louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01252394: Correspondence of ScO2 and Cardiac Output in Hemodialysis
Official title: ScO2 and Cardiac Output - Correspondence Study in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis
Lead sponsor: Danish State Hospital
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients

Brief summary: The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.


Eligibility criteria: Inclusion Criteria:

Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology.

Exclusion Criteria:

Age below 18 years. Failure to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen E
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Dep. of Nephrology, Copenhagen University Hospital.
name: Soeren D Ladefoged, MD
role: STUDY_DIRECTOR
References:
citation: Cordtz J, Olde B, Solem K, Ladefoged SD. Central venous oxygen saturation and thoracic admittance during dialysis: new approaches to hemodynamic monitoring. Hemodial Int. 2008 Jul;12(3):369-77. doi: 10.1111/j.1542-4758.2008.00283.x.
Clinical trial NCT03918694: Vitamin C Supplement for Lumbar Spine Surgery
Official title: Vitamin C Supplementation for Lumbar Spine Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Surgery
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 55
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups: placebo and Vitamin C
Primary purpose: TREATMENT

Brief summary: By doing this study, researchers hope to learn effects of Vit C on lumbar spine surgery outcomes.

Detailed description: Lumbar spine surgeries are common procedures for management of low back pain and their prevalence is increasing. However, their outcomes are less than optimal.

An effective and inexpensive solution to minimizing surgical complications and expediting recovery following lumbar spine surgery could be supplementation using high doses of vitamin C, also known as ascorbic acid. Vit C can help reduce oxidative stress and inflammation and improve immune system and body's own chemicals to fight pain.

The researchers want to examine if Vit C is effective in decreasing pain and pain medications and improving function. Gaining a better understanding of effects of Vit C on patient recovery may lead to improved outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to have a lumbar spine fusion
* Can read and understand the English language
* BMI 35 or less

Exclusion Criteria:

* Patients taking certain medications
* lumbar spine laminectomy or discectomy
* taking a Vit C supplement
* pregnancy
* Cauda equine syndrome or spinal tumor
* neurological, neurodegenerative or cognitive issues
* renal pathology
* sickle cell anemia
* iron metabolism disorder

Primary outcomes:
measure: Recruitment feasibility outcome
timeFrame: up to 7 weeks
measure: Adherence feasibility outcome
timeFrame: up to 7 weeks
measure: Pain intensity: numeric rating pain scale
timeFrame: up to 7 weeks
measure: Pain medication consumption
timeFrame: up to 7 weeks
measure: Function
timeFrame: up to 7 weeks
measure: Would healing
timeFrame: up to 7 weeks
Secondary outcomes:
measure: Beck depression inventory
timeFrame: up to 7 weeks
measure: Vit C level
timeFrame: up to 7 weeks
measure: Beck anxiety inventory
timeFrame: up to 7 weeks
measure: 2011 Fibromyalgia (FM) survey
timeFrame: up to 7 weeks
measure: fatigue questionnaire
timeFrame: up to 7 weeks
measure: Pittsburg sleep scale
timeFrame: up to 7 weeks
measure: Pain catastrophizing scale
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Neena Sharma, PT, PhD, CMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890994: Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)
Official title: Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: MBI
Molecular Breast Imaging
Breast Cancer
DCIS
Breast
Calcifications
Microcalcifications
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients will be identified by the radiologist based on findings in their mammographic, ultrasound or MRI studies. Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study.

Brief summary: In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.

Detailed description: Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent \< 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.

Eligibility criteria: Inclusion Criteria:

* Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy.
* Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5).
* Women between 25 and 90 years of age.

Exclusion Criteria:

* Unable to understand or sign a consent form.
* Pregnant or lactating.
* Physically unable to sit upright and still for 30-40 minutes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dietlind L. Wahner-Roedler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282394: Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Official title: Newborn Abdominal Massage to Prevent Hyperbilirubinemia: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Newborn Jaundice
Keywords: newborn massage
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia


Eligibility criteria: Inclusion Criteria:

* Newborn admitted to the well newborn/postpartum care unit at UC Davis Medical Center
* Less than 48 hours of age at enrollment

Exclusion Criteria:

* Infant has already received phototherapy
* Mother/birthing person is incarcerated
* Infant unexpected to discharge into parental care
* Parental inability to speak or read in English
* Infant without parent rooming-in with them in the hospital

Primary outcomes:
measure: Acceptability of the newborn massage intervention
timeFrame: Through study completion, up to one year
measure: Feasibility of recruitment
timeFrame: Ascertained following completion of recruitment of 30 study participants. Through study completion, up to an average of one year.
Secondary outcomes:
measure: Difference between transcutaneous bilirubin level and AAP phototherapy threshold on the day of discharge
timeFrame: Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
measure: Number of stools in prior 24 hours (at hospital discharge)
timeFrame: Value at obtained at hospital discharge will be evaluated at the end of study completion, up to one year
measure: Timing of first transitional (non-meconium) stool passage
timeFrame: Ascertained at 1-2 week survey
measure: Parental satisfaction with newborn massage
timeFrame: 7-14 day survey
measure: Proportion of participants who read with baby in the last 24 hours
timeFrame: 1-2 week survey
measure: Proportion of participants who read with baby in the last week
timeFrame: 1-2 week survey
measure: Breastfeeding at 1 week of age
timeFrame: 1-2 week survey
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis
state: California
Study officials:
affiliation: UC Davis Health
name: Laura Kair, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535794: HPV Vaccine Acceptability Among Young Men Who Have Sex With Men
Official title: Exploring the Potential for Social Network Site-delivered Interventions to Increase HPV Vaccine Uptake Among Men Who Have Sex With Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Vaccine Attitudes
HPV Vaccine Intention
Keywords: HPV vaccine
acceptability
males
men who have sex with men
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-02-20
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be an internet-based, cross-sectional study targeting all US profiles of two separate online social/sexual networking communities of YMSM. A recruitment email will be sent internally to all active US profiles for men 18-26 years old.

Brief summary: The FDA has recently approved Gardasil for the prevention of anal cancer in people aged 9-26. Men who have sex with men (MSM) have disproportionately high rates of anal cancer and could benefit greatly from vaccination. Vaccine uptake among young MSM (YMSM) is poor, and little is known about factors associated with vaccine acceptance in this population. With the risk of anal cancer among MSM higher than the risk of cervical cancer among women before routine cytological screening was introduced, acceptance of a prophylactic vaccine in this subgroup is the most cost-effective and attainable strategy to greatly reduce the prevalence of anal cancer. While the investigators can assume the human papillomavirus (HPV) vaccine has many acceptable concepts among these men, there are multiple barriers which may potentially interfere with their likelihood of initiating the vaccine series. Vaccine catch-up rates among women of a similar age has been poor, and there is no reason to expect this to be higher among men. One potential strategy to increase vaccine uptake in this catch-up group is to implement a patient-driven program to promote vaccination among men.

This project will contribute to the investigators understanding of how the investigators can utilize social networks to identify barriers to HPV vaccination among YMSM, and how to potentially influence a patient-driven vaccination effort to increase uptake among men in the catch-up age group. This research will inform future interventions to targeted populations that may be incorporated into online social networking websites to encourage HPV vaccination.


Eligibility criteria: Inclusion Criteria:

* 18-26 years old
* male

Exclusion Criteria:

* younger than 18 years old
* older than 26 years old
* female

Primary outcomes:
measure: HPV vaccine acceptability
timeFrame: Spring 2012
Secondary outcomes:
measure: Attitudes towards HPV vaccination
timeFrame: Spring 2012
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References:
Clinical trial NCT05797194: The Association Between SIRI and POD in Older Patients
Official title: The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Elderly
Surgery
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 116
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients were scheduled to undergo elective orthopedics surgery under spinal anesthesia with an expected hospital stay of at least 3 days and received postoperative patient- controlled analgesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The confusion assessment method (CAM) questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.

Brief summary: Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.


Eligibility criteria: Inclusion Criteria:

* Hospital stay of at least 3 days
* More than or equal to 65 years old
* Elementary education or above
* Able to communicate
* American Society of Anesthesiologists (ASA) physical status I-III
* Mini-mental State Examination (MMSE) scores ≥ 22 points

Exclusion Criteria:

* Preoperative delirium
* Severe mental diseases
* Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies

Primary outcomes:
measure: Confusion assessment method (CAM) score
timeFrame: Baseline (Before surgery)
measure: CAM score
timeFrame: Postoperative day 1
measure: CAM score
timeFrame: Postoperative day 2
measure: CAM score
timeFrame: Postoperative day 3
Secondary outcomes:
measure: The level of systemic inflammation response index (SIRI) in peripheral blood.
timeFrame: Baseline (Before surgery)
measure: Mini-mental State Examination (MMSE) score
timeFrame: Baseline (Before surgery)
measure: MMSE score
timeFrame: postoperative day 1
measure: MMSE score
timeFrame: postoperative day 3
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02193594: Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Official title: Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastroesophageal Junction Adenocarcinoma
Keywords: Preoperative concurrent chemoradiotherapy
Neoadjuvant chemoradiotherapy
Gastroesophageal junction adenocarcinoma
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
name: Peking University People's Hospital
name: Beijing Friendship Hospital
First posted: 2014-07-17
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the gastroesophageal junction.
* Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
* Eastern Cooperative Oncology Group (ECOG) performance status≤2.
* Informed consent obtained.

Exclusion Criteria:

* Combined with other malignant tumors.
* Eastern Cooperative Oncology Group (ECOG) performance status\>2.
* Combined with severe organ dysfunction.
* Pregnancy

Primary outcomes:
measure: The patient's survival time and recurrence time
timeFrame: Up to 3 years
Secondary outcomes:
measure: The number of patients with complications
timeFrame: Within 30 days after the day of operation
Other outcomes:
measure: The pathologic profiles and the pathologic response rates
timeFrame: Within 30 days after the day of operation
Locations:
city: Haidian District
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jiafu Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636294: Borderline COVID-19 PCR Test Result
Official title: Follow-up of Patients With a Borderline COVID-19 PCR Test Result
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Virus
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Ambulant (majority)
* Hospital personnel
* Hospitalized patients

Brief summary: Follow-up of patients with a borderline PCR result. Data of patients that were re-tested within 96 hours after receiving a borderline COVID-19 PCR result are reviewed.

This is a retrospective study.


Eligibility criteria: Inclusion Criteria:

* Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.

Exclusion Criteria:

* Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.

Primary outcomes:
measure: Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.
timeFrame: 3 days
Secondary outcomes:
measure: Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.
timeFrame: 1 day
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Clinical Laboratory Jessa Hospital
state: Limburg
Study officials:
References:
citation: Boeckmans J, Cartuyvels R, Hilkens P, Bruckers L, Magerman K, Waumans L, Raymaekers M. Follow-up testing of borderline SARS-CoV-2 patients by rRT-PCR allows early diagnosis of COVID-19. Diagn Microbiol Infect Dis. 2021 Jun;100(2):115350. doi: 10.1016/j.diagmicrobio.2021.115350. Epub 2021 Feb 18.
Clinical trial NCT01669694: Pelvic Floor Physical Therapy-Biomarkers Project
Official title: Women's Urology Center-Physical Therapy-Biomarkers Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Pain
Keywords: Pelvic Pain
Pelvic Floor Physical Therapy
Biomarkers
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.

Brief summary: This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.

Detailed description: Collection points will be baseline, and at the last PT visit.

Eligibility criteria: Inclusion Criteria:

* Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.

Exclusion Criteria:

* all others

Primary outcomes:
measure: The change in biomarkers pre- and post-pelvic floor PT
timeFrame: pre- and post- pelvic floor PT
Secondary outcomes:
measure: Evaluation of biomarkers in relation to clinical findings
timeFrame: pre- and post- pelvic floor PT
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Women's Urology Center
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Donna J Carrico, NP, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: STUDY_CHAIR
References: