6 months since initial diagnosis
* Rated severe
* Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
* Refractory to topical steroids

Exclusion Criteria:

* Female patients who are pregnant or want to become pregnant
* Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
* Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

Primary outcomes:
measure: Physicians global assessment
measure: at week 12 or 24
Secondary outcomes:
measure: Response rate per treatment group
measure: Modified total lesion symptom score
measure: Patients global assessment
measure: at week 12 or 24
measure: Time to relapse
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Thomas Ruzicka, MD
Study officials:
affiliation: University of Düsseldorf, Dermatological Hospital, Germany
name: Thomas Ruzicka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
Clinical trial NCT01969175: Effect of a Low-glycemic-load and Milk-free Diet on Acne Severity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effect of a low-glycemic-load and milk-free diet on acne severity.

IGF-1 and a phosphorylated product of the mTORC pathway (p70S6K) will be assessed in both groups to explore the mTORC signaling pathway, which is thought to be related to clinical improvement in previous studies.


Eligibility criteria: Inclusion Criteria:

* Mild, moderate or severe acne (GAGS score 15-44)
* Age: 14-20 years old
* Presence of acne for at least 2 months

Exclusion Criteria:

* Diabetes
* Polycystic ovary syndrome
* Use of hormonal contraceptives
* Previous use of oral retinoids
* Use of oral antibiotics or topical antibacterial or retinoid agents in the last 2 months
* Use of medications known to cause or exacerbate acne including lithium, oral or injected retinoids, some anticonvulsant drugs, medications containing iodides or bromides
* Drug or alcohol abuse.
* Active smokers
* Anticipated difficulty attending visits or fear of blood draws

Primary outcomes:
measure: GAGS Acne severity scale
timeFrame: 13 weeks
Secondary outcomes:
measure: Serum insulin like growth factor 1 (IGF-1)
timeFrame: 13 weeks
measure: Diet acceptability and adherence
timeFrame: 13 weeks
measure: p70S6K
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
Study officials:
References:
citation: Kwon HH, Yoon JY, Hong JS, Jung JY, Park MS, Suh DH. Clinical and histological effect of a low glycaemic load diet in treatment of acne vulgaris in Korean patients: a randomized, controlled trial. Acta Derm Venereol. 2012 May;92(3):241-6. doi: 10.2340/00015555-1346.
citation: Smith RN, Mann NJ, Braue A, Makelainen H, Varigos GA. A low-glycemic-load diet improves symptoms in acne vulgaris patients: a randomized controlled trial. Am J Clin Nutr. 2007 Jul;86(1):107-15. doi: 10.1093/ajcn/86.1.107.
citation: Reynolds RC, Lee S, Choi JY, Atkinson FS, Stockmann KS, Petocz P, Brand-Miller JC. Effect of the glycemic index of carbohydrates on Acne vulgaris. Nutrients. 2010 Oct;2(10):1060-72. doi: 10.3390/nu2101060. Epub 2010 Oct 18.