louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06439849: Single Patient Compassionate Use / Expanded Access L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment of Diffuse Midline Glioma
Official title: Single Patient Compassionate Use / Expanded Access L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment of Diffuse Midline Glioma, H3 K27/K28-altered (TRIANGLE)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: DIPG Brain Tumor
Diffuse Brainstem Glioma
H3 K27M
H3 K28M
GBM
Keywords: S-Gboxin
S-Gboxin (lyophilized form)
Lead sponsor: Petrov, Andrey
Sponsor class: OTHER
First posted: 2024-06-03
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: F. 50y.o. 77kg, DS confirmed 18 Nov. 2022 Received treatment: 11 courses of TMZ (240mg) Radiotherapy 30 courses of 1.8Gr (total 54 Gr, TMZ 140 mg on RT). Bevacizumab intravenously -400 mg -0-14-28-42 (December-February 2023). Severe side effects. The attending physician discontinued bevacizumab after 4 courses. In remission for 11 months. According to the results of the MRI dated April 28, 2024, continued growth.

Neurological status is good. Reflexes are not impaired. To date, treatment options have been exhausted. Participation of the patient in Clinical Trials is impossible. As of April 2024, negative dynamics. The patient signed an informed consent agreement. Information on taking L-S-Gboxin (Lyophilisate) as part of a compassionate program - explained.

Written consent of the attending physician for the patient's participation in the Compassion Program (TRIANGLE) with L-S-Gboxi (Lyophilisate) - received.

(medical documentation will be available on clinicaltrials.gov within a month from the date of publication - patient's consent to publish the medical history and examination results has been obtained)

Detailed description: TREATMENT PLAN

Оn days 1 to 3 of treatment, the patient will receive a sublingual form of the lyophilized form of L-S-Gboxin at a dose of 5 mg/kg.

If there is no toxicity, on days 4 to 14 the patient will receive a sublingual form of the lyophilized form of S-Gboxin at a dose of 10 mg/kg.

The first course of treatment is 14 days. On day 20, MRI + PET-CT monitoring is carried out to assess the dynamics of tumor growth. Based on the results of the examination plan, the attending physician and the main investigator make a decision on the continuation of treatment and the duration of the second course of therapy.

Eligibility criteria: Inclusion Criteria:

unacceptable for single patient

Exclusion Criteria:

* unacceptable cardiotoxicity
* cerebrospinal fluid dissemination
* systemic infection or viral disease, other associated symptoms that may jeopardize the patient's safety (at the discretion of the treating physician)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00946049: Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material
Official title: Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material (VICRYL PLUS® vs. VICRYL®, Ethicon) in Intraoral Dentoalveolar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Colonization
Keywords: Checking clinical antibacterial effect of Vicryl Plus compared to conventional Vicryl in intraoral surgery
Bacteria
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-07-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were removed postoperatively and adhered bacteria were investigated.


Eligibility criteria: Inclusion Criteria:

* planned surgical extraction of 1 to 4 wisdom teeth
* no inflammation and pain within the planned surgical area
* legal age
* clinically healthy patient

Exclusion Criteria:

* allergy to Triclosan or phenols
* gravidity/lactation
* immunosuppression due to drugs or diseases
* severe general diseases
* long-term medication
* intake or use of other antibiotical drugs/devices

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Albert-Ludwigs-University Freiburg, Department for Oral and Maxillofacial Surgery
Study officials:
References:
Clinical trial NCT02976649: Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery
Official title: Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Procedures
Keywords: Morbid obesity
Bariatric surgery
Multi-dimensional score
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbid obese patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass.

Brief summary: The purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission.

Detailed description: A multi-dimensional score of 7 risk factors was proposed which may help in identifying morbidly obese patients undergoing bariatric surgeries who will need admission to a critical care unit postoperatively for follow up.

Eligibility criteria: Inclusion Criteria:

* patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass during the period from January to June 2016.

Exclusion Criteria:

* Patients were excluded in case of postoperative surgical complications, conversion to open surgery or in case of redo.

Primary outcomes:
measure: Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission
timeFrame: Through study completion, an average of six months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
Study officials:
affiliation: Anesthesiology department, Faculty of Medicine, Ain Shams University
name: Walid H. Nofal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01763749: Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin
Official title: Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.


Eligibility criteria: Inclusion Criteria:

* Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
* 20\~85 years old
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subject who did not undergo or failed Stent Implantation
* Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
* Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
* Subjects with uncontrolled severe hypertension
* Subjects with high risk of hemorrhage like blood coagulation disorders

  :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
* Subjects with intractable arrhythmia, intracranial hemorrhage
* Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
* Subjects with Severe hepatopathy(AST and ALT \> 10 times the upper limit of normal)
* Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
* Subjects considered as unsuitable based on medical judgement by investigators

Primary outcomes:
measure: Change from baseline in P2Y12% inhibition at week 4
timeFrame: Baseline, week 4
Secondary outcomes:
measure: Change from baseline in VerifyNow P2Y12 reaction unit at week 4
timeFrame: Baseline, week 4
measure: Change from baseline in VerifyNow Aspirin Reaction Unit at week 4
timeFrame: Baseline, week 4
measure: Change from baseline in maxymal platelet aggregation at week 4
timeFrame: Baseline, week 4
Other outcomes:
measure: Adverse events
timeFrame: Baseline, week 4
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital
state: Seochogu
Study officials:
affiliation: Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital
name: Ki-Bae Seung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198549: Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics
Official title: Phase IV Post-Approval Evaluation of Vitrase as an Adjuvant to Increase the Absorption and Dispersion of Other Injected Anesthetics for Ophthalmic Surgical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Adjuvants, Anesthesia
hyaluronate lyase
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 40
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: The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics


Eligibility criteria: Inclusion Criteria:

* Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

* Known allergy to bee venom

Primary outcomes:
measure: To evaluate physician acceptance of efficacy of Vitrase as an adjuvant to increase absorption and dispersion of anesthetics used for ophthalmic surgical procedures
Secondary outcomes:
measure: To determine physician usage of and satisfaction with Vitrase in the 6200 USP unit vial
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03484949: Web-Mediated Risk Assessment for Endoscopic Screening of Gastric Cancer
Official title: Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy for Gastric Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric cancer
Screening
Risk assessment
Lead sponsor: State Key Laboratory of Cancer Biology
Sponsor class: NETWORK
Collaborators: name: Tang-Du Hospital
name: Xijing Hospital
First posted: 2018-04-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Gastric cancer is one of the most common malignancies in China. Early detection is critical for gastric cancer management. However, the diagnosis rate of patients with early gastric cancer is still low. Therefore, the investigator design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve early gastric cancer diagnosis rate.


Eligibility criteria: Inclusion Criteria:

* 1.Age 18-60. 2.Signed informed consent

Exclusion Criteria:

* 1.Severe back ground disease including malignancy. 2.State after gastric surgery. 3.COPD, CHF, CRF and any disease with respiratory disturbances. 4.Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

Primary outcomes:
measure: Diagnostic rate of patients with early gastric cancer
timeFrame: 2020
Secondary outcomes:
measure: Characterization of the high-rik individual for gastric cancer
timeFrame: 2020
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dake Chu
state: Shaanxi
Study officials:
References:
Clinical trial NCT04120649: Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
Official title: Comparison Between Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients who having endometrial carcinoma

Brief summary: Endometrial cancer is the most common malignant disease of the female genital tract and the seventh most common cause of cancer death in women in Western countries. Histological type, grade and depth of myometrial invasion are prognostic factors in early stage disease as well as risk factors for lymph node metastasis. Systematic lymphadenectomy has recently been questioned for stage I disease based on the results from two randomized trials


Eligibility criteria: Inclusion Criteria:

* Not virgin
* Not having congenital anomalies
* Early stage
* Body mass index less than 35

Exclusion Criteria:

* virgin
* advanced stage
* sever infection especially in the pelvis
* lymphadenopathy for any cause
* lymphadenectomy for any cause
* BMI more than 35
* Synchronous malignancies

Primary outcomes:
measure: the validity of Mayo criteria risk stratification model
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02298049: An fMRI Study of Satiation in Healthy Volunteers.
Official title: Satiation Attenuates BOLD Activity in Brain Regions Involved in Reward and Increases Activity in an Inhibitory Control Area: an fMRI Study in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Keywords: fMRI
reward
satiation
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2014-11-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To our knowledge no study has assessed the effects of a meal on neural responses to food cues and compared this with a condition simulating natural inter-meal hunger levels. This is important, as the existing literature often compares the effect of fasting to satiation, which may not reflect typical appetite processes. Thus, the purpose of this research was to examine the effect of a satiating lunch compared to a normal pre-meal state on blood oxygen level dependent (BOLD) activity in the human brain, as measured using functional magnetic resonance imaging (fMRI).

Detailed description: We hypothesized that satiation would be associated with decreased brain activity across brain regions involved in both appetite and reward such as ventromedial prefrontal cortex, orbitofrontal cortex, ventral striatum, hypothalamus, insula, amygdala and hippocampus. 16 healthy participants (8 males) were scanned on two separate test days, before and after eating a meal to satiation, or after not eating for 4 hours (satiated vs. pre-meal). fMRI BOLD signals to the sight and/or taste of the stimuli were recorded. Participants were given questionnaires to complete about their mood state and appetite before and after all scans.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Sufficiently fluent in English to understand the task and the instructions

Exclusion Criteria:

* Currently taking medication
* Past or current depression/dieting,
* Smokers
* Food allergies
* Diabetes
* Pregnancy
* BMI score outside the normal range
* Any contraindications to fMRI scanning (e.g. pacemakers, mechanical heart valve, hip replacement, metal implants)

Primary outcomes:
measure: Activation differences between satiated and pre-meal scan fMRI BOLD signal
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Jason M Thomas, MRes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas JM, Higgs S, Dourish CT, Hansen PC, Harmer CJ, McCabe C. Satiation attenuates BOLD activity in brain regions involved in reward and increases activity in dorsolateral prefrontal cortex: an fMRI study in healthy volunteers. Am J Clin Nutr. 2015 Apr;101(4):697-704. doi: 10.3945/ajcn.114.097543. Epub 2015 Jan 21.
Clinical trial NCT02890849: Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
Official title: Clinical Research for the Consistency Analysis of PD-L1 in Cancer Tissue and Plasma Exosome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NSCLC
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The detection of tissue PD-L1 immunohistochemistry in Non-small cell lung cancer (NSCLC) has an important role in guiding for the treatment of immune detection point. At the same time,tissue detection is time-consuming and laborious, liquid biopsy can reflect the information of tumor tissue,PD-L1 mRNA in plasma exosomes (pExo) is expected to be simple, rapid, non-invasive means of detection. The project is planned to explore the consistency analysis of PD-L1 expression level detected in cancer tissues and pExo.We have designed to detected the expression levels of PD-L1 mRNA and protein in cancer tissue and detected the expression levels of PD-L1 mRNA in pExo.By using variance analysis of repeated measures design information. Thus exploring the consistency analysis of PD-L1 expression level detected in tissues and pExo,guiding clinical practice of radiotherapy combining with immunotherapy.


Eligibility criteria: Inclusion Criteria:

1. Pathological histology and/or cytology confirmed malignant tumor;
2. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria:

1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
2. Patients with a history of autoimmune disease;
3. Patients with participating in other clinical trials at the same time;
4. Other cases that researchers believe that patients should not participate in the present trial.

Primary outcomes:
measure: The match rate of PD-L1 protein expression in cancer tissue and PD-L1 mRNA expression in pExo.
timeFrame: up to one and a half years
Secondary outcomes:
measure: The match rate of PD-L1 protein expression and PD-L1 mRNA in tumor tissue.
timeFrame: up to one and a half years
Other outcomes:
measure: Correlation between PD-L1 mRNA expression in pExo and immune indexes.
timeFrame: up to one and a half years
Locations:
Study officials:
References:
Clinical trial NCT01741649: Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
Official title: Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Surgical wound infection
Clorhexidine
Povidone
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.


Eligibility criteria: Inclusion Criteria:

* Gestational age \> 32 weeks
* Emergency cesarean section

Exclusion Criteria:

* Allergy to clorhexidine
* Allergy to povidone
* Evidence of infection in the surgical site
* Loss to follow up at 15 days
* Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.

Primary outcomes:
measure: Surgical Site infection (SSI)
timeFrame: 3 days
Secondary outcomes:
measure: Hospitalization
timeFrame: 15 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
References:
Clinical trial NCT00175149: Active Vitamin D Effect on Left Ventricular Hypertrophy
Official title: The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Left Ventricular Hypertrophy
Keywords: CKD 3-4
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease (S-creatinin \> 150 and \< 600 mikroM)
* Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay)
* Stable blood pressure during the last 6 months (less than (160/95)
* B-hemoglobin \> 6 mmol/l
* EKG with sinus rhythm and no sign of Q-wave infarction
* Expected follow up 6 month

Exclusion Criteria:

* Pregnancy
* Kidney transplantation
* Malignant disease

Primary outcomes:
measure: The effect of dihydroxycholecalciferol on left ventricular hypertrophy
timeFrame: 6 month
Secondary outcomes:
measure: Changes in the activity of the renin-angiotensin system
timeFrame: 6 month
measure: Changes in left ventricular function
timeFrame: 6 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Renal Medicne C, Skejby Hospital
Study officials:
affiliation: Deparment of Renam Medicine C, Skejby Hospital
name: Per Ivarsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of Renal Medicine C, Skejby Hospital
name: Per Ivarsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: