louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04994548: Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension
Official title: Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Neoplasms
Cirrhosis
Portal Hypertension
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Study population: 112 patients with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Brief summary: Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.

This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.


Eligibility criteria: Inclusion Criteria:

* older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Exclusion Criteria:

* younger than 18

Primary outcomes:
measure: technical success of early esophageal cancer resection
timeFrame: baseline
Secondary outcomes:
measure: adverse events per procedure (immediate bleeding, perforation)
timeFrame: baseline
measure: morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)
timeFrame: up to 4 weeks
measure: Potential risk factors for adverse events
timeFrame: baseline
measure: preemptive methods to the risk of bleeding
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03412448: The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac Surgery
Official title: The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Cardiac Surgery
Opioid Use
Keywords: chronic pain
cardiac surgery
opioids
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 320
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: population that has undergone cardiac surgery at the MHI.

Brief summary: The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.

Detailed description: This study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. Data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. Additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.

Eligibility criteria: Inclusion Criteria:

All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection.

Exclusion Criteria:

Patients who have declined to be contacted after surgery as noted on the MHI form "Consent for futur projects".

All patients who accepted to be contacted but decline to participate when contacted after their surgery.

Patients who cannot be reached by phone. Patients who cannot speak French

Primary outcomes:
measure: Prevalence of CPOP
timeFrame: 6 (+ or - two weeks) months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References:
citation: Choiniere M, Watt-Watson J. Persistent postoperative nonanginal pain after cardiac surgery. CMAJ. 2014 Aug 5;186(11):855. doi: 10.1503/cmaj.114-0057. No abstract available.
citation: Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
citation: Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
Clinical trial NCT02986048: Proton Therapy Patient Registry
Official title: Proton Therapy Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Treatment With Proton Beam Radiation Therapy
Keywords: proton beam
registry
radiation
cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with proton beam at the UH Proton Therapy Center

Brief summary: The purpose of this study is to establish a database (or "registry") of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients.

Detailed description: The primary objective of this non-therapeutic registry study is to create a secure longitudinal database of patients treated with proton therapy at the UH Proton Therapy Center. This will allow reporting patient, tumor, and treatment characteristics as well as outcome data pertaining to disease control and complications for this relatively rare radiation modality.

Eligibility criteria: Inclusion Criteria:

* Patients treated with proton beam at the UH Proton Therapy Center
* Patients who have the ability to understand and be willing to sign a written informed consent document

Exclusion Criteria:

* Patients or legal guardians who are unable to understand informed consent document

Primary outcomes:
measure: Number of participants treated at UH Proton Therapy Center by proton beam therapy
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: David B Mansur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205448: Fall Prevention Study Among Seniors in Bomlo
Official title: Early Identification and Intervention in Risk of Falling Among Seniors i Bomlo Municipality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall
Lead sponsor: Bomlo Municipality
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief summary: Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.

Detailed description: Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.

Eligibility criteria: Inclusion Criteria:

* Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.

Exclusion Criteria:

* Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment

Primary outcomes:
measure: Fall-related injuries
timeFrame: First year
Secondary outcomes:
Other outcomes:
Locations:
city: Bremnes
country: Norway
facility: Bomlo municipality
state: Bomlo
Study officials:
affiliation: Bomlo Municipality
name: Kjetil A Gjoesaeter
role: STUDY_CHAIR
References:
Clinical trial NCT02495948: Comparison of Two Marketed Silicone Hydrogel Lenses
Official title: One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-07-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.


Eligibility criteria: Inclusion Criteria:

* Sign informed consent document;
* Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
* Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
* Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
* History of herpetic keratitis, corneal surgery or irregular cornea;
* Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only one lens;
* Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
timeFrame: Day 30, each product
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Trial Manager, Vision Care, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03321448: TMTP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer
Official title: Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Laparoscopic Sentinel Lymph Node Detection in Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cervical Cancer
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: investigators aimed to determine the validity of our novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of laparoscopic SLN mapping


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, married, without childbearing requirements at the time of consent.
* FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
* Subject has provided written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant
* Ongoing participation in another clinical trial with an investigational drug with 3 months
* Own allergy towards ICG and/or alcohol
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Primary outcomes:
measure: Detection rate of sentinel lymph node
timeFrame: 1 day
Secondary outcomes:
measure: Sensitivity
timeFrame: 7 days
measure: Specificity
timeFrame: 7 days
measure: Incidence of adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical Colledge, HUST
state: Hubei
Study officials:
References:
Clinical trial NCT02525848: Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
Official title: Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.

Detailed description: Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.

Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.

Eligibility criteria: Inclusion Criteria:

• ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.

Exclusion Criteria:

* Central or peripheral neurological pathologies.
* History of drug abuse, chronic pain, or psychiatric disorders.
* Pregnant women
* Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.

Primary outcomes:
measure: incidence (%) of postoperative nausea and vomiting
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: non invasive blood pressure
timeFrame: intra-operative from induction of general anesthesia till end of surgery.
measure: heart rate
timeFrame: Intra-operative from induction of anesthesia till end of surgery.
measure: side effects
timeFrame: 24 h postoperative.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hala saad Abdel-Ghaffar
state: Assiut governorate
Study officials:
affiliation: Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687348: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy
Official title: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mastectomy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia.

Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected.

Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested.

Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability.

Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.


Eligibility criteria: Inclusion Criteria:

* Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
* Age: upper to 18 years
* Weight: upper to 50 kg

Exclusion Criteria:

* Cutaneous infection in the point of draining
* Clinical Disorder(Confusion) of the coagulation
* Retreat(Withdrawal) of the consent in the course of protocol
* Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of 'drug lidocaine'"
timeFrame: 36 MONTHS
Secondary outcomes:
measure: analgesic postoperative efficacy
timeFrame: 36 MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
Clinical trial NCT05761548: Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging
Official title: Study on the Development of Neonatal Cerebral Blood Flow Based on Ultrafast Ultrasound Doppler Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Birth
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From May 2022 to May 2023, newborns hospitalized in neonatal and NICU wards in the Peking University Third Hospital.

Brief summary: Recently, with the development of perinatal medicine in China, the establishment of neonatal intensive care unit (NICU) and the improvement of respiratory support technology, the survival rate of preterm and term neonates has been significantly improved. However, the brain development of preterm neonates is incomplete compared with that of full-term neonates. Therefore, during the extrauterine cultivation of preterm neonates, clinical intervention should be carried out according to their brain development to achieve the same development status as that of full-term neonates. There are many clinical inspection methods to monitor the brain development of preterm neonates, such as EEG, functional near-infrared spectroscopy imaging, etc. However, these technologies cannot assess the brain development of premature infants systematically and completely. Because of the existence of neurovascular coupling, brain function and cerebral blood flow are closely related, so the detection of cerebral blood flow can reflect brain development and brain function. Ultrafast ultrasound power Doppler imaging technology is an emerging, real-time, high-resolution microvascular imaging technology. In this study, we first used ultrafast ultrasound power Doppler imaging technology to image the cerebral blood flow of preterm neonates at different gestational ages to evaluate the development of cerebral blood flow of preterm and term neonates and provide guidance for the clinical intervention of preterm neonates.


Eligibility criteria: Inclusion Criteria:

* neonates without cerebral diseases

Exclusion Criteria:

* neonates with cerebral diseases

Primary outcomes:
measure: Intrauterine cerebral blood flow development of neonates
timeFrame: 30 min
measure: Extrauterine cerebral blood flow development of neonates
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05329948: Application of Haptonomy and Pregnancy Adjustment, Paternal Attachment
Official title: The Effect of Haptonomy Application on Pregnancy Adjustment and Prenatal Attachment of Fathers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Father-Child Relations
Keywords: fetus
midwifery
pregnancy
haptonomy
father
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 286
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy.

Therefore, this study; It was aimed to evaluate the effect of haptonomy application on prenatal attachment of fathers and compliance with pregnancy and to contribute to the midwifery literature of the results.

Detailed description: In accordance with the literature review, no similar study was found in our country. The reason for the application of haptonomy in pregnancy is the sense of touch, which develops in the first 2 months of pregnancy and is an emotional sense. The pregnancy process is experienced not only by the mother, but also by the fathers, so it is thought that the application of haptonomy, which is the science of love, communication and feeling together, will confirm the emotional existence of the baby in the prenatal period, and support the attachment of the father and the adaptation of the mothers to pregnancy. Therefore, this study; The aim of this study was to evaluate the effect of haptonomy application on prenatal attachment of fathers and adaptation of pregnant women to pregnancy.

Eligibility criteria: Inclusion Criteria:

* At least primary school graduate,
* Being at the 24th and 32nd week of pregnancy
* Living with your partner

Exclusion Criteria:

* Having problems with his wife
* Living apart with his wife
* Pregnant women who have completed the 32nd gestational week

Primary outcomes:
measure: The Effect of Haptonomy Application Prenatal Attachment of Fathers
timeFrame: one month
Secondary outcomes:
measure: The Effect of Haptonomy Application on Pregnancy Adjustment
timeFrame: one month
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kars Harakani Devlet Hastanesi
Study officials:
affiliation: Atatürk University Faculty of Health Sciences Department of Midwifery Yakutiye/Erzurum
name: Sibel ÖZTÜRK, Asst.Prof.
role: STUDY_DIRECTOR
affiliation: Kafkas University Faculty of Health Sciences Department of Midwifery Merkez/Kars
name: Nazlı AKAR, Phd
role: PRINCIPAL_INVESTIGATOR
References: