louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01560000: Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
Official title: Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food
Keywords: The focus of this study is to determine satiety
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine the satiety value of different bran fibers on appetite \& subsequent food intake with acute consumption. Satiety will be measured subjectively by visual analogue scales (VAS).

Detailed description: Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes

Eligibility criteria: Inclusion Criteria:

* healthy women between the ages of 18-40
* body mass index between 18.5-29.9kg/m2
* eat breakfast regularly
* nonsmoking
* not taking weight loss medications
* non-dieting (weight stable over the past 3 months)
* spoken and written English literacy.

Exclusion Criteria:

* antibiotic use within the past 6 months
* cardiovascular disease
* diabetes mellitus
* cancer in the past 5 years
* renal or hepatic disease
* recent bacterial infection
* gastrointestinal conditions affecting digestion or absorption
* weight loss\>5kg in prior 3 months (intentional or unintentional)
* history of drug or alcohol abuse in prior 6 months
* food allergies
* high fiber intake(3 or more servings of high fiber foods per day)
* lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
* restrained eater(score\>10 on the dietary restraint factor of the Three Factor Eating Questionnaire)
* concurrent or recent (within 30 days) participation in an intervention study.

Primary outcomes:
measure: Satiety response
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korczak R, Lindeman K, Thomas W, Slavin JL. Bran fibers and satiety in women who do not exhibit restrained eating. Appetite. 2014 Sep;80:257-63. doi: 10.1016/j.appet.2014.05.025. Epub 2014 May 27.
Clinical trial NCT03675100: Neurotrophic Factors, Tight Junction Proteins, and Cytokines in IBS
Official title: Expression of Neurotrophic Factors, Tight Junction Proteins, and Cytokines According to the Irritable Bowel Syndrome Subtype and Sex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Tight Junction Alteration
Pathophysiology
Keywords: Irritable bowel syndrome
Subtype
Tight junction
Sex
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the role of neurotrophic factors (NGF, GDNF, TRPV-1), to quantity tight junction proteins (ZO-1, occludin, claudin) and cytokines (IL-8, TNF-a, IL-1b) in the colonic mucosa of IBS patients and also clarify sex differences in the pathophysiology of IBS.


Eligibility criteria: Inclusion Criteria:

* Control group Those who were between 18 and 80 years old and did not have any abnormalities in colonoscopy
* Irritable bowel syndrome group Patients who diagnosed as irritable bowel syndrome according to the ROME III criteria

Exclusion Criteria:

* history of IBD
* abdominal operation
* severe systemic disease
* malignancy,

Primary outcomes:
measure: NGF, GDNF, and TRPV-1 mRNA expression of colonic mucosa
timeFrame: up to 24 weeks
Secondary outcomes:
measure: ZO-1, Occludin, and Claudin mRNA expression of colonic mucosa
timeFrame: up to 24 weeks
measure: IL-8, TNF-a, and IL-1b mRNA expression of colonic mucosa
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428700: Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C
Official title: Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation
First posted: 2011-09-05
Enrollment: 275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in ITN030ST (NCT00135694)

Brief summary: Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.


Eligibility criteria: Inclusion Criteria:

* Specimens derived from subjects enrolled in the ITN030ST study.
* Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy.

Exclusion Criteria:

* Withdrawal of consent for the ITN030ST study.
* Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.

Primary outcomes:
measure: Expression levels of mRNA and miRNA in peripheral blood cells, serum, and tissue at the time of for cause and protocol biopsies, and the diagnostic effectiveness of identified patterns
timeFrame: +/- 10 day window from time of clinically indicated biopsy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Abraham Shaked, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Manikkam Suthanthiran, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05723900: Evaluation of Pulp Response to Castor Oil
Official title: Comparative Evaluation of Pulp Response to Castor Oil Versus Formocresol as Pulpotomy Medicaments in Primary Teeth :An in Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Response to Castor Oil
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 31
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth


Eligibility criteria: Inclusion Criteria:

* healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons

Exclusion Criteria:

* caries primary canines Presence of systemic pathology

Primary outcomes:
measure: The degree of pulp inflammation using score.
timeFrame: 2 weeks to 3 months
measure: The presence or absence of dentin chips formation by using scores 0 or 1.
timeFrame: 2 weeks to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Tanta University
name: shomaa Mostafa Hadwa, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00579800: Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation
Official title: Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Vibrant-DE
IDEAL
MRI
Breast
07-091
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 76
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (MRI). The information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer.


Eligibility criteria: Inclusion Criteria:

* Female patients over the age of 21 undergoing a diagnostic Breast MRI.

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination
* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients under the age of 21.
* Female patients who are pregnant.

Primary outcomes:
measure: To evaluate the feasibility of three new pulse sequences for breast MRI using newly developed software; FIESTA, Vibrant DE and IDEAL
timeFrame: conclusion of the study
Secondary outcomes:
measure: To quantitatively and qualitatively assess performance of the three breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146000: Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain
Official title: Effect of Topical Lidocaine-prilocaine Cream Versus Rectal Meloxicam Suppository on Relief of Post-episiotomy Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 190
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postpartum perineal pain is a very common complaint. It can have negative consequences for mother and child including disability in daily functioning for the mother; for example, it can interfere in taking care of her infant and in breastfeeding. Early pain management is thus relevant to provide relief and prevent chronicity.

Perineal pain is particularly common following childbirth. Macarthur 2004, in a prospective cohort study involving 447 women in Canada, reported an incidence of perineal pain, in the first day after birth, of 75% in women with an intact perineum


Eligibility criteria: Inclusion Criteria:

1. Primiparas
2. Normal vaginal delivery
3. Mediolateral episiotomy
4. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

1. Patients who had postpartum hemorrhage
2. Patients who had manual removal of the placenta
3. Patients with contraindications to non steroidal drugs
4. Patients with a multiple perineal lacerations

Primary outcomes:
measure: The mean difference of visual analog scale after delivery
timeFrame: immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02293200: CPR Feedback Devices
Official title: TWO METHODS OF TRAINING TO IMPROVE CHEST COMPRESSION EFFECITVENESS BY MEDICAL STUDENTS AND BYSTANDERS: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare two methods of training in CPR, standard basic life support and CPR using CPR feedback device.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases

Primary outcomes:
measure: Effective compressions compression with correct depth (40-50mm), correct hand position and complete decompressions
timeFrame: 1 month
Secondary outcomes:
measure: effective compressions ratio effective compressions [%] multiplied by flow time [%]
timeFrame: 1 month
measure: Flow time sum of all periods during which chest compressions were performed.
timeFrame: 1 month
measure: absolute hands-off time sum of all periods without chest compressions or ventilation
timeFrame: 1 month
measure: Compression depth compression in correct depth (40-50mm) measured by the software is connected to the manikin and computer
timeFrame: 1 month
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053700: Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea
Official title: Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea- a Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rosacea
Keywords: Rosacea, Bromonidine, intensed pulse light
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an interventional, prospective single blinded study. Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. In addition half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
Primary purpose: TREATMENT

Brief summary: This is an interventional and prospective study. The study is designed to evaluate the additional benefits of a combination of IPL treatment and local application of Bromonide 0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).

Detailed description: Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. In addition half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.

Eligibility criteria: Inclusion Criteria:

* patient (male or female) must be over 18 yaers old of age and fulfil one of the following:

  1. Suffer from ETR
  2. Suffer from PPR
  3. Suffer from a combination of ETR and PPR.

Exclusion Criteria:

* 1.Under 18 years old of age. 2.Pregnant women. 3.Systemic treatment of rosacea at the previous six months before enrollment. 4.Topical treatment of rosacea at the previous one month before enrollment. 5.Phymatous or occular rosacae.

Primary outcomes:
measure: patient self-assessment questionaires score change
timeFrame: three months after initiation of treatment compared to Baseline
measure: Physicians' unblinded score assessment
timeFrame: three months after initiation of treatment compared to Baseline
measure: Physicians' unblinded score assessment
timeFrame: six months after initiation of treatment compared to Baseline
measure: patient self-assessment questionaires score change
timeFrame: six months after initiation of treatment compared to Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical center, Petach Tikva
name: Assi Levi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111200: Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders
Official title: Comparative Efficacy of Phenylbutyrate vs. Benzoate in Urea Cycle Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urea Cycle Disorders, Inborn
Keywords: urea cycle disorders
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject participation will require three, separate, four-day study periods at least one week apart. During one study period (also called a treatment arm), subjects will take sodium phenylbutyrate; during another they will take sodium benzoate; during another they will take a combination of the two medications.

We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or a combination of the two.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects with (a) a history of frequent dietary protein intolerance, (b) a history of chronic or acute liver diseases which may result in altered hepatic synthetic capacity (e.g., hepatitis), (c) acute or chronic disease or on medications that in the opinion of the clinical investigators will interfere with the measurements (e.g., drugs which may have hepatotoxicity as potential side effects), (d) a physical disability that will interfere with their ability to either conform to the dietary regimes or undergo the isotopic infusions, (e) pregnancy or recent (\<6 months)/current lactation, (f) intercurrent evidence of significant hyperammonemia (more than 100 µmol/L), (g) any clinical abnormality of Grade 3 or greater according to the Common Terminology Criteria for Adverse Events v.4.0 (CTCAE), (h) any condition(s) not covered by the CTCAE, or (i) a severe or life-threatening toxicity at screening, will be excluded from the study. Subjects taking ammonia scavenger medications will not be enrolled.

Primary outcomes:
measure: Urinary Hippuric Acid
timeFrame: 4 days per arm
measure: Urinary PAGN Excretion
timeFrame: 4 days per arm
measure: Total Nitrogen as a Conjugate of the Drug
timeFrame: 4 days per arm
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center/Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Juan C Marini, DVM., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Sandesh CS Nagamani, MD, FACMG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04989400: Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion
Official title: Use of Ulipristal Acetate in Induction of Second Trimester Missed Abortion in Women With Previous Caesarian Section: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Second Trimester Abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this work is to assess the effectiveness and safety of Ulipristal Acetate in the management of 2nd trimester missed abortion along with misoprostol in pregnant women with previous caesarean section versus the use of misoprostol only with placebo as regards the time needed for abortion,Hypothesis: In pregnant women with 2nd trimester missed abortion with previous caesarean section , Ulipristal Acetate may decrease the time interval to achieve abortion when combined with Misoprostol in comparison to misoprostol alone.the included women divided to 2 groups Group A: will receive Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal according to FIGO guidelines 2017.Group B: will receive placebo then 12 hours later start misoprostol 100µg every 6 hours buccal according to FIGO guidelines 2017. then we assess Induction-to-abortion interval time.


Eligibility criteria: Inclusion Criteria: • Women with 2nd trimester missed abortions

* Gestational age 13-26 weeks.
* Women with a previous caesarian section scar,(para 1cs till para 4 cs).
* Women counseled and chose medication abortion rather than surgical evacuation

Exclusion Criteria:

* Women with an accompanying medical disorder such as: Preeclampsia, Diabetes Mellitus or Heart disease.
* Primigravida women or non scarred uterus.
* Women with previous myomectomy or hysterotomy scar or upper segment caesarean section scar.
* Induction of abortion in women with congenital fetal malformations or positive fetal pulsations due to medical disorder.
* Women with placenta previa .
* Allergy or contraindications to either Ulipristal acetate or Misoprostol.
* Women with inevitable abortion in the form of vaginal bleeding or uterine contractions

Primary outcomes:
measure: Induction-to-abortion interval time.
timeFrame: 2 weeks
Secondary outcomes:
measure: complete evacuation between both groups
timeFrame: 2 weeks
measure: need for hysterotomy
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
References: