louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02822833: The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Neoplasm
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.


Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of endometrial cancer
* Clinical stage I or II

Exclusion Criteria:

* Contraindications for operation (hematological or coagulation disorders)
* Advanced stage
* Pregnancy or puerperium
* Fertility preserving surgery

Primary outcomes:
measure: Sensitivity and specificity of sentinel lymph node frozen section
timeFrame: 6 months
measure: Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
timeFrame: 6 months
Secondary outcomes:
measure: Negative and positive predictive values for sentinel lymph node frozen section
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine Department of Ob&Gyn
Study officials:
References:
Clinical trial NCT03366233: The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Official title: The Role of Brain Activation and Cerebral Blood Flow in Mental Fatigue.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Fatigue
Healthy
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the changes in brain activation and cerebral blood flow due to mental fatigue in a placebo-controlled study. More specifically we want to assess whether brain activation \[measured with Blood Oxygen Level Dependent (BOLD) functional resonance imaging (fMRI)\] is decreased during a Flanker task in a mentally fatigued state and whether this coincides with a decline in cognitive performance. In addition we also want to evaluate whether cerebral blood flow \[measured with arterial spin labeled (ASL) fMRI\] in a resting state is reduced when mentally fatigued.


Eligibility criteria: Inclusion Criteria:

* Healthy (No neurological/cardiorespiratory/psychological disorders)
* No medication
* Non-smoker
* Between 18 and 35 years old

Exclusion Criteria:

* Injuries
* Illness
* Pacemaker, neurostimulator, medication pump or metal implants
* Use of medication or any kind of drugs
* Use of alcohol, caffeine and heavy efforts 24 hours before each trial
* Not eating the same meal the night before and the morning of each trial

Primary outcomes:
measure: Blood Oxygen Level Dependent - Signal during a 10-min cognitive task (i.e. Flanker task)
timeFrame: Blood Oxygen Level Dependent - Signal will be measured during a 10-min Flanker task that will be completed immediately prior and after the 90-min task that is completed in both trials.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Human Physiology and Sports Physiotherapy Research Group
state: (non-US)
Study officials:
References:
citation: Van Cutsem J, Van Schuerbeek P, Pattyn N, Raeymaekers H, De Mey J, Meeusen R, Roelands B. A drop in cognitive performance, whodunit? Subjective mental fatigue, brain deactivation or increased parasympathetic activity? It's complicated! Cortex. 2022 Oct;155:30-45. doi: 10.1016/j.cortex.2022.06.006. Epub 2022 Jun 30.
Clinical trial NCT05576233: • Comparison of Blood Culture Contamination Rates
Official title: Comparison of Blood Culture Contamination Rates Between the Use of Povidine Iodine/Alcohol for Skin Antisepsis and the Use of Chlorhexidine/Alcohol (ChloraPrep) for Skin Antisepsis: An Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Culture Contamination
Keywords: Blood culture contamination
Chloraprep ( alcohol/ chlorhexidine)
Povidine/iodine
Topical disinfectants
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.

Detailed description: Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.

Full randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.

Eligibility criteria: Inclusion Criteria:

* patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to

Exclusion Criteria:

* The patents with central lines will be excluded.
* The patient who were transferred from ICU's will be excluded.

Primary outcomes:
measure: Blood Contamination
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00559533: A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors
Official title: A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* solid tumor malignancies;
* failed prior therapies, or no standard therapy available;
* ECOG performance status of 0-2.

Exclusion Criteria:

* patients receiving any other agent or therapy to treat their malignancy;
* pre-existing gastrointestinal disorders which may interfere with absorption of drugs;
* clinically significant cardiovascular disease.

Primary outcomes:
measure: MTD and associated dose schedule
timeFrame: Every 28 days
Secondary outcomes:
measure: Clinical response
timeFrame: Event driven
measure: Dose-limiting toxicities.
timeFrame: Throughout study
measure: Pharmacokinetic profile
timeFrame: Throughout study
measure: Comparison safety and tolerability of daily versus twice daily dosing regimens
timeFrame: approximately 18 months
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Bordeaux
country: France
city: Lyon
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03940833: Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Official title: Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Asclepius Technology Company Group (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.


Eligibility criteria: Inclusion Criteria:

1. 18 years to 80 years, expected survival \> 3 months
2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry
3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease
4. ECOG performance status of 0 - 1
5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN
6. No serious allergic constitution
7. No other serous diseases that conflicts with the clinical program
8. No other cancer history
9. Female participants of reproductive potential must have a negative serum pregnancy test
10. Subjects must have signed written, informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive
3. Active hepatitis B or hepatitis C infection
4. Recent or current use of glucocorticoid or other immunosuppressor
5. Serious mental disorder
6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases
7. Participate in other clinical research in the past three months
8. Previously treatment with any gene therapy products

Primary outcomes:
measure: Occurrence of treatment related adverse events as assessed by CTCAE v4.03
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Department of Hematology, Wuxi People's Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.
Clinical trial NCT01925833: Adenoma Detection by Polypectomy During Both Insertion and Withdrawal
Official title: Comparison of Adenoma Detection by Polypectomy During Both Insertion and Withdrawal Versus Only Withdrawal of Colonoscopy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma of Large Intestine
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 1142
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. \<1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of adenoma per patient
timeFrame: 4 weeks
Other outcomes:
measure: Polyp miss rate
timeFrame: 4 weeks
Locations:
Study officials:
References:
citation: Gweon TG, Lee SW, Ji JS, Lee JR, Kim JS, Kim BW, Choi H. Comparison of adenoma detection by colonoscopy between polypectomy performed during both insertion and withdrawal versus during withdrawal only: a multicenter, randomized, controlled trial. Surg Endosc. 2020 Dec;34(12):5461-5468. doi: 10.1007/s00464-019-07342-4. Epub 2020 Jan 17.
Clinical trial NCT00861133: Cryptogenic Stroke Study
Official title: Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cryptogenic Stroke
Keywords: cardiac monitor
loop recorder
stroke
ECG
Implantable Loop Recorder
cryptogenic
ILR
Lead sponsor: Transoma Medical
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.


Eligibility criteria: Inclusion Criteria:

* Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
* Negative brain image for hemorrhagic stroke
* In sinus rhythm at time of enrollment

Exclusion Criteria:

* Know history of atrial fibrillation
* Previous implanted cardiac device (ppM or ICD)
* Serious illness making it unlikely to survive one year
* Known secondary cause of stroke

Primary outcomes:
measure: Incidence of atrial fibrillation at one year from Sleuth implantation.
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Western University, Canada
name: Andrew Krahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02024633: Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer
Official title: Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy.
* ECOG Performance Status of 0 to 1.
* Adequate organ function as defined by study-specified laboratory tests.
* Signed informed consent form.
* Willing and able to comply with study procedures.

Exclusion Criteria:

* Previous chemotherapy or target therapy.
* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions.
* Systemically active steroids.
* Another investigational product within 28 days prior to receiving study drug.
* Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug.
* Infection with HIV, hepatitis B or C at screening.
* Pregnant or lactating.
* Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.

Primary outcomes:
measure: The number of patients who suffer adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Tumor response assessed by RECIST 1.1
timeFrame: 3 months
measure: Progression-free survival
timeFrame: 4 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang Univercity School of Medcine
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang Univercity School of Medcine
name: Tingbo Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214733: A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
Official title: An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
* Patients successfully completed studies WA17823 and WA18696 in South Africa
* Body weight \<150 kg

Exclusion Criteria:

* Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
* Previous treatment with any cell depleting therapies
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696

Primary outcomes:
measure: Safety (incidence of adverse events)
timeFrame: 104 weeks
measure: Safety (laboratory assessments e.g. hematology)
timeFrame: 104 weeks
Secondary outcomes:
measure: Efficacy: Change in Disease Activity Score (DAS28)
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Diepkloof
country: South Africa
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: