louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00730600: Effect of THAI Traditional Massage on Bone Markers
Official title: Acute Changes in Biochemical Markers of Bone Resorption and Formation After THAI Traditional Massage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Thai Traditional massage
Bone Formation
Bone Resorption
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to explore the skeletal effect of Thai traditional massage by examining the changes in biochemical markers of bone turnover immediately after the massage.

Detailed description: Each subject received Thai traditional massage for 2 hours by a single masseuse.

Eligibility criteria: Inclusion Criteria:

* Healthy Thai women aged 20 to 40 years
* Have been massaged by Thai Traditional massage style

Exclusion Criteria:

* Hyperparathyroidism, Thyrotoxicosis, Diabetes Mellitus, Rheumatoid Arthritis, Cancer
* Antiresorptive agent, Teriparatide and Glucocorticoid
* Swelling Joints

Primary outcomes:
measure: Biochemical markers of bone resorption; C-terminal telopeptide of type I collagen (CTx-I) and of bone formation; total procollagen type 1 amino-terminal propeptide (P1NP)level
timeFrame: 2 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University, Bangkok, Thailand 10400
name: Sunee - Saetung, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05800600: Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
Official title: Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

Detailed description: This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.

Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years
* Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.
* Anemia defined as Hgb \<10.5 g/dL during chemotherapy.
* Iron storage levels of ferritin \<500 ng/mL and iron saturation \<35%
* Ability to understand and willingness to sign a written informed consent and HIPAA consent document

Exclusion Criteria:

* Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \< 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior parenteral iron infusion in the past 4 weeks
* The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
* Concurrent systemic infection at the time of enrollment.
* Known hypersensitivity to Iron sucrose
* Pregnant or breast feeding. Refer to section 4.4 for further detail.
* Anemia from another established etiology (i.e MDS, Myeloma)

Primary outcomes:
measure: Mean change from baseline to highest Hgb value
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of transfusions during neo-adjuvant period
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Iberia Sosa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732900: Gene Expression in Cumulus Cells to Predict Pregnancy
Official title: The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In vitro fertilization
Assisted reproduction
pregnancy outcome
cumulus cells
Lead sponsor: Gema Diagnostics
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 133
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.


Eligibility criteria: Inclusion Criteria:

* Aged 21-39 years
* IVF cycle 1 or 2
* BMI \<35
* Fertilization method: ICSI and/or IVF
* Day 3 or day 5 embryo transfer
* Treatment cycle intended for single or double embryo transfer
* Use own oocytes, not oocyte donor
* ≥ 3 embryos at final assessment
* Donor sperm acceptable
* Willing to comply with protocol and study procedures

Exclusion Criteria:

* Polycystic Ovarian Syndrome
* Presence of fibroid(s): \>4 cm intramural or submucosal fibroids
* History of chemotherapy or radiation to the abdomen or pelvis
* Use of donor oocytes
* Use of reinseminated oocytes
* Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
* Concurrent participation in another clinical study
* (Male): Surgically removed sperm
* (Male): \<5 million sperm count

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: Recorded at post-transfer week 4-9
Secondary outcomes:
Other outcomes:
Locations:
city: Oak Brook
country: United States
facility: Reproductive Medicine Institute
state: Illinois
city: Indianapolis
country: United States
facility: IVF Indiana
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Troy
country: United States
facility: Reproductive Medicine Associates of Michigan
state: Michigan
Study officials:
affiliation: IVF Indiana
name: John Jarrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.
Clinical trial NCT00004700: Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperinsulinism
Keywords: endocrine disorders
hyperinsulinism
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.

Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Pinchas Cohen
role: STUDY_CHAIR
References:
Clinical trial NCT01280500: Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN
Official title: Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-01-20
Enrollment: 1040
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal is to identify best practices for improving health outcomes for patients with asthma using comparative effectiveness research within an Agency for Healthcare Research and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be achieved by completing the following aims: (1) Create a centralized database for comparative effectiveness research on asthma by combining clinical and billing data from one of the largest healthcare systems in the country (Carolinas Healthcare System) with data from the school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully developed integrated approach to asthma management based on the Chronic Care Model; (3) Develop and implement a "shared decision making" approach for asthmatic patients from disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing CDC funded school-based asthma intervention that will allow program evaluation and link school nurses with providers; (5) Evaluate and compare the effectiveness of these three asthma management strategies on: overall healthcare consumption and medical costs; quality of life, school absenteeism and performance; asthma clinical measures; and medication utilization; and (6) Disseminate findings across the state via the statewide PBRN and other network partners. This project has the potential to impact over 30,000 asthma patients across the Carolinas including many patients from disadvantaged backgrounds.


Eligibility criteria: Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

Primary outcomes:
measure: Reducing Hospitalizations and Emergency Department Visits
timeFrame: 2011-2013
Secondary outcomes:
measure: Improving Adherence to Medication
timeFrame: 2011-2013
measure: Improve Quality of Life
timeFrame: 2011-2013
measure: Reduced School Absenteeism
timeFrame: 2011-2013
measure: Improved Self-Efficacy
timeFrame: 2011-2013
measure: Improved School Performance
timeFrame: 2011-2013
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: CMC Elizabeth Family Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Department of Family Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael F Dulin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733200: Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
Official title: Surgical Treatment of Hilar Cholangiocarcinoma: Minor or Major Liver Resection?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Surgical Treatment
Hepatectomy
Keywords: Minor Liver Resection
Major Liver Resection
Hilar
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: Hepatic Surgery Clinical Research Centre of Hubei, China
First posted: 2008-08-12
Sex: ALL
Minimum age (years): 26
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The investigators conducted a prospective study to determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in 138 patients with hilar cholangiocarcinoma. In selected patients, minor liver resection was a good treatment.

Detailed description: Objective: To determine the safety and efficacy of minor and major hepatectomy selected by predetermined criteria in patients with hilar cholangiocarcinoma (HC).

Summary Background Data: For HC treated with hepatectomy, the extent of liver resection remains controversial despite extensive studies.

Methods: From January 2000 to December 2007, we prospectively studied patients who received surgical treatment for HC. Of the 187 patients who were surgically treated, 138 (73.8%) underwent resection with a curative intent. Minor hepatectomy was carried out in 93 patients who had Bismuth-Corlette types I, II and III HC without hepatic artery/portal vein invasion; and major hepatectomy in 45 patients who had type III HC with hepatic artery/portal vein invasion, or type IV HC.

Eligibility criteria: Inclusion Criteria:

* Criteria for resectability were absence of peritoneal or liver metastases, tumor extension to beyond secondary biliary branches bilaterally, tumor extension to secondary portal venous branches bilaterally

Exclusion Criteria:

* not in accordance with the above criteria

Primary outcomes:
measure: On multivariate analysis, prognostic factors significantly impacted on long-term survival were UICC tumor stage and histopathologic grade.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05496400: Anemia of Prematurity and Hemodynamics
Official title: Effect of Anemia of Prematurity and Its Treatment on Hemodynamics of Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any of the following will be excluded at the time of assessment:

* Hemolytic disease of the newborn.
* Shock.
* Sepsis.
* Ultrasonographic abnormalities of kidney, heart and cerebral structures.

Brief summary: The aim of this work to study the hemodynamic changes accompanying anemia of prematurity in neonates with gestational age ≤32 weeks and the effect of its treatment on hemodynamics.

Detailed description: This prospective observational study aims to evaluate the hemodynamic changes provoked by anemia of prematurity and transfusion of packed red blood cells (RBCs). Nonanemic inpatient premature infants (Hematocrit\>30%) will be compared with pretransfusional anemic inpatient premature infants. Anemic premature infants will be assessed before and 24 hours after the transfusion of pRBCs. Cerebral, intestinal and renal blood flow velocities, cardiac output parameters will be measured in premature neonates who will fulfill the eligibility criteria of the study.This study will be conducted at the neonatal intensive care units in Alexandria University Hospitals.

Eligibility criteria: Inclusion Criteria:

* Preterm infants ≤32 weeks gestational age, regardless their weight with postnatal age 3-6 weeks.

Exclusion Criteria:

-

Primary outcomes:
measure: 1. Cardiac output:
timeFrame: 3-6 weeks postnatal age
measure: 2. Cerebral blood flow velocities
timeFrame: 3-6 weeks postnatal age
measure: 3. Intestinal blood flow velocities
timeFrame: 3-6 weeks postnatal age
measure: 4.Renal blood flow velocities
timeFrame: 3-6 weeks postnatal age
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Ahmed Adel El Beheiry, PhD
role: STUDY_CHAIR
affiliation: Faculty of medicine, Alexandria University, Egypt
name: Amany Tolba Elsebaee, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02412800: Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation
Official title: Risk Factors of Postoperative Acute Lung Injury Following Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lung Injury
Keywords: Extravascular lung water
Pulmonary vascualr permeability index
Liver transplantation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Liver transplant recipients in NTUH, Taipei, Taiwan. From 2004-2014.

Brief summary: Postoperative acute lung injury (ALI) during the first 72 hours after liver transplantation is not uncommon. Injury may occur because liver transplantation is often associated with prolonged operative time, large volumes of fluid administration and transfusion, as well as inflammatory responses related to ischemia-reperfusion injury. For more precise perioperative fluid and hemodynamic management, modern monitoring systems, such as the pulse contour cardiac output (PiCCO) system, have been devised and reported in recent years. The PiCCO system uses the thermodilution technique to determine the cardiac index (CI) and thoracic fluid indices such as the intrathoracic blood volume index (ITBVI), extravascular lung water index (EVLWI), and pulmonary vascular permeability index (PVPI), all of which may reflect pulmonary fluid and injury status. However, perioperative changes in thoracic fluid indices in liver transplantation and their associations with postoperative ALI are not yet clear. In this study, the investigators aimed to determine patterns of change in perioperative thoracic fluid indices and compare these changes in recipients who did or did not develop postoperative ALI. Furthermore, the investigators will also try to determine the potential risk factors following liver transplantation.


Eligibility criteria: Inclusion Criteria:

* End stage liver disease receiving liver transplantation in NTUH.
* Age: 6 months old to 75 years old

Exclusion Criteria:

* history of pulmonary resection,
* chronic respiratory insufficiency
* cardiac dysfunction
* failure of the surgery.

Primary outcomes:
measure: Postoperative acute lung injury
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Natioanal Taiwan University Hospital
name: Kuang Cheng Chan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05899400: A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Official title: A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis, Pulmonary
Lead sponsor: Diascopic, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2023-06-12
Enrollment: 400
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: 400 Male and Female Ugandan Africans

Brief summary: A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides


Eligibility criteria: Inclusion Criteria:

* Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory

Exclusion Criteria:

* No samples from outside Makerere's Domain

Primary outcomes:
measure: Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).
timeFrame: Study completed over the grant period 2019 - 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: Makerere University
name: Moses Joloba, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03305900: Determinants of Formate Concentrations
Official title: Lifestyle, Metabolite and Genetic Determinants of Formate Concentrations in a Cross-sectional Study of Young, Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: formate
one-carbon metabolism
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: University of Dublin, Trinity College
First posted: 2017-10-10
Enrollment: 1701
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Serum formate was measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin

Brief summary: Formate is an important metabolite, serving as a donor of one-carbon groups to the intracellular tetrahydrofolate pool. However, little is known of its circulating concentrations or of their determinants. This study seeks to define formate levels and their determinants in a young, healthy population.

Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects, males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate levels will be compared with other one-carbon metabolites, vitamin status, potential formate precursors, genetic polymorphisms, and lifestyle factors.


Eligibility criteria: Inclusion Criteria:

* Trinity College Dublin students with Irish grandparents

Exclusion Criteria:

* None

Primary outcomes:
measure: Formate concentrations
timeFrame: Single baseline measurement; cross sectional, observational study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Dublin, Trinity College
name: Anne Molloy, Ph.D.
role: STUDY_CHAIR
References:
citation: Brosnan JT, Mills JL, Ueland PM, Shane B, Fan R, Chiu CY, Pangilinan F, Brody LC, Brosnan ME, Pongnopparat T, Molloy AM. Lifestyle, metabolite, and genetic determinants of formate concentrations in a cross-sectional study in young, healthy adults. Am J Clin Nutr. 2018 Mar 1;107(3):345-354. doi: 10.1093/ajcn/nqx065.