louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02288013: Uterine Closure at C-section by Stratafix Tissue Control Device: Randomized Case-Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
uterine closure technique
materials used
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Johnson & Johnson Medical Companies
First posted: 2014-11-11
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparative study of the surgical outcome of 2-layers closure technique of uterine incision in Cesarean section using bidirectional barbed suture (Stratafix) and conventional suture material (Vicryl) regarding the time of closure and the need of secondary additional suturing or tearing of uterine muscles during suturing.

Detailed description: A Randomized prospective case control study to evaluate the surgical outcome of using the new barbed bidirectional tissue controlling device in reducing the time and blood loss at uterine closure during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure is used and the occurrence of any tearing of the uterine muscles at the time closure of the uterine incision will be also studied. These will be the primary outcome measure and the secondary outcome measure will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative fever, and the number of sutures required to close the uterine incision.

Eligibility criteria: Inclusion Criteria:

* All pregnant patients with an indication for delivery by C section

Exclusion Criteria:

* Patient refusing to participate in the study

Primary outcomes:
measure: Time needed to close the uterine incision
timeFrame: 6 minutes
Secondary outcomes:
measure: blood loss during uterine closure
timeFrame: intraoperative during uterine closure
Other outcomes:
measure: Duration of hospital stay
timeFrame: Six weeks following the cesarean delivery (completion of the postpartum period)
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Cairo University
name: Mohamed Z Ahmed, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002313: A Study of Nystatin in HIV-Infected Patients
Official title: Extended Maintenance Protocol for Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection (NOTE: Continuation Study Intended Only for Patients Who Have Completed FDA 103B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Nystatin
Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.

Detailed description: Patients who have completed protocol FDA 103B are offered the option of receiving extended maintenance. Patients who have received no prior ddI are treated either with intravenous nystatin alone (at the same dose level administered in FDA 103B) or with a regimen of intravenous nystatin and ddI alternating on 3-week cycles. Treatment continues for 12 weeks.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Completed 12 weeks of therapy with intravenous nystatin on protocol FDA 103B.
* No evidence of toxicity or progression of disease on protocol FDA 103B. (See protocol FDA 103B for initial entry requirements.)

Active drug or alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Twelve Oaks Hosp
state: Texas
Study officials:
References:
citation: Rios A, Brewton G, Crofoot G, Quesada J, Lenk R, Lopez-Berenstein G. A phase I-II clinical study of Nystatin-LF IV in patients with HIV infections. Int Conf AIDS. 1993 Jun 6-11;9(1):483 (abstract no PO-B26-2089)
Clinical trial NCT03476213: Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming
Official title: Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia Awareness
Keywords: Anesthesia Awareness
Dreaming in anesthesia
Total intravenous anesthesia
Target-controll infusion
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group A will be anesthetized using TIVA, group B using TCI
Primary purpose: PREVENTION

Brief summary: This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.

Detailed description: Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.

Eligibility criteria: Inclusion Criteria:

* Glasgow Coma scale 15
* ASA Physical Status Classification System I - III
* planed surgery for brain tumor to 5 hours
* postoperative awakening

Exclusion Criteria:

* NYHA III, IV
* abuse of stimulating drugs, grass, alcohol dependence
* BMI over 40 in females and over 35 in men
* propofol alergie
* awake operations
* postoperative arteficial ventilation

Primary outcomes:
measure: reduction of awareness
timeFrame: 5 hours
Secondary outcomes:
measure: reduction of haemodynamical instability
timeFrame: 5 hours
measure: reduction of norepinephrine dose
timeFrame: 5 hours
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Pavel Dostal, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00752713: Strain-Encoded Magnetic Resonance Imaging in Acute Myocardial Infarction
Official title: Strain-Encoded Magnetic Resonance Imaging for Evaluation of Left Ventricular Function and Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: AMI,
Reperfusion
successful
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2008-09-15
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Consecutive Patients with AMI 3+/-1 days after successful reperfusion
* Ten healthy volunteers serving as control group

Brief summary: The aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI).

Detailed description: CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. Measurements were obtained for each segment in a modified 17 segment model. Wall motion and infarcted tissue were evaluated semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and MR-tagging was performed.

Eligibility criteria: Inclusion Criteria:

* Patients with AMI after successful reperfusion
* Healthy volunteers in control group

Exclusion Criteria:

* No reperfusion

Primary outcomes:
measure: Left ventricular function
timeFrame: 01.01.2007 until 01.02.2007
Secondary outcomes:
measure: Transmurality
timeFrame: 01.01.2007 until 01.02.2007
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Mirja Neizel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neizel M, Korosoglou G, Lossnitzer D, Kuhl H, Hoffmann R, Ocklenburg C, Giannitsis E, Osman NF, Katus HA, Steen H. Impact of systolic and diastolic deformation indexes assessed by strain-encoded imaging to predict persistent severe myocardial dysfunction in patients after acute myocardial infarction at follow-up. J Am Coll Cardiol. 2010 Sep 21;56(13):1056-62. doi: 10.1016/j.jacc.2010.02.070.
Clinical trial NCT02330913: Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy
Official title: Novel Esophago-Jejunal Anastomosis Method During Totally Laparoscopic Total Gastrectomy: π-shape Esophagojejunostomy, Three-in-one Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: total gastrectomy
intracorporeal
totally laparoscopic
esophagojejunostomy
anastomosis
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic gastrectomy became a good option for early gastric cancer. Surgical trend is gradually changed to totally laparoscopic gastrectomy from laparoscopy-assisted gastrectomy requiring mini-laparotomy. Various types of intracorporeal anastomosis have been introduced for esophagojejunostomy during total gastrectomy. We invented a novel anastomosis method using linear stapler for total gastrectomy. Three procedures (Jejunal resection, esophageal resection and closure of common entry hole after anastomosis) was performed with only one stapler. Therefore, the novel method is simple and fast. Also, this new technique is better economically than previously introduced anastomosis using linear stapler because lesser number of stapler is required. We want to demonstrate the feasibility of novel intracorporeal anastomosis method during laparoscopic total gastrectomy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Males or Females, aged≥20 years and ≤80 years
* Without serosa invasion, extraperigastric lymph node metastasis and other organ metastasis stage in preoperative evaluation, (cT1-3N0-1M0)
* Beyond the indication of ESD
* Tumor location in high body of stomach or requiring total gastrectomy
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
* American Society of Anesthesiolosists (ASA) score of 1 to 3
* The patient has given their written informed consent to participate in the study

Exclusion Criteria:

* Simultaneous malignancy in other organ
* Experience of previous laparotomy
* Experience of gastric resection including wedge resection
* Vulnerable subject

Primary outcomes:
measure: Anastomosis related complication rate
timeFrame: During 30 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Seung Wan Ryu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008436: Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemostasis
Keywords: Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
First posted: 2009-11-05
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.

The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing heart surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of blood units transfused to the patients after surgery till discharge
timeFrame: 30 days
measure: Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes
timeFrame: 10 minutes
Secondary outcomes:
measure: Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery.
timeFrame: 3, 6, 12, 24 hours
measure: Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes
timeFrame: 1,2,3,5,7,10 minutes after application
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References:
Clinical trial NCT02012036: Study To Optimize Photodynamic Transurethral Resection of the Bladder (TUR-B) In Clinical Practice
Official title: OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Photodynamic Transurethral Resection of the Bladder (TUR-B)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bladder cancer patients

Brief summary: The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.


Eligibility criteria: Inclusion Criteria:

* Indication of TURB due to suspicion of NMIBC (patients suspected to have non muscle invasive bladder cancer).
* Subject able to comply with the protocol.
* Written informed consent available.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients of the solvent.
* Porphyria.
* Gross haematuria.
* Women of child-bearing potential.
* Repeated TURB (control TURB) as part of follow-up after previous TURB.
* Bacillus Calmette-Guerin (BCG) or Mitomycin / intravesical chemotherapy instillation therapy in the last 12 weeks or any other contraindications according to the SmPC.
* Subjects not able to give informed consent.

Primary outcomes:
measure: Detection rate
timeFrame: At TUR-B visit, up to 1 year
Secondary outcomes:
measure: Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score
timeFrame: At TUR-B visit, up to 1 year
measure: Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations
timeFrame: At TUR-B visit, up to 1 year
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef, Klinik fuer Urologie
city: Sindelfingen
country: Germany
facility: Klinikverbund Südwest
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03438136: Adult Broad Learning Experiment (ABLE): Feasibility Study
Official title: Adult Broad Learning Experiment (ABLE): Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
First posted: 2018-02-19
Enrollment: 22
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the participants will participate in the intervention, and the other half will be assigned to a no contact control group.
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the feasibility of enrolling and retaining older adults in a 15-week intervention that will implement six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously. These six factors will be implemented via concurrent classes at the UCR Extension center (OSHER Lifelong Learning Institute).


Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* Fluent in English
* Have not been diagnosed with a cognitive condition (e.g., Mild Cognitive Impairment, Alzheimer's, and Dementia)
* Currently not experiencing a mental health disorder (e.g., anxiety, depression, Schizophrenia)
* Have normal eye vision or corrected-to-normal eye vision
* Not proficient in any of the three skills that will be taught during the intervention. Proficiency of skills will be determined by participants' self-report of their experience with each skill. Only potential participants who self-report having less than one or more years of experience with any of the three skills in the past 10 years or as having less than 5 years of experience more than 50 years ago will be considered as being "unfamiliar" with that skill (or skills) and will be qualified to participate in the study.

Exclusion Criteria: n/a

Primary outcomes:
measure: Screening-to-enrollment ratio
timeFrame: Beginning of the intervention (Week 1)
measure: Intervention adherence
timeFrame: Throughout the intervention (15 weeks)
measure: Enjoyment of intervention activities
timeFrame: Week 15
Secondary outcomes:
measure: Executive Function
timeFrame: Pre-test to post-test (15 weeks: Week 1; Week 15)
measure: Broad Learning Adult Questionnaire
timeFrame: Pre-test to post-test (15 weeks: Week 1; Week 15)
Other outcomes:
Locations:
city: Riverside
country: United States
facility: University of California, Riverside
state: California
Study officials:
References:
Clinical trial NCT01346436: Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
Official title: Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rectal Prolapse
Pelvic Organ Prolapse
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 50
Sex: FEMALE
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 randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.

Detailed description: Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.

Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.

However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.

Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.

The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.

Eligibility criteria: Inclusion Criteria:

* women
* proven pelvic floor dysfunction
* informed consent

Exclusion Criteria:

* Age \<18 years old
* Patient unable to communicate or to understand the study
* Patient refusing to participate to the study
* contraindication to laparoscopy

Primary outcomes:
measure: Perioperative outcomes
timeFrame: up to 30 days
Secondary outcomes:
measure: Functional results
timeFrame: At 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva, Department of Surgery
Study officials:
affiliation: University Hospital, Geneva
name: Nicolas C Buchs, MD
role: PRINCIPAL_INVESTIGATOR
References: