louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03068728: Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
Official title: Analysis of Hemostatic Agents Compared to Physiologic Hemostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhino Sinusitis
Keywords: bilateral chronic rhino sinusitis
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2017-03-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: After sinus surgery, the surgeon will randomize the patient to one of six hemostatic agents and place that product in one sinus cavity, while leaving the other sinus cavity without packing. The treatment group will be compared to control.
Primary purpose: TREATMENT

Brief summary: This study is a prospective comparison between absorbable hemostatic agents as a group and the body's natural hemostatic ability without aid of therapy in patients undergoing bilateral sinus surgery with or without septoplasty.

Detailed description: The purpose of this study is to evaluate the efficacy of absorbable hemostatic agents in comparison with physiologic hemostasis after endoscopic sinus surgery. The investigators aim to determine the relative efficacy of hemostatic agents to halt epistaxis and compare this with the degree of epistaxis observed without therapy and evaluate objective healing parameters.

Eligibility criteria: Inclusion Criteria:

-≥18 to \<75 years of age with bilateral chronic or recurrent rhino sinusitis recalcitrant to medical therapy that requires endoscopic sinus surgery

-sinuses should have a similar degree of disease involvement bilaterally.

Exclusion Criteria:

* massive sinonasal polyposis,
* history of underlying immunologic diseases, AIDS, cystic fibrosis, immunoglobulin deficiency, immotile cilia syndrome, and neutropenia,
* known hypersensitivity to the aforementioned agents,
* women who are pregnant or breastfeeding,
* anyone with a known allergy to any of the treatments (potato starch, iodine, shellfish)
* anyone with a known coagulopathy

Primary outcomes:
measure: Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.
timeFrame: 6 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Jastin L Antisdel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03814161: FRailty Among Elderly Emergency Department Patients With Outcome Measures
Official title: FRailty Among Elderly Emergency Department Patients With Outcome Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Geriatric, Frailty, Emergency Department
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 211
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients aged 65 years and above attending Emergency Department, National University Hospital, Singapore irrespective of reason for attendance and are planned for discharge from the Emergency Department.

Brief summary: Our study aims to compare 4 clinical frailty scores, namely Clinical Frailty Scale (CFS), Edmonton Frail Scale (EFS), FRAIL 5-item scale (FRAIL) and SARC-F Sarcopenia Score (SARC-F), which can potentially be adopted for daily practice in the busy ED. It is timely as we projected that we will be seeing more elderly patients attending the ED for various medical and surgical conditions. Their attendance at the ED would be a good opportunity to screen for frailty among them, and to intervene to prevent adverse outcomes such as ED re-attendance or subsequent hospitalisation that might lead to poor functional outcomes and higher dependence on step-down care facilities.


Eligibility criteria: Inclusion Criteria:

- Elderly patients aged 65 years and above attending ED irrespective of reason for attendance.

Exclusion Criteria:

* Haemodynamically unstable patients
* Inability to obtain informed consent
* Inability to obtain reliable information from patient or caregiver (e.g. deafness, blindness, language barriers)
* Vulnerable populations (e.g. prisoners)
* Patients who are planned for hospital admission from the ED

Primary outcomes:
measure: 1-month Adverse Event Occurrence (composite)
timeFrame: At 1 month after index ED visit
Secondary outcomes:
measure: 3-month Adverse Event Occurrence (composite)
timeFrame: At 3 months after index ED visit
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Ying Wei Yau
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
Clinical trial NCT00631761: Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
Official title: Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethrocystoscopy Skills
Keywords: urethrocystoscopy
cystoscopy
objective structured assessment of surgical skills (OSATS)
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2008-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).

Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.

Develop an intervention (1.5 hour workshop) which can be replicated by other residency programs in order to enhance learning of diagnostic cystoscopy. The workshop should be adequate for practicing Gynecologists as well as they already have experience with diagnostic hysteroscopy which uses many of the same concepts.

Detailed description: The OSATS and a written examination will be used to assess residents skills and knowledge pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica of human bladder for baseline competency using the above tools. Then approximately half will be randomly selected to undergo an educational intervention (a workshop teaching diagnostic urethrocystoscopy). As we are interested in short-term acquisition, about a week later all residents will be retested using the same methods. Grades on the exam will be kept confidential.

Eligibility criteria: Inclusion Criteria:

* All Obstetrics \& Gynecology and Urology resident physicians training at the University of Cincinnati

Exclusion Criteria:

* Any above resident with extensive training in cystoscopy

Primary outcomes:
measure: measure competency and change in urethrocystoscopy skills
timeFrame: 2 months
Secondary outcomes:
measure: Establish validity and reliability of measurement tools (OSATS) used to evaluate urethrocystoscopy skills
timeFrame: 2 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnat
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Sam Siddighi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddighi S, Kleeman SD, Baggish MS, Rooney CM, Pauls RN, Karram MM. Effects of an educational workshop on performance of fourth-degree perineal laceration repair. Obstet Gynecol. 2007 Feb;109(2 Pt 1):289-94. doi: 10.1097/01.AOG.0000251499.18394.9f.
Clinical trial NCT01015261: Allogenic Bone Marrow Transplantation (BMT) Compare With Cytoreduction and Chemotherapy in Acute Lymphoblastic Leukemia (ALL) Patients
Official title: Comparison of Efficacy of Allogenic Bone Marrow Transplantation With Cytoreduction and Chemotherapy in ALL Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
BMT
Chemotherapy
Allogenic
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with newly diagnosed Acute lymphoblastic leukemia after providing consent, will be screened for eligibility. Eligible patients will be treated with Vincristine (1 mg/m2 at Day 1 and Day 8), Dexamethasone 24 mg/d day 1-15 and IT at Days 1, 4, 8 and 12. At day 14 patients will be randomized in two group. BMT group who have donor and Chemotherapy group who don't have suitable donor. BMT group treated with allogenic Bone Marrow Transplantation and Chemotherapy treated with Cyclophosphamide at day 15, Daunorubicin at day 15-18, Vincristine at day 15 and 22 and Dexamethasone at day 12-28 followed by standard chemotherapy. In BMT group patients will be received CNS radiotherapy at +100 day after transplantation.


Eligibility criteria: Inclusion Criteria:

* Diagnose of Acute lymphoblastic leukemia
* Age between 16 to 50 year
* New case of ALL

Exclusion Criteria:

* Primary CNS involvement
* Primary Testis involvement
* Previously treated

Primary outcomes:
measure: Efficacy of allogenic BMT compare with cytoreduction and chemotherapy in ALL patient
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival after BMT compare with chemotherapy.
timeFrame: 1 year
measure: Disease Free Survival after BMT compare with chemotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hematology-Oncology & SCT Research Center
Study officials:
affiliation: Hematology-Oncology and SCT Research Center
name: Ardeshir Ghavamzadeh, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04646161: Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
Official title: Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes

Brief summary: This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,

Detailed description: The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins

Eligibility criteria: Inclusion Criteria:

* 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders

Exclusion Criteria:

* 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol

Primary outcomes:
measure: Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale
timeFrame: During the intervention
Secondary outcomes:
measure: cervical dilataion < 4 mm
timeFrame: During the intervention
measure: Pain at insertion according to VAS
timeFrame: During the intervention
measure: Subjective sensation of satisfaction graduated as VAS like scale
timeFrame: During the intervention
measure: side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting
timeFrame: During the intervention
measure: side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia
timeFrame: During the first 24 hours
measure: side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion
timeFrame: After 30 days of intervention
measure: Duration of insertion(min)
timeFrame: During the intervention
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01008761: Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children
Official title: A Double Blind Randomized Control Trail of Azithromycin for the Acute Management of Wheezy Pre-school Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Pre-school child
Wheezy episode
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2009-11-06
Enrollment: 440
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if treatment of pre-school children with a history of wheeze who present to an Emergency Department with an acute wheezing episode with azithromycin for 5 days will resolve their symptoms more quickly, will require less short acting beta agonist (SABA), and allow these children to remain symptom free for a longer period of time.


Eligibility criteria: Inclusion Criteria:

* 12-60 months
* wheeze on auscultation

Exclusion Criteria:

* antibiotic use in the past 30 days
* macrolide allergy
* underlying medical condition
* significant co-morbidities
* current enrollment
* language barrier or no access to phone for follow up

Primary outcomes:
measure: To determine if treatment of pre-school children with a history of wheeze who present to an Emergency department (ED) with an acute wheezing episode with Azithromycin for 5 days will resolve their symptoms more quickly
timeFrame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months
Secondary outcomes:
measure: Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will cause these children to use less rescue beta2 agonists than those treated with placebo
timeFrame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months
measure: Treatment of pre-school children with acute wheezing symptoms with 5 days of azithromycin will allow these children to remain free of subsequent wheezy episodes longer than those treated with placebo.
timeFrame: Patient is followed by phone day 1,3,5,7,14, with an in person return visit on day 21 and then by phone again every 2 weeks for 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: Alberta children's Hospital/University of Calgary
name: David W Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stollery Children's Hospital Edmonton
name: Piush Mandhane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02008461: Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Supra-ventricular Tachyarrhythmias
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).


Eligibility criteria: Inclusion Criteria:

* atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
* secondary atrial fibrillation

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm

Primary outcomes:
measure: number of episodes of atrial fibrillation
timeFrame: 1 year
Secondary outcomes:
measure: serious adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT00786461: The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Official title: The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bartholin´s Cyst
Keywords: silver nitrate
marsupialisation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
First posted: 2008-11-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment.

It is expected that silver nitrate treatment is effective, simple, inexpensive and the least anaesthetic requiring procedure, which can easily be carried out in the outpatient setting.

Detailed description: Background and objective:

Bartholin gland cysts and abscesses are common problems in women of reproductive age. The traditional treatment of Bartholin´s cyst or abscess is marsupialization, which has disadvantages, such as pain of long duration, scarring, risk of general anaesthesia and risk of recurrence. In the present study we use silver nitrate in the treatment of Bartholin's cyst or abscess and compare to marsupialization. We expect lower healing time, lower recurrence rate and less pain with the silver nitrate treatment.

Methods and materials:

30 patients with Bartholin´s cyst or abscess will be investigated. It is prospective randomized study. The silver nitrate treatment is performed under local anaesthesia on an outpatient basis. A simple vertical incision 1 cm in length is made in the vaginal mucosa and the underlying cyst or abscess wall. A crystalloid silver nitrate stick of 5 mm in diameter and 5 mm in length is inserted into the cyst or abscess cavity.

The standard marsupialization treatment is performed under general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Women with a age of 18-60 years
* Should read and understand Danish
* All women inclusive pregnant should have a Bartholins cyst or abscess

Exclusion Criteria:

* Subject who cannot give written informed consent

Primary outcomes:
measure: Recidive of bartholin´s cyst or abscess and Dyspareunia after treatment
timeFrame: up to one year after treatment
Secondary outcomes:
measure: Wound healing, local burning, sequelae, hospitalisation time
timeFrame: 3-4 weeks after treatment
Other outcomes:
Locations:
city: Randers
country: Denmark
facility: Randers Central Hospital
Study officials:
References:
Clinical trial NCT00512161: Placement of Permanent Pacemaker Study
Official title: A Retrospective Study to Determine the Frequency of Indications That Lead to the Placement of Permanent Pacemakers After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Procedures
Keywords: Any patient undergoing elective cardiac surgery
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiopulmonary Bypass Patients without a pacemaker already in place

Brief summary: The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation.

1. Type of cardiac surgery
2. Gender of patient
3. Patient's age
4. Preoperative heart rhythm and rate
5. Duration on cardiopulmonary bypass
6. Immediate post cardiopulmonary bypass heart rhythm and rate.
7. All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.
8. Underlying heart rhythm and rates when permanent pacemaker is placed.
9. Ejection fraction before surgery
10. Ejection fraction immediately post-cardiopulmonary bypass

Detailed description: The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation. Through investigation into the co-morbidities, diagnoses, or histories associated with an endpoint permanent pacemaker placement, it is possible that we will garner a better idea of who will require PPP.

Eligibility criteria: Inclusion Criteria:

* All patients between the ages of 18-99 years.
* All patients undergoing cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients who have permanent pacemakers in place.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gregory E. Kerr, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: John J. Savarese, M.D.
role: STUDY_CHAIR
References: