louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00502931: A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices
Official title: A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resting Metabolic Rate
Lead sponsor: Microlife
Sponsor class: INDUSTRY
First posted: 2007-07-18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka "Gem") was introduced as a convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy needs. Several validation and comparison studies were conducted to determine if the Gem device is accurate and reliable. The purpose of this study was to conduct a systematic review of previous studies that evaluated the accuracy and reliability of the Gem devices.


Eligibility criteria: Inclusion Criteria:

* Random or counterbalanced assignment of participants to eliminate measurement bias; similar subject positioning for both Gem and reference system measurement or adjustment to a measurement for positioning differences; and use of a measurement protocol that is similar to the established "best practice" guidelines for employing indirect calorimetry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Microlife Health Solutions
state: Colorado
Study officials:
affiliation: Microlife USA, Inc.
name: Scott O McDoniel, M.Ed.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03455231: Short Course Radiotherapy in Complicated Bone Metastases Palliation
Official title: Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
complicated bone metastases
radiotherapy
pain
quality of life
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 45
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 study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.

Detailed description: The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.

Eligibility criteria: Inclusion Criteria:

* radiologically proven complicated bone metastasis
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \< 3

Exclusion Criteria:

* prior RT to the same region

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: 1 year
Secondary outcomes:
measure: Acute toxicity
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
measure: Pain relief
timeFrame: 1 year
measure: Late toxicity
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy
name: Alessio G. Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capuccini J, Macchia G, Farina E, Buwenge M, Genovesi D, Caravatta L, Nguyen NP, Cammelli S, Cilla S, Wondemagegnhu T, Uddin AFMK, Aziz Sumon M, Cellini F, Valentini V, Deodato F, Morganti AG. Short-course regimen of palliative radiotherapy in complicated bone metastases: a phase i-ii study (SHARON Project). Clin Exp Metastasis. 2018 Oct;35(7):605-611. doi: 10.1007/s10585-018-9931-9. Epub 2018 Aug 18.
Clinical trial NCT06161831: HPV Vaccine Reminders - SEARCH II Study
Official title: SEARCH II: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Human Papillomavirus Vaccination
Keywords: Human papillomavirus
Vaccination
Text message
SMS
mHealth
Uganda
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Makerere University
name: National Cancer Institute (NCI)
First posted: 2023-12-08
Enrollment: 396
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This RCT will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.

Detailed description: Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.

Eligibility criteria: Inclusion Criteria:

* Be a parenting adult of an adolescent girl aged 10-14 years
* Reside in Kampala and/or the surrounding districts
* Speak English or Luganda
* Have a cell phone with text messaging capability
* Must have ability to consent

Exclusion Criteria:

* Parenting adult speaks other language than English or Luganda only
* Parenting adult already enrolled in the study for another child
* Participation in previous HPV vaccine reminder study

Primary outcomes:
measure: Time to Receipt of First HPV Vaccine Dose
timeFrame: 12 months
measure: Time to Receipt of Second HPV Vaccine Dose
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Kampala
country: Uganda
facility: Makerere University/Mulago Hospital
Study officials:
affiliation: Columbia University
name: Melissa S Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578431: Artificial Sweeteners in Breast Milk
Official title: Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Diabetes Mellitus
Overweight
Keywords: Artificial sweeteners
Non-nutritive sweeteners
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status.

The groups are

1. Normal weight (BMI \< 25),
2. Over weight (BMI \> 27),
3. Diabetic
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.


Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* Able to give consent
* Able to produce enough amounts of breastmilk
* Danish/English speakers
* Pre-pregnancy BMI below 25 (20 subjects)
* Pre-pregnancy BMI above 27 (20 subjects)
* Diabetes type 1 or 2 (20 subjects)

Exclusion Criteria:

* Under the age of 18 years old
* Unable to give consent
* Unable to produce enough amounts of breastmilk
* Non-Danish/English speakers
* If they have consumed artificial sweeteners 24 hours prior to trial

Primary outcomes:
measure: Breastmilk from mother
timeFrame: Baseline, after 30 mins and afterwards once and hour for six hours
measure: Blood from mother
timeFrame: Baseline, after 30 mins and afterwards once and hour for six hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01407731: Protein Expression in Human Neuroblastoma Tumor Samples
Official title: Analysis of Intersectin Expression in Primary Human Neuroblastomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Keywords: disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
stage 4S neuroblastoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-08-02
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with neuroblastoma.

Brief summary: RATIONALE: Studying protein expression in samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat neuroblastoma.

PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.

Detailed description: OBJECTIVES:

* To determine whether intersectin (ITSN1) proteins are present at elevated levels in primary human tumor samples.

OUTLINE: Archived tumor tissue samples are analyzed for intersectin (ITSN1) expression by western blot assays with enhanced chemiluminescence and exposed to X-ray film. The films are scanned, and levels of ITSN1 signal are quantified by densitometry.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with neuroblastoma
* Banked primary tumor samples from patients with stage 1, 2, 3, and 4 disease

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: John P. O'Bryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592331: A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
Official title: A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.

Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or placebo. In-unit period is 6 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Must agree to use a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study drug
* Donation of blood over 500 mL within 6 weeks before drug administration

Exclusion Criteria:

* Concomitant disease or condition or treatment that could interfere with the conduct of the study or would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
* Allergy to lidocaine
* Suspicion of regular consumption of drug of abuse
* Regular smoker (\> 5 cigarettes, \> 1 pipeful or \> 1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
* Participation in an investigational drug or device study (last administration of study drug or installation of device) within 6 weeks before RO5508887 administration and within 5 mean half-lives of receiving previous investigational drug before RO5508887 administration. In addition, subject cannot participate unless completely recovered from previous invasive or study procedure
* Donation of blood over 500 mL within 6 weeks before drug administration

Primary outcomes:
measure: Plasma levels of amyloid biomarkers
timeFrame: Pre-dose and up to fullow up, 8-12 days post dose
measure: Cerebral spinal fluid levels of amyloid biomarkers
timeFrame: Pre-dose and up to 30 hours post-dose
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 6 months
measure: Pharmacokinetics: Plasma and cerebral spinal fluid concentrations of RO5508887 (and metabolites)
timeFrame: Pre-dose and up to 72 hours post-dose
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04707131: A Study of Single Ascending Dose of LEM-S401 in Healthy Participants
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cicatrix
Scar Prevention
Keywords: Scars
Scar prevention
Fibrosis
Lead sponsor: Lemonex
Sponsor class: INDUSTRY
First posted: 2021-01-13
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.

Detailed description: This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects.

Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 19 to ≤ 65 years at screening

Exclusion Criteria:

* Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other
* History of drug abuse or positive urine drug screen at screening
* For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects

Primary outcomes:
measure: The safety and tolerability of LEM-S401 evaluated by incidence of adverse events
timeFrame: Up to 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
Study officials:
affiliation: Lemonex Inc.
name: Lemonex Inc. Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00539331: Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients
Official title: A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small Cell Lung Cancer
NSCLC
AZD2171
Paclitaxel/Carboplatin
Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-04
Enrollment: 6
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: The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.


Eligibility criteria: Inclusion Criteria:

* Having histologically or cytologically confirmed NSCLC
* Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
* WHO performance status 0-1

Exclusion Criteria:

* Untreated unstable brain or meningeal metastases
* Patient with inappropriate laboratory tests values
* Patient with poorly controlled hypertension

Primary outcomes:
measure: PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer
timeFrame: Assessed at each visit during Part A
measure: PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)
timeFrame: time to progression
Secondary outcomes:
measure: PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel
timeFrame: Assessed at each visit during Part A
measure: PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival
timeFrame: time to death
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
affiliation: Sakai hospital Kinki University School of Medicine
name: Masahiro Fukuoka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Xiaojin Shin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04714931: Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)
Official title: Sentinel Lymph Node Assessment In Ovarian Cancer - Turkish Gynecologic Oncology Group Study (TRSGO-SLN-005)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Sentinel Lymph Node
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, Controlled, not randomized
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

Detailed description: Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.

Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.

Eligibility criteria: Inclusion Criteria:

* Patients with Early stage ovarian cancer

Exclusion Criteria:

* Patient who had been administrated chemotherapy prior to surgery
* Patients who had diagnosed with malignancy other than ovarian cancer.
* Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
* Patients who have allergy for the tracers.

Primary outcomes:
measure: Sentinel lymph node localization
timeFrame: 12 months
measure: Sentinel lymph node technique accuracy in ovarian cancer
timeFrame: 12 months
measure: PPV and NPV of sentinel lymph node procedure in ovarian cancer
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Sentinel lymph node detection rate
timeFrame: 12 months
Secondary outcomes:
measure: Tracer comparisons
timeFrame: 12 months
measure: Assessment of the sentinel tecniques
timeFrame: 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem MAA University Maslak Hospital
Study officials:
affiliation: Acibadem MAA University Maslak Hospital
name: Mete Gungor, Prof.
role: STUDY_DIRECTOR
References: