louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01457092: Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis
Official title: Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Not Responding to Plastic Stenting: a Prospective Study With Two Years Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Biliary Strictures
Chronic Pancreatitis
Keywords: benign biliary strictures
chronic pancreatitis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

Detailed description: Endoscopic treatment of benign biliary strictures include the placement of plastic stents or Self-Expandable Metal Stents. Long term results of placement of a single plastic stent are disappointing. Better results have been obtained by endoscopic insertion of multiple plastic stents.

Biliary Self-Expandable Metal Stents used for malignant strictures are uncovered or partially covered with a plastic coating. More recently, fully covered SEMS have been developed and are now available on the market and due to their removability are proposed also for benign indications.

Uncovered and partially covered biliary Self-Expandable Metal Stents for chronic pancreatitis-related benign biliary strictures on long-term may clog due to tissue ingrowth through the uncovered meshes.

Removable fully covered Self-Expandable Metal Stents seem to be an attractive option for CP-related BBS, but scarce data are available in the literature.

The investigators conducted a feasibility, prospective, tertiary single-centre trial to investigate the durable resolution of chronic pancreatitis-related benign biliary strictures after temporary insertion of FC SEMS with unflared-ends and flared-ends.

Eligibility criteria: Inclusion Criteria:

1. age ≥18 years,
2. symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and
3. patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.

Exclusion Criteria:

1. benign biliary strictures secondary to compression from a pancreatic pseudocyst;
2. patients with associated pancreatic neoplasia
3. ongoing alcohol abuse (ethanol \> 80 g/day).

Primary outcomes:
measure: Stricture dilatation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03946592: Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Submental Fat
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-05-10
Enrollment: 148
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

Detailed description: DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)

Eligibility criteria: Inclusion Criteria:

* Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
* Dissatisfaction with the submental area expressed by the subject as a rating of 1\~3 using the SSS as determinded on Visit 1.
* Less than 35kg/m2 in body mass index on Visit1.
* Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.

Exclusion Criteria:

* History of any intervention to treat SMF
* History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
* Evidence of any cause of enlargement in the submental area.
* History or current symptoms of dysphagia.

Primary outcomes:
measure: PA-SMFRS, SA-SMFRS
timeFrame: 12 week after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang university hospital
Study officials:
References:
Clinical trial NCT01618292: Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
Official title: Cohort Study of Bowel Function Following Robotic-assisted Laparoscopic Sacrocolpopexy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Constipation
Bowel Dysfunction
Irritable Bowel Syndrome
Keywords: pelvic organ prolapse
constipation
bowel dysfunction
irritable bowel syndrome (IBS)
CRADI-8
CRAIQ-7
splinting with defecation
excessive straining
bowel movements
fecal incontinence
bowel symptoms
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 393
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women suffering from pelvic organ prolapse who underwent a robotic assisted laparoscopic sacral colpopexy between January 2007 and August 2011.

Brief summary: Compare changes in bowel function before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy. Compare objective anatomic outcomes before, 6 months and one year after Robotic-assisted laparoscopic sacral colpopexy.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent robotic assisted laparoscopic sacral colpopexy

Exclusion Criteria:

* Any other procedure for the treatment of pelvic organ prolapse

Primary outcomes:
measure: Changes in bowel function
timeFrame: preoperatively, 6 months, and one year post-surgery
Secondary outcomes:
measure: Objective anatomic outcomes
timeFrame: preoperatively, 6 months, and one year after surgery
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Patrick Culligan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315392: A Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures
Official title: A Randomized Study of Immediate and Delayed Closure of Type II and IIIa Open Tibia Fractures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II and IIa Open Tibia Fractures
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Orthopaedic Research and Education Fund
First posted: 2011-03-15
Enrollment: 451
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. This study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. The study was designed to compare immediate and delayed closure of Gustilo type II and IIIa tibia diaphyseal fractures. The primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.


Eligibility criteria: Inclusion Criteria:

* Gustilo type II-IIIa tibia fracture
* age greater than 15 years
* fractures amenable to intramedullary nailing

Exclusion Criteria:

* excessive wound contamination
* patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention
* impaired or absent consciousness
* refusal of consent

Primary outcomes:
measure: infection rate
measure: hospital readmissions
measure: tibial fracture healing
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolians HealthCare System
name: Michael J Bosse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501292: Changes in the Distribution of Mitochondria During Oocyte Maturation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-12-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine in-vitro fertilization with ICSI

Brief summary: Cytoplasmatic maturation is an important event in the general maturation of of the oocyte. Mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. The aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (ICSI). These oocytes will not undergo ICSI because of their immaturity. Usually, they are discarded. In addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent ICSI but did not become fertilized and are discarded.


Eligibility criteria: Inclusion Criteria:

* Infertile patients needing IVF treatment

Exclusion Criteria:

* Patients not requiring the ICSI procedure

Primary outcomes:
measure: The patterns of mitochondrial distribution within the cytoplasma of oocytes during nuclear maturation
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00127192: A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)
Official title: Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 363
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus

Exclusion Criteria:

* Patients with type 1 diabetes mellitus

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Glycosylated Albumin at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Iwamoto Y, Taniguchi T, Nonaka K, Okamoto T, Okuyama K, Arjona Ferreira JC, Amatruda J. Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus. Endocr J. 2010;57(5):383-94. doi: 10.1507/endocrj.k09e-272. Epub 2010 Mar 24.
Clinical trial NCT01559792: Band to Bypass - Metabolism Kinetics in Gastric Bypass and Banding
Official title: Gastric Banding to Bypass - Metabolism Kinetics in Gastric Bypass and Banding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Bypass
Gastric Banding
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all with normal glucose tolerance - patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

Brief summary: The investigators want to study the changes in secretion of gastrointestinal hormones, absorption and metabolism of food and liquids before and after gastric bypass and in patients who are gastric banded but are getting conversion to a gastric bypass. All patients are with normal glucose tolerance. The investigators hypothesis that food uptake/absorption of food is faster after gastric bypass and the secretion of gastrointestinal hormones change.


Eligibility criteria: Inclusion Criteria:

* Normal glucose tolerance
* Patients who are undergoing gastric bypass and patients with a gastric band to are converted to gastric bypass

Exclusion Criteria:

* Diabetes,
* Study population must undergo gastric bypass

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre hospital
Study officials:
References:
citation: Bojsen-Moller KN, Jacobsen SH, Dirksen C, Jorgensen NB, Reitelseder S, Jensen JE, Kristiansen VB, Holst JJ, van Hall G, Madsbad S. Accelerated protein digestion and amino acid absorption after Roux-en-Y gastric bypass. Am J Clin Nutr. 2015 Sep;102(3):600-7. doi: 10.3945/ajcn.115.109298. Epub 2015 Aug 5.
citation: Jacobsen SH, Bojsen-Moller KN, Dirksen C, Jorgensen NB, Clausen TR, Wulff BS, Kristiansen VB, Worm D, Hansen DL, Holst JJ, van Hall G, Madsbad S. Effects of gastric bypass surgery on glucose absorption and metabolism during a mixed meal in glucose-tolerant individuals. Diabetologia. 2013 Oct;56(10):2250-4. doi: 10.1007/s00125-013-3003-0. Epub 2013 Jul 27.
Clinical trial NCT01724892: Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epithelial Defect After Phototherapeutic Keratectomy
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK). Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has numerous serious complications, especially glaucoma. Loteprednol, a new generation of corticosteroid has less potency than dexamethasone and was proposed to has less side effect regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after PRK and risk of glaucoma.


Eligibility criteria: Inclusion Criteria:

* the patient with epithelial defect after phototherapeutic keratectomy

Exclusion Criteria:

* the patient with systemic disease such as diabetes and connective tissue disease
* the patient with ocular surface disease such as dry eye and recurrent corneal erosion

Primary outcomes:
measure: corneal epithelial healing
timeFrame: 1 month
Secondary outcomes:
measure: intraocular pressure
timeFrame: 6 month
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Onsiri Thanathanee
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
affiliation: Khon Kaen University
name: Onsiri Thanathanee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
citation: Thanathanee O, Sriphon P, Anutarapongpan O, Athikulwongse R, Thongphiew P, Rangsin R, Suwan-apichon O. A randomized controlled trial comparing dexamethasone with loteprednol etabonate on postoperative photorefractive keratectomy. J Ocul Pharmacol Ther. 2015 Apr;31(3):165-8. doi: 10.1089/jop.2014.0107. Epub 2015 Jan 2.
Clinical trial NCT01424592: In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)
Official title: Inpatient Portable Sleep Apnea Testing of Hospitalized Medical Patients for the Evaluation of Obstructive Sleep Apnea Prospectively Compared to Outpatient Laboratory-based Polysomnography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Portable sleep apnea testing
Positive airway pressure therapy
Polysomnography
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2011-08-29
Enrollment: 140
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: Patients admitted to the hospital under the general medicine service referred for evaluation of suspected obstructive sleep apnea.

Brief summary: Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography.

* Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization.
* These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge.
* Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea

Exclusion Criteria:

* Patients admitted to surgical or obstetrics/gynecology services
* Patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea)
* Patients with certain social histories (prisoners)
* Patients unable to use CPAP (facial deformity and traumatic facial injuries).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H Stroger Hospital of Cook County
state: Illinois
Study officials:
affiliation: Attending Physician, Pulmonary, Critical Care and Sleep Medicine
name: Swamy Nagubadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attending Physician, Pulmonary, Critical Care and Sleep Medicine
name: Aiman Tulaimat, MD
role: STUDY_CHAIR
affiliation: Fellow Physician, Pulmonary, Critical Care and Sleep Medicine
name: Rohit Mehta, MD
role: STUDY_DIRECTOR
References:
citation: Nagubadi S, Mehta R, Abdoh M, Nagori M, Littleton S, Gueret R, Tulaimat A. The Accuracy of Portable Monitoring in Diagnosing Significant Sleep Disordered Breathing in Hospitalized Patients. PLoS One. 2016 Dec 19;11(12):e0168073. doi: 10.1371/journal.pone.0168073. eCollection 2016.
Clinical trial NCT03359889: PraxbindTM India PMS Program
Official title: Post Marketing Surveillance Program of Praxbind Use in India.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-12-02
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, who receive PraxbindTM prescribed as per the approved label

Brief summary: This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.


Eligibility criteria: Inclusion Criteria:

- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding

- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Exclusion Criteria:

-Participation in a PraxbindTM clinical trial

Primary outcomes:
measure: Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
timeFrame: Up to 7 days following treatment.
Secondary outcomes:
measure: Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
timeFrame: Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical centre
city: Bengaluru
country: India
facility: Columbia Asia Referral Hospital
city: Hyderabad
country: India
facility: Care Hospital
Study officials:
References: