louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00543673: Tolerance of Healthy, Term Infants to Infant Formulas
Official title: Tolerance of Healthy, Term Infants to Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Healthy
Keywords: Healthy term infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 180
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula


Eligibility criteria: Inclusion Criteria:

* judged to be in good health.
* singleton from a full term birth with a gestational age of 37-42 weeks
* birth weight was \> 2490 g (\~5 lbs 8 oz)
* between 0 and 8 days of age at enrollment.
* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
* Infant has been treated with antibiotics.

Primary outcomes:
measure: Mean rank stool consistency (MRSC)
timeFrame: Study Day 1 to Visit 3
Secondary outcomes:
measure: MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting
timeFrame: 4 months
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: The Pediatric Clinic
state: Arkansas
city: Tampa
country: United States
facility: USF
state: Florida
city: Dalton
country: United States
facility: North Georgia Clinical Research, White's Pediatrics
state: Georgia
city: Dubuque
country: United States
facility: Medical Associates Clinic
state: Iowa
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC
state: Nebraska
city: Poughkeepsie
country: United States
facility: The Childrens Medical Group LLC
state: New York
city: Charlotte
country: United States
facility: Levine Childrens Hospital
state: North Carolina
city: Huber Heights
country: United States
facility: Ohio Pediatrics, Inc.
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
affiliation: Abbott Nutrition, Abbott Laboratories
name: Timberly A. Williams, M.S.
role: STUDY_CHAIR
References:
citation: Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513.
Clinical trial NCT02429973: Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Official title: Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: Osteosarcoma
Lead sponsor: Broto, Javier Martín, M.D.
Sponsor class: INDIV
First posted: 2015-04-29
Enrollment: 33
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

Detailed description: The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed before any trial test
* Age equal or less than 80 years
* Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
* Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
* Measurable disease, acoording to RECIST criteria
* ECOG 0-2

Exclusion Criteria:

* Patients who have been irradiated on target lesions
* ECOG \>2
* Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
* History of other cancers except basal cell cancer or cervical cancer adequately treated
* Serious cardiovascular disease

Primary outcomes:
measure: Progression free survival (PFS) rate
timeFrame: 4 months
Secondary outcomes:
measure: Tumor response according to RECIST
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Virgen del Rocío Hospital
name: Javier Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01934673: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Malaysia
Official title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 1668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

Brief summary: This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in subjects with type 2 diabetes in Malaysia.


Eligibility criteria: Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 2 years and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy

Primary outcomes:
measure: Proportion of patients having HbA1c ((glycosylated haemoglobin) as measured during survey) less than 7%
timeFrame: Evaluated at the first visit (only one study visit)
Secondary outcomes:
measure: Mean Fasting Plasma Glucose (FPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean Postprandial Plasma Glucose (PPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean HbA1c of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having dyslipidemia
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having hypertension
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having cardiovascular complications
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having peripheral vascular disease
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic nephropathy
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic eye complications
timeFrame: Evaluated at the first visit (only one study visit)
Other outcomes:
Locations:
city: Selangor Darul Ehsan
country: Malaysia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02129673: A Phase 1/2 Multicenter, Randomized, Study to Evaluate the Safety and Efficacy of VS101 Subconjunctival Latanoprost Insert in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase 1/2 Multicenter, Randomized, Controlled Dose-Finding Study to Evaluate the Safety and Ocular Hypotensive Efficacy of 3 Dose Levels of the VS101 Subconjunctival Latanoprost Insert for 3 Months in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Intra-ocular pressure
Slow Release
Controlled release
Lead sponsor: ViSci Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Slow release formulation of latanoprost is compared for safety and pressure-lowering efficacy with topically administration of commercially available latanoprost in patient with glaucoma and ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Open angle glaucoma or Ocular Hypertension

Exclusion Criteria:

* uncontrolled medical conditions
* wearing of contact lenses

Primary outcomes:
measure: Intra-ocular pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Intra-ocular pressure
timeFrame: Week 8
measure: Intra-ocular pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Speciality Eyecare Centre
state: Washington
Study officials:
References:
Clinical trial NCT02141373: Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Official title: Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: seroma
axillary
dissection
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Glubran 2 as a surgical glue maybe effective in reducing seroma formation post axillary dissection in breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* The Patient should be above 18 years old
* The Patients has Node positive breast cancer
* The Patient is eligible for axillary dissection in addition to a surgical intervention for the primary tumor
* Patients whose sentinel lymph nodes test positive during surgery.
* The patient is willing to sign an informed consent to participation

Exclusion Criteria:

* Platelet count is less than 100000
* Obese patients with a BMI of more than 35
* Patients who need immediate breast reconstruction surgery
* Patients who are receiving anticoagulation therapy or have coagulation disorders
* Pregnant or lactating patients
* Patients who are on steroid therapy
* Patients who received chest radiotherapy
* Patients who received neoadjuvant chemotherapy

Primary outcomes:
measure: Total drainage volume
timeFrame: 3 months
measure: Total seroma aspirate volume
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: 3 months
measure: Duration of fluid drainage
timeFrame: 3 months
measure: Time to drain removal
timeFrame: 3 months
measure: Number of seroma aspirations
timeFrame: 3 months
measure: Additional costs incurred due to the need of aspirations
timeFrame: 3 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: King Hussein Cancer Center
name: Mahmoud Al Masri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Masri M, Alawneh F, Daoud F, Ebous A, Hamdan B, Al-Najjar H, Al-Masri R, Abufara M. Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial. Front Oncol. 2021 Jan 25;10:580861. doi: 10.3389/fonc.2020.580861. eCollection 2020.
Clinical trial NCT03879473: Direct Oral Anticoagulant Management for Cardiac Device Implantation
Official title: Influence of Peri-procedural Management of Direct Oral Anticoagulants on the Incidence of Pocket Hematoma in Patients Undergoing Cardiac Rhythm Device Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulant, Perioperative
Lead sponsor: Institut Necker Enfants Malades
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment
* undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy
* informed

Brief summary: Each year, tens of thousands of cardiac rhythm devices including pacemaker (PM) or implantable cardioverter-defibrillator (ICD) are implanted in France. More than 25% of patients undergoing cardiac device implantation receive long-term anticoagulation therapy, that increases the incidence of pocket hematoma with potential serious consequences for patients. Although more and more patients receive direct oral anticoagulants (DOACs), limited data currently exist on the perioperative management of DOAC-treated patients undergoing cardiac device implantation and the optimal strategy remains unclear. Especially, the time of DOAC resumption after the procedure is controversial.

We hypothesize that the time of DOAC resumption is the main risk factor of bleeding event in DOAC-treated patients undergoing cardiac device implantation, that is to say that a delayed DOAC resumption \> 48 hours following the procedure will reduce pocket hematoma incidence compared with an early resumption, ≤ 48 hours, without increasing thromboembolic events. We propose here an observational multicentre national study to find out the optimal strategy.


Eligibility criteria: Inclusion Criteria:

* receiving DOAC (apixaban, rivaroxaban, dabigatran) for stroke prevention in atrial fibrillation at least 5 days prior to enrolment
* undergoing a cardiac rhythm device implantation (implantation or replacement of PM (1 or 2 leads) and ICD (1or 2 leads) with or without cardiac-resynchronization therapy
* informed

Primary outcomes:
measure: number of patients with clinically significant pocket hematoma
timeFrame: 30 +/- 5 days
Secondary outcomes:
measure: number of patients with thromboembolic event
timeFrame: 30 +/- 5 days
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
Study officials:
affiliation: INSERM 1140
name: Anne-Céline Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03001973: High Quality Evidence of Chinese Lupus Nephritis (HELP)
Official title: High Quality Evidence of Chinese Lupus Nephritis (HELP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Nephritis
Keywords: Lupus nephritis
Patient survival
Renal survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Lupus nephritis patients

Brief summary: The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.

Detailed description: The investigators are registering Lupus nephritis (LN) and developing a LN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. Patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. We will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival will be compared using the LN database.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnosis as lupus nephritis

Exclusion Criteria:

* No

Primary outcomes:
measure: All-cause mortality and cardiovascular mortality of LN patients
timeFrame: 10years
measure: A composite renal outcome of LN patients
timeFrame: 10years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Tian N, Zhou Q, Yin P, Chen W, Hong L, Luo Q, Chen M, Yu X, Chen W. Long-Term Kidney Prognosis and Pathological Characteristics of Late-Onset Lupus Nephritis. Front Med (Lausanne). 2022 May 30;9:882692. doi: 10.3389/fmed.2022.882692. eCollection 2022.
citation: Yin P, Zhou Y, Li B, Hong L, Chen W, Yu X. Effect of low and high HDL-C levels on the prognosis of lupus nephritis patients: a prospective cohort study. Lipids Health Dis. 2017 Dec 6;16(1):232. doi: 10.1186/s12944-017-0622-3.
Clinical trial NCT02075073: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Official title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Trastuzumab (SB3, EU Sourced Herceptin® and US Sourced Herceptin®) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 109
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies.
* history of and/or current cardiac disease
* previously received any monoclonal antibody or fusion protein.
* history of cancer including lymphoma, leukaemia and skin cancer.
* Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
* intake medication with a half-life \> 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
timeFrame: 57 days
measure: Maximum Serum Concentration (Cmax)
timeFrame: 57 days
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
timeFrame: 57 days
Secondary outcomes:
measure: Time to Cmax (Tmax)
timeFrame: 57 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Samsung Investigational Site
Study officials:
affiliation: Samsung Bioepis Co., Ltd.
name: Saumsung Bioepis
role: STUDY_DIRECTOR
References:
citation: Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, Kim Y, Kim H, Fuhr R. A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects. Clin Ther. 2016 Jul;38(7):1665-1673.e3. doi: 10.1016/j.clinthera.2016.06.002. Epub 2016 Jun 29.
Clinical trial NCT00642473: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Official title: A Phase II Trial Assessing Metronidazol Actavis 1% Topical Cream in the Prevention and Treatment of Erlotinib Associated Rash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 34
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 evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with Tarceva treatment, in participants with non-small cell lung cancer. The first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with Tarceva (150 mg orally daily). The corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). The second cohort of Tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. In both cohorts, efficacy will be evaluated at Week 2 and Week 4. The anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* non-small cell lung cancer
* eligible to start treatment with erlotinib

Exclusion Criteria:

* hypersensitivity to metronidazole

Primary outcomes:
measure: Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 2
timeFrame: After 2 weeks of metronidazole treatment
measure: Percentage of Participants With Erlotinib Associated Rash Stratified by Severity Grade at Week 4
timeFrame: After 4 weeks of metronidazole treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Goeteborg
country: Sweden
city: Lund
country: Sweden
city: Malmoe
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Vaxjo
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: