louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06655285: The Impact of Inflammatory Adhesion on the Prognosis of Colon Cancer Patients
Official title: The Impact of Tumor-associated Inflammatory Adhesion on the Prognosis of Colon Cancer Patients: a Study Based on the SEER and Chinese Multi-center Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Colon Cancer
Prognosis
Tumor-associated inflammatory adhesion
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study utilized the Chinese multi-center database as well as the SEER 17 registries database. The Chinese multi-center database contains data of patients between January 2010 and December 2021, at 3 institutions. SEER\*Stat software (version 8.4.1.1) was used for collecting 17 registries cohort data on patients diagnosed with NMIBC between 2010 and 2019.

Brief summary: The purpose of this study is to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients.

Detailed description: In some colon cancer patients, although adhesions between the tumor tissue and surrounding organs are found during surgery, postoperative pathology confirms that the tumor has not directly invaded the adhered organs; instead, the adhesions are caused by tumor-associated inflammation. This condition is defined as tumor-associated inflammatory adhesion.

Currently, the impact of tumor-associated inflammatory adhesion on patient prognosis is still unclear. This study aims to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients through the Surveillance, Epidemiology, and End Results (SEER) and Chinese multi-center databases.

Eligibility criteria: Inclusion Criteria:

1. The patient was pathologically diagnosed as colon adenocarcinoma by endoscopic biopsy before operation.
2. All patients were considered to have tumors invading adjacent organs during surgery
3. All patients underwent radical surgery.

Exclusion Criteria:

1. Patients with distant metastasis, recurrent colon cancer and pT4b CRC were excluded.

Primary outcomes:
measure: Overall survival time (OS)
timeFrame: up to 10 years
measure: Cancer-specific survival time (CSS)
timeFrame: up to 10 years
measure: Recurrence free survival time (RFS)
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT04143685: Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
Official title: Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prelabor Rupture of Membranes
Premature Rupture of Membrane
Keywords: PROM
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

Detailed description: Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.

This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Eligibility criteria: Inclusion Criteria:

* Women in their 1st - 4th delivery
* Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
* Vertex presentation
* Singleton pregnancy

Exclusion Criteria:

* Multiple pregnancy
* Previous cesarean section
* Chorioamnionitis on admission
* \>2 symptomatic uterine contractions in 10 minutes
* Prostaglandins hypersensitivity
* Contraindication for vaginal delivery

Primary outcomes:
measure: Vaginal delivery rate
timeFrame: During delivery
Secondary outcomes:
measure: Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
timeFrame: During delivery
measure: chorioamnionitis rate
timeFrame: During or after delivery up to 7 days
measure: Uterine tachysystole
timeFrame: During delivery
measure: Neonatal morbidity
timeFrame: After delivery until discharge
measure: Neonatal morbidity
timeFrame: immediately after delivery
measure: Neonatal morbidity
timeFrame: up to 7 days after delivery
measure: Neonatal morbidity
timeFrame: up to 7 days after delivery
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
References:
Clinical trial NCT04667585: Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Official title: Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oropharynx Cancer
Keywords: PET-CT
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
Primary purpose: OTHER

Brief summary: The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.


Eligibility criteria: Inclusion Criteria:

* Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization (ISH) and/or positive HPV PCR
* Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment
* Zubrod/ECOG score of 0-1
* Weight loss \<10% in the 3 months prior to diagnosis
* ≥ 18 years of age
* No prior chemotherapy for their current cancer diagnosis

Exclusion Criteria:

* Prior radiotherapy to the head and neck
* Medical contraindications to radiation therapy
* Absence of gross disease on imaging prior to beginning radiation therapy
* Distant metastatic disease
* Medical contraindication to PET/CT
* History of active cancer other than non-melanoma skin cancer within the last 5 years

Primary outcomes:
measure: Progression-free survival
timeFrame: from initiation of radiation therapy through study completion, an average of 2 years
Secondary outcomes:
measure: locoregional progression-free survival
timeFrame: from initiation of radiation therapy through study completion, an average of 2 years
measure: distant disease-free survival
timeFrame: from initiation of radiation therapy through study completion, an average of 2 years
measure: overall survival
timeFrame: from initiation of radiation therapy through study completion, an average of 2 years
measure: progression free survival correlation in PET/CT responders versus PET/CT non-responders
timeFrame: 2 years
measure: Acute adverse events
timeFrame: 7 weeks
measure: Long term adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
Study officials:
affiliation: DUHS
name: David Brizel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255485: The Neurobehavioral Effects of Anesthetics on Infants With Hearing Impairment
Official title: Long Term Neurobehavioral Effects of Anesthetics and Cochlear Implantation on Infants With Hearing Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long Term Neurobehavioral Effects
Keywords: infant
anesthesia
neurobehavioral development
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing cochlear implantation under general anesthesia

Brief summary: The long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. A retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. When infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. In this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after unilateral or bilateral cochlear implantation.


Eligibility criteria: Inclusion Criteria:

1. Infants aged between 6 months and 2 years old undergoing cochlear implantation under general anesthesia in 9th hospital
2. Patients who have not participated in other clinical trials
3. ASA class I-II selective operation without any acute infectious diseases or systematic diseases
4. Infant's family members agree to participated in the trials and sign the informed consent

Exclusion Criteria:

1. Reject to sign the informed consent and participate in the trials
2. Patients with severe liver and kidney damage or other heart, lung and nervous system diseases
3. The Gesell developmental scale is less than 86 in motor behavior and physical energy
4. With a history of intrauterine distress, umbilical cord around the neck, hypoxia and jaundice
5. Infant who is allergic to egg and milk
6. Family history of malignant hyperthermia
7. Allergy to anesthetic drugs

Primary outcomes:
measure: change of Baseline Gesell Developmental Scale after 6 month
timeFrame: change in 6 months after surgery
Secondary outcomes:
measure: change of Baseline Gesell Developmental Scale after 12 month
timeFrame: change in 12 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai No.9 People's Hospital
Study officials:
affiliation: Shanghai No.9 People's Hospital
name: Jingjie Li, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT01481285: Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Official title: Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bioelectrical Impedance Measurement
Adults
Lead sponsor: Seca GmbH & Co. Kg.
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 992
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data of 992 healthy adults are planned to be collected.

Brief summary: The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.


Eligibility criteria: Inclusion Criteria:

The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".

Exclusion Criteria:

* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* extensive tattoos at arms or legs

Primary outcomes:
measure: Bioelectrical Impedance of 1, 1.5, 2, 3, 5, 7.5, 10, 15, 20, 30, 50, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz
timeFrame: about 15 minutes
Secondary outcomes:
measure: Verification of equivalence to a predicate device in accordance to Premarket Notification [510(k)] process of the FDA for product approval in the U. S.
timeFrame: about 15 minutes
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Institute for Transfusion Medicine
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Sven Peine, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355185: Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences
Official title: Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: Seed movement
implants
prostate brachytherapy
localized
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Association of Radiation Oncology
name: Sanofi
First posted: 2011-05-18
Enrollment: 20
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: Patients seen at an academic institution (tertiary centre ...Cross Cancer Institute) for consideration of prostate brachytherapy

Brief summary: There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.

Detailed description: Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.

Eligibility criteria: Inclusion Criteria:

* treated with prostate brachytherapy
* low risk or intermediate risk prostate cancer
* ambulatory
* stable medical condition
* 18 years of age or older
* capable of informed consent

Exclusion Criteria:

* no use of any hormonal therapy
* unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Nawaid Usmani, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Ronald Sloboda, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sloboda RS, Usmani N, Pedersen J, Murtha A, Pervez N, Yee D. Time course of prostatic edema post permanent seed implant determined by magnetic resonance imaging. Brachytherapy. 2010 Oct-Dec;9(4):354-61. doi: 10.1016/j.brachy.2009.09.008. Epub 2010 Jan 29.
Clinical trial NCT01169285: Efficiency and Efficacy of the Distress Thermometer in the Burn and Wound Population (Research Mentoring High Student Project)
Official title: Prospective Observational
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Keywords: Burn Department Nursing Staff
Lead sponsor: Saint Elizabeth Regional Medical Center
Sponsor class: OTHER
First posted: 2010-07-26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burn Department Nurses and Burn Patients

Brief summary: The purpose of the study is to test the efficiency and efficacy of the Distress Thermometer of patients admitted to the tertiary Burn and Wound Center. The American Cancer Society and the National Comprehensive Cancer Network published treatment guidelines in 2005 adopting the use of the Distress Thermometer as the preferred adjunct assessment tool of a patient's emotional well-being. A literature search provided extension of the tool to a Cardiac Follow-up Clinic. The Distress Thermometer is currently used with oncology patients at Saint Elizabeth.

The emotional well being of patients and their significant others is a hallmark of wholistic care. The simple Likert scale of 0-10 has a trigger for further assessment and/ or intervention at four. The validity testing of the tool was done against the Hospital Anxiety and Depression Scale (HADS) and the Brief Symptom Inventory (BSI-18).

The purpose of this study is to measure the efficiency and efficacy of the documentation of the Distress Thermometer to patients admitted to a tertiary Burn and Wound Care Center. The frequency of the documentation will be counted and type of documentation will be categorized.


Eligibility criteria: Inclusion Criteria:

* nursing staff will be nurses working the evening/night shift beginning at 1900.

Exclusion Criteria:

* all patients on the ventilator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01443585: Clinical Evaluation of a Progressive Addition Lens (PAL)
Official title: Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyopia
Keywords: Progressive Addition Lens
Multifocal
Presbyopia
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2011-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.

This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.


Eligibility criteria: Inclusion Criteria:

* An ability to comprehend and give an informed consent for participation in the trial
* Presbyopia

Exclusion Criteria:

* Concurrent participation in another clinical trial
* Age\<18
* For female subjects: pregnancy \\ planning a pregnancy \\ lactating at the time of enrollment
* Imbalanced diabetes \\ high blood pressure \\ thyroid disease
* Infectious disease
* Inability (cognitively) to comprehend the instructions given during the trial and to comply with them

Primary outcomes:
measure: Horizontal Intermediate Visual Field
timeFrame: Baseline
measure: Visual Acuity
timeFrame: Baseline
measure: Horizontal Near Visual Field
timeFrame: Baseline
measure: Field of comfortable reading on a computer screen
timeFrame: Baseline
measure: Horizontal Far Visual Field
timeFrame: Baseline
Secondary outcomes:
measure: Subjective Evaluation of Visual Quality
timeFrame: 2-3 weeks
measure: Overall Subjective Feedback
timeFrame: 2-3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ziv Medical Center, Zefat, Israel
name: Yosef Pikel, M.D
role: PRINCIPAL_INVESTIGATOR
References: