louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00553176: The Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
Official title: Crohn's Therapy, Resource, Evaluation, and Assessment Tool Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Infliximab
Immune disorder
Remicade
Registry
Crohn's Disease
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-04
Enrollment: 6273
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: Adult patients diagnosed with Crohn's Disease

Brief summary: The purpose of this study is to evaluate the long-term clinical, economic and humanistic outcomes of various treatment regimens, including infliximab, in Crohn's disease in real world medical practice.

Detailed description: The TREAT (The Crohn's Therapy, Resource, Evaluation, and Assessment Tool) registry is a prospective, observational, multicenter, long-term registry featuring clinical, economic, and humanistic measures characterizing the treatment of Crohn's disease. The physicians will track treatments and patient outcomes over at least a 5-year period. Physicians are expected to manage patients as they would under normal practice conditions. No predefined schedule of visits or medical procedures are required. Data are collected on a semi-annual basis by physicians documenting assessment of disease severity, medication use, and adverse events. Upon enrollment, patients complete a health assessment questionnaire. As this is an observational study, no study drugs are administered. Through the course of the Registry, analyses will be performed to support submissions to health authorities, and questions of academic interest.

Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with Crohn's Disease

Exclusion Criteria:

* Patients participating in clinical trials for Crohn's disease or other conditions also were not eligible to be enrolled in the TREAT™ Registry
* Patients who are unable to participate in the program for 2 years or more.

Primary outcomes:
measure: To document the variety of treatment regimens currently employed in the management of Crohn's disease
timeFrame: Five years
Secondary outcomes:
measure: To assess clinical, economic, and humanistic outcomes of treatment
timeFrame: Five years
measure: To assess the long-term impact of various Crohn's disease treatment regimens
timeFrame: Five years
measure: To assess long-term outcomes specifically associated with the use of Remicade
timeFrame: Five years
measure: Collection of adverse events
timeFrame: Five years
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Biotech, Inc.
name: Janssen Biotech, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00871676: Use of Chewing Gum to Facilitate Appetite Control and Weight Loss
Official title: Use of Chewing Gum to Facilitate Appetite Control and Weight Loss in Overweight Individuals Treated by Lifestyle Modification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2009-03-30
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study was to test the use of chewing gum as an adjunct to lifestyle modification to facilitate appetite control and weight loss in overweight and obese individuals.


Eligibility criteria: Inclusion Criteria:

* 21-75 years of age
* Body Mass Index of 25-45 inclusive

Exclusion Criteria:

* major medical psychiatric conditions
* medications know to effect weight
* full or partial dentures
* 18 or fewer teeth
* regular gum chewing (≥ 2 pieces/day)
* use of any tobacco product
* sensitivity to the following ingredients (mint, magnolia bark, eggs, or English Muffins)
* history of PKU
* sensitivity or allergy to aspartame
* current/history of alcohol abuse or addiction (within 5 year)
* recreational drug use
* recent significant weight change (+/- 5% in previous 6 months)
* currently pregnant or nursing and willingness not to get pregnant during course of study
* participation in any other research studies
* proximity to clinic (within one hour)
* access to reliable transportation

Primary outcomes:
measure: Weight loss
timeFrame: Week 16 and 52
Secondary outcomes:
measure: Appetite control
timeFrame: Weeks 4, 8, 12, 16 and 52
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Thomas A Wadden, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018576: Delayed Cord Clamping in Premature Infants
Official title: Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothermia
Anemia
Keywords: delayed cord clamping
premature infants
hypothermia
anemia
intraventricular hemorrhage
Anemia in premature infants
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 6
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Detailed description: Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Eligibility criteria: Inclusion Criteria:

* premature infants at 24-28 completed weeks gestation at the time of delivery
* informed consent obtained from parents prior to delivery

Exclusion Criteria:

* multiple gestation (twins, triplets, etc)
* prolonged fetal bradycardia
* placental abruption or previa
* maternal illness
* major congenital anomalies
* maternal fever in labor
* fetal illness (e.g. isoimmune hemolysis)

Primary outcomes:
measure: Initial body temperature
timeFrame: At birth
Secondary outcomes:
measure: Hematocrit at birth and 24 hours of age
timeFrame: first day of life
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis
name: Mark A Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622076: Postoperative Catheterization After Anterior Colporrhaphy
Official title: Randomised Controled Multicenter Trial Regarding the Appropriate Length of Postoperative Catheterization After Anterior Colporrhaphy for Repair of Cystocele
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystocele
Cystitis
Keywords: postoperative
Catheterization
colporrhaphy
cystocele
cystitis
Lead sponsor: Atrium Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2008-02-22
Enrollment: 230
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised controled multicenter trial about the appropriate length of postoperative catheterization after anterior colporrhaphy. Patients are included at the moment that they are planned for surgery and are allocated to one of the study arms after the operation in the recovery by a digital randomisation-procedure. 230 patients will be enrolled in the study and half of the patients will have a catheter during five days postoperatively and the other half will be catheterized only during two days. Main outcome measurements regards replacement of a catheter because of bladder retention and the occurence of cystitis.


Eligibility criteria: Inclusion Criteria:

* all patients planned for a cystocele repair

Exclusion Criteria:

* patients who already have voiding problems before the operation not related to the cystocele
* patients that are not capable of understanding our patient information form because of mental status or language

Primary outcomes:
measure: how many patients do need replacement of a catheter because of urine retention in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy
timeFrame: 6-8 hours after removal of catheter
Secondary outcomes:
measure: how many patients develop cystitis after catheterization in both groups: 2 days versus 5 days in dwelling catheterization after anterior colporrhaphy
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: atriumMC
city: Maastricht
country: Netherlands
facility: Maastricht university medical center
Study officials:
affiliation: Atrium Medical Center
name: Frans Roumen, Dr
role: STUDY_DIRECTOR
affiliation: Maastricht University
name: Mirjam Weemhoff, DRS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT01071876: BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS
Official title: BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obstructive Sleep Apnea
Excessive Daytime Sleepiness
Keywords: Sleep disorder
obstructive sleep apnea
excessive daytime sleepiness
patients with OSA treated by CPAP presenting EDS
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 244
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: Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.

This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

Detailed description: The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.

The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Eligibility criteria: Inclusion Criteria:

* patients with OSA treated by nCPAP but still complaining with EDS
* ESS score \> or = 12

Exclusion Criteria:

* patient suffering from insomnia without OSA
* co-existing narcolepsy
* patient with sleep debt not due to OSA
* acute or chronic severe disease

Primary outcomes:
measure: ESS change (Epworth Sleepiness Scale)
timeFrame: at week 12 /52 versus baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
Study officials:
affiliation: Bioprojet
name: Evelyne De Paillette, MD
role: STUDY_DIRECTOR
References:
citation: Pepin JL, Georgiev O, Tiholov R, Attali V, Verbraecken J, Buyse B, Partinen M, Fietze I, Belev G, Dokic D, Tamisier R, Levy P, Lecomte I, Lecomte JM, Schwartz JC, Dauvilliers Y; HAROSA I Study Group. Pitolisant for Residual Excessive Daytime Sleepiness in OSA Patients Adhering to CPAP: A Randomized Trial. Chest. 2021 Apr;159(4):1598-1609. doi: 10.1016/j.chest.2020.09.281. Epub 2020 Oct 26.
Clinical trial NCT01758276: Obstetric Complications in Women Who Smoke During Pregnancy
Official title: Obstetric Complications in Women Who Smoke During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking
Keywords: smoking, pregnancy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-01-01
Enrollment: 21000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women who delivered in McGill University health center between 2001-2008

Brief summary: This will be a retrospective study. Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.

Detailed description: This will be a retrospective study using the McGill University Obstetrics and Neonatal database (MOND). This is a comprehensive database the contains details on all women delivering in McGill University Health Center in Montreal Canada.

Details on all women who delivered in McGill University between 2001-2007 will be retrieved anonymously from the MOND database (McGill University Obstetrics and Neonatal database). Women will be divided to 2 groups according to their smoking status in pregnancy. Obstetric complications will be recorded in both groups.

Statistic tests would be applied in order to assess relation between smoking and Obstetrical complications.

Eligibility criteria: Inclusion Criteria:all

* All women who delivered in McGill University health center between 2001-2008

Exclusion Criteria:

* delivery prior to 24 weeks (data on \<24 weeks not included in the database..)

Primary outcomes:
measure: Neonatal Intensive Care Unit admission rate in women who smoke in pregnancy
timeFrame: pregnancy 40 weeks
Secondary outcomes:
measure: Birthweight
timeFrame: 40 weeks of pregnancy
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419976: Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
Official title: Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fasting
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 879
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.

Detailed description: The investigators will study a noninvasive no risk process by which we can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy. In non-fasting individuals, the risk of a sedation related complication such as aspiration increases and often the procedure must be aborted and repeated on another day following more prolonged fasting and medication administration. This adds to increased cost and delay to patient care.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

  1. Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy
  2. Willing and able to consent to research protocol
  3. Fasting as required per routine instruction for upper endoscopy
  4. Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on
  5. Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy

     Exclusion Criteria:

  <!-- -->

  1. Non-fasting per protocol, or known to have had food or drink outside of routine protocol
  2. \< 18 years of age
  3. Unable or unwilling to consent to research protocol
  4. Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)
  5. Unable to consume refreshment post procedurally
  6. Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)

Primary outcomes:
measure: Electronically characterize what the human breath smells like during a fasting state
timeFrame: breath analysis obtained pre (approximately 10 minutes procedure)
measure: Electronically characterize what the human breath smells like during a non- fasting state
timeFrame: breath analysis obtained post endoscopic procedure (approximately 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00989976: Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Official title: Individual Differences in Diabetes Risk: Role of Sleep Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Diabetes
Keywords: Sleep
Diabetes Risk
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).


Eligibility criteria: Inclusion Criteria:

* Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:

  * age 18 to 29 years,
  * normal weight or modestly overweight (BMI ≤ 27 kg/m2 for women, BMI ≤ 28 kg/m2 for men),
  * normal findings on clinical examination, normal routine laboratory tests results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep disorders.
* Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
* An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index \> 5/hour) and periodic limb movement disorder (PLM arousal index \>1/hour).
* Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.

Exclusion Criteria:

* Tobacco use.
* Habitual alcohol use of more than 2 1 drink per day.
* Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.

We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.

Primary outcomes:
measure: diabetes risk as assessed by disposition index
timeFrame: Dec. 2011
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 NCT04962776: Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
Official title: A Randomised Controlled Study of Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Length of Hospital Stay
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgery is known to be associated with stress response affecting in a negative way the clinical outcome and patient experience. The stress response includes both sympathetic nervous system activation and systemic inflammatory response. The pituitary- sympathetic one leads to a number of metabolic changes as hyperglycemia, nitrogen loss and lipolysis on the other hand the systemic inflammatory response aggravates the perioperative metabolic changes. One of components of ERAS is preoperative carbohydrate load. Oral carbohydrate was associated with attenuation of the postoperative metabolic stress response. Nitrate rich drinks before exercises have a promising impact due to improving blood flow, mitochondrial efficiency, glucose uptake and the sarcoplasmic calcium handling all of which maximize resistance to fatigue and improved exercise performance.


Eligibility criteria: Inclusion Criteria:

* Patients ageing from 18 to 60 years,
* American Society of Anesthesiologists (ASA) physical status I,II
* scheduled for elective open gynecological surgeries

Exclusion Criteria:

Patients with

* Previous chemotherapy treatment,
* Disseminated malignant disease,
* BMI more than 40,
* Known allergy to one or more of the study medications
* Refusal to participate in the study
* Patients diagnosed with diabetes milieus either type I or type II,
* Patients with previous bariatric surgeries
* Patients under medications that delay gastric emptying (tricyclic anti-depressants, chronic use of laxatives)

Primary outcomes:
measure: The length of hospital stay (Days)
timeFrame: The study end point will be 7 days from the operation or when patient will be discharged from hospital which of which will be earlier.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References: