louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00117780: Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes
Official title: Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-07-08
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for more than 1 year
* Subject treated by any kind of insulin regimen and whatever the number of injections
* HbA1c = 7.5% and = 10%

Exclusion Criteria:

* Type 2 diabetes
* Treatment by oral anti-diabetic drugs
* Severe medical conditions

Primary outcomes:
measure: Mean HbA1c
timeFrame: after 4 months of insulin detemir treatment
Secondary outcomes:
measure: HbA1c
measure: Adverse events
measure: Insulin dose requirements during initial 4 months of treatment and during 3 months extension
measure: Weight
measure: Blood glucose
measure: Hypoglycaemia
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Luxembourg
country: Luxembourg
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Le Floch JP, Levy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. doi: 10.2337/dc08-0332. Epub 2008 Oct 22.
Clinical trial NCT02057380: A Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
Official title: A Phase II Open-label Rollover Study for Subjects That Have Participated in an Astellas Sponsored Linsitinib Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Solid Tumors
Keywords: Paclitaxel
Linsitinib
OSI-774
Advanced Solid Tumor
Tarceva
Erlotinib
OSI-906
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 13
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: The purpose of this study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.


Eligibility criteria: Inclusion Criteria:

* Subject must currently be participating in an Astellas sponsored linsitinib trial that has ended with respect to the overall study analysis.
* Subject must not have met criteria for discontinuation or have progressed on the current linsitinib study in which they are participating.
* Subject must be deriving benefit from continued treatment.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Site US10004
state: California
city: Tampa
country: United States
facility: Site US10006
state: Florida
city: Baltimore
country: United States
facility: Site US10002
state: Maryland
city: Ann Arbor
country: United States
facility: Site US10008
state: Michigan
city: Oklahoma City
country: United States
facility: Site US10001
state: Oklahoma
city: Porto Alegre
country: Brazil
facility: Site BR55005
state: Rio Grande Do Sul
city: Ostrava-Poruba
country: Czechia
facility: Site CZ42001
city: Berlin
country: Germany
facility: Site DE49002
city: Wuerzburg
country: Germany
facility: Site DE49001
city: Szczecin
country: Poland
facility: Site PL48001
state: Zachodniopomorskie
city: Singapore
country: Singapore
facility: Site SG65002
city: Khon Kaen
country: Thailand
facility: Site TH66003
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Executive Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04497662: Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
Official title: A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Kiniksa Pharmaceuticals International, plc
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

Detailed description: This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).

Safety assessments will include adverse events (AEs), concomitant medications, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood samples for PK, PD, and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period.

Eligibility criteria: Key Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2

Key Exclusion Criteria:

* Poor peripheral venous access
* Clinically-significant illness within 4 weeks of dose administration
* Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening

Primary outcomes:
measure: TEAEs following IV dosing
timeFrame: Up to 65 days post dose
measure: TEAEs following SC dosing
timeFrame: Up to 65 days post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Clinic
state: Texas
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
state: Queensland
Study officials:
References:
Clinical trial NCT05029362: SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
Official title: SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: LGBTQI
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.


Eligibility criteria: Inclusion Criteria:

* Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their lifetime and smokes everyday
* Have an interest in quitting smoking in the next 15 days
* Have a cellphone number with an unlimited short messaging service (SMS) plan
* Have US mailing and email addresses
* Positive cotinine saliva test results

Exclusion Criteria:

* Individuals who are found to have a prepaid cell phone
* Individuals who are found to have a cellphone number that does not work or is registered to someone else
* Pregnant or breastfeeding women
* Contraindication for nicotine patch
* Regular use of tobacco products other than cigarettes
* Current use of tobacco cessation medications
* Enrolled in another smoking cessation study
* Non-English speakers
* Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions

Primary outcomes:
measure: Perceived Usability as Assessed by the System Usability Scale (SUS)
timeFrame: 1 month after quit date
Secondary outcomes:
measure: Engagement as Assessed by the Number of Text Messages Sent and Received by Study Participants After Enrollment.
timeFrame: 1 month after enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Irene Tami-Maury, DMD, MSc, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646462: Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer
Official title: Systematic Lymph Node Sampling and Analysis in Patients Undergoing Radical Resection for Pancreatic Cancer. A National Danish Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: pancreas adenocarcinoma, lymph node metastases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla) referred for pancreas resection

Brief summary: Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Detailed description: Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

Eligibility criteria: Inclusion Criteria:

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)

Exclusion Criteria:

Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

Primary outcomes:
measure: Ratio of malignant/total number of lymph nodes
timeFrame: 12 months
Secondary outcomes:
measure: Number of N1 patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT00843362: 24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction
Official title: A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor, Induced
Cervical Ripening
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 133
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks

Exclusion Criteria:

* premature rupture of the membranes, history of a previous caesarean section,
* maternal clinical contraindications to the administration of prostaglandins,
* fetal malpresentation

Primary outcomes:
measure: spontaneous vaginal delivery
Secondary outcomes:
measure: induction to labour time
measure: induction to delivery time
measure: rate of failed induction
measure: cost per patient
measure: rate of caesarean section for fetal heart rate abnormalities
measure: 5 minute Apgar score < 7
measure: arterial cord blood pH <7.1
measure: uterine hyperstimulation
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Department of Obstetrics and Gynaecology, University of Brescia
Study officials:
References:
Clinical trial NCT02577562: Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study
Official title: Zenith® Fenestrated AAA Endovascular Graft Clinical Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Abdominal Aortic Aneurysms
Aorto-iliac Aneurysms
Juxtarenal Aneurysms
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-10-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.


Eligibility criteria: Inclusion Criteria:

* Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria:

* Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* Renal artery stenosis greater than 50 percent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: Shands Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: The Indiana Heart Hospital
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT02044562: Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
Official title: Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasopharyngeal Carcinoma
Keywords: dietary nitrate
radiotherapy
nasopharyngeal carcinoma
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Detailed description: Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.

Exclusion Criteria:

* Patients with local invasion or metastatic foci in salivary glands, detected by MRI and PET-CT prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.

Primary outcomes:
measure: plasma nitrate level
timeFrame: one day after nitrate supplementation
Secondary outcomes:
measure: quality of life
timeFrame: one day after nitrate supplementation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University School of Stomatology
state: Beijing
Study officials:
affiliation: Professor and Vice President of Capital Medical University
name: Songlin Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06160362: The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
Official title: The Safety and Efficacy of Double-target CART-19 and 20 Cells in Relapse and Refractory Patients With CD19+/CD20+ Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-hodgkin Lymphoma,B Cell
Keywords: non-Hodgkin's lymphoma
CART
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with relapsed and refractory CD19+/CD20+ NHL.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as R/R NHL
3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
4. Having at least one measurable lesions
5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
6. Life expectancy no less than 3 months
7. enough main organ function
8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study
9. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months
2. Active GVHD
3. History of severe pulmonary dysfunction
4. Active malignant tumor need be treated at the same time
5. Uncontrolled active acute/chronic infection
6. Severe autoimmune diseases or congenital immunodeficiency
7. Untreated active hepatitis
8. HIV-positive, AIDS patients and syphilis infection
9. History of severe allergies to biological products
10. Patients with a history of mental illness
11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Primary outcomes:
measure: safety as assessed by the occurrence of study related adverse events
timeFrame: from the date of recieving intravenous CART cells up to one month
Secondary outcomes:
measure: objective response rate
timeFrame: 28 days and 3 months after recieving intravenous CART cells
measure: peripheral blood CART cell copy number
timeFrame: from the date of recieving intravenous CART cells up to one month
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Zhihua Yao, M.D. Ph.D
role: STUDY_DIRECTOR
References: