louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01338948: Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
Official title: A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.

Detailed description: To assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.

Diagnosis of early stage gastric cancer -\> CT scanning \& EUS for staging -\> (Registration) -\> Robotic surgery with image reconstruction -\> Conversion rate, Tumor location \& vascular anatomy correlation.

Eligibility criteria: Inclusion Criteria:

* Patients who are older than 20 years
* Histologically confirmed gastric adenocarcinoma
* Patients who want robotic gastric cancer surgery
* Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS \& CT scan
* No history of drug allergy
* creatinine \< 1.5 X upper normal limit
* Informed consent

Exclusion Criteria:

* Previous history of upper abdominal surgery
* Patient refused the study

Primary outcomes:
measure: rate of conversion (to laparotomy or laparoscopy assisted)
timeFrame: within 24 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Matsuki M, Kanazawa S, Kanamoto T, Inada Y, Kani H, Tanikake M, Yoshikawa S, Narabayashi I, Tatsumi Y, Nishimura H, Lee SW, Nomura E, Okuda J, Tanigawa N. Virtual CT gastrectomy by three-dimensional imaging using multidetector-row CT for laparoscopic gastrectomy. Abdom Imaging. 2006 May-Jun;31(3):268-76. doi: 10.1007/s00261-005-0360-2. No abstract available.
citation: Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.
Clinical trial NCT01670448: PECBLOCK for the Treatment of Pain After Breast Surgery
Official title: The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: Postoperative pain
Chronic pain prevention
Regional anesthesia
Mastectomy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: University Hospital, Limoges
First posted: 2012-08-22
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* women aged 18-85 yrs old
* patients ASA status I-IV

Exclusion Criteria:

* refusal of the PECBLOCK
* allergy to a drug used in the protocol (local anesthetic)
* patients with chronic pain before the surgery

Primary outcomes:
measure: Pain score at rest in the recovery room
timeFrame: 30 min after entering the recovery room or just before morphine administration if needed
Secondary outcomes:
measure: Total morphine consumption in the recovery room
timeFrame: in the recovery room before discharge (after 1 h on average))
Other outcomes:
measure: Total sufentanil consumption during surgery
timeFrame: at the end of surgery (1-2 h on average)
measure: Assess any complication from PECBLOCK
timeFrame: first 24 hours post surgery
Locations:
city: Montreal
country: Canada
facility: CHUM
state: Quebec
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
affiliation: CHU Limoges
name: Jérôme Cros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUM
name: Pierre Beaulieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cros J, Senges P, Kaprelian S, Desroches J, Gagnon C, Labrunie A, Marin B, Crepin S, Nathan N, Beaulieu P. Pectoral I Block Does Not Improve Postoperative Analgesia After Breast Cancer Surgery: A Randomized, Double-Blind, Dual-Centered Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):596-604. doi: 10.1097/AAP.0000000000000779.
Clinical trial NCT00266448: Whole Body Washing With Chlorhexidine for the Eradication of MRSA
Official title: The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA - a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MRSA-Colonization
Keywords: MRSA
eradication
chlorhexidine
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2005-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).

Detailed description: The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.

Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.

Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.

Eligibility criteria: Inclusion Criteria:

* persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA

Exclusion Criteria:

* ongoing systemic or local antimicrobial treatment directed against MRSA
* hypersensitivity to mupirocin or chlorhexidine
* pregnancy
* previous enrolment

Primary outcomes:
measure: efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage
Secondary outcomes:
measure: development of MRSA infection
measure: tolerance to the antiseptic whole body treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: Hygiene-Institut University Hospital Heidelberg
name: Constanze Wendt, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wendt C, Schinke S, Wurttemberger M, Oberdorfer K, Bock-Hensley O, von Baum H. Value of whole-body washing with chlorhexidine for the eradication of methicillin-resistant Staphylococcus aureus: a randomized, placebo-controlled, double-blind clinical trial. Infect Control Hosp Epidemiol. 2007 Sep;28(9):1036-43. doi: 10.1086/519929. Epub 2007 Jul 3.
Clinical trial NCT02165748: Severe Intraoperative Hyperglycemia During Craniotomy and Postoperative Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Craniotomy for Brain Surgery
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing craniotomy for brain surgery

Brief summary: Aim of this prospective observational study -in patients undergoing craniotomy for supra or infratentorial surgery as elective or emergency procedure- is to test the hypothesis that severe intraoperative hyperglycemia (BGC ≥180mg/dl) is associated with an increased incidence of infections within the first postoperative week (pneumonia, blood stream, urinary, surgical site/wound and cerebral infections)(NCT01923571).


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Undergoing elective or emergency craniototmy

Exclusion Criteria:

* Age \<18

Primary outcomes:
measure: Incidence of infections in patients presenting intraoperative severe hyperglycemia during craniotomy
timeFrame: 7 days
Secondary outcomes:
measure: survival during the study period
timeFrame: 7 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of ROme "La Sapienza"
Study officials:
affiliation: Department of Anesthesiology, University of ROme "La Sapienza"
name: Federico Bilotta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gruenbaum SE, Toscani L, Fomberstein KM, Ruskin KJ, Dai F, Qeva E, Rosa G, Meng L, Bilotta F. Severe Intraoperative Hyperglycemia Is Independently Associated With Postoperative Composite Infection After Craniotomy: An Observational Study. Anesth Analg. 2017 Aug;125(2):556-561. doi: 10.1213/ANE.0000000000001946.
Clinical trial NCT05465148: Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
Official title: Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Autism Spectrum Disorder
Keywords: Fecal Matter Transplant
FMT
Autism
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 1000 participants (any biological sex) that have a shipping address within the USA will be enrolled. Participants of all ages will be admitted into the study; minors - under the age of 18 will be required to provide the assent form or a parental permission form, in addition to the Informed Consent Form signed by the parents/guardians prior to any study related activities.

Brief summary: This observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT (fecal matter transplant) therapy and to develop a statistical model that can improve FMT donor-recipient matching. Participants are recruited through NovelBiome only, this study will NOT utilize other clinical sites.

Detailed description: This longitudinal, observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT therapy and to develop a statistical model that can improve FMT donor-recipient matching.

Participant phenotype data and samples are collected at several time points relative to their receiving FMT therapy.

Participants will collect stool, urine, environmental swabs, saliva, and blood at home via VLS's (Viome Life Sciences) at-home kits mailed to them by VLS. The at-home samples are collected by participants (and when appropriate LAR/guardian). The samples are then returned to VLS via postage-paid mailers (provided). These samples are analyzed by the VLS laboratory.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ASD, from medical records, self-diagnosed and/or LAR reported (LAR = legally authorized representative)
* Plans to undergo FMT treatment at a Novel Biome Clinic
* Consented to participate in the study

Exclusion Criteria:

* Active cancer therapy
* Antibiotic use within 30 days prior to starting the FMT therapy. FMT therapy itself starts with antibiotic treatment.

Primary outcomes:
measure: Prevalence of species in samples from people with ASD
timeFrame: 10 years
measure: Prevalence of species in samples that led to successful FMT therapy
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072848: Mathematically Arterialised Testing of Hypercapnic Subjects Study
Official title: A Prospective Observational Cohort Study to Investigate the Physiological Agreement Between Arterial Sampling (the Reference Method) and Mathematically Arterialised Venous Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercapnic Respiratory Failure
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Aalborg University
First posted: 2019-08-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with suspected chronic hypercapnic respiratory failure admitted as part of routine clinical care for consideration of home NIV.

Brief summary: Prospective observational cohort study of patients admitted to hospital with suspected hypercapnic respiratory failure and requiring treatment with non-invasive ventilation (NIV) as part of standard, routine management. Contemporaneous blood gas samples will be obtained via arterial, capillary, and venous methods. The venous samples will undergo mathematical arterialisation via the v-TAC system. In line with standard medical care, arterial samples will be obtained before starting NIV and at two set points afterwards (day 1 post-NIV, and pre-discharge). Pre-existing clinical thresholds will be used to assess the reliability of v-TAC against ABG, the existing gold standard and will conduct a retrospective model of decision-making once the blood sampling component of the study is concluded.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or above.
* Admitted for consideration of home Non Invasive Ventilation.
* Due to undergo arterial blood gas sampling as part of routine clinical care

Exclusion Criteria:

* Inability to provide informed consent.
* Clinical necessity to perform blood gas sampling prior to allowing sufficient time for informed consent.
* Inability to obtain reliable SpO2 readings

Primary outcomes:
measure: Change in blood carbon dioxide level (PaCO2)
timeFrame: Between day 0 and day 1
Secondary outcomes:
measure: Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)
timeFrame: Between day 0 and day 1
measure: Change in PaCO2 between ABG versus v-TAC versus Capillary Blood Gas (CBG) versus Venous Blood Gas (VBG)
timeFrame: Between day 0 and through to study completion, up to 3 days
measure: Relative difficult in sampling
timeFrame: Between day 0 and through to study completion, up to 3 days
measure: Patient experience
timeFrame: Between day 0 and through to study completion, up to 3 days
measure: Patient preference
timeFrame: Between day 0 and through to study completion, up to 3 days
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Royal Papworth Hospital
name: Michael Davies
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00564148: Intravitreal Avastin in Proliferative Retinopathies
Official title: Intravitreal Injections With Avastin in Proliferative Retinopathies Related to the Production of VEGF Having Different Causes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Neovascularization
Keywords: antiVEGF therapy
Lead sponsor: Ophthalmological Association Edelweiss
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study intends to assess the effect of Avastin injections in different proliferative retinopathies due to different causes

Detailed description: Proliferative retinopathies due to different causes represent important causes for the visual acuity loss. Conventional treatments may sometimes improve the visual function, whereas other times, the visual acuity continue to decrease, in spite of all the medical, surgical or laser treatments.

Intravitreal injections with anti-VEGF agents (ex. Avastin for our trial) seem to be an important tool for certain difficult situations in which at the ocular fundus, out of different reasons (advanced age, diabetes mellitus, retinal veins occlusions, etc)new pathologic vessels appear, causing devastating changes in the posterior and anterior segment as well.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of a proliferative retinopathy (AGE RELATED MACULAR DEGENERATION,DIABETIC PROLIFERATIVE RETINOPATHY, etc)
* distance acuity \< 0.5
* age \> 20 years

Exclusion Criteria:

* noncooperative patients
* ocular infections / inflammations

Primary outcomes:
measure: The following parameters will be assessed in order to evaluate the Avastin effect: visual acuity, lesions's area at the ocular fundus
timeFrame: one year
Secondary outcomes:
measure: The intraocular pressure will be measured during the whole study in order to assess the possible side effects of Avastin injections
timeFrame: one year
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Ochiul Diabetic
Study officials:
affiliation: Ophthalmological Association Edelweiss
name: NARCISA IANOPOL, researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852748: Validation of Venogenic Hypothesis for Cough, Exertional and Sexual Headaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Keywords: headache
Lead sponsor: French Society for the Study of Migraine Headache
Sponsor class: OTHER
First posted: 2009-02-27
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 suffering of cough, exertional and sexual headaches

Brief summary: Clinical and neuroradiologic study concerning patients suffering of cough, exertional and sexual headaches disorders (pathophysiology) concerning a venous hypothesis implication, redescribe clinical headaches specifications, confirmed if cough headaches is a clinical entity and if it has neuroradiologic differences with effort or sexual activity headaches.


Eligibility criteria: Inclusion Criteria:

* patients suffering of headache disorders

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: assistance publique hopitaux de marseille CHU Timone
Study officials:
References:
Clinical trial NCT06505148: Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
Official title: Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pediatric Disorder
Keywords: non opioid
pain management
pediatric pain
pediatric pain management
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Baylor Scott and White Health
First posted: 2024-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be prescribed the acetaminophen and ibuprofen alternating every 3 hours. And the other group will be prescribed acetaminophen and ibuprofen combine treatment.
Primary purpose: TREATMENT

Brief summary: To examine the difference in pain control in the pediatric general surgery population alternating acetaminophen and Ibuprofen q 3 hours vs giving them simultaneous combination therapy around the clock.

Detailed description: The purpose of the study is to compare the difference in pain control in the pediatric general surgery population of those who receive alternating acetaminophen and ibuprofen every 3 hours to those who receive acetaminophen and ibuprofen combined therapy around the clock. Additionally, to investigate the difference in parent adherence to pain treatment plans between the alternating group from the combined group.

Eligibility criteria: Inclusion Criteria:

* Age group: 3 years to 18 years
* General surgery service (hernia, appendectomy, chole, circumcision, wounds, vacs, implanted central line, etc.)

Exclusion Criteria:

* Patients who are allergic to acetaminophen and/or ibuprofen
* Patients being evaluated by SANE or evaluated for nonaccidental trauma
* Patients admitted post-op

The study will take place at McLane Children's Hospital Temple Market. Patients who are pregnant.

Primary outcomes:
measure: Faces, Legs, Activity, Cry, and Consolability (FLACC) pain assessment scale.
timeFrame: 24, 48, and 72 hours after surgery
measure: Pain Visual Analog Scale (VAS)
timeFrame: 24, 48, and 72 hours after surgery
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 24, 48, and 72 hours after surgery
Secondary outcomes:
measure: Parent/ guardian adherence
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Temple
country: United States
facility: Baylor Scott & White Health Temple Market
state: Texas
Study officials:
References: