louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01032525: Monroe County Inflammatory Bowel Disease (IBD) Registry
Official title: Epidemiologic Study of Inflammatory Bowel Disease in Monroe County, New York
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's Disease
Ulcerative Colitis
IBD
Inflammatory Bowel Disease in Monroe County, NY
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Centocor Ortho Biotech Services, L.L.C.
First posted: 2009-12-15
Enrollment: 720
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of monroe County who had been diagnosed with Crohn's Disease or Ulcerative Colitis

Brief summary: This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).


Eligibility criteria: Inclusion Criteria:

* Patients with IBD who sign consent from 1995-2001

Exclusion Criteria:

* Patients without IBD

Primary outcomes:
measure: not complete
timeFrame: not complete
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04169425: Laparoscopic Surgery of Rectal Cancer and Ileostomy
Official title: Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ileostomy - Stoma
Ileostomy; Complications
Leakage, Anastomotic
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 67
Maximum age (years): 86
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma.

Brief summary: Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.

Detailed description: From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.

Eligibility criteria: Inclusion Criteria:

* adult patients (aged 18 years and over)
* patients submitted to elective Anterior Rectal Resection

Exclusion Criteria:

* chronic use of immunosuppressant agents
* urgent surgery

Primary outcomes:
measure: Number of participants with anastomotic leakage
timeFrame: 90 days
Secondary outcomes:
measure: Number of participants with post-operative complications
timeFrame: 90 days
measure: Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever
timeFrame: 90 days
measure: Number of participants with surgical site infection
timeFrame: 90 days
measure: Number of participants with abdominal collections
timeFrame: 90 days
measure: Number of participants with anastomotic bleeding
timeFrame: 90 days
measure: Number of participants with perforation
timeFrame: 90 days
measure: Number of participants with anastomotic stenosis
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05914025: The Effect of a Brief Online Behavioral Activation Intervention
Official title: The Effect of a Brief Online Behavioral Activation Intervention by Activity Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Palo Alto University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Depression is a worldwide phenomena that has a severe personal, social and societal impact. One such impact is an over $200 billion worldwide economic cost. While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists. As such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments. A series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms. It is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions. This study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used Amazon Mechanical Turk as a recruitment source.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* United States Resident

Exclusion Criteria:

* Non-US resident
* Younger than 18 years old

Primary outcomes:
measure: Depression level
timeFrame: 3 days
measure: Self-reported mood
timeFrame: 3 days
measure: Daily Enjoyment
timeFrame: At time of original survey
Secondary outcomes:
measure: Confidence, Motivation, and Usefulness
timeFrame: 3 days
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Online Recruitment/Palo Alto University Campus
state: California
Study officials:
References:
Clinical trial NCT02891525: The Influence of Sweet Substrates on Hunger, Gastrointestinal Hormones and the Migrating Motor Complex
Official title: The Effect of Caloric and Non-caloric Sweeteners on Hunger, Gastrointestinal Hormones as Well as on Antral and Duodenal Motility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators aimed at evaluating the role of sweet taste receptors in the gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or acesulfame-K were compared with placebo administration for their effects on gastrointestinal motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin) and hunger feelings.


Eligibility criteria: Inclusion Criteria:

* BMI\<30 kg/m² for the lean volunteers
* Female or male subjects aged 18 to 60
* Subject is capable and willing to give informed consent
* Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception

Exclusion Criteria:

* Female volunteer is pregnant or breastfeeding
* GI diseases, major abdominal surgery
* Volunteers that have food allergies, especially fructose intolerance
* Major psychiatric illnesses
* Volunteers that use drugs affecting the GI tract or the central nervous system
* Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor
* Volunteers that have undergone surgical procedure for weight loss

Primary outcomes:
measure: Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
timeFrame: 3 hours after administration, continuous measurement with high resolution manometry
Secondary outcomes:
measure: Change in gut hormone release measured by specific radioactive immunoassays
timeFrame: 3 hours after administration, blood sample every 15 min
measure: Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm
timeFrame: 3 hours after administration, assessment every 5 min
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer-Gerspach AC, Biesiekierski JR, Deloose E, Clevers E, Rotondo A, Rehfeld JF, Depoortere I, Van Oudenhove L, Tack J. Effects of caloric and noncaloric sweeteners on antroduodenal motility, gastrointestinal hormone secretion and appetite-related sensations in healthy subjects. Am J Clin Nutr. 2018 May 1;107(5):707-716. doi: 10.1093/ajcn/nqy004.
Clinical trial NCT04806425: The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization
Official title: The Cardioprotective Effect of Intralipid in Decreasing the Ischemic Insults During Off-pump Coronary Artery Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing myocardial ischemia , given during preconditioning in off pump coronary artery revascularization


Eligibility criteria: Inclusion Criteria:

* patients between 40 to 75 undergoing off bump CABG surgery

Exclusion Criteria:

* emergency surgery
* Ejection fraction less than 50%
* redo procedures
* history of allergy to peanuts

Primary outcomes:
measure: ICU stay
timeFrame: long icu stay is considered if more than 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: (Select)
Study officials:
References:
Clinical trial NCT03646825: Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Official title: Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Observe Effect of Antioxidant on Sperm DNA Fragmention
Lead sponsor: Colorado Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients pursuing IVF for treatment of infertility

Brief summary: Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.

Detailed description: Male patients will be recruited based on having a high DNA fragmentation (chromatin \>16) no other severe male factor infertility (\>5million/ml, count, \> 10%motility and \>1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily

Eligibility criteria: Inclusion Criteria:

-Sperm Chromatin \>16%, sufficient ejaculate sperm for ICSI

Exclusion Criteria:

* Severe male factor infertility

Primary outcomes:
measure: Sperm DNA fragmentation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
Study officials:
affiliation: Study Coordinator
name: Rachel Makloski
role: STUDY_CHAIR
References:
Clinical trial NCT01009125: Healthcare Access and Utilization Among Living Kidney Donors
Official title: Randomized Trial of Financial Incentives to Increase Response Rates to a Mailed Survey of Healthcare Access and Utilization Among Living Kidney Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donor
Keywords: questionnaires
health care surveys/methods
motivation
living donors
living kidney donation
Lead sponsor: St. Barnabas Medical Center
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a mailed survey to persons who served as living kidney donors at Saint Barnabas Medical Center. The experimental component of this study (the clinical trial) is a randomized trial of two monetary incentives for the living kidney donors invited to participate in the study. Kidney donors will be randomized to receive one of two incentives in the mailed survey packet: $2 cash vs. $5 cash. The main outcome measure is the response rate to the survey.


Eligibility criteria: Inclusion Criteria:

* Persons who donated a living donor kidney at Saint Barnabas Medical Center between January 2000 and December 2006 are eligible to participate

Exclusion Criteria:

* Current address outside the continental United States
* Persons who donated a living donor kidney prior to January 2000 or after December 2006
* Persons who indicated they no longer wished to be contacted by Saint Barnabas Medical Center

Primary outcomes:
measure: Survey response rate
timeFrame: 2 weeks, 2 months (primary), 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
Study officials:
affiliation: St. Barnabas Medical Center
name: Francis L Weng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03446625: Resveratrol as a Preventive Treatment of OHSS
Official title: Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: resveratrol
OHSS
PCOS
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

Detailed description: Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition

Eligibility criteria: Inclusion Criteria:

* Number of follicles greater than 12 mm after ovarian stimulation
* Number of retrieved oocytes greater than 21

Exclusion Criteria:

* \>35 years-old
* PCOS
* Endometriosis
* Systemic pathology
* Positive serologies for HBV, HBC and HIV
* Abnormal karyotype

Primary outcomes:
measure: Serum VEGF levels
timeFrame: 1 day
Secondary outcomes:
measure: Hemoconcentration
timeFrame: 1 day
measure: Serum estradiol levels
timeFrame: 1 day
measure: Ascitis
timeFrame: 1 day
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ivi Madrid
Study officials:
References:
citation: Ortega I, Villanueva JA, Wong DH, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Resveratrol reduces steroidogenesis in rat ovarian theca-interstitial cells: the role of inhibition of Akt/PKB signaling pathway. Endocrinology. 2012 Aug;153(8):4019-29. doi: 10.1210/en.2012-1385. Epub 2012 Jun 19.
citation: Ortega I, Wong DH, Villanueva JA, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Effects of resveratrol on growth and function of rat ovarian granulosa cells. Fertil Steril. 2012 Dec;98(6):1563-73. doi: 10.1016/j.fertnstert.2012.08.004. Epub 2012 Sep 6.
citation: Basini G, Tringali C, Baioni L, Bussolati S, Spatafora C, Grasselli F. Biological effects on granulosa cells of hydroxylated and methylated resveratrol analogues. Mol Nutr Food Res. 2010 Jul;54 Suppl 2:S236-43. doi: 10.1002/mnfr.200900320.
Clinical trial NCT06920225: Transmeridian Travel in Elite Female Athletes
Official title: Transmeridian Travel in Elite Female Athletes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transmeridian Travel
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will investigate whether maintaining a home-based time zone schedule will attenuate any decrements to sleep and performance experienced following transmeridian travel in elite female athletes.


Eligibility criteria: Inclusion Criteria:

* Athlete on the roster of an NCAA Division 1 Team
* Has worn WHOOP device for at least 3 months

Exclusion Criteria:

* Musculoskeletal injury or cardiometabolic disease limiting participation in regular team activities
* Pre-diagnosed sleep condition that would negatively affect sleep quantity or quality

Primary outcomes:
measure: Sleep Quantity
timeFrame: Daily for 5 days
measure: Sleep Quality
timeFrame: Daily for 5 days
measure: Resting Heart Rate (RHR)
timeFrame: Daily for 5 days
measure: Heart Rate Variability (HRV)
timeFrame: Daily for 5 days
measure: Muscular Power
timeFrame: Daily for 3 days
measure: Muscular Strength
timeFrame: Daily for 3 days
Secondary outcomes:
measure: Reaction Time
timeFrame: Daily for 5 days
measure: Subjective Sleep Quality
timeFrame: Daily for 5 days
measure: Subjective Recovery
timeFrame: Daily for 5 days
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Institute of Sports Sciences & Medicine
state: Florida
Study officials:
References:
Clinical trial NCT03156725: Assessment of Iron Absorption From Aspergillus Oryzae
Official title: Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Bioavailability
Keywords: Iron Bioavailability
hepcidin
ferritin
iron absorption
iron status
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects were two meals on two consecutive days with the stable isotopes.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.

Detailed description: Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value \<30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.

Eligibility criteria: Inclusion Criteria:

* Marginal iron status (Serum ferritin \<30ug/L)
* BMI in the range 18.5-24.9 kg/m2
* Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study
* Willing to consume stable iron isotope labelled supplement
* Willing to stop getting blood drawn 2 weeks prior to the study and during the study
* Willing to give multiple blood samples at beginning and end of study

Exclusion Criteria:

* Pregnant
* Lactating
* Smoker
* Anemic (hemoglobin \< 120 g/L)
* Has gastro-intestinal disease/condition that can affect absorption
* Allergic to any of the meal components

Primary outcomes:
measure: iron absorption
timeFrame: 15 days
Secondary outcomes:
measure: iron status
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Iowa State University
name: Manju B Reddy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04942925: Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Official title: Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Ametropia
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will receive treatment based upon the randomized treatment sequence assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Detailed description: The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous PRECISION1 or INFUSE contact lens wearer.
* Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
* Routinely sleeps in contact lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance VA (logMAR) With Study Lenses
timeFrame: Day 8 (-0/+3 days), each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Orlando
country: United States
facility: Alcon Investigator 6355
state: Florida
city: Eden Prairie
country: United States
facility: Alcon Investigator 6583
state: Minnesota
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References: