louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139372: An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
Official title: An Evaluation of the Daytime Use of an Investigational Lubricant Eye Drop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye, artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the subjective assessments of an investigational lubricant eye drop.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* Current use of Refresh Liquigel, GenTeal Gel Drops or Refresh Celluvisc at least twice daily

Exclusion Criteria:

* Must not have worn contact lenses within 7 days preceding enrollment
* Must not have had punctal plugs inserted within 30 days preceding enrollment

Primary outcomes:
measure: Daytime Use Assessment: "I would use this product at bedtime for my dry eye symptoms" Likert scale (i.e. strongly disagree, disagree, neither disagree nor agree, agree, strongly agree)
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03224572: The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
Official title: The Effect of Vitamin C on Quality of Life of Terminal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Vitamin C Deficiency
Keywords: vitamin C
quality of life
terminal cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized double-blinded controlled trial
Primary purpose: TREATMENT

Brief summary: This study determines whether high dose vitamin C is effective for quality of life in terminal cancer patients.

Detailed description: The investigator's project is a single medical center, randomized double- blinded trial. The target group is terminal cancer patients at Palliative care clinics. The experimental group will receive intravenous high-dose vitamin C 30 g in 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The control group will receive 500 ml normal saline in 1-hour infusion, once per week, and total 4-week treatment. The primary outcome is the improvement of quality of life, measured by European Organization for Research and Treatment of cancer (EORTC). The secondary outcome is the survival analysis.The participants will be followed up weekly for 2 weeks, then bi-weekly for 6 months.

Eligibility criteria: Inclusion Criteria:

-Terminal colon cancer patients without pleural effusions, who will not receive any curative radiotherapy or chemotherapy.

Exclusion Criteria:

* Renal metastasis or obstructive uropathy by radiology
* Nephrotic syndrome
* Creatinine over 1.5mg/dl
* Urolithasis
* Under other folk therapy or vitamin infusion therapy
* Those who can't exercise the right of consent
* Those who can't answer the questionaires
* Glucose-6-Phosphate Dehydrogenase Deficiency
* Severe lower leg edema or general edema

Primary outcomes:
measure: The improvement of quality of life (QOL)
timeFrame: 6 months
Secondary outcomes:
measure: Survival analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Ying Chen, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00090272: A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)
Official title: A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Surgery
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 952
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: The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

Detailed description: The duration of treatment is 1 day.

Eligibility criteria: Inclusion Criteria:

Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria:

* Surgery must be scheduled in advance.
* There must be adequate time to complete preoperative bowel preparation

Primary outcomes:
measure: Surgical site infection following elective colorectal surgery based on surgical site assessment.
Secondary outcomes:
measure: Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Itani KM, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. N Engl J Med. 2006 Dec 21;355(25):2640-51. doi: 10.1056/NEJMoa054408.
citation: Goldstein EJ, Citron DM, Merriam CV, Abramson MA. Infection after elective colorectal surgery: bacteriological analysis of failures in a randomized trial of cefotetan vs. ertapenem prophylaxis. Surg Infect (Larchmt). 2009 Apr;10(2):111-8. doi: 10.1089/sur.2007.096.
citation: Itani KM, Wilson SE, Awad SS, Jensen EH, Finn TS, Abramson MA. Polyethylene glycol versus sodium phosphate mechanical bowel preparation in elective colorectal surgery. Am J Surg. 2007 Feb;193(2):190-4. doi: 10.1016/j.amjsurg.2006.08.024.
citation: Itani KM, Jensen EH, Finn TS, Tomassini JE, Abramson MA. Effect of body mass index and ertapenem versus cefotetan prophylaxis on surgical site infection in elective colorectal surgery. Surg Infect (Larchmt). 2008 Apr;9(2):131-7. doi: 10.1089/sur.2007.034.
Clinical trial NCT02179372: Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases
Official title: Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Crohn's Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.


Eligibility criteria: Inclusion Criteria:

* Age ranged between18 and 80 years.
* Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic and histologic criteria) in clinical remission (SCCAI = 0) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Patients affected by Crohn's Disease (diagnosed on the base of clinic, endoscopic and histologic criteria) ) in clinical remission (CDAI \< 150) from at least 3 months and in stable therapy (without therapeutic modifications in the three previous months) with 5-ASA, immunomodulators and/or biologics.
* Fecal calprotectin at baseline \> 150 μg/g.

Exclusion Criteria:

* Patients affected by Ulcerative Colitis and Crohn's Disease respectively with a SCCAI ≥ 1 and a CDAI ≥150.
* Patients on steroid therapy.
* Patients in therapy wih warfarin or other anticoagulants.
* Known or supposed ipersensitivity to eicosapentaenoic acid/omega 3.
* Women in fertile age which refuse to use contracceptives specified in the study (oral contraception, IUD) and breastfeed women.
* Patients with severe clinical conditions which the investigator consider to controindicate patient partecipation at the study.
* Therapy modifications and/or assumption of sperimental therapies within three months before the study inclusion.
* Patients unable to follow protocol procedures and to sign the informate consent.

Primary outcomes:
measure: changes in fecal calprotectin levels
timeFrame: baseline, 3 months and at 6 months
Secondary outcomes:
measure: number of clinical flares of diseases
timeFrame: at 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi
Study officials:
References:
citation: Scaioli E, Sartini A, Bellanova M, Campieri M, Festi D, Bazzoli F, Belluzzi A. Eicosapentaenoic Acid Reduces Fecal Levels of Calprotectin and Prevents Relapse in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1268-1275.e2. doi: 10.1016/j.cgh.2018.01.036. Epub 2018 Jan 31.
Clinical trial NCT00901472: Sleep Disordered Breathing and Diabetes
Official title: Sleep Disordered Breathing and Blood Glucose Control in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obstructive Sleep Apnea
Keywords: Type 2 diabetes,
obstructive sleep apnea
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians in the endocrinology or primary care clinic will self-identify themselves for participation in response to flyers posted at the check-in desk.

Brief summary: The hypothesis of this study is: sleep disordered breathing (SDB), specifically, obstructive sleep apnea, is associated with poorer glucose in the existing type 2 diabetic condition.

In an exploration of this hypothesis, the investigators hope to provide evidence linking SDB to increased severity of disease in the type 2 diabetic patient. By doing so, the investigators ultimately seek to support investigating the use of SDB interventions as an additional method of care in the treatment of type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* adult female and male patients with type 2 diabetes who are followed by University of Chicago physicians

Exclusion Criteria:

* patients with the diagnosis of type 1 diabetes (DM); newly diagnosed Type 2 DM patients
* patients with the diagnosis of OSA using CPAP for either 4 or more hours per night or 5 nights per week

Primary outcomes:
measure: Improvement in glucose tolerance
timeFrame: Day 1 to day 10.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Eve Van Cauter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05710172: Evaluation of Auditory Mirror-therapy for Tinnitus
Official title: Evaluation of Auditory Mirror-therapy for Tinnitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tinnitus
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2023-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the effects of wearing auditory mirror earmuffs on tinnitus and on audiometry.The auditory mirror earmuffs is a device that re-routes auditory input from the left side of the head to the right ear, and vice verse, thereby flipping the auditory input. This procedure is called Auditory Mirror Therapy (AMT).

Detailed description: The goal of this study is to determine efficacy of a 21 day, 3 hours per day intervention of auditory mirror therapy (AMT) for chronic tinnitus. Hypothesis: AMT, as contrasted to a sham device, will significantly reduce symptom ratings on the Tinnitus Functional Index (TFI) scale. Along with TFI, additional measures will be collected every two days throughout the intervention; Tinnitus Handicap Index, Visual Analogue Scale, Minimum Masking Level (MML) and Residual Inhibition (RI), and Auditory Mirror Therapy Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* Ages 18-80 years old
* Chronic Tinnitus (\> 3months)

Exclusion Criteria:

* Use of hearing aids
* No history of significant drug or alcohol use
* No history of debilitating neurological or psychiatric illnesses
* No current or past history of balance-, vertigo- and/or vestibular- symptoms including Ménières disease

Primary outcomes:
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in Tinnitus Handicap Inventory (THI)
timeFrame: 3 weeks
measure: Change in Visual Analogue Scale (VAS)
timeFrame: 3 weeks
measure: Change in Minimum Masking Level (MML) and residual inhibition (RI)
timeFrame: 3 weeks
Other outcomes:
measure: Auditory Mirror Therapy Questionnaire
timeFrame: 3 weeks
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References:
citation: Linnman C. Auditory Mirror Therapy for Tinnitus: A Pilot Study. J Am Acad Audiol. 2022 Apr;33(4):220-223. doi: 10.1055/a-1749-9279. Epub 2022 Dec 6.
Clinical trial NCT01651572: Comparison Between Cisatracurium and Rocuronium in Terms of Recovery of the Muscular Strength in the Postoperative Phase After Surgery and General Anaesthesia
Official title: Assessment of Post-operative Residual Curarization (PORC) Incidence in Patients Undergoing Surgery With General Anaesthesia; Comparison Between Cisatracurium and Rocuronium. A Randomised, Single-blind Phase 4 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Residual Curarization
Residual Neuromuscular Block
Keywords: Postoperative residual curarization
Residual neuromuscular block
Complications
Postoperative
Neuromuscular function
Neuromuscular block
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.


Eligibility criteria: Inclusion Criteria:

* general anaesthesia with need to use of neuromuscular-blocking agents
* awakening and extubation of the patient in the operating room and permanence in the PACU for at least 60 minutes
* age 18-80
* surgical operations lasting at least 1 hour
* ASA class I-III
* possibility to apply TOF-monitoring with thumb-acceleromyography
* women of childbearing age not using contraceptives
* women of childbearing age using contraceptives

Exclusion Criteria:

* subjects unable to give a valid consent
* patients in emergency situations
* patients not awakened and not extubated in the operating room
* age above 80 years or under 18 years
* surgical operations lasting less than an hour
* ASA class IV
* impossibility to apply and/or perform TOF-monitoring
* neuromuscular diseases
* intake of therapies interfering with the neuromuscular function
* patients having contraindications for either studied drug
* pregnant women
* women who are breast-feeding

Primary outcomes:
measure: Incidence of PORC
timeFrame: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
Secondary outcomes:
measure: Incidence of PORC - comparison between Cisatracurium and Rocuronium
timeFrame: Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes.
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
Study officials:
affiliation: Università degli Studi di Padova - Azienda Ospedaliera di Padova
name: Carlo Ori, Prof. M.D.
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera di Padova
name: Paolo Feltracco, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05292872: Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Official title: Replicate Studies Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cholangitis
Keywords: Primary Biliary Cholangitis
Primary Biliary Cirrhosis
PBC
Hepatic Impairment
Liver
Lead sponsor: Intercept Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Target RWE
name: Syneos Health
name: Komodo Health, Inc.
First posted: 2022-03-23
Enrollment: 4577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet diagnostic criteria in each database between 01 Jun 2015 and 31 Dec 2021 and who meet the eligibility criteria were considered for these studies.

Brief summary: This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims database. The study is designed to evaluate the effectiveness of obeticholic acid (OCA). All patients who meet diagnostic criteria for PBC in the database between 01 Jun 2015 and 31 Dec 2021 and who meet all eligibility criteria were considered for this study.


Eligibility criteria: Key Inclusion Criteria:

1. Definite or probable PBC diagnosis
2. Inadequate response or intolerance to UDCA
3. Age ≥18 years at the index date
4. Continuous enrollment and evaluable data for at least 12 months before the index date (inclusive)

Key Exclusion Criteria:

1. History or presence of other concomitant liver diseases
2. History of non-skin malignancy or melanoma
3. History of HIV
4. Medical conditions that may cause non-hepatic increases in ALP
5. Patients with laboratory values indicative of hepatic decompensation or significant hepatobiliary injury
6. History of liver transplant
7. Evidence of fenofibrate, or bezafibrate use
8. History or presence of hepatic decompensating events

Primary outcomes:
measure: Risk of the First Event of the Composite Events
timeFrame: Up to 67 months
Secondary outcomes:
measure: Risk of Death
timeFrame: Up to 67 months
measure: Risk of Liver Transplantation
timeFrame: Up to 67 months
measure: Risk of Hospitalization for Hepatic Decompensation
timeFrame: Up to 67 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Intercept Pharmaceuticals, Inc
state: California
Study officials:
affiliation: Intercept Pharmaceuticals
name: Lynda Szczech, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03348072: Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses
Official title: Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Jehovah's withnesses having undergone cardiac surgery between 1991 till 2012 (blood perfusions refused) and paired control group having had the same surgical interventions (blood perfusions allowed)

Brief summary: This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject.

The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery with extra corporeal blood circulation
* Informed consent given

Exclusion Criteria:

* Dementia (must be able to answer the questionnaire)
* Control group: refusal of blood transfusions

Primary outcomes:
measure: Quality of life (score)
timeFrame: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
measure: Survival rate
timeFrame: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Pierre Wauthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wauthy P, Pierrakos C, Chebli L, Tortora R. Long-term survival and quality of life in Jehovah's witnesses after cardiac surgery: a case control study. BMC Cardiovasc Disord. 2019 Mar 29;19(1):73. doi: 10.1186/s12872-019-1061-z.