louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02210013: Differences in Ovarian Aging Between Caucasian and Indian Women
Official title: Ethnicity as a Determinant of Ovarian Aging: Differences Between Caucasian and Indian Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age of the Patients and the Body Mass Index in Both Groups
Keywords: AMH, AFC, aging, ethnicity
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian infertile women and Indican infertile women age \< 42 years old, with both ovaries present, undergoing an IVF treatment due to male factor, tubal disease or previous failed IUI.

Brief summary: The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The investigators will collect data about ovarian reserve markers and also the results after ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian response after IVF stimulation between both groups.

Detailed description: A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second IVF cycle will be included.

The date we will collect in both groups include the age, the body mass index, and the ovarian reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH) and antimullerian hormone (AMH) serum levels.

The investigators will also determine the number of oocytes retrieved and the metaphase two oocytes in both groups after IVF stimulation.

Eligibility criteria: Inclusion Criteria:

* Women aged \< 42 years old, with both ovaries present, undergoing a first or second IVF treatment due to male factor, tubal disease or previous failed intrauterine insemination (IUI).

Exclusion Criteria:

* Women diagnosed of polycystic ovary syndrome according to Rotterdam criteria, endometriosis stage III-IV, or previous pelvic inflammatory disease.

Primary outcomes:
measure: AMH levels produced by granulosa cells
timeFrame: day 1
Secondary outcomes:
measure: Number of oocytes
timeFrame: day 1
Other outcomes:
Locations:
Study officials:
affiliation: IVI Madrid
name: Carlos Iglesias, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NOVA IVI
name: Manish Banker, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NOVA IVI
name: Nalini Mahajan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: IVI Madrid
name: Leyre Herrero, Ph. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: IVI VALENCIA
name: Antonio Pellicer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: IVI Madrid
name: Juan Antonio Garcia-Velasco, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05573113: Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Official title: Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Necrotizing Enterocolitis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
name: American College of Radiology
First posted: 2022-10-10
Enrollment: 182
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Detailed description: Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.

Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.

Eligibility criteria: Inclusion Criteria

* Admitted to the NICU at CMKC or KUMC
* With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

Exclusion Criteria

• Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

Primary outcomes:
measure: Impact of imaging algorithm on diagnostic thinking
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Sherwin Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266913: Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
Official title: Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hyperbilirubinemia, Neonatal
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 126
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.


Eligibility criteria: Inclusion Criteria:

* Between 2 and 28 days old
* Having jaundice
* Gestational age between 35-42 weeks

Exclusion Criteria:

* Less than 2 days or more than 28 days old
* Gestational age out of the range of 35-42 weeks
* Infants whose parents refused to cooperate
* Patients with sepsis and other comorbid conditions

Primary outcomes:
measure: Duration of phototherapy
timeFrame: 6 days
Secondary outcomes:
measure: Discharge rate
timeFrame: 6 days
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Children hospital
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Rakhshaneh Goodarzi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02453113: Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment
Official title: Immune-Related Trafficking and Signaling in Human Skin Associated With Low-Power, Infrared Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Response Impaired
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beckman Laser Institute University of California Irvine
First posted: 2015-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this is that the researcher can use low power Near Infrared laser treatment non-painful and non-damaging dose to changes the skin properties.The researcher can prove that signaling and a significant increase in the number of skin cells in skin tissue exposed to the laser can improve the human skin immune system to help improve human body response to vaccines.

Detailed description: The researcher can use low power laser light one-minute exposures delivered to the skin at non-painful and non-damaging dose. The resulted in significant immunologic changes in the skin that included up-regulation of specific skin tissue and skin genes and the activation and mobilization of specific skin cells.

In the first part of the study, the researcher will make a determination of the laser irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute will be identified as that subject's maximum tolerable irradiance. After all subjects are tested, researcher will select the highest irradiance that was tolerated and use this in the second phase of the study.

Approximately 24 hours after the first test exposures, each subject will receive a one minute laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will be collected from laser treated site a untreated.

One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate RNA and protein expression.

Eligibility criteria: Inclusion Criteria:

* Adult men and women with skin type 1 and 2
* Not pregnant

Exclusion Criteria:

* Use of systemic steroids, topical steroids, tanning solutions and anticoagulant
* History of HIV, mentally incompetent, prisoner, alcohol or drug impairment
* Abnormal photosensitivity

Primary outcomes:
measure: Change in Skin Tissue Response to a Vaccine
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
city: Charlestown
country: United States
facility: Vaccine and Immunotherapy Center Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Beckman Laser Institute
name: Kristen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266613: TruGraf® Testing in High-Risk Kidney Transplant Recipients
Official title: Molecular Biomarkers in Renal Transplant Recipients at Higher Risk of Acute Rejection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplant Rejection
Lead sponsor: Transplant Genomics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Methodist Hospital Research Institute
First posted: 2020-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients with high immune risk who are undergoing routine management

Brief summary: This is an observational study to evaluate TruGraf® testing in high immune risk kidney transplant recipients. TruGraf is the first and only non-invasive test approved by Medicare to rule out silent rejection in stable kidney transplant recipients.


Eligibility criteria: Inclusion Criteria:

* High immune risk kidney transplant recipients defined by one of the following criteria: either a positive pretransplant donor specific anti-human leukocyte antigen (HLA) antibody, or a pre-transplant panel reactive antibody \>75%.
* Recipient of a primary or subsequent deceased-donor or living donor kidney transplantation.
* Stable serum creatinine (current serum creatinine \<2.3 mg/dl, \<20% increase compared to the average of the previous 3 serum creatinine levels).
* Kidney transplant patients who are at least 30 days post-transplant.

Exclusion Criteria:

* Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
* Recipients who do not meet criteria of high-immune risk.
* Recipients of previous non-renal solid organ and/or islet cell transplantation.
* Infection with HIV.
* Infection with BK.
* Patients that have nephrotic proteinuria (urine protein \>3 gm/day).

Primary outcomes:
measure: Clinical Utility of TruGraf Results
timeFrame: 1 year
measure: Correlation of TruGraf Results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
Study officials:
affiliation: Transplant Genomics, Inc.
name: John Holman, MD
role: STUDY_DIRECTOR
References:
citation: Marsh CL, Kurian SM, Rice JC, Whisenant TC, David J, Rose S, Schieve C, Lee D, Case J, Barrick B, Peddi VR, Mannon RB, Knight R, Maluf D, Mandelbrot D, Patel A, Friedewald JJ, Abecassis MM, First MR. Application of TruGraf v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients With Stable Renal Function. Transplant Proc. 2019 Apr;51(3):722-728. doi: 10.1016/j.transproceed.2019.01.054. Epub 2019 Jan 26.
citation: First MR, Peddi VR, Mannon R, Knight R, Marsh CL, Kurian SM, Rice JC, Maluf D, Mandelbrot D, Patel A, David J, Schieve C, Lee D, Lewis P, Friedewald JJ, Abecassis MM, Rose S. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplant Proc. 2019 Apr;51(3):729-733. doi: 10.1016/j.transproceed.2018.10.024. Epub 2018 Dec 11.
Clinical trial NCT05276713: Outcome of Tucidinostat-Based Therapy in HR+ Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor
Official title: A Single-center Study of the Outcome of Tucidinostat-Based Therapy in Hormone Receptor-Positive Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitor Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 50
Sex: FEMALE
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: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Detailed description: Cyclin-dependent kinase (CDK) 4/6 inhibitors have changed the treatment pattern of patients with hormone receptor-positive HER2-negative advanced breast cancer significantly prolongling patients'PFS and OS,but there is no optimal therapy after its progression.Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor, ACE trial demonstrated that tucidinostat plus exemestane improved PFS compared with placebo plus exemestane in HR+,MBC patients that progressed after previous endocrine therapy,only 7 patients enrolled in the trial had previously received CDK4/6 inhibitors.The aim of this trial is to evaluate the efficacy of tucidinostat-based therapy in hormone receptor-positive metastatic breast cancer patients previously treated with CDK4/6 inhibitor therapy in the real world.

Eligibility criteria: Inclusion Criteria:

* 1.woman, age \> 18 years old 2.Diagnosed with HR+/HER2- Metastatic Breast Cancer 3.Patients received tucidinostat-based therapy after progression on CDK4/6 inhibitor 4.Complete medical history was available

Exclusion Criteria:

* 1.Medical history was incomplete

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Tao wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00301613: Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN
Official title: MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Henoch-Schoenlein Purpura
Nephritis
Keywords: Henoch-Schonlein purpura nephritis Mycophenolate mofetil
Cyclophosphamide
treatment
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2006-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

Detailed description: Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and crescent formation at onset have high risks of progressing to end stage renal failure. Though clinical studies have shown that steroids in combination with cyclophosphamide could reduce proteinuria and preserve renal function, this protocol is associated with many side effects, and is not effective in some patients.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF),could inhibit multifarious effects on endothelial cells, including adhesion molecular expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitis. Clinical studies also showed that MMF was effective in the treatment of lupus nephritis with vasculitic lesions. These findings suggest that MMF might be effective in the treatment of severe HSPN, which is a kind of vasculitic lesion. This prospective open-labeled clinical trial study investigates the efficiency of MMF in the treatment of severe HSPN compared with pulse intravenous cyclophosphamide. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of MMF compared with cyclophosphamide in the treatment of severe HSPN.

Eligibility criteria: Inclusion Criteria:

* 16-50 years
* Biopsy proved HSP
* Proteinuria ≥ 3.0 g/24hr
* Scr \< 5.0 mg/dl

Exclusion Criteria:

* Cytotoxic drug treatment such as CTX, CsA, MMF for morn than 1 month-3 months prior to enrolled
* Pregnancy
* Active/serious infections
* Previous diagnosed diabetes mellitus type 1 or 2

Primary outcomes:
measure: To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Zhi-Hong Liu, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01129713: Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
Official title: Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastroesophageal Reflux Disease (GERD)
Heartburn
Indigestion
Keywords: GERD
Acid Reflux
Heartburn
Regurgitation
Indigestion
Lead sponsor: Effexus Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Southern Arizona VA Health Care System
First posted: 2010-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.

Detailed description: We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* Ages 18-75
* EE Los Angeles grades C or D
* Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
* Able to read, understand, and complete study questionnaires and record
* Able to understand the study procedures and sign informed consent
* Able to comply with all study requirements

Exclusion Criteria:

* Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
* Subjects with previous upper gastrointestinal surgery
* Subjects with clinically significant underlying comorbidity
* Helicobacter pylori positive
* Clinically significant GI bleed within the last 3 months
* Esophagitis not related to acid reflux
* Bleeding disorder
* Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
* Women pregnant or lactating
* History of allergic reaction to any Proton Pump Inhibitor (PPI)
* Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS \> 3 times/week
* Any medication dependant on gastric acid for optimal absorption

Primary outcomes:
measure: Primary objective is to evaluate the relationship between healing and study drug allotment.
timeFrame: 3 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona Veterans Health Care System
state: Arizona
Study officials:
affiliation: Southern Arizona VA Health Care System
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References: