louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04509570: A Prospective & Retrospective Study on Ectopic Lymphoid-like Structures in Chronic Skins of Autoimmune Bullous Diseases
Official title: A Prospective & Retrospective Study on the Presence of Ectopic Lymphoid-like Structures and Intralesional Steroid Injection for the Chronic Skin Lesion of Autoimmune Bullous Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autoimmune Bullous Disease
Keywords: ELS
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 41
Sex: ALL
Minimum age (years): 19
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 identify the presence or absence of ectopic lymph node-like structures in skin lesions of patients with autoimmune bullous disease and the subtypes of the cells deposited there. In addition, this study clarifies the therapeutic effect of intralesional steroid injection in patients with pemphigus harboring ectopic lymph node-like structure.


Eligibility criteria: Inclusion Criteria:

\<Presence of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>

Prospective study Inclusion Criteria:

1. Adults over 19
2. Patietns who voluntarily signed the consent form
3. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests

Retrospective study Inclusion Criteria:

1. Samples in human-derived banks from March 2013 to October 2018
2. Patients who are diagnosed with autoimmune bullous disease through clinical, histological and serological tests
3. Adults over 19 \<Treatment of Ectopic Lymphoid-like Structures in the Skin lesion of Autoimmune Bullous Disease Patients\>

Prospective study Inclusion Criteria:

1. Adults over 19
2. Patients who voluntarily signed the consent form
3. Patients who have skin lesions harboring ectopic lymph node-like structure in a prospective or retrospective manner
4. Patients who have chronic lesions sustained for more than 4 months during the treatment of systemic corticosteroids

Retrospective study Inclusion Criteria:

1. Patients who have skin lesions harboring ectopic lymph node-like structure in a retrospective manner
2. Paitents who have been treated for intralesional steroid injection
3. Patients who have data of photography to compare the clinical effects before and after intralesional corticosteroid treatment.

Exclusion Criteria:

1. Patients who do not meet the criteria for autoimmune bullous disease

Primary outcomes:
measure: Clinical outcome: size of lesions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The presence or absence of ectopic-lymph node-like structure by histologic evaluation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT04757870: Macro-scale Estimators of Covid-19's Worldwide Cases and Deaths
Official title: Determination of the Macro Scale Risk Factors in COVID19 Occurrence and Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID19
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
name: Hacettepe University
First posted: 2021-02-17
Enrollment: 1790
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID19 cases

Brief summary: In this study, investigators try to estimate Covid-19 Cases and Deaths using countrywide annual macro-scale indicators (i.e., estimators) such as non-communicable disease data from WHO (who. int), social and economical indicators from UN (un.org) and Worldbank (worldbank.org), and Covid-19 Cases and Deaths from Worldometer (https://www.worldometers.info).

Detailed description: There are some known risk factors for the emergence and mortality of Covid-19 cases. There are also some regulations and recommendations by healthcare executives and government officers such as wearing masks, social distance, staying at home, lockdowns, and so forth. On the other hand, there could be other social, economic, and health-related factors in the society level that discriminate between countries significantly in terms of having considerable differences regarding both the frequency and mortality of Covid-19. The aim of the present study is to find out these social, economic, and health-related factors that could explain some significant portion of Covid-19 cases and deaths worldwide.

This study involves 171 countries of which required datasets are commonly available in the UN, Worldometer, and WHO. The investigators will obtain macro-scale indicators like non-communicable disease data from WHO (who. int), social and economical indicators from UN (un.org) and Worldbank (worldbank.org), and Covid-19 data from Worldometer (https://www.worldometers.info).

The investigators will conduct statistical data analysis and create predictive models in order to determine indicators. The investigators will also consider that possible different models for explaining Covid-19 Cases and mortality in both common and different estimators could explain the variations in countrywide deaths and cases.

Eligibility criteria: Inclusion Criteria:

* All recorded cases by the authority

Exclusion Criteria:

* None

Primary outcomes:
measure: Occurence
timeFrame: december 2020
Secondary outcomes:
measure: Mortality
timeFrame: december 2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05401370: Role of Methylene Blue in Parotid Surgery
Official title: Role of Methylene Blue Dye in Identification of Facial Nerve in Parotid Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parotid Tumor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 20
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: usefulness of the methylene blue staining for identification of facial nerve in parotid gland surgery

Detailed description: The specific surgical morbidity remains significant in parotid gland surgery. In addition to temporary facial weakness and permanent facial nerve injury, postparotidectomy depression and Frey's syndrome (gustatory sweating) are specific for this type of surgery. To reduce the surgical morbidity, several modifications of parotidectomy have been implemented but postsurgical complications remain especially facial nerve injury . To overcome this difficulty, an identification method might be used such as preoperative intravital staining of the gland with methylene blue (MB).

Although MB staining is not designed to be used as a sole technique, it can be combined with other techniques such as identification of the anatomic landmarks. MB staining is simple, inexpensive, and not time consuming technique.It is an indirect facial nerve identification technique, because there is no nerve handling,thus decreasing iatrogenic nerve impairment.After injection of the parotid gland with MB dye, fine white nerve fibers can be observed . Tumors in the parotid gland are also easily seen because they are not stained and will be visible in the surgical field.

Eligibility criteria: Inclusion Criteria:

* All new cases presented with primary benign or malignant parotid tumors.

Exclusion Criteria:

* Cases with secondary tumors of the gland

Primary outcomes:
measure: Number of cases that don't develop post surgical parotidectomy facial nerve weakness after using preoperative intravital staining of the gland with methylene blue dye.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Ismail Ali Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00239070: Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
Official title: A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: EC-MPS, renal transplantation, de novo patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This extension study is to assess the long-term safety of EC-MPS


Eligibility criteria: Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

-

Primary outcomes:
measure: To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.
Secondary outcomes:
measure: To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT01723670: Evaluation of Effects of Multiple Dose Regimens of CHF 5074 on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Multiple Dose Regimens of CHF 5074 for up to 2 Years on Potential Biomarkers of Neurodegeneration in Subjects With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: CERESPIR
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effects of multiple dose regimens of CHF 5074 administered once per day up to 2 years on potential biomarkers of neurodegeneration in subjects with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* One or two Ɛ4 alleles of the apolipoprotein E (APOE) gene.
* Diagnosis of amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.

Exclusion Criteria:

* Diagnosis of Alzheimer's disease.
* Any medical condition that could explain the subject's cognitive deficits.
* MRI scans having evidence of pre-specified brain abnormalities.
* History of stroke.
* Vitamin B12 or folate deficiency.
* Skin cancers and any cancer that is being actively treated.
* Diagnosis of schizophrenia or recurrent mood disorder.
* Abnormal kidney function.
* Concomitant use of any study prohibitive medication.

Primary outcomes:
measure: To determine the effects on change from baseline on brain atrophy
timeFrame: pre-dose, Months 6, 12, 18, 24 and Washout
Secondary outcomes:
measure: To determine the presence of other biomarkers of neuronal degeneration
timeFrame: Day 1
measure: To determine the presence of other biomarkers of neuronal degeneration
timeFrame: Month 24
Other outcomes:
measure: Change from baseline in cognitive performance
timeFrame: pre-dose, Month 6, Month 12, Month18, Month 24
measure: Change from baseline in global clinical status
timeFrame: pre-dose, Month 6, Month 12, Month 18, Month 24
Locations:
Study officials:
affiliation: Memory Enhancement Center of America
name: Joel S Ross, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05475470: Blade Finger Technique for Safe Laparoscopic Entery
Official title: A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Operative Surgical Procedure
Insufflation
Safety Issues
Keywords: veress needle
Hasson's technique
laparoscopic access
blade-finger technique
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-07-27
Enrollment: 1005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: blade-finger technique is a new technique for laparoscopic access which is safe

Detailed description: after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 year-old.
* underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.

Exclusion Criteria:

* Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
* Patients with distended abdomen due to bowel obstruction.
* Patients with uncorrected coagulopathy.

Primary outcomes:
measure: time needed to access the peritoneal cavity
timeFrame: the first 15 minutes of operation
measure: numbers of trials till the good peritoneal access achieved
timeFrame: the first 15 minutes of operation
Secondary outcomes:
measure: rate of complications
timeFrame: the first 15 minutes of operation
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References:
Clinical trial NCT00135070: Hospital In-Patient Insulin Study
Official title: A Randomised Study Comparing Continuous Intravenous Insulin Infusion With Subcutaneous Insulin Analogues in Hospitalised Patients With Type II Diabetes and Hyperglycaemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2005-08-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperglycaemia has been shown to increase morbidity and mortality in patients with critical illness, myocardial infarction and stroke. This study aims to look at patients with hyperglycaemia and reduce their blood sugar levels using differing combinations of subcutaneous and intravenous insulin.

Detailed description: This is a randomised trial involving patients with type II diabetes who are brought into the hospital with a problem other than a diabetic emergency. Patients will be included, who have a blood sugar \> than 17mmols. They will be randomised to one of two groups and either given intravenous or subcutaneous insulin. Outcome measures are length of stay, glucose control and comparison of the two regimens. Cost implications will also be analysed.

Eligibility criteria: Inclusion Criteria:

* Type II diabetes
* Blood glucose \> 17mmols

Exclusion Criteria:

* Type I diabetes
* Hyperosmolar non-ketotic coma (HONK)
* Diabetic ketoacidosis (DKA)
* Myocardial infarction (MI)
* Vomiting

Primary outcomes:
measure: Glucose control
Secondary outcomes:
measure: Length of stay
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: The Royal Bournemouth Hospital
name: David Kerr, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697970: Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Official title: Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Hepatitis B
Engerix™-B
Recombinant Hepatitis B vaccine
Adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

Detailed description: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry.
* Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

* Pregnancy or lactation.
* Positivity for anti hepatitis antibodies.
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL.
* Elevated serum liver enzymes.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: After two doses and after the booster dose
Secondary outcomes:
measure: Occurrence and intensity of local and general solicited symptoms
timeFrame: 8 days after vaccination
measure: Anti-HBs antibody concentrations
timeFrame: Screening, M1, 2, 3, 4, 6, 12, 13
measure: Occurrence of unsolicited adverse events
timeFrame: 30-day after vaccination
measure: Occurrence of serious adverse events
timeFrame: During the study period and 30 days after the last vaccination
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02141152: Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model
Official title: Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 895
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with treatment-refractory malignancy

Brief summary: The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.

Detailed description: This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.

If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.

defined below: NEXT 1 trial is screening and feasibility -\> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)-\>NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed metastatic malignancy
* Written informed consent

Exclusion Criteria:

* patients who do not agree with biopsy
* patients who do not have enough tissue for acquisition

Primary outcomes:
measure: Response rate
timeFrame: expected average of 3 years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: expected average of 3 years
measure: feasibility
timeFrame: expected average of 3 years
measure: feasibility
timeFrame: expected average of 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
name: Won Ki Kang, MD
role: STUDY_CHAIR
References:
citation: Kim ST, Kim KM, Kim NKD, Park JO, Ahn S, Yun JW, Kim KT, Park SH, Park PJ, Kim HC, Sohn TS, Choi DI, Cho JH, Heo JS, Kwon W, Lee H, Min BH, Hong SN, Park YS, Lim HY, Kang WK, Park WY, Lee J. Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients and Utility for Biomarker-Selected Clinical Trials. Oncologist. 2017 Oct;22(10):1169-1177. doi: 10.1634/theoncologist.2017-0020. Epub 2017 Jul 12.