louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06404554: A Prediction Model of Anastomotic Stricture After Rectal Cancer
Official title: A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Rectal Cancer
Anastomotic Stenosis
Keywords: nomogram
rectal cancer
anastomotic stricture
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 1542
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who underwent anterior resection for rectal cancer at the Department of Gastrointestinal Surgery, Northern Jiangsu People's Hospital. All participants received radical treatment consistent with total mesorectal excision (TME) principles

Brief summary: Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.


Eligibility criteria: Inclusion Criteria:

1. pathological confirmation of rectal cancer;
2. eligibility for surgical intervention;
3. undergoing first rectal cancer surgery;
4. acquisition of written informed consent from patients and their families;
5. no history of hypertrophic scar or allergic predispositions.

Exclusion Criteria:

1. absence of postoperative follow-up or anastomosis details;
2. patients subjected to Hartmann or Miles procedures;
3. emergency surgery candidates due to conditions like perforation or obstruction;
4. diagnosis of multiple primary malignancies;
5. intraoperative discovery of widespread implant metastases within the abdominal cavity;
6. severe comorbidities;
7. anastomotic recurrence of rectal cancer;
8. patients who had undergone stapled hemorrhoidopexy

Primary outcomes:
measure: patients with anastomotic stricture
timeFrame: up to six months
measure: patients without anastomotic stricture
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yifan Cheng
state: Jiangsu
Study officials:
References:
Clinical trial NCT01519154: Sedation MRI - Propofol Versus Propofol-Ketamin in Children
Official title: Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation
Keywords: deep sedation
propofol
ketamine
child
preschool child
infant
recovery and quality of sedation
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 347
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Children \< 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are

1. propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h
2. propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h

both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow.

Hypothesis:

1. reduces recovery time compared to propofol mono sedation
2. combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation
3. combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono sedation


Eligibility criteria: Inclusion Criteria:

* MRT in deep sedation
* outpatient
* \> 3 months to \<= 10 years

Exclusion Criteria:

* tracheal intubation required
* contraindication of ketamine or propofol
* additional painful procedure requiring analgesics

Primary outcomes:
measure: Recovery time
timeFrame: 1 - 3 hours post anaesthesia
Secondary outcomes:
measure: Demission time
timeFrame: 1 - 4 hours post anaesthesia
measure: PONV
timeFrame: 24 hours
measure: Cerebral perfusion
timeFrame: first 10 minutes of MRI
measure: Incidence of emergence delirium
timeFrame: 1 - 4 hours post anaesthesia
measure: Quality of sedation
timeFrame: during MRI, on the average 45 minutes
measure: respiratory and cardiovascular adverse events
timeFrame: during sedation, on the average 60 minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Achim J Schmitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288754: Detection of Tumor DNA in Blood Samples From Cancer Patients
Official title: Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Tumors
Keywords: DNA in Tumors
cfDNA
WGS
Advanced stage cancer
Solid tumors
Lead sponsor: Lexent Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.

Brief summary: The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
* Starting treatment or a new line of treatment
* Able to understand and grant informed consent
* Able to have their blood drawn

Exclusion Criteria:

* Unable to grant informed consent or comply with all study procedures.
* Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia

Primary outcomes:
measure: Correlation between the tumor load score and patient response to therapies.
timeFrame: 5 years
Secondary outcomes:
measure: Determination of particular mutation events which underlie the basis of any established correlation with therapy response.
timeFrame: 5 years
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Cancer Care Associates
state: California
Study officials:
affiliation: Lexent Bio
name: Haluk Tezcan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535054: Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
Official title: An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Lead sponsor: Trima, Israel Pharmaceutical Products
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 125
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.


Eligibility criteria: Inclusion Criteria:

* Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
* Use artificial tears or any other treatment for these symptoms three or more times a day.

Exclusion Criteria:

* Known hypersensitivity to Phenoxyethanol.
* Pregnant and lactating women.
* Receive other ophthalmic medication (except for eyelid hygiene preparations).
* Graft-versus-host disease patients.
* Participated during the last month in another clinical trial.

Primary outcomes:
measure: Schirmer Test, Lissamine Green Test and BUT.
timeFrame: On enrollment and one month later.
Secondary outcomes:
measure: Questionaire
timeFrame: One, three and four weeks after treatment commencement.
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Department of Ophthalmology, Assaf Harofeh Medical Center,
Study officials:
affiliation: Department of Ophthalmology, Assaf Harofeh Medical Center,
name: David Zadok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. doi: 10.1055/s-2004-813715. German.
citation: Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. doi: 10.1055/s-2006-927266. German.
Clinical trial NCT01446354: Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery
Official title: Does the Intraoperative Thromboelastometry-guided Coagulation Management Reduce the Administration of Allogeneic Blood Products in Cardiac Surgery With the Help of Hypothermic Cardiac Arrest? A Retrospective Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Blood component transfusion
Hypothermic
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 200
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: Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest

Brief summary: Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

Detailed description: The investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of HCA from January 2009 to June 2011.

The investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. In addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

Eligibility criteria: Inclusion Criteria:

* Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011

Exclusion Criteria:

* none

Primary outcomes:
measure: Transfusion of allogeneic blood products
timeFrame: within 24 hours including surgery
Secondary outcomes:
measure: Proportion of patients without allogeneic blood products
timeFrame: 24 hours including surgery
measure: Adverse events
timeFrame: within 24 hours including surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Anesthesia and Intensive Care Medicine
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Daniel Bolliger, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06100354: Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.
Official title: Study of Patient Preferences in Relation to the Fitting of a Personalized and Connected Joint Prosthesis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prosthesis User
Orthopedic Disorder
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is the population that comes for consultation and needs a hip, knee or shoulder replacement.

Brief summary: The goal of this observational study is to learn about patients' preference toward the use of customized and connected prosthesis. The main questions it aims to answer are:

* What is the acceptability of new customization and connectivity technologies by patients?
* Are they all at the same level of acceptability?

Participants will have to answer to a questionnaire of choice.


Eligibility criteria: Inclusion Criteria:

* More than 18
* Non opposition expressed
* Should have a hip, knee or shoulder joint replacement

Exclusion Criteria:

* Opposition expressed
* Having already a hip, knee or shoulder joint prosthesis

Primary outcomes:
measure: Gathering preferences for a customized and connected prosthesis by Discrete choice analysis, and with a questionnaire called "Discrete Choice Experiment", based on RUT (Random Utility Theory).
timeFrame: 6 month
Secondary outcomes:
measure: Measuring the ease of use of new technologies through ATI (Affinity for Technology Interaction) scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalo Universitaire de Brest
state: Bretagne
Study officials:
affiliation: Centre Hospitalo Universitaire de Brest
name: Eric Stindel, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00164554: Fetal Alcohol Syndrome/ARND Research Consortion
Official title: Fetal Alcohol Syndrome/ARND Research Consortion-Oklahoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fetal Alcohol Syndrome
Keywords: treatment
control
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Oklahoma
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Children will receive comprehensive evaluations through the UOHSC ABC program The assessment for the child will include: medical issues (including medication), dysmorphic examination, intellectual assessment, academic achievement, language, and motor skills. This program will provide appropriate non-study services and referrals. Eligible families will be randomly assigned to treatment group or control group. Treatment group will receive Parent Child Interaction Therapy (PCIT). The Control group will receive standard referrals and services through the ABC program and the parent education/advocacy component of the project.

Detailed description: PCIT has been adapted by the applicant for group administration. The intervention will consist of 90-minute sessions of PCIT once a week for 14 weeks. During PCIT sessions parents and children will participate in activities that promote interactions. A behavior specialist who will be observing through a two-way mirror assists parents in development of appropriate behaviors and interaction techniques. Parents will be prompted by use of in-ear devices (i.e., bug in the ear). This intervention has been shown to be effective in other populations. For each family, individualized goals for parent-child interactions will be set and reviewed each session. Homework assignments also will be given.

Parent Component: Three 90-minute sessions conducted in a group format. Topics will include: FAS/ARND education, impact of FAS/ARND on families, specific development of a child with FAS/ARND, and FAS/ARND social skills and deficits.

Evaluation Plan: Treatment and control groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 6, 12, and 18-month follow-ups. Process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., behavior, family functioning, etc) measures will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Children ages 3 to 7 years

Primary outcomes:
measure: compliance with directives
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: John Mulvihill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05129553: Béa Applicator and Béa Cervical Cap Safety and Usability Study
Official title: Béa Applicator and Béa Cervical Cap Usability Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Safety and Usability
Lead sponsor: StepOne Fertility
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a Clinical Study Designed to Validate the Usability and Safety of the Over-the-counter (OTC) Béa Applicator and Béa Cervical Cap Device in a Home Use Environment.

Detailed description: Female participants will undergo a baseline physical assessment performed by a physician at the study site. The participants will then be given the Béa Applicator and Béa Cervical Cap device with accompanying instructions and a semen collection pot. The participants will return home to use the device as per the Instruction for Use (IFU). The Béa Cervical Cap will remain in place for a minimum of 4 hours and a maximum of 6 hours. At the follow-up assessment, the investigator will investigate all primary objectives via a physical exam or via questioning the participant.

Eligibility criteria: Inclusion Criteria:

* People who are able to and for whom it is medically safe to conceive
* Heterosexual couples and individuals, of any race or ethnicity, who are sexually active
* 18 - 40 years of age
* Trying to conceive
* Signed Informed Consent
* Approximately nineteen per cent (19%) of participants will present with a retroverted uterus as found in the general female population.

Exclusion Criteria:

* Vaginal prolapse (female)
* Hysterectomy (female)
* Erectile dysfunction (male)
* Diagnosis and/or treatment of vaginitis or sexually transmitted infection (STI) within the last month
* Colposcopy with biopsy surgery within the last three (3) months (female)
* Treatment for dysplasia surgery within the previous three (3) months (female)
* Vaginal/cervical surgery within the last three (3) months (female)
* Current pregnancy (female)
* Unable to read and understand English, as assessed by REALM
* Presence of noticeable lesions, open sores, viral warts, and any other genital abnormalities (female \& male)

Primary outcomes:
measure: Correctly place semen in the device
timeFrame: 0.5 hrs
measure: Correctly inserting the device into the vagina
timeFrame: 1 hrs
measure: Correctly positioning of the device over the cervical os
timeFrame: 4-6 hrs
measure: Correctly withdraw the device from the vagina
timeFrame: 4-6 hrs
measure: The device causes trauma or harm
timeFrame: 4-6 hrs
measure: Presence of semen in the cap
timeFrame: 4-6 hrs
measure: Correctly dispose of the used device after use
timeFrame: 4-6 hrs
measure: Correctly avoid sexual activity while the device is in place
timeFrame: 4-6 hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06532253: Long-term Safety Trial with NVDX3
Official title: Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Distal Radius Fractures
Degenerative Lumbar Spondylolisthesis
Lead sponsor: Novadip Biosciences
Sponsor class: INDUSTRY
Collaborators: name: PrimeVigilance
name: Data Investigation Company Europe (DICE)
First posted: 2024-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An study evaluating the long-term safety of all patients previously treated with NVDX3.

Detailed description: An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.

Eligibility criteria: Inclusion Criteria:

1. Patient being implanted with NVDX3.
2. Previously participated to one of the NVDX3 core clinical trials.
3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.

Exclusion Criteria:

No exclusion criteria are applicable.

Primary outcomes:
measure: Long-term safety of the NVDX3 implant
timeFrame: Between screening (V0) and 120 months post-core study (V10)
Secondary outcomes:
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
Study officials:
affiliation: Centre Hospitalier du Luxembourg
name: Torsten Gerich, MD
role: PRINCIPAL_INVESTIGATOR
References: