louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02012062: Concurrent Nimotuzumab Versus Cisplatin With Radiotherapy for Locoregionally Advanced NPC
Official title: Phase Ⅲ Study of Neoadjuvant TPF Chemotherapy Followed by Radiotherapy With Concurrent Nimotuzumab or Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma (NPC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Neoadjuvant chemotherapy
Concurrent chemotherapy
Nimotuzumab
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Fujian Province Tumor Hospital
name: The First Affiliated Hospital of Xiamen University
First posted: 2013-12-16
Enrollment: 160
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: The study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced NPC. Three hundreds and twenty patients will be recruited into this study.

Detailed description: Scheme:

Eligible stage III and IVA/B NPC patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio.

- Arm Cisplatin:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with IMRT

- Arm nimotuzumab:

Neoadjuvant TPF chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-FU 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with IMRT

Eligibility criteria: Inclusion Criteria:

* Histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx.
* Stage III and IVA/B NPC patients
* KPS \>70
* Age between 18-70
* AGC \> 2000, platelets \> 100,000, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min

Exclusion Criteria:

* Histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma.
* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
* Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
* Patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin)
* Prior radiation treatment to the head and neck or any prior chemotherapy

Primary outcomes:
measure: Number of Participants with Adverse Events (severe radiation-induced skin and mucosal toxicities)
timeFrame: From Day 1 to Day 90 of radiotherapy
Secondary outcomes:
measure: PFS
timeFrame: 3 years
measure: OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References:
Clinical trial NCT01083862: Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Health literacy
patient education
health behaviors
chronic disease management
shared decision-making
patient-centered decision making
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
First posted: 2010-03-10
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study objective was to explore the impact of health literacy on effectiveness of an educational intervention describing life-style and behavior modification for patients "Living with Coronary Artery Disease." Our hypothesis was that a VHS/DVD version of this educational program would be "superior" to printed material alone in its impact on patients' knowledge about coronary artery disease and important life-style changes. Furthermore, we believed this effect would be most notable among patients with low health literacy. We also were interested in the impact of the interventions on secondary outcomes including - health behaviors, health outcomes and patients' subjective experiences.

Detailed description: 187 patients with coronary artery disease (CAD) were randomized to one of two educational interventions prior to scheduled ambulatory visit: VHS/DVD plus printed booklet; or booklet alone. Main measures included health literacy, CAD knowledge assessment; clinical outcomes and health behaviors including - blood pressure, weight, smoking status, exercise and dietary habits.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18,
* Diagnosis of ischemic heart disease.

Exclusion Criteria:

* Nursing home resident,
* Did not speak English, or
* Had a significant visual impairment that precluded their ability to read or watch television.

Primary outcomes:
measure: cardiovascular disease knowledge assessment score
timeFrame: immediate and 6 months
Secondary outcomes:
measure: Smoking status
timeFrame: over 6 months of study
measure: Diet
timeFrame: Over six months of study
measure: Exercise
timeFrame: Over 6 months of study
measure: Weight
timeFrame: over 6 month study
measure: Blood Pressure
timeFrame: over 6 months of study
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: General Internal Medicine Hoxworth Practices
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mark H Eckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06714162: A Dietary Supplement Examined for Anti-ageing Effects
Official title: A 12-week Randomized Controlled Clinical Trial Evaluating the Efficacy of a Dietary Supplement in an Adult Population.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ageing Signs
Lead sponsor: Prenetics Global
Sponsor class: INDUSTRY
Collaborators: name: San Francisco Research Institute
First posted: 2024-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: dietary supplement for healthy ageing


Eligibility criteria: Inclusion Criteria: Healthy Adults -

Exclusion Criteria: Diseases deemed to be unable to participate in the study

-

Primary outcomes:
measure: Cogntiion
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04378062: Pain After Proximal Digital Amputation Prevention
Official title: Pain After Proximal Digital Amputation Prevention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Amputation Neuroma
Amputation
Keywords: Pain
Amputation Neuroma
Finger Amputation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: American Society for Surgery of the Hand
First posted: 2020-05-07
Enrollment: 39
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: Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).

Detailed description: Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.

Eligibility criteria: Inclusion Criteria:

* Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
* Patients have the capacity to complete the informed consent process

Exclusion Criteria:

* Patients less than 18 years of age, prisoner, or other vulnerable population
* Patients with significant concomitant ipsilateral extremity injuries that would confound study
* Patients requiring emergent, staged (guillotine-type) amputations of any kind

Primary outcomes:
measure: bMHQ
timeFrame: 3 months postop minus preop; 6 months postop minus preop
Secondary outcomes:
measure: NPS
timeFrame: 3 months postop minus preop; 6 months postop minus preop
measure: Grip strength
timeFrame: 3 months postop minus preop; 6 months postop minus preop
Other outcomes:
measure: Tinel's sign
timeFrame: Tinel's sign at 3 months; Tinel's sign at 6 months
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Joshua Adkinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Scott N Loewenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04199962: Genomics in Infection and Sepsis to Predict Organ Dysfunction and Outcomes in Sepsis
Official title: Genomic Approaches for Predicting Severity of Organ Dysfunction and Outcomes in Sepsis: a Prospective Cohort Study in Adult Critically Ill Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Infection
Pneumonia
Keywords: sepsis
infection
pneumonia
organ dysfunction
critical illness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted with community acquired pneumonia to a tertiary hospital in Hong Kong.

Brief summary: This is a prospective cohort study using gene expression to study patients with infection and sepsis from pneumonia.

Detailed description: This is a prospective cohort study using single cell transcriptomic profiling and plasma DNA tissue mapping on patients with pneumonia with or without sepsis. The major application of the investigator's study would be the discovery of gene expressions in different leucocytes and plasma DNA associated with each type of organ dysfunction in sepsis. These include cardiovascular, respiratory, hepatic, renal, neurological and haematological dysfunction. This would help prediction, diagnosis and development of therapies to treat sepsis. Leucocyte single cell transcriptome and plasma DNA tissue mapping may addresses the limitations of current evidence in 3 ways: (1) differentiate patients with uncomplicated pneumonia versus pneumonia with associated sepsis, (2) correlation with types and severity of organ dysfunction and (3) identifying molecular phenotypes of sepsis.

Eligibility criteria: Inclusion Criteria:

All of the following:

* newly admitted adult patients (≥ 18 years old)
* suspected community acquired pneumonia (CAP)
* compatible history of either sputum or cough or fever or rigors within 1 week
* chest X-ray infiltrates

Exclusion Criteria:

Any of the following:

* chest symptoms not solely accounted by pneumonia (cardiac failure, non cardiogenic pulmonary oedema, suspected pulmonary embolism, suspected secondary acute respiratory distress syndrome)
* immunosuppression
* current malignancy
* blood samples for gene expression could not be taken within 24 hours of admission
* prisoner/cogni tive impairment
* blood transfusion within 1 month
* hospitalization within 1 month

Primary outcomes:
measure: blood single cell transcriptome in infection and sepsis
timeFrame: within 24 hours of hospital admission
Secondary outcomes:
measure: blood single cell transcriptome as marker of organ dysfunction
timeFrame: at time points 0, 24 and 72 hours
measure: plasma DNA
timeFrame: at time points 0, 24 and 72 hours
measure: blood single cell transcriptome as predictor of clinical outcome
timeFrame: at time points 0, 24 and 72 hours
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT05715762: Determine the Effects of Prone Positioning and NO in COVID-19 ARDS by EIT
Official title: Determine the Effects of Prone Positioning and Nitric Oxide in Adult COVID-19 Patients With ARDS by Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome, Adult
COVID-19
Keywords: Respiratory Distress Syndrome
COVID-19
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients who have COVID-19-associated acute respiratory distress syndrome

Brief summary: We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography.

Detailed description: The investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography (EIT).

The EIT assessment is performed in patients ventilated in supine position, supine position with NO inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with NO inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. Arterial blood gas (ABG) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.

Eligibility criteria: Inclusion Criteria:

* adult patients who have COVID-19-associated acute respiratory distress syndrome

Exclusion Criteria:

* patients who refuse to participate in the study; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.

Primary outcomes:
measure: oxygenation status
timeFrame: 1 day
measure: regional distribution of pulmonary perfusion
timeFrame: 1 day
measure: regional distribution of pulmonary ventilation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01229462: Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.


Eligibility criteria: Inclusion Criteria:

* Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers
* No anticipated wearing of contact lenses during study

Exclusion Criteria:

* Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)
* Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months
* Required regular use of other ocular medications except for occasional use of artificial tears

Primary outcomes:
measure: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05155462: Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty
Official title: Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Angioplasty
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-13
Enrollment: 330
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: Patient 18 or over, treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a

Brief summary: Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.


Eligibility criteria: Inclusion Criteria:

* Patient treated by the peripheral angioplasty department of Claude Galien Hospital from January 2010 and with at least 1 year of follow-up after the revascularization procedure
* Patient treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
* Stenosis or restenosis (history of balloon angioplasty, active balloon or bare stent)
* Degree of stenosis ≥ 50% by angiographic evaluation visual, by CT scan or by Doppler ultrasound
* Patient affiliated or beneficiary of a social security scheme
* Patient aged 18 or over
* Patient having been informed and not opposing this research

Exclusion Criteria:

* Medical history of myocardial infarction or stroke within 3 months of the revascularization procedure
* Unstable angina at the time of the revascularization procedure
* Sepsis at the time of the revascularization procedure
* Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Hospitalized without consent
* Pregnant, breastfeeding or parturient woman

Primary outcomes:
measure: Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT01767662: Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneus
Official title: Natural History and Effectiveness of Parents' Manipulation in Newborn With Talipes Calcaneovalgus,a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Talipes Calcaneovalgus
Keywords: TCV
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 160
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine effectiveness of parents' manipulation in newborn with talipes calcaneovalgus over observation group.

Detailed description: Talipes calcaneovalgus is one of the common foot deformity in newborn. Most of patients can be cure without specific treatment. Manipulation was easy method that parents can preform by their own and may be beneficial in speeding resolution of deformity.

Eligibility criteria: Inclusion Criteria:

* all newborn with talipes calcaneovalgus

Exclusion Criteria:

* patient associated with congenital musculoskeletal anomaly
* patient with other serious medical condition

Primary outcomes:
measure: percent of success treatment with in six month
timeFrame: six month
Secondary outcomes:
measure: duration from start treatment until cure
timeFrame: six month
Other outcomes:
measure: failure of treatment
timeFrame: six month
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital Mahidol University
Study officials:
affiliation: Department of orthopaedic surgery Faculty of medicine siriraj hospital Bangkok Thailand
name: Kamolporn Kaewpornsawan, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705562: Tolerance of Healthy Term Infants Fed Infant Formulas
Official title: Tolerance of Healthy Term Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant, Newborn
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 190
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.


Eligibility criteria: Inclusion Criteria:

* Healthy, term infants; singleton birth; 37-42 weeks of age; \>2490gms at birth; 0-8 days of age

Exclusion Criteria:

* medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 0-8 days of age until 28 days of age
Secondary outcomes:
measure: GI and intake parameters
timeFrame: 0-8 to 28 days of age
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Global Clinical Investigation
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Coralville
country: United States
facility: University of Iowa
state: Iowa
city: Dubuque
country: United States
facility: Medical Associates Clinic
state: Iowa
city: Bardstown
country: United States
facility: Kentucky Pediatric Research
state: Kentucky
city: Owensboro
country: United States
facility: PediaResearch, Inc
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC
state: Nebraska
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Abbott Nutrition
name: Steven Davis, PhD
role: STUDY_DIRECTOR
References: