louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04489394: Quintex® Follow-up After One Year Minimum
Official title: Prospective Follow-up Study of the Aesculap Quintex® Anterior Cervical Plating System After a Minimum of One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Spondylolisthesis
Trauma
Spinal Stenosis
Deformity of Spine
Pseudoarthrosis of Spine
Cervical Spondylosis
Instability; Back
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-07-28
Enrollment: 60
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: adult patients

Brief summary: Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the first thoracolumbar VBR (C2-T1), who received a Quintex plate for stabilisation


Eligibility criteria: Inclusion Criteria:

- all patients who received a Quintex® Anterior Cervical Plate since 2014 until approx. end 2018 (minimum Follow-up is one year) in the study center

Exclusion Criteria:

* Patient informed consent not signed
* Patients living outside a radius of 80 km around the study center

Primary outcomes:
measure: Clinical Results measured by Neck Disability Index (NDI)
timeFrame: One retrospective visit, between one and approx. five years post-op.
Secondary outcomes:
measure: Neck and arm pain
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Patient satisfaction
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Quality of life measured by EQ-5D-5L
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Dysphagia assessment
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Complications
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Postoperative Need for Pain medication
timeFrame: One retrospective visit, between one and approx. five years post-op.
measure: Radiological outcome from standard x-rays
timeFrame: One retrospective visit, between one and approx. five years post-op.
Other outcomes:
Locations:
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
Study officials:
References:
citation: Bruchmann B, Kilian F. Follow-up of a new titanium cervical plate for fusion of the cervical spine. Orthop Rev (Pavia). 2023 Oct 12;15:84651. doi: 10.52965/001c.84651. eCollection 2023.
Clinical trial NCT06491394: Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats
Official title: Effect of Lactoferrin Administration on Rhabdomyolysis-induced Heart and Kidney Injury in Rats
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rhabdomyolysis
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 24
Sex: MALE
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?
2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?


Eligibility criteria: Inclusion Criteria:

* • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g

Exclusion Criteria:

* No exclusion criteria as this study is used to detect effects of drugs on experimental rats.

Primary outcomes:
measure: Nrf2 expression
timeFrame: 2 months
measure: AMPK levels
timeFrame: 2 months
measure: HO-1 levels
timeFrame: 2 months
Secondary outcomes:
measure: iron levels
timeFrame: 2 months
measure: MDA levels
timeFrame: 2 months
measure: TAC levels
timeFrame: 2 months
measure: GSH levels
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01321294: Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Laparoscopic Antireflux Surgery
Lead sponsor: General Public Hospital Zell am See
Sponsor class: OTHER
First posted: 2011-03-23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gastroesophageal reflux disease
* Long history of GERD symptoms
* Persistent or recurrent symptoms despite optimal medical treatment
* Persistent or recurrent complications of GERD
* Reduced quality of life owing to increasing esophageal exposure to gastric juice
* Pathological values in the preoperative evaluated functional parameters

Exclusion Criteria:

* Previous esophageal or gastric surgery
* Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV)
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zell am See
country: Austria
facility: General Public Hospital Zell am See
state: Salzburg
Study officials:
References:
citation: Koch OO, Kaindlstorfer A, Antoniou SA, Luketina RR, Emmanuel K, Pointner R. Comparison of results from a randomized trial 1 year after laparoscopic Nissen and Toupet fundoplications. Surg Endosc. 2013 Jul;27(7):2383-90. doi: 10.1007/s00464-013-2803-0. Epub 2013 Jan 30.
Clinical trial NCT02603094: Gastric pH in Intubated Children - Part Two
Official title: Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Fasting
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk

Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction


Eligibility criteria: Inclusion Criteria:

age \> 1 / \< 16 years ASA class l or ll elective surgery requiring general anaesthesia using tracheal intubation

Exclusion Criteria:

disease or dysfunction of gastrointestinal tract chronic diseases or conditions not compatible with ASA class l or ll

Primary outcomes:
measure: gastric pH
timeFrame: within 10 min after tracheal intubation
Secondary outcomes:
measure: gastric aspirate volume
timeFrame: within 10 min after tracheal intubation
measure: subjective feeling of hunger/thirst
timeFrame: baseline
measure: Postoperative Nausea and Vomiting (PONV) in recovery unit
timeFrame: recovery period, on the average within 90 minutes after end of anaesthesia
measure: Behaviour during recovery period
timeFrame: recovery period, on the average within 90 minutes after end of anaesthesia
measure: Behaviour during anaesthesia induction
timeFrame: on the average within 20 minutes after arrival of patient in operating theatre
measure: Nurse's Impression of patient's satisfactory
timeFrame: baseline
measure: blood Ketone measurement
timeFrame: intraoperative
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Childrens Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Achim J Schmitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt AR, Buehler KP, Both C, Wiener R, Klaghofer R, Hersberger M, Weiss M, Schmitz A. Liberal fluid fasting: impact on gastric pH and residual volume in healthy children undergoing general anaesthesia for elective surgery. Br J Anaesth. 2018 Sep;121(3):647-655. doi: 10.1016/j.bja.2018.02.065. Epub 2018 May 3.
Clinical trial NCT00849394: Evaluation of Protein in the Urine in Patients Receiving Bevacizumab
Official title: An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectal Cancer
Keywords: bevacizumab
proteinuria
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2009-02-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 106 patients receiving bevacizumab doses of \< 10 mg/kg at a rate of 0.5 mg/kg/min in hematology/oncology outpatient clinic. Most of the patients are likely to have advanced stage colon or rectal cancer.

Brief summary: This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years older
* Patients must be receiving his/her first dose of bevacizumab
* Patients must sign an informed consent

Exclusion Criteria:

* Patients receiving \> 10 mg/kg doses of bevacizumab

Primary outcomes:
measure: To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.
timeFrame: 3-6 months
Secondary outcomes:
measure: To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria.
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center School of Pharmacy
name: Sachin Shah, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04914494: Cancer Predictive Score on Breast MRI
Official title: Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Women imaging
Diagnostic Imaging
Magnetic Resonance Imaging
Breast biopsy
Breast cancer detection
predictive factors
Radiology
Breast lesion diagnosis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 428
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 to 50 years old

Brief summary: Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.

The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.


Eligibility criteria: Inclusion criteria:

* women aged 18 and more
* performed MRI-guided breast biopsy

Exclusion criteria:

- Not MRI-guided breast biopsy

Primary outcomes:
measure: Number of participants with MRI characteristics of breast lesions
timeFrame: 1 day
Secondary outcomes:
measure: predictive score for the benignity of lesions seen on MRI
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Patrice TAOUREL, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04309994: Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction
Official title: Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Attack
Cardioplegia Solution Adverse Reaction
Coronary Artery Bypass Grafting (CABG)
Keywords: heart attack
cardioplegia solution
Minimal extracorporeal circulation system (MiECC)
Myocardial protection system (MPS)
Coronary artery bypass grafting (CABG)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients which underwent isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system) at the department of cardial surgery University Hospital Basel Switzerland

Brief summary: The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent a CABG using MPS® or Cardioplexol ®
* Heart attack less than 7 days before surgery

Exclusion Criteria:

* use of other cardioplegia solution than Cardioplexol ® or MPS®
* other inventions than CABG
* explicit will of the patient that his data may not be used
* denied general consent

Primary outcomes:
measure: myocardial damage
timeFrame: patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)
Secondary outcomes:
measure: 30 days Mortality
timeFrame: 30 days after CABG
measure: length of stay in the intensive care unit
timeFrame: perioperative during hospital stay for CABG (for approximately 15 days)
measure: Number of participants with bleedings
timeFrame: perioperative during hospital stay for CABG (for approximately 15 days)
measure: Number of participants with postoperative arrhythmia
timeFrame: perioperative during hospital stay for CABG (for approximately 15 days)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Cardiac Surgery Clinic University Hospital Basel
Study officials:
affiliation: Cardiac Surgery Clinic, University Hospital Basel
name: Oliver Reuthebuch, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06128291: Concomitant Posterior Colporrhaphy on Bowel Functions in Pelvic Organ Prolapse Repair
Official title: The Impact of Concomitant Posterior Colporrhaphy on Bowel Functions in Women Who Received Pelvic Organ Prolapse Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse; Female
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 283
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

Brief summary: Compare the changes of preoperative and postoperative posterior colporrhaphy.

Detailed description: Introduction:

Concomitant posterior colporrhaphy was frequently used during pelvic organ prolapse repair.

Objectives:

To evaluate the correlation between the presence of bowel symptoms and s rectocele severity and elucidate the impact of posterior colporrhaphy on bowel functions.

Methods:

Medical records of all consecutive women who received concomitant posterior colporrhaphy for their pelvic organ prolapse repairs were reviewed. In general, all women were requested to answer bowel incontinence assessment questionnaires before and after surgery.

Possible results:

Differences in rectocele severities between the presence or absence of fecal incontinence, flatus incontinence, constipation, diarrhea or sensation of residual stool will be shown.

Eligibility criteria: Inclusion Criteria:

* women with pelvic organ prolapse planned to receive concomitant posterior colporrhaphy

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Number of participants with fecal incontinence
timeFrame: before the operation, postoperative one month and three months.
measure: Number of participants with flatus
timeFrame: before the operation, postoperative one month and three months.
measure: Number of participants with constipation
timeFrame: before the operation, postoperative one month and three months.
measure: Number of participants with diarrhea
timeFrame: before the operation, postoperative one month and three months.
measure: Number of participants with sensation of residual stool
timeFrame: before the operation, postoperative one month and three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034891: Women At Risk: The High Risk Breast Cancer Program
Official title: Women At Risk: The High Risk Breast Cancer Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: BRCA mutation
benign breast disease
family history of breast cancer
strong family history of breast cancer
atypical ductal hyperplasia
atypical lobular hyperplasia
high risk for breast cancer
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
Collaborators: name: Women At Risk
First posted: 2009-12-18
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of the breast center at New York Presbyterian Hosptial/ Columbia University Medical Center

Brief summary: The purpose of this study is to increase understanding of women who are at high risk for developing breast cancer. Data from this group will be collected and entered into a registry. This registry serves as a clinical database to support research in prevention, early detection and treatment of breast cancer.

Detailed description: This is a longitudinal cohort study that collects data of eligible women at risk for developing breast cancer. Patient information will be entered into a secured computerized database that is used for research on the prevention, early detection and treatment of breast cancer.

Eligibility criteria: Inclusion Criteria:

* one or more first-degree relatives (mother, daughter, or sister) with pre-menopausal breast cancer
* two or more first-degree relatives with post-menopausal breast cancer
* tested positive for a BRCA1 or BRCA2 mutation
* a history of biopsy-proven atypical ductal hyperplasia or atypical lobular hyperplasia
* a history of biopsy-proven lobular neoplasia (lobular carcinoma in situ)

Exclusion Criteria:

* DCIS (ductal carcinoma in situ)
* previous diagnosis of breast cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Women At Risk, Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Women At Risk, Weill Cornell
state: New York
Study officials:
affiliation: Columbia University/New York Presbyterian Hospital
name: Kathie-Ann Joseph, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chun J, Pocock B, Joseph KA, El-Tamer M, Klein L, Schnabel F. Breast cancer risk factors in younger and older women. Ann Surg Oncol. 2009 Jan;16(1):96-9. doi: 10.1245/s10434-008-0176-8. Epub 2008 Nov 1.
Clinical trial NCT04057391: Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography
Official title: Understanding Patient Experience and Preferences for the QT Scanner Compared to Mammography
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Breast Cancer Screening
Lead sponsor: QT Ultrasound LLC
Sponsor class: INDUSTRY
Collaborators: name: Analysis Group, Inc.
First posted: 2019-08-15
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study target population are women who have experience with both the QT Scanner and mammography.

Brief summary: This study aims to characterize patient experience, satisfaction and preference for use of the QT Scanner in comparison to mammography by directly engaging women who have experience with both technologies.

Detailed description: The objectives will be addressed by first conducting structured one-on-one interviews with about 20 women (Qualitative Phase), and then administering a web-based patient survey with quantitative measurements in about 200 women (Quantitative Phase). The current Protocol registration pertains to the first, qualitative phase of the study.

Eligibility criteria: Inclusion Criteria:

* Have used the QT Scanner
* Have used mammography
* Speak English
* Willing to provide consent and participate in the survey

Exclusion Criteria:

• Excluded if all Inclusion Criteria are not met

Primary outcomes:
measure: Qualitative phase: structured one-on-one interviews
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Analysis Group, Inc.
state: Massachusetts
Study officials:
References:
citation: Acquadro C, Berzon R, Dubois D, Leidy NK, Marquis P, Revicki D, Rothman M; PRO Harmonization Group. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health. 2003 Sep-Oct;6(5):522-31. doi: 10.1046/j.1524-4733.2003.65309.x.
citation: Blumen H, Fitch K, Polkus V. Comparison of Treatment Costs for Breast Cancer, by Tumor Stage and Type of Service. Am Health Drug Benefits. 2016 Feb;9(1):23-32.
citation: Johnson FR, Zhou M. Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective. Value Health. 2016 Sep-Oct;19(6):741-745. doi: 10.1016/j.jval.2016.04.008.