louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03169842: Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
Official title: Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cyst
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.

Detailed description: Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.

For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.

Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).

Eligibility criteria: Inclusion Criteria:

* All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
* Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study

Exclusion Criteria:

* Inability to perform pancreatic cyst fluid sampling
* \<1mL of cyst fluid is aspirated during EUS-FNA

Primary outcomes:
measure: Cyst fluid glucose level
timeFrame: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
References:
Clinical trial NCT04980742: Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study
Official title: Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-cardiac Surgery
Blood Transfusion Complication
Prognosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)

Brief summary: Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.

Detailed description: Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, the following results were obtained:

1. Perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention;
2. Risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion;
3. The relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients

Eligibility criteria: Inclusion Criteria:

* The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)

Exclusion Criteria:

* No

Primary outcomes:
measure: mortality
timeFrame: 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: ANH
Study officials:
affiliation: The Second Affiliated Hospital of Zhejiang University Medical College
name: Min Yan, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02920242: A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Travelers' Diarrhea
Keywords: Travelers
diarrhea
rifaximin
equivalence
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 28
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: This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.

It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.

The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.


Eligibility criteria: Inclusion Criteria:

* Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
* International travelers with a duration of stay in host country long enough to attend schedules visits.
* Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

* Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
* Pregnant, breast feeding or planning pregnancy
* Acute diarrhea for \> 72 hours immediately prior to randomization.
* Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.

Primary outcomes:
measure: Clinical Cure Rate
timeFrame: study day 5 +/- 1 day
Secondary outcomes:
measure: Time to Last Unformed Stool
timeFrame: within 5 study days
measure: Proportion of Patients With Clinical Failure
timeFrame: within 5 study days
measure: Proportion of Patients With Improvement of Diarrheal Syndrome
timeFrame: within 5 study days
measure: Number of Unformed Stools
timeFrame: within 5 study days
measure: The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
timeFrame: within 5 study days
measure: Microbiological Cure Rate
timeFrame: study day 5
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Sandoz Investigative Site
Study officials:
References:
Clinical trial NCT01847742: EMDR Intervention for Psychological Trauma Among Syrian Refugees
Official title: EMDR Treatment for Psychological Trauma Among Syrian Refugees in Kilis, Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Trauma
Lead sponsor: Istanbul Sehir University
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To implement an EMDR (Eye Movement Desensitization and Reprocessing)intervention to treat the trauma symptoms among Syrian Refugees.

Detailed description: In this project we aim to treat the posttraumatic stress disorder (PTSD) symptoms among Syrian refugees through an effective psycho-therapy technique called Eye Movement Desensitization and Reprocessing (EMDR). Randomly selected refugees will be assessed through MINI PLUS for the diagnose of PTSD. Eighty refugees with PTSD will be randomly allocated to either 7 sessions EMDR or wait-list control group.Symptoms of PTSD (MINI PLUS, HTQ, IES-R) and depression and anxiety (BDI, HSCL)will be assessed at pre- and post-treatment and 4 weeks follow-up.

However, to our knowledge this is one of the first intervention studies which will be conducted in a refugee camp. Therefore we expect to have some practical and logical problems. In order to see the feasibility and efficacy of EMDR among Syrian refugees, before the main study we aim to run a pilot study with less participants. In the pilot we will assess the posttraumatic stress symptoms with Impact of Event Scale-Revised (IES-R) and the depressive symptoms through Beck Depression Inventory (BDI-II).

Eligibility criteria: Inclusion Criteria:

* trauma symptoms

Exclusion Criteria:

* pregnancy
* current or past psychotic disorder
* current or past substance abuse or dependence
* serious physical illness
* active suicidal ideation

Primary outcomes:
measure: score on Harvard Trauma Questionnaire (at the main study)
timeFrame: before and after the treatment,an expected average of 7 weeks of EMDR treatment
measure: Impact of Event Scale Revised (at the pilot study and the main study)
timeFrame: pre- and post treatment
Secondary outcomes:
measure: score on HSCL for depressive and anxiety symptoms (at the main study)
timeFrame: before and after the treatment, an expected average of 7 weeks of EMDR treatment
measure: Score on BDI-II (pilot study and the main study)
timeFrame: before and after EMDR treatment, an expected average of 7 weeks of EMDR treatment
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Kilis Camp for Refugees
Study officials:
References:
citation: Acarturk C, Konuk E, Cetinkaya M, Senay I, Sijbrandij M, Gulen B, Cuijpers P. The efficacy of eye movement desensitization and reprocessing for post-traumatic stress disorder and depression among Syrian refugees: results of a randomized controlled trial. Psychol Med. 2016 Sep;46(12):2583-93. doi: 10.1017/S0033291716001070. Epub 2016 Jun 29.
Clinical trial NCT05409742: Masseter Muscle Activity and Post-operative Pain in a Group of Egyptian Children Treated With Hall Technique Vs Modified Hall Technique
Official title: Masseter Muscle Activity and Post-Operative Pain in A Group of Egyptian Children With Carious Primary Molars Treated With Hall Vs Modified Hall Technique: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Masseter Muscle Activity
Keywords: Hall technique
Modified Hall technique
Stainless steel crowns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to evaluate postoperative pain and masseter muscle activity in a group of Egyptian children with carious primary molars treated with Hall Vs modified Hall Technique (with proximal and occlusal reduction).


Eligibility criteria: Inclusion Criteria:

* Children 5-7 years with carious lower second primary molars
* Both genders.
* Systemically and mentally healthy.

Exclusion Criteria:

* History of systemic or mental conditions.
* Special health care needs who require pharmacological management before dental treatment.
* Acute dental pain or trauma.
* Extremely uncooperative children who require being treated under general anesthesia.

Primary outcomes:
measure: Masseter muscle activity measured by Electromyograph
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo University
state: EL-Manial
Study officials:
References:
Clinical trial NCT03506542: Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C
Official title: Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Cataract
Wound Heal
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Aeon Astron Europe B.V.
First posted: 2018-04-24
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized and have phacotrabeculectomy augmented with either OLO (Ologen) or MMC (Mitomycin C).
Primary purpose: TREATMENT

Brief summary: 1. Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
2. Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
3. Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

Detailed description: * Prospective randomized comparative study
* Patients with cataract and:

primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)

* Phacotrabeculectomy augmented with OLO or MMC
* Follow-up - 12 months

Eligibility criteria: Inclusion Criteria:

* Cataract
* Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication

Exclusion Criteria:

* Difficulty in reading or speaking Polish
* Previous ocular surgery
* Pregnant and breastfeeding women
* Angle closure glaucoma
* Secondary glaucoma except pseudoexfoliation glaucoma
* Ocular diseases with excessive scarring
* Allergy to collagen or Mitomycin C

Primary outcomes:
measure: Mean intraocular pressure (IOP) after the surgery
timeFrame: 12 months
Secondary outcomes:
measure: Mean best corrected visual acuity (BCVA) (LogMAR)
timeFrame: 12 months
measure: Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)
timeFrame: 12 months
measure: Mean number of antiglaucoma medications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmology Clinic, Medical University in Lublin, Poland
name: Tomasz Żarnowski, MD PhD Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04855942: Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger
Official title: Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trigger Finger
Stenosing Tenosynovitis
Keywords: extracorporeal shock wave
trigger finger
stenosing tenosynovitis
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study design is mainly to compare the therapeutic effect to trigger finger between extracorporeal shock wave (PiezoWave2 ECO, produced by Richard Wolf) and traditional physiotherapy.
Primary purpose: TREATMENT

Brief summary: Trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. Conservative treatment includes NSAIDs or other analgesic agents, activity modification, splint, and physiotherapy. Operation could be considered if conservative treatments fails. With literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well.

Extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. Although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. The purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.


Eligibility criteria: Inclusion Criteria:

* Quinnel classification grade 2 or 3
* who has only one trigger

Exclusion Criteria:

* who had ever treated the trigger finger
* who has other musculoskeletal disease of the upper limb
* who has severe coagulopathy disease
* who is pregnant
* who has arrhythmia or has a pacemaker
* there is sensory impairment, scar, edema at the trigger finger
* who has cognitive dysfunction

Primary outcomes:
measure: Quinnell stages of triggering
timeFrame: 15 weeks
measure: 11-point numeric scale of pain
timeFrame: 15 weeks
measure: Chinese quick DASH (disabilities of the Arm, Shoulder, and Hand questionnaire)
timeFrame: 15 weeks
measure: strength of hand grip
timeFrame: 15 weeks
measure: sonographic image
timeFrame: 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00641342: Prevention of Parastomal Hernia by Primary Mesh Insertion
Official title: Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Parastomal Hernia
Keywords: Parastomal hernia
Onlay mesh
Sublay mesh
Pain
Health questionnaire
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Hvidovre University Hospital
name: Copenhagen University Hospital at Herlev
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Hillerod Hospital, Denmark
name: Vejle Hospital
name: Zealand University Hospital
First posted: 2008-03-24
Enrollment: 198
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: Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.


Eligibility criteria: Inclusion Criteria:

* Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.

Exclusion Criteria:

* ASA \> 3
* Acute surgery
* Known immune deficiency
* Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
* Pregnancy
* Known inflammatory bowel disease
* Lack of written informed consent

Primary outcomes:
measure: Parastomal hernia verified by CT-scan
timeFrame: one year after surgery, reassessed after 2, 3 and 5 years
Secondary outcomes:
measure: Clinically detected parastomal hernia
timeFrame: one year after surgery, reassessed after 2, 3 and 5 years
measure: Pain
timeFrame: one year after surgery, reassessed after 2, 3 and 5 years
measure: Disease specific and general health questionnaire
timeFrame: one year after surgery, reassessed after 2, 3 and 5 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital, Hvidovre
state: Copebhagen
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital, Gentofte
state: Copenhagen
Study officials:
affiliation: University Hospital of Copenhagen, GEntofte
name: Ismail Gögenur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01299142: Safety and Pharmacokinetics Study of Human Monoclonal Antibody (FGI-101-1A6)
Official title: Phase I Study of Human Monoclonal Antibody (FGI-101-1A6) in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
antibodies
monoclonal
virus
Lead sponsor: Functional Genetics Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2011-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the safety and tolerability of the anti-TSG101 human monoclonal antibody (FGI-101-1A6)when administered intravenously to healthy volunteers.

Detailed description: Primary -

- To compare the safety profile of a single intravenous administration of FGI-101-1A6 as compared with Placebo

Secondary

* To evaluate the pharmacokinetics (PK) of a singel intravenous administration of FGI-101-1A6
* To evaluate the immunogenicity of FGI-101-1A6

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers ages 18-45
* Normal laboratory (blood tests) results

Exclusion Criteria:

* Prior immunization with live-attenuated vaccines

Primary outcomes:
measure: Safety assessments
timeFrame: 60 days following infusion
Secondary outcomes:
measure: Pharmacokinetic analysis (PK)
timeFrame: 60 days following infusion
measure: Immunogenicity
timeFrame: From day 1 up to day 60 following infusion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
References: