louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01366469: Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting
Official title: Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Chronic Obstructive Pulmonary Disease
Keywords: coronary artery bypass grafting
coronary artery disease
chronic obstructive pulmonary disease
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients from Cardiothoracic surgery service

Brief summary: The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims:

Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure.

Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (\> 24 hours), pneumonia, and/or tracheostomy.

Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.


Eligibility criteria: Inclusion Criteria:

* Undergoing elective CABG
* Current diagnosis of COPD
* Ability to provide signed informed consent to participate
* \> 18 years of age

Exclusion Criteria:

* Concomitant valve surgery
* Urgent or emergent coronary surgery
* Current steroid therapy
* Active smoker and/or positive urine co-nicotine

Primary outcomes:
measure: Primary outcome measure
timeFrame: During Hospitalization
Secondary outcomes:
measure: Secondary outcome measure
timeFrame: 30 Day Follow-up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Omar M Lattouf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03374969: Differential DNA Methylation as a Function of a Parenting Intervention
Official title: Differential DNA Methylation as a Function of a Parenting Intervention: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maltreatment, Child
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 44
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to experimentally assess whether an early parenting intervention for maltreating parents results in differential epigenetic marking of children's genome, particularly of DNA associated with immune system functioning, obesity, and mental health.

Detailed description: This study assesses whether a 10-session intervention for maltreating parents effects the epigenome of young children who have experienced early maltreatment. Families are randomly assigned to the experimental condition (Attachment and Biobehavioral Catch-Up) or a treatment control (Developmental Education for Families). Biological samples and behavioral observations of parenting will be collected pre- and post- intervention. Biological samples will be used to conduct whole genome analyses of differential DNA methylation that occur as a result of the intervention. Behavioral observations of parent-child interactions will be used to assess the efficacy of the intervention in altering parenting behaviors.

Eligibility criteria: Inclusion Criteria:

* Parents will be considered potentially eligible if they have a child between the ages of 6 and 20 months and have a history of substantiated or unsubstantiated report of maltreatment or domestic violence. After obtaining informed consent, observational assessments of sensitivity will be conducted, allowing screening of parents with low levels of sensitivity (who are expected to benefit more from the intervention than others). Only those parents who have scores in the insensitive range will be included in the full study.

Exclusion Criteria:

* Children with known serious medical issues (e.g., cerebral palsy) will be excluded from the sample. Also, high-risk parents will be screened for sensitivity to ensure that they will benefit from the intervention. Only those who are screened as relatively insensitive (1-2 on a 5 point coding scale) will be included in the full study.
* If the primary caregiver loses custody of the child before completion of the project, the participant will be withdrawn from the study.
* If the primary caregiver is incarcerated before completion of the study, the subject will be withdrawn from the study.

Primary outcomes:
measure: Whole Genome DNA Methylation
timeFrame: from date of enrollment to 1 month after completing the intervention
Secondary outcomes:
measure: Parental Sensitivity
timeFrame: On date of enrollment, each intervention session, and 1 month after completing the intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02748668: Extracorporeal Membrane Oxygenation (ECMO): Blood Cells
Official title: Extracorporeal Membrane Oxygenation: Blood Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Extracorporeal Membrane Oxygenation
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
First posted: 2016-04-22
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients on ECMO and 100 control patients will be enrolled into the study.

Brief summary: The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.


Eligibility criteria: ECMO group:

Inclusion Criteria:

* Greater than or equal to 18 years of age
* Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.

Exclusion Criteria:

* Subject is less than 18 years of age
* Known prisoner

Control Subjects:

Inclusion Criteria

* Greater than 18 years of age
* Without any known cardiovascular, lung, or autoimmune disease.

Exclusion Criteria:

* Less than or equal to 18 years of age
* Known cardiovascular, lung, or autoimmune disease

Primary outcomes:
measure: All cause mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Renzo Loyaga-Rendon, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756568: The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
Official title: The Diagnostic Utility of Ultrasound in Pelvic Inflammatory Disease (PID)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pelvic Inflammatory Disease
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 139
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: to check the Pelvic Inflammatory Disease (PID) using Ultrasound

Brief summary: Pelvic inflammatory disease (PID) represents a significant and complex health issue affecting women, particularly those of reproductive age. Characterized by the infection and inflammation of the reproductive organs, PID often results from ascending infections primarily caused by sexually transmitted pathogens, such as Neisseria gonorrhoeae and Chlamydia trachomation. However, it can also be associated with endogenous bacteria or occur following surgical procedures.

Detailed description: The diverse manifestations of PID from asymptomatic cases to acute presentations, pose significant challenges in diagnosis and prompt treatment. Accurate diagnosis is crucial, as untreated infections can lead to severe complications, including infertility, chronic pelvic pain, and ectopic pregnancies.

Eligibility criteria: Inclusion Criteria:

* Women of reproductive age (18-45 years) presenting with symptoms suggestive of pelvic inflammatory disease (PID).
* Patients who have been clinically diagnosed with PID based on symptoms such as lower abdominal pain, fever, abnormal vaginal discharge, and tenderness upon pelvic examination.
* Patients who have undergone preliminary diagnostic tests, such as high vaginal swab (HVS) and urine microscopy, culture, and sensitivity (m/c/s), prior to ultrasound assessment.

Exclusion Criteria:

* Pregnant women, due to potential confounding factors in ultrasound findings and differential diagnosis.
* Patients with chronic pelvic pain not related to acute PID episodes.
* Patients who do not provide informed consent for participation in the study.
* Patients with a history of recent pelvic surgery within the last 6 months, as postoperative changes may affect ultrasound findings.

Primary outcomes:
measure: ultrasound
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT00325468: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Official title: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Bone Mineral Density
Keywords: bone loss
osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density


Eligibility criteria: Inclusion Criteria:

* Subject must be ambulatory
* Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
* signed informed consent must be obtained before any study-specific procedures

Exclusion Criteria:

* Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
* Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
* Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
* Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

Primary outcomes:
measure: Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
timeFrame: 8 years
measure: Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
timeFrame: 8 years
measure: Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8
timeFrame: 8 years
Secondary outcomes:
measure: Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8
timeFrame: 8 years
measure: Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8
timeFrame: 8 years
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.
Clinical trial NCT07010068: Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study
Official title: Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study - (TGF-NUTRIALLO Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malnutrition (Calorie)
Stem Cell Transplant Complications
Keywords: Stem Cell Transplant
malnutrution
gvhd
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open-label, randomized, multicentric, interventional TGF-β2-enriched supplementation (Modulen IBD ®) in patients submitted to allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Primary purpose: SUPPORTIVE_CARE

Brief summary: prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.


Eligibility criteria: Inclusion Criteria:

* Intact intestinal tract
* Life expectancy more than 12 weeks
* Allogeneic stem cell transplantation
* Signed informed consent

Exclusion Criteria:

* Active hematological disease at the beginning of conditioning
* Personal history of inflammatory bowel diseases
* Personal history of bowel resection
* Personal history of gastric bypass procedures
* Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome)
* Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD

Primary outcomes:
measure: Prevention
timeFrame: given from day -7 to day +28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asst Degli Spedali Civili Di Brescia
name: Enrico Morello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000268: Cocaine Abuse and Attention Deficit Disorder - 3
Official title: Cocaine Abuse and Attention Deficit Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York State Psychiatric Institute
First posted: 1999-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder

Detailed description: To evaluate the safety and efficacy of methylphenidate and bupropion in treating individuals with adult Attention Deficit Disorder.

Eligibility criteria: Inclusion Criteria:

current adult ADHD current cocaine dependence

Exclusion Criteria:

no current major depression

Primary outcomes:
measure: Side effects
measure: Craving
measure: Drug use
measure: ADHD symptoms
measure: Improvement in functioning
measure: Tolerability
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Herbert Kleber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131468: Prevention of Drug Induced Ototoxicity in Peritoneal Dialysis Patients by N-Acetylcysteine
Official title: The Evaluation of the Protective Effect of N-Acetylcysteine Against Drug Induced Ototoxicity in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug-induced Ototoxicity in Peritoneal Dialysis Patients
Keywords: ototoxicity
aminoglycoside
vancomycine
peritoneal dialysis
peritonitis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether N-acetylcysteine is effective in the prevention of hearing loss in both ears due to aminoglycoside and/or vancomycine induced ototoxicity in peritoneal dialysis patients.


Eligibility criteria: Inclusion Criteria:

* End-stage renal disease
* Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
* Clinical diagnosis of a peritonitis episode in a continuous ambulatory peritoneal dialysis patient
* Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode

Exclusion Criteria:

* Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
* Detection of mechanical occlusion of external ear
* Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
* History of a continuous ambulatory peritoneal dialysis related peritonitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University School of Medicine Department of Nephrology
Study officials:
affiliation: Erciyes University School of Medicine
name: Bulent Tokgoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tokgoz B, Ucar C, Kocyigit I, Somdas M, Unal A, Vural A, Sipahioglu M, Oymak O, Utas C. Protective effect of N-acetylcysteine from drug-induced ototoxicity in uraemic patients with CAPD peritonitis. Nephrol Dial Transplant. 2011 Dec;26(12):4073-8. doi: 10.1093/ndt/gfr211. Epub 2011 May 6.
Clinical trial NCT06102668: Survival and PN Dependence in SBS Patients
Official title: Long-term Survival and Parenteral Nutrition Dependence in Adult Patients With Non-malignant Short Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Lead sponsor: The First Affiliated Hospital of University of Science and Technology of China
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
First posted: 2023-10-26
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SBS caused by extensive bowel resection with a remnant small intestine length of \<200cm.

Brief summary: Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The objective of this study was to determine the longterm survival and parenteral nutrition dependence of adult patients with SBS.

Detailed description: Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. Patients with SBS often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. SBS can cause various metabolic and physiologic disturbances. Although parenteral nutrition is a life-saving measure for many patients with SBS, patients with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few studies have reported the survival and PN dependence in adult SBS patients in China.

Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with SBS.

Exclusion Criteria:

* age \<18 years; patients with active malignant tumors.

Primary outcomes:
measure: Survival
timeFrame: 2012/1/1-2019/1/1
measure: Parenteral nutrition dependence
timeFrame: 2012/1/1-2019/1/1
Secondary outcomes:
measure: Risk factors
timeFrame: 2012/1/1-2019/1/1
measure: Cause of death
timeFrame: 2012/1/1-2019/1/1
Other outcomes:
Locations:
Study officials:
affiliation: Jinling Hospital, China
name: JIANFENG GONG, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429468: A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Official title: A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.


Eligibility criteria: Inclusion Criteria:

* Males and females ages 19 to 55
* If female, must be of non-child bearing potential or practicing birth control
* Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)

Exclusion Criteria:

* Intolerance towards ethanol
* Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
* Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
* History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
* Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
* Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase

Primary outcomes:
measure: Standard pharmacokinetic assessments
measure: statistical, clinical and laboratory procedures
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Abbott
name: Rita Jain, MD
role: STUDY_DIRECTOR
References: