louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05925413: Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
Official title: Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 41
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: Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

1. written informed consent signed prior to enrolment.
2. age \> 18 years, both sexes
3. patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II
4. no previous antitumor therapy
5. Child-Pugh A or B7.
6. with measurable lesions (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria).
7. ECOG PS score: 0 to 1.
8. expected survival of \>12 weeks.
9. Adequate organ function

Exclusion Criteria:

1. BCLC C stage HCC
2. In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> CTCAE Version 5.0 adverse events of grade 2).
3. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT).
4. Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
5. Patients with tumor thrombus reaches or exceeds the portal vein.
6. History of other malignancies.
7. History of allergic reactions to related drugs.
8. History of organ transplantation.
9. Pregnant women, nursing mothers.
10. Patients have other factors that may interfere with patient enrollment and assessment results.
11. Refuse follow-up as required by this study protocol and refuse to sign informed consent.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to two years
measure: Overall survival (OS)
timeFrame: Up to two years
measure: Adverse events (safety)
timeFrame: Up to two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06423313: Effects of Anesthesia Type on QoR-40
Official title: The Comparison of Total Intravenous Anesthesia and Inhalation Anesthesia Effects on Postoperative Recovery by Quality of Recovery (QoR-40) in Septorhinoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
İnhalation Anesthetics
Quality of Recovery
Keywords: total intravenous anesthesia
anesthesia maintenance
inhalation anesthesia
quality of recovery-40
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include intubated patients who will undergo septorhinoplasty surgery under general anesthesia, aged 18-65 years, in the American Society of Anesthesiology (ASA) I-II-III risk class.

Brief summary: To compare the effects of total intravenous anesthesia and inhalation anesthesia used for maintenance on postoperative recovery in patients undergoing septorhinoplasty surgery under general anesthesia, using the recovery quality score (QoR-40).


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* ASA I-II-III risk group
* Patients whose consent was obtained with an informed consent form
* Patients who will undergo septorhinoplasty surgery

Exclusion Criteria:

* -ASA \>3
* Psychiatric illness that prevents them from answering the questionnaire
* Patients with a history of chronic opioid and benzodiazepine use as it may affect recovery time
* Severe renal and hepatic insufficiency
* Severe respiratory and cardiovascular disease
* Patients with a body mass index \>30 kg m2
* Patients with a known history of allergy or contraindication to any of the drugs to be used in the study

Primary outcomes:
measure: quality of recovery-40 questionnaire
timeFrame: up to 24 hour after surgery
Secondary outcomes:
measure: postoperative complications
timeFrame: up to 24 hour after surgery
measure: duration of extubation
timeFrame: end of the surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References:
Clinical trial NCT04215913: Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)
Official title: Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Keywords: PSC
Integrative Analysis
IHC
WES
RNA sequencing
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
name: Anhui Medical University
First posted: 2020-01-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with pulmonary sarcomatoid carcinoma

Brief summary: Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

Detailed description: The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 70 years with histologically proven LCLC
* No severe major organ dysfunction
* World Health Organization (WHO) performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 70
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy

Primary outcomes:
measure: 10 years overall survival
timeFrame: 10 years overall survival
Secondary outcomes:
measure: 10 years disease-free survival
timeFrame: 10 years disease-free survival
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Da Fu
state: Shanghai
Study officials:
References:
citation: Boland JM, Mansfield AS, Roden AC. Pulmonary sarcomatoid carcinoma-a new hope. Ann Oncol. 2017 Jul 1;28(7):1417-1418. doi: 10.1093/annonc/mdx276. No abstract available.
Clinical trial NCT03300713: MOther-Child Interaction Assessment TRAINING for Pediatricians
Official title: MOther-Child Interaction Assessment TRAINING for Pediatricians
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior Disorders
Mother-child Relations
Depression, Postpartum
Keywords: Mass screening
Pediatrician training
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-10-03
Enrollment: 3504
Sex: ALL
Minimum age (years): 23
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.


Eligibility criteria: Inclusion Criteria:

* Each child will be included WITH his biological mother at the first-month visit after birth.
* Age: 1 month + / - 15 days (child), accompanied by his biological mother
* Mother able to read French;
* Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.

Exclusion Criteria:

* Preterm babies.
* Children from a twin or multiple pregnancy.
* Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
* Refusal to participate after clear information about the study;
* Refusal to sign the consent letter;
* Refusal to be informed of a diagnostic hypothesis;
* Participants not covered by the Social Security system;
* Participants incapable of consenting or under legal protection (guardianship or curatorship).

Primary outcomes:
measure: Frequency of pathological Alarm Distress BaBy (ADBB) scores
timeFrame: in 12-month-aged children.
Secondary outcomes:
measure: Frequency of pathological Alarm Distress BaBy (ADBB) scores
timeFrame: in 4, 9 and 24 month-aged children
measure: Frequency of digestive disorders
timeFrame: in 4, 9, 12 and 24 month-aged children
measure: Number of daytime sleep hours
timeFrame: in 4, 9, 12 and 24 month-aged children
measure: Number of nighttime awakenings
timeFrame: in 4, 9, 12 and 24 month-aged children
measure: Scores on maternal self-evaluation scales (Likert scales)
timeFrame: at 12 and 24 months postpartum
measure: Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
timeFrame: in 4, 9, 12 and 24 month-aged children
measure: Frequency of maternal psychotropic medication
timeFrame: in 4, 9, 12 and 24 month-aged children
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Lille
name: Renaud Jardri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05242913: Effects of Resistant Potato Starch on the Gut Microbiota
Official title: A Randomized Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of Resistant Potato Starch (SolnulTM) on Intestinal Flora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Keywords: Microbiota
Resistant Potato Starch
Bristol Stool Chart
Diarrhea
Constipation
Bloating
Abdominal Pain
Gas
Well-being
Lead sponsor: MSP Starch Products Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.

Exclusion Criteria:

* Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.

Primary outcomes:
measure: Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
timeFrame: Four weeks
Secondary outcomes:
measure: Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups
timeFrame: One week
measure: Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups
timeFrame: One week, four weeks
measure: Fecal SCFA (mmol/kg stool) changes from baseline
timeFrame: One week, four weeks
measure: Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores
timeFrame: One week, four weeks
measure: Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale
timeFrame: One week, four weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Nutrasource Pharmaceutical and Nutraceutical Services
state: Ontario
Study officials:
affiliation: Nutrasource Pharmaceutical and Nutraceutical Services
name: Anthony Beir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118413: Ultrasound Guided Bilateral Erector Spinae Plane Block in Caesarean Delivery
Official title: Bilateral Ultrasound Guided Low Thoracic Erector Spinae Plane Block for Postoperative Analgesia in Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Cigli Regional Training Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector Spinae plane block (ESPB) is a regional anesthesia technique described three years ago. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that ESPB could be efficacious for providing postoperative analgesia in the cesarean section, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided bilateral low thoracic ESPB in cesarean section.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* patients undergoing cesarean section under general anesthesia morbidly obesity, ASA III - IV , infection of the skin at the site of needle puncture area, patients with known allergies to any of the study drugs, coagulopathy, recent use of analgesic drugs

Primary outcomes:
measure: 24 hours opioid consumption
timeFrame: 24 hour
Secondary outcomes:
measure: Numeric rating scale for postoperative pain intensity
timeFrame: 24 hour
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Cigli regional research hospital
Study officials:
affiliation: izmir cigli regional hospital
name: Aygun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamak Altinpulluk E, Garcia Simon D, Fajardo-Perez M. Erector spinae plane block for analgesia after lower segment caesarean section: Case report. Rev Esp Anestesiol Reanim (Engl Ed). 2018 May;65(5):284-286. doi: 10.1016/j.redar.2017.11.006. Epub 2018 Jan 17. English, Spanish.
citation: Santonastaso DP, de Chiara A, Addis A, Mastronardi C, Pini R, Agnoletti V. Ultrasound guided erector spinae plane block for post-operative pain control after caesarean section. J Clin Anesth. 2019 Dec;58:45-46. doi: 10.1016/j.jclinane.2019.05.009. Epub 2019 May 7. No abstract available.
citation: Aygun H, Thomas DT, Tulgar S. Comment to Santonastaso et al. 'J Clin Anesth 2019; 58: 45-46' and report of erector spinae plane block series in caesarean delivery patients. J Clin Anesth. 2020 Mar;60:4-5. doi: 10.1016/j.jclinane.2019.08.008. Epub 2019 Aug 16. No abstract available.
Clinical trial NCT06227013: Promoting Whistleblowing Among Nurses: A Randomized Controlled Trail
Official title: Promoting Whistleblowing Among Nurses: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nurse's Role
Keywords: Nurses
Whistleblowing
Lead sponsor: Port Said University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, two-arm Randomized Control Trail (RCT)
Primary purpose: SUPPORTIVE_CARE

Brief summary: this study aims to investigate the effect of Whistleblowing intension Among Nurses by applying whistobloating education program

Detailed description: the study aims to assess the effectiveness of Whistleblowing intervention program on nurses'Whistleblowing intensions.

Hypotheses:

H1: Nurses participating in the Whistleblowing intervention will report, post intervention, high level of Whistleblowing intensions compared with those nurse nurses in control group

Eligibility criteria: Inclusion Criteria:

* licensed nurses who worked in direct contact with patients in their services had at least six month of experience in the nursing profession, agreed to participate in the study

Exclusion Criteria:

* participating in any intervention program within the last 12 months

Primary outcomes:
measure: easuring the change of the Whistleblowing intension of nurses
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03450213: Astigmatism in Keratoconus Patients
Official title: Comparison of Anterior and Posterior Corneal Astigmatism in Patients With Keratoconus and Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.

Detailed description: Keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.Pentacam used diagnose \& detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography.

In the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian.

The aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with keratoconus using the following criteria:

Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening .

Exclusion Criteria:

* Unwillingness to participate in the study .
* Corneal scarring.
* Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration .
* Previous ocular surgery.

Primary outcomes:
measure: Comparison between astigmatism in patients with keratoconus and normal people.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.
Clinical trial NCT02411513: Acute Treatment of Migraine Using the CEFALY Device
Official title: Open-trial on the Acute Treatment of Migraine Using the CEFALY Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 investigate the efficacy of e-TNS with the Cefaly® device as an acute treatment for a migraine attack. This open clinical trial will study the acute treatment of migraine using the Cefaly® device, prior to development of a sham-controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patient with a history of episodic or chronic migraine with or without aura, meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine- recurrent painful ophthalmoplegic neuropathy, migrainous infarction)
* The patient must be experiencing a migraine attack lasting for at least 3 hours, with pain intensity stabilized for at least 1 hour. The location of the headache should be frontal, retro- or peri- orbital, on one or either side.

Exclusion Criteria:

* Pregnant women
* Patients having received treatment with onabotulinum toxin (e.g., Botox, Dysport, Xeomin) to the head in the prior 4 months
* Patients having received supraorbital nerve blocks in the prior 4 months
* Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
* Patients with only temporal or occipital headaches
* Patients taking opioid medications
* Patients having taken abortive migraine medication in the prior 3 hours
* Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded while the neurostimulation has already started).
* Implanted metal or electrical devices in the head
* Cardiac pacemaker or implanted or wearable defibrillator

Primary outcomes:
measure: Change of pain intensity at 1 hour (VAS score)
timeFrame: 1 hour
Secondary outcomes:
measure: Change of pain intensity at 2 hours (VAS score)
timeFrame: 2 hours
measure: Patients with no need of medication at 2 hours
timeFrame: 2 hours
measure: Patients with no need of medication at 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Headache Center
state: New York
Study officials:
References: