louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06357000: Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes
Official title: Association Between Time From PCI to Cancer Surgery and Cardiovascular and Oncologic Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cancer
Keywords: Time
Percutaneous coronary intervention
Cancer surgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 3621
Sex: ALL
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: Early-stage cancer patients who underwent PCI before the cancer surgery.

Brief summary: To evaluate the association between time from PCI to cancer surgery and cardiovascular and oncologic outcomes in early-stage cancer patients, A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.

Detailed description: Early-stage-cancer patients with a history of PCI who underwent cancer surgery (N = 3621) were included. The patients were divided into two groups based on the time between the dates of PCI and cancer surgery (\&lt;12 months and ≥12 months). Patients were stratified into early-surgery and late-surgery, defined as patients who underwent surgery ≥1 and \&lt;1 month after cancer diagnosis. Outcomes included bleeding, spontaneous myocardial infarction (MI), repeat revascularization, cancer recurrence, and death.

Eligibility criteria: Inclusion Criteria:

* men and women aged ≥18 years who were diagnosed with cancer and underwent cancer surgery within 1 year following diagnosis.
* patients who underwent PCI (procedure code: M6551-M6572, O1640-O1649, OA640-OA649) prior to the cancer surgery

Exclusion Criteria:

* participants who received neoadjuvant or adjuvant treatment for cancer

Primary outcomes:
measure: Occurence of Bleeding
timeFrame: up to 5 years
Secondary outcomes:
measure: Occurence of Spontaneous myocardial infarction
timeFrame: up to 5 years
measure: Occurence of Repeat revascularization
timeFrame: up to 5 years
measure: Occurence of Cancer recurrence
timeFrame: up to 5 years
measure: Occurence of All cause death
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01571700: Investigation of Dysynchrony in Patients With Pulmonary Hypertension
Official title: Investigation of Dysynchrony in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Hypertension
Keywords: Mechanical Dysynchrony
Electrical Dysynchrony
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be approached during their routine pulmonary hypertension clinic visit.

Brief summary: The purpose of the study is to determine whether patients with pulmonary hypertension (PH) have dysynchrony, and if so whether it is electrical or mechanical. Once this has been determined, during a catheterization the investigators will test if pacing the heart improves blood circulation.

Detailed description: This is a two part study of ventricular dysynchrony in patients with pulmonary hypertension. The first part is an observational study, reviewing routinely obtained clinical information (such as echocardiograms) to assess whether patients with pulmonary hypertension have electrical or mechanical dysynchrony. If so, we will proceed to the second part of the study which will assess whether temporarily pacing the right ventricle, during a clinically indicated catheterization can acutely improve hemodynamics. We will also gather control data for phase 1 from clinically indicated echos and ECG's in patients with ASD's (RV volume load) and in patients who are evaluated for an innocent murmur ( Nl heart). We hope to learn whether patients with pulmonary hypertension, and compromised right ventricles have electrical and mechanical dysnchrony. If this is true, it is theoretically possible that resynchronization (pacing) of the right ventricle could improve hemodynamics, symptoms and long term outcomes.

Eligibility criteria: Inclusion Criteria:

* Pulmonary artery mean pressure at rest of 25 mm Hg
* Controls (for phase 2) Patients undergoing transcatheter closure of secundum ASD Patients undergoing echocardiogram and ECG as part of work-up for functional murmur who have normal intracardiac anatomy

Exclusion Criteria:

* Reversible cause of pulmonary hypertension
* Age \< 5 yrs (for phase 2)

Primary outcomes:
measure: Electrical or Mechanical Dysynchrony
timeFrame: Open
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stan
name: Jeffrey Feinstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220400: Ketamine Prevent POCD
Official title: Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrosis of Femoral Head
Knee Osteoarthritis
Keywords: Postoperative cognitive dysfunction
Ketamine
Surgery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 484
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. In present study investigators hypothesized that low dose ketamine would prevent the cognition decline after orthopedic surgery in aged patients.


Eligibility criteria: Inclusion Criteria:

* Elder than 60
* Easily communicated with Chinese
* Selected to kneel or hip replacement
* Agree to take part into this clinical trail

Exclusion Criteria:

* Existing cerebral disease， or have a history of neurological and psychiatric disease including AD, stroke and psychosis
* Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
* Several audition or vision disorder
* Preoperative systolic Blood pressure over 190mmHg or diastolic pressure \>100mmHg
* Existing a history of hyperthyroidism
* Patient with glaucoma
* Unwillingness to comply with the protocol or procedures

Primary outcomes:
measure: Short-term cognitive changes after surgery
timeFrame: The day before surgery and 7 days after surgery (or before leave hospital)
measure: Long-term cognitive changes after surgery
timeFrame: The day before surgery and 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01766700: The Role of No-Calorie Beverages Within a Weight Loss Program
Official title: The Role of No-Calorie Sweetened Beverages Within a Weight Loss Behavior Change Program and During Subsequent Weight Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity, weight loss, weight maintenance
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Temple University
First posted: 2013-01-11
Enrollment: 308
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The no calorie drink study is looking for over 300 people to participate. The study is evaluating the effect of no calorie beverages on weight loss and weight maintained over time in people who drink diet beverages every day as compared to water only drinkers during the 1 year study period.

Detailed description: This investigation aims to test the hypothesis that the amount of weight lost and maintained over time in an intensive behavioral weight management program will be equivalent in subjects consuming beverages containing no calorie sweeteners as compared to water beverages.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index: 27 - 40 kg/m2
* Must drink no calorie, sweetened drinks

Exclusion Criteria

* Cardiovascular disease
* Uncontrolled blood pressure
* Smoker
* Medications that affecting metabolism
* Oral steroids
* History of stroke or seizures
* Thyroid disease
* Type 1 or 2 diabetes
* Cushings syndrome
* Renal disease
* Liver disease
* Cancer in the past 5 years
* HIV
* Active tuberculosis
* Major psychiatric disorders

Primary outcomes:
measure: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks.
timeFrame: Data will be measured at 12 weeks.
Secondary outcomes:
measure: This investigation is an equivalency trial to determine whether weight lost and maintained during the 1 year study differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers.
timeFrame: Data will be collected at end of study.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Health and Wellness Center
state: Colorado
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: University of Colorado, Denver
name: James Hill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Gary Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters JC, Wyatt HR, Foster GD, Pan Z, Wojtanowski AC, Vander Veur SS, Herring SJ, Brill C, Hill JO. The effects of water and non-nutritive sweetened beverages on weight loss during a 12-week weight loss treatment program. Obesity (Silver Spring). 2014 Jun;22(6):1415-21. doi: 10.1002/oby.20737.
Clinical trial NCT01803100: Characterizing and Comparing the Profile of Microorganisms From Specific Body Sites and Environmental Surfaces in Newly Disinfected Patient Rooms
Official title: Study of the Temporal Profile and Bi-directional Transmission of Microorganisms Between Patients and Environmental Surfaces.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Keywords: Bacterial Colonization
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Durham VA Medical Center
First posted: 2013-03-04
Enrollment: 80
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: The cohort will be selected from hospitalized inpatients who are admitted into freshly-cleaned patient rooms and provides consent to participate in this study.

Brief summary: Overall Aim: To describe and to assess the change in the temporal profile and transmission of microorganisms between patients and environmental surfaces after admission into a newly disinfected room.

Study Activities: Investigators will prospectively and concurrently perform microbiological sampling of body sites (nose, throat, axillae, perineal and wounds) high touch surfaces (e.g. bedside rail, bed surface, toilet seat, IV pump and tray table) for consented adult patients admitted to freshly cleaned patient rooms. The microbiological sampling of body sites is already performed in many units of the hospital as standard of care. Infection and readmission related data from enrolled patients will be collected for upto 1 year after enrollment.

Data analysis: Standard surveillance for hospital-acquired infections will be performed by the infection control group of the hospital. The identity and the nature of micro-organisms colonizing the high touch surfaces of rooms and of patient's body sites will be determined and compared. Risks involved is no more than minimal risk.


Eligibility criteria: Inclusion Criteria:

* Eligible patients who provide informed consent.

Exclusion Criteria:

* Pediatric patients under 18 years of age,
* Patients who cannot or do not provide consent

Primary outcomes:
measure: Changes in the Profile of Epidemiologically-Important Organism
timeFrame: Day 3, 7 and each week after enrollment
Secondary outcomes:
measure: Time to Change in the Profile of Epidemiologically Important Organism
timeFrame: Day 3, 7 and each week after enrollment
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Luke Chen, MBBS MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578900: Quality of Life and Sjögren Syndrome
Official title: Quality of Life in a Portuguese Population With Primary Sjögren Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Xerostomia
Hyposalivation
Quality of Life
Sjogren's Syndrome
Keywords: Xerostomia
Hyposalivation
Quality of Life
Sjogren's Syndrome
Lead sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
Sponsor class: OTHER
Collaborators: name: University of Lisbon
name: Portuguese Institute of Rheumatology
name: Dentaid SL
First posted: 2018-07-06
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aims of this study are: To compare salivary pH changes and stimulation efficacy of two different Gustatory Stimulants of Salivation (GSSS) in patients with Primary Sjögren Syndrome (PSS); To evaluate Primary Sjögren syndrome (PSS) impact and gustatory stimulants of salivary secretion (GSSS) on oral health related quality of life measured by a Portuguese version of Oral Health Impact Profile-14 (OHIP-14) and specific Xerostomia assessment questionnaires.

The Products to be used are the Xeros® Dentaid system and a citric based mouthwash.


Eligibility criteria: Inclusion Criteria:

* unstimulated whole saliva secretion rate \< 0.1 ml/min
* stimulated whole saliva secretion rate \> 0.2 ml/min
* above 18 years of age
* Primary Sjogren Syndrome diagnostic according to the European-American Consensus Group

Exclusion Criteria:

* wearer of complete dental prosthesis
* those who were pregnant or lactating
* non-speakers of Portuguese.

Primary outcomes:
measure: Time of GSSS induced pH drop below 4.5
timeFrame: 20 minutes
measure: Overall and sub domains scores for each questionnaire
timeFrame: 15 days
Secondary outcomes:
measure: Salivary stimulant induced salivary flow
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03663400: Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples
Official title: Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18-70 with moderate to severe ulcerative colitis defined as a total mayo score between 6 and 12, and an endoscopic subscore of 2 or 3.

Brief summary: This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.


Eligibility criteria: Inclusion Criteria:

* Total mayo score between 6 and 12
* Endoscopic subscore of 2 or 3

Exclusion Criteria:

* Recent use of antibiotic therapy (\<4 weeks)
* Current extreme diet (parenteral nutrition, specific carbohydrate diet).
* Active infection or malignancy.
* Significant underlying liver or renal disease.

Primary outcomes:
measure: GWAS analysis pretreatment
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Hudesman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03642600: The Gut Microbiome in Women With Polycystic Ovary Syndrome
Official title: Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Obesity
Metabolic Syndrome
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are:

* dietary advice plus myo-inositol and folic acid
* dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions.

Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment.


Eligibility criteria: Inclusion Criteria:

* PCOS according to ROtterdam criteria
* BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2

Exclusion Criteria:

* pregnancy
* pancreatitis (in the past)
* oral contraceptive pill use
* inflammatory bowel disease
* auto-immune disease
* immuno-modulatory drugs
* antidiabetic drugs
* anti-inflammatory drugs

Primary outcomes:
measure: weight loss
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Sharon Lie Fong
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Sharon Lie Fong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088100: Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery
Official title: The Correlation Between Certain Clock-gene Genotypes and POCD (Post-operative Cognitive Dysfunction)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genotype
Cognitive Impairment
Keywords: POCD
clock-gene genotypes
HPER3
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 279
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out of the 976 patients included in the ISPOCD2 study (Abildstrom H, Christiansen M et al. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology 2004;101:855-61)100 patients with POCD whose blood samples are stored will be included together with 100 controls (without POCD), who will be matched by type of surgery, age and sex.

Brief summary: The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5 genotype carries a higher risk of post-operative cognitive dysfunction.


Eligibility criteria: Inclusion Criteria:

* patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia

Exclusion Criteria:

* daily use of major tranquilizers or antipsychotic medication
* known disease of the CNS
* score less than 24/30 points in MMSE

Primary outcomes:
measure: HPER3 genotype
timeFrame: 3 months
Secondary outcomes:
measure: Post-operative morbidity
timeFrame: ½ year
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital - Gastro unit
Study officials:
affiliation: Herlev Hospital
name: Melissa V Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abildstrom H, Christiansen M, Siersma VD, Rasmussen LS; ISPOCD2 Investigators. Apolipoprotein E genotype and cognitive dysfunction after noncardiac surgery. Anesthesiology. 2004 Oct;101(4):855-61. doi: 10.1097/00000542-200410000-00009.
citation: Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.
citation: Voigt Hansen M, Rasmussen LS, Jespersgaard C, Rosenberg J, Gogenur I. There is no association between the circadian clock gene HPER3 and cognitive dysfunction after noncardiac surgery. Anesth Analg. 2012 Aug;115(2):379-85. doi: 10.1213/ANE.0b013e318253d6b3. Epub 2012 Apr 27.