louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03824977: Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
Official title: Prognostic Value of the 6-minute Stepper Test in Non-small Cell Lung Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasm Malignant
Resectable Lung Non-Small Cell Carcinoma
Keywords: lung resection
low technology
six minutes stepper test
sit to stand test
physiotherapy
lung surgery
post-operative complications
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients are included. On the day of the surgical consultation, the patient is informed of the modalities of the study by the thoracic surgeon and collects his non-opposition of participation. He is also evaluated by a physiotherapist, who supervises the realization of 6MST and STST.

Brief summary: The objective of this study is to evaluate the performances of the Six-Minute Stepper Test (6MST) and Sit To Stand test (STST) to predict post-operative complications after minimally invasive lung cancer resection.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Non-small cell lung cancer stage I to II, justifying major resection by VATS or RATS (segmentectomy, lobectomy, pneumonectomy), with or without histological confirmation

Exclusion Criteria:

* Partial or total amputation localized to the lower limb;
* Weight greater than 100 kg;
* Orthopedic, vascular or neurological disorders leading to the incapacity of realize the 6MST;
* Patient under tutorship or curatorship;
* Pregnant woman.
* Surgery canceled

Primary outcomes:
measure: occurrence of a post-operative complication grade ≥ 2 on the Clavien-Dindo scale within three months after surgery
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Boujibar , F
Study officials:
References:
citation: Boujibar F, Gillibert A, Bonnevie T, Rinieri P, Montagne F, Selim J, Cuvelier A, Gravier FE, Baste JM. The 6-minute stepper test and the sit-to-stand test predict complications after major pulmonary resection via minimally invasive surgery: a prospective inception cohort study. J Physiother. 2022 Apr;68(2):130-135. doi: 10.1016/j.jphys.2022.03.001. Epub 2022 Apr 5.
Clinical trial NCT01553877: Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Official title: Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Moderately Malnourished Children
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.


Eligibility criteria: Inclusion Criteria:

* 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day.

Exclusion Criteria:

* loss of appetite,
* oral lesion,
* congenital anomaly/acquired disorder affecting growth,
* severe acute malnutrition (SAM) defined by:

  * MUAC \< 115 mm or
  * WL \< -3 Z score or
  * bipedal edema,
  * persistent diarrhea,
  * tuberculosis,
  * any other chronic illness.

Primary outcomes:
measure: Acceptability of at least one Ready -to-Use Complementary Food supplement
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: ICDDR,B
Study officials:
References:
citation: Ahmed T, Choudhury N, Hossain MI, Tangsuphoom N, Islam MM, de Pee S, Steiger G, Fuli R, Sarker SA, Parveen M, West KP Jr, Christian P. Development and acceptability testing of ready-to-use supplementary food made from locally available food ingredients in Bangladesh. BMC Pediatr. 2014 Jun 27;14:164. doi: 10.1186/1471-2431-14-164.
Clinical trial NCT02339077: Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
Official title: Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stillbirth
Keywords: Group B Streptococcus, stillborn
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 354
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stillborn infants (gestational age \>= 28 weeks gestation) born at CHBAH

Brief summary: This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths

Detailed description: A prospective, descriptive study will be undertaken involving mothers who have a stillbirth at Chris Hani Baragwanath Academic Hospital (CHBAH), a secondary-tertiary care hospital, from 2014 up until 2016.

Eligibility criteria: Inclusion Criteria:

* Pregnant women delivering a stillbirth at CHBAH
* Participants aged ≥18 years
* Able to understand and comply with planned study procedures
* Provides written informed consent (either generic ICF or V98_28OBTP)

Exclusion Criteria:

* Refuses to consent to study participation

Primary outcomes:
measure: Determine the number of stillbirths who have GBS isolated from cord blood, gastric aspirates, placenta and/ or skin swabs
timeFrame: Birth
Secondary outcomes:
measure: Number of stillbirths occurring at CHBAH, and identify potential causes of the stillbirths (maternal and obstetric risk factors)
timeFrame: Birth
measure: Number of stillbirths related to a probable Infectious cause
timeFrame: Birth
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Respiratory and Meningeal Pathogen Research Unit
state: Gauteng
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
Study officials:
References:
Clinical trial NCT04601077: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
Official title: Pilot Study: The Evaluation of Nitric Oxide Generating Lozenges on Outcome in Newly Diagnosed COVID-19 Patient of African American and Hispanic Origin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Nitric Oxide Innovations LLC
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 524
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo Control
Primary purpose: TREATMENT

Brief summary: This study is a multi-center, randomized, double blinded, prospective, placebo controlled study. Patients upon diagnosis of COVID-19 (Corona Virus Disease-19) will be eligible to participate in the study. The purpose of this study is to find out the side effects and ability to take the study drug, Nitric Oxide (NO) lozenges when taken twice daily by mouth. If this study shows that the drug has no or few, acceptable side effects, it will then include up to 840 participants to find out if the drug can reduce bad outcomes of COVID-19 infection (hospitalization, ICU admission, death). In each part of the study, half of the subjects will receive the study drug and the other half will be given a placebo (inactive pill).


Eligibility criteria: Inclusion Criteria:

1. Male or female of 50-85 years of age
2. Subjects with recent COVID-19 diagnosis (within 72 hours), that are symptomatic (fever, cough, SOB, weakness, or other flu-like symptoms).
3. Agrees to comply with study procedures (diary, oximeter readings, telephone follow up).
4. Has given voluntary, written, informed consent to participate in the study.
5. Identifies as African American or Hispanic Origin
6. Patients must have at least 1 risk factor (history of hypertension (BP\> 140/99) CHF, angina, prior MI, coronary angiography with one significantly occluded vessel, diabetes mellitus, obesity, or smoking, (for at least 5 years).

Exclusion Criteria:

1. Females who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
2. Patients unresponsive or unable to take anything by mouth (NPO).
3. Individuals who are cognitively impaired and/or who are unable to give informed consent.
4. Blood pressure below 110 mmHg systolic and 60 mmHg diastolic on entry into study.
5. History of syncope or other symptoms of orthostatic hypotension.
6. History of methemoglobinemia.
7. Severe case of G6PD deficiency

Primary outcomes:
measure: Low blood pressure
timeFrame: 30 days
measure: dizziness
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of hospitalization, ICU admission, intubation, dialysis and death
timeFrame: 30 Days
Other outcomes:
Locations:
city: Lake Bluff
country: United States
facility: American Institute of Therapeutics
state: Illinois
Study officials:
References:
Clinical trial NCT01799577: Comparison of 2-Dimensional and 3-Dimensional Laparoscopic Visions
Official title: Comparison of 2-Dimensional and New Generation 3-Dimensional Laparoscopic Visions In An Experimental Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Self Evaluation
Keywords: laparoscopy, accuracy, duration
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Medical doctors

Brief summary: This study tests the hypothesis that use of the 3-D laparoscopic vision system (Viking Systems, La Jolla, CA) can significantly improve technical ability on a complex laparoscopic tasks in an experimental model.

Detailed description: 7 tasks on a 3-D laparoscopic instrument fitted to the trainer box and subjective criteria (4 point lickert scale) were evaluated for this study. Totally twenty-four participants (8 experienced, 8 minimal experienced and 8 novices) were evaluated for different 10 tasks (touch the marked circle, pass the two circle with needle, pick-beads and place, grape the suture, move the needle from one instrument to another instrument, pick-and-place, cutting, three different suturing) in term of total task time and error number. Statistical Package Program was used to perform statistical analyses. The data were presented as arithmetic means and standard deviations were calculated in each group. A P value of \<0.05 was considered to be statistically significant.

Eligibility criteria: Inclusion Criteria:

medical doctors

Exclusion Criteria:

disabled person (about arms or vision problems)

Primary outcomes:
measure: In order to test whether the 3-D laparoscopy vision system is superior or not than the 2-D laparoscopic vision system.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Trainig and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: TANER USTA, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Usta TA, Ozkaynak A, Kovalak E, Ergul E, Naki MM, Kaya E. An assessment of the new generation three-dimensional high definition laparoscopic vision system on surgical skills: a randomized prospective study. Surg Endosc. 2015 Aug;29(8):2305-13. doi: 10.1007/s00464-014-3949-0. Epub 2014 Nov 21.
Clinical trial NCT01353677: Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
Official title: Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic stem cell transplantation
QOL
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: Medical College of Wisconsin
First posted: 2011-05-16
Enrollment: 390
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric and adult allogeneic HCT recipients

Brief summary: This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Detailed description: QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Eligibility criteria: Inclusion Criteria:

1. Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
3. Patient must have a valid mailing address within the United States to receive QOL surveys.
4. Ability to speak and read English.
5. Patients with access to a telephone.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: CIBMTR/ Medical College of Wisconsin
name: Douglas Rizzo, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455377: Lung Function and Airway Inflammation in Portland Cement Workers
Official title: Airway Inflammation in Cement Dust Exposed Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Inflammation
Peripheral Blood Inflammation Markers
Cement Dust Exposure
Keywords: Cement dust exposure
Induced sputum
Airway inflammation
Peripheral blood inflammation markers
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Rikshospitalet University Hospital
name: Helse Sor-Ost
First posted: 2007-04-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers from Norways largest cement plant

Brief summary: The aim of the study is to examine inflammation in the airways and in peripheral blood, in workers in a cement plant i Norway.

Detailed description: OBJECTIVE: Former studies have presented conflicting data on the association between exposure to Portland cement dust and respiratory effects. Our goal is to examine inflammation in the airways and in peripheral blood in subjects exposed to cement-dust.

METHODS: All non smoking, dust exposed, workers from one department in the largest cement plant in Norway, are invited to participate. The workers will perform spirometry and induced sputum (IS) after a period of regular work with cement dust exposure, and again after a minimum of 5 days without exposure. Information on respiratory symptoms, allergy and former respiratory disease will be given on a self-reported questionnaire. IS was performed and processed as described by Pin et al. Differential cell counts will be carried out. Inflammatory markers in induced sputum and in peripheral blood will be measured. We want to use a crossover design were the cases are used as their own controls, but we will also include external controls.

Eligibility criteria: Inclusion Criteria:

* Cement dust exposure
* Non-smoker or ex-smoker \>3 years

Exclusion Criteria:

* Infectious disease during the last 3 weeks
* Chronic airway disease

Primary outcomes:
measure: Percentage of neutrophile cells in induced sputum
timeFrame: Before and after a period of exposure
measure: Concentration of Interleukin 1beta in induced sputum
timeFrame: Before and after a period of exposure to cement production dust
Secondary outcomes:
Other outcomes:
Locations:
city: Skien
country: Norway
facility: Sykehuset Telemark
state: Telemark
Study officials:
affiliation: Department of respiratory medicine, Radiumhospitalet-Rikshospitalet Medical Centre, Oslo
name: Johny Kongerud, MD, Phd,
role: STUDY_CHAIR
References:
citation: Fell AK, Sikkeland LI, Svendsen MV, Kongerud J. Airway inflammation in cement production workers. Occup Environ Med. 2010 Jun;67(6):395-400. doi: 10.1136/oem.2009.047852. Epub 2009 Oct 22.
Clinical trial NCT01893177: Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)
Official title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Inflexal V
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.


Eligibility criteria: Inclusion Criteria:

* Healthy female and male adults aged ≥18 on Day 1
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative of the investigator
* Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Primary outcomes:
measure: Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)
timeFrame: Day 22 +/- 2 days
Secondary outcomes:
measure: Incidence of solicited local adverse events
timeFrame: Days 1 to 4 inclusive
measure: Incidence of solicited systemic adverse events
timeFrame: Days 1 to 4 inclusive
measure: Incidence of unsolicited adverse events
timeFrame: Days 1 to 22 inclusive
Other outcomes:
Locations:
city: Arzo
country: Switzerland
facility: CROSS Research S.A. - Phase I Unit
Study officials:
affiliation: Cross Research S.A.
name: Milko Radicioni, MD
role: PRINCIPAL_INVESTIGATOR
References: