louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00329472: Efficacy Study of Induction Chemotherapy Before Surgery in Operable Non-small Cell Lung Cancer
Official title: Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2006-05-24
Enrollment: 0
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: This study is randomized phase III trial designed to assess whether (preoperative) neoadjuvant chemotherapy followed by surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (experimental treatment) improves 3-year disease-free survival, compared to surgery plus adjuvant chemotherapy with gemcitabine and cisplatin (standard treatment) in stage IB, IIA, IIB and T3N1 non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven NSCLC patients
* All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest CT and PET-CT
* 18 year of ages or older
* ECOG performance status 0-1
* Uni-dimensionally measurable lesion by RECIST criteria
* No prior chemotherapy or radiotherapy for NSCLC
* Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
* Adequate bone marrow function: Hb \> 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥ 100,000/μL
* Adequate liver and renal function: Total bilirubin \< 2 x ULN, AST/ALT \< 3 x ULN, serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
* Written informed consent

Exclusion Criteria:

* Superior sulcus tumor
* Prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer at least 5 years
* Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
* Recent myocardial infarction within 6 months
* Patients with post-obstructive pneumonia or serious infection
* Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method.)
* Patients with psychological problem

Primary outcomes:
measure: 3-year disease-free survival
Secondary outcomes:
measure: overall survival
measure: pattern of relapse
measure: quality of life
measure: operative mortality and toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Keunchil Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04072172: Microcautery for the Treatment of Spider Leg Veins
Official title: Microcautery Evaluation for Treatment of Leg Spiders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microcautery for Leg Veins
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To Evaluate the role of micro-cauterization use in the treatment and disappearance of spider leg veins.

Detailed description: Spider veins on the lower limbs are very common and have been reported to be presented in 41% of women over 50 years old. Sclerotherapy as a traditional treatment for spider veins has a low cost, though it may have adverse sequelae. Lasers have shown fewer but still substantial complications as well.1 Spider veins are small superficial veins that widen and become visible, often on the legs and most cutaneous spider veins are abnormalities of the horizontal vascular skin plexus or capillary loops.2 Spider leg veins are composed of a feeder vessel and ectatic venous sprouts in the reticular dermis. Their depth is between 180 µm and 1 mm in the skin.3 Spider veins may have a diameter that reaches several millimetres and can be blue, purple or red and may appear in the form of thin lines, webs or branches.4 There is a scarce available data from literature about the role of micro-cauterization in the treatment of spider veins. The micro-cauterization is an alternative in management of spider veins that delivered via Mole Freckle Pen German Technology.4 Cautery is a safe and effective tool for the treatment of superficial and small skin lesions. It is simple, cheap, and requires minimal training and the results are usually satisfactory Technology Specifications with insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5 The current study aims to evaluate the role for micro-cauterization in the treatment and disappearance of spider leg veins.

Eligibility criteria: Inclusion Criteria:

* were patients with spider veins of less than 2.0 mm in diameter.

Exclusion Criteria:

* were patients with diabetes, anticoagulation therapy and/or patients with a known history of keloids

Primary outcomes:
measure: Short term results after 3 weeks.
timeFrame: 3 weeks
Secondary outcomes:
measure: Long term results after 3 months.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Doaa M. Selim, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00270972: The Evaluation of OrCel for the Treatment of Venous Ulcers
Official title: A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency
Leg Ulcer
Keywords: Venous leg ulcer
Venous insufficiency
OrCel
Lead sponsor: Ortec International
Sponsor class: INDUSTRY
First posted: 2005-12-29
Enrollment: 60
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: This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy.

Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.


Eligibility criteria: Inclusion Criteria:

* Any race, between 18 and 85 years of age
* Male or female
* Chronic venous insufficiency
* Ulcer size between 2 and 20 sq cm, inclusive
* Ulcer present for at least one month
* ABI \>0.7

Exclusion Criteria:

* Decrease in wound size \>35% during Screening Phase
* Infection at ulcer site
* Uncontrolled diabetes mellitus
* Malnutrition
* Previous treatment with excluded medications

Primary outcomes:
measure: Investigator Assessment of wound healing
Secondary outcomes:
measure: Planimetric assessment of wound healing
measure: Photographic assessment of wound healing
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Baptist Medical Center South
state: Alabama
city: Phoenix
country: United States
facility: Associated Foot and Ankle Specialists
state: Arizona
city: Castro Valley
country: United States
facility: Eden Podiatry Group
state: California
city: Poway
country: United States
facility: PPH Center for Wound Care and Hyperbaric Medicine
state: California
city: Terre Haute
country: United States
facility: Wound Healing Center
state: Indiana
city: Bay Shore
country: United States
facility: Southside Hospital
state: New York
city: New York
country: United States
facility: St Luke's Roosevelt
state: New York
city: Reading
country: United States
facility: Center for Advanced Wound Care
state: Pennsylvania
city: Warren
country: United States
facility: Warren General Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: Hyperbaric and Wound Care Associates
state: Wisconsin
Study officials:
References:
Clinical trial NCT01678872: A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Official title: A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Lead sponsor: Oxford BioMedica
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the long term safety of an experimental gene transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Must have received a subretinal injection of RetinoStat
* Must have been enrolled in Protocol RS1/001/10

Exclusion Criteria:

* Did not receive RetinoStat® as part of the RS1/001/10 protocol

Primary outcomes:
measure: The incidence of adverse events
timeFrame: 14 years
Secondary outcomes:
measure: The change from baseline in BCVA.
timeFrame: 14 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Baltimore
country: United States
facility: John Hopkins University Hospital
state: Maryland
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: John Hopkins University Hospital
name: Peter Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06019572: Spine Trauma in the Elderly
Official title: Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Injury
Trauma
Surgery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study hospital is a publicly funded tertiary care center serving a region of approximately 2.3 million inhabitants and the region's only level 1 trauma center. Patients were identified through the surgical management software Orbit (Evry Healthcare Systems, Solna, Sweden).

Brief summary: Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.


Eligibility criteria: Inclusion Criteria:

* All patients surgically treated for subaxial spine injuries between 2006 and 2018

Exclusion Criteria:

* Missing records

Primary outcomes:
measure: Postoperative complications
timeFrame: 30-day postoperative period
measure: Mortality
timeFrame: End of the study period (or end of data collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT04376372: Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children
Official title: Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children : is There a Neurophysiological and Functional Difference With Natural Lefthanders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Brachial Plexus Palsy
Keywords: upper limb paresis
developmental
functiona laterality
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Group 1 : healthy lefthanded typical developing children and adolescents with righthanded parents Group 2 : Forced lefthanded NBPP children and adolescents with righthanded parents

Brief summary: The aim of the project is to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP).

Detailed description: A cross-sectional case-control study design to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP). Controls are natural lefthanded typical developing children and adolescents.Case and controls are matched for age, gender and activity level.

Eligibility criteria: Inclusion Criteria:

* typical developing
* lefthanded
* NBPP or healthy
* righthanded parents
* 6-23 years

Exclusion Criteria:

* history of other locomotor or neurological disorder than NBPP
* history of brain surgery
* history of psychiatric disorder

Primary outcomes:
measure: Strength-1
timeFrame: Baseline
measure: Strength-2
timeFrame: Baseline
measure: Strength-3
timeFrame: Baseline
measure: Sensibility hand
timeFrame: Baseline
measure: Handedness
timeFrame: Baseline
measure: Baseline measure : brain imaging
timeFrame: Baseline
measure: Baseline measure : movement pattern
timeFrame: Baseline
measure: Body representation
timeFrame: Baseline
Secondary outcomes:
measure: quality of life-1
timeFrame: Baseline
measure: quality of life-2
timeFrame: Baseline
measure: Activity-1
timeFrame: Baseline
measure: Activity-2
timeFrame: Baseline
measure: Activity-3
timeFrame: Baseline
measure: Activity-4
timeFrame: Baseline
measure: shoulder function cases
timeFrame: Baseline
measure: Function( for cases)
timeFrame: Baseline
measure: cognition
timeFrame: baseline
measure: muscle and nerve function
timeFrame: baseline
measure: writing
timeFrame: baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Physical Medicine and Rehabilitation
state: Oost Vlaanderen
Study officials:
affiliation: Physical Medicine and Rehabilitation
name: Ruth Van der Looven, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669772: Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Volunteers
Official title: Study on the Effects of DA-9701 on Gastrointestinal Motility on Healthy Adult Males and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2012-08-21
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: DA-9701 is a new prokinetic agent formulated with Pharbitis Seed and Corydalis Tuber. These plants have been used in oriental traditional medicine for the treatment of gastrointestinal maladies. In a stage 3 trial, its' efficacy has been compared to that of itopride in functional dyspepsia patients and proved to have comparable safety and efficacy. However, its' exact effect on the gastrointestinal motility has not been completely elucidated. This study will study the effects of DA-9701 on the healthy adult gastrointestinal tract.


Eligibility criteria: Inclusion Criteria:

* Healthy adults of either sex, at least 20 years of age
* Having no abdominal discomfort or pain
* No diseases diagnosed by screening gastroduodenoscopy
* Having given voluntary written consent

Exclusion Criteria:

* Currently participating or having participated in another drug trial within four weeks of trial start.
* Women of childbearing age who are either pregnant, breast-feeding or not under proper contraceptive methods.
* A history of surgery which may affect gastrointestinal motility.
* Subjects with gastrointestinal bleeding, mechanical obstruction or perforation.
* Subjects with irritable bowel syndrome or inflammatory bowel disease.
* Subjects with serious conditions involving the liver, kidneys, heart, lung or endocrinology system.
* Psychiatric disease patients, substance abuse subjects such as alcohol or drugs.
* Subjects who have taken drugs that may affect the study outcome such as antibiotics, corticosteroids or NSAIDS within 1 month or motility agents, H2 receptor blockers, proton pump inhibitors, anticholinergics, erythromycin or antipsychotics within 2 weeks.
* Other reasons that the investigator considers valid.

Primary outcomes:
measure: Study the effects of DA-9701 on GI motility in healthy adult volunteers
timeFrame: 3weeks
Secondary outcomes:
measure: Examine the effects of DA-9701 by Scintigraphic transit measurement
timeFrame: 3weeks
measure: Examine the effects of DA-9701 by EGG/Drink test
timeFrame: 3weeks
measure: Examine the effects of DA-9701 by SPECT
timeFrame: 3weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's hospital
Study officials:
affiliation: CU Korea, Seoul St Mary's Hospital
name: Myong Ki Baeg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00904072: Integrated Novel Clinical Decision Support System (CDSS) in a Computerized Physician Order Entry System
Official title: Integrated a Novel Clinical Decision Support System (CDSS) in a Computerized Physician Order Entry System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluate the Impact of the CDSS
Keywords: CDSS
prescribing error
prescribing errors influenced by CDSS
CPOE
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 50000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The prescriptions which induced the alert windows pop out.

Brief summary: The purpose of this study is to understand the impact of CDSS by knowing the prescribers actions to the CDSS, also the influence of prescribing error announced by pharmacists.

Detailed description: 1. To assess the sensitivity of the CDSS which could identify some specific prescribing errors (ex: duplication of drugs, dosage that exceed the maximum dose,prescribes drugs that have drug-drug interactions).
2. To identify what kind of drugs are most likely to cause duplication use by the physicians, and what kind of drugs are most likely to exceed the maximum dosage, also to know what kind of drugs are most likely to cause drug-drug interaction that physicians encounter during prescribing.
3. To evaluate the percentage of physician acceptance of the prescribing errors identify by the CDSS.
4. What's the impact of CDSS on pharmacist announced prescribing error.

Eligibility criteria: Inclusion Criteria:

* The prescriptions which induced the alert windows pop out.

Exclusion Criteria:

* The prescriptions which not induced the alert windows pop out.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Taipei, Taiwan
Study officials:
affiliation: National Taiwan University Hospital
name: Fe-Lin Lin Wu, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06899672: Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study
Official title: Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dimensional Changes
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This quasi-experimental comparative study investigates the effects of incorporating various self-disinfecting agents-0.2% Chlorhexidine (CHX), 1% Chitosan solution, 0.2% Silver Nitrate (AgNO3), green-synthesized Silver Nanoparticles (AgNPs), and 15% PVP-Iodine-on the linear dimensional stability of dental alginate impressions. Alginate is widely used in dentistry but is prone to dimensional changes and contamination. This study aims to assess whether integrating these disinfectants can reduce microbial risks without compromising the material's dimensional accuracy, thereby improving infection control and the precision of dental prostheses


Eligibility criteria: Inclusion Criteria:

* Dental stone casts free from excessive porosity, fractures, or other visible defects that could affect dimensional stability measurements.
* Typodont models with intact maxillary arch configurations.

Exclusion Criteria:

* Distorted impressions, under-extended impressions, impressions that detach from the tray before pouring, and impressions with voids, on visual inspection.
* Dental cast with a fracture component, incomplete pouring, and those with voids or bubbles.

Primary outcomes:
measure: Linear Dimensional Stability of Alginate Impressions
timeFrame: 1 hour after impression making and cast pouring
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00749372: MRI Screening for Patients With Myelodysplastic Syndrome (MDS), Who Have Received Multiple Red Blood Cell Transfusions
Official title: T2* Cardiac MRI Screening of Highly Transfused Patients With Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelodysplastic Syndrome (MDS)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A known risk of red blood cell transfusions is that it puts excess iron into the patient's body. Researchers are continually seeking the most effective method of measuring iron concentration. The purpose of this study is to determine how much iron has been deposited in a patient's heart and liver as a result of having received red blood cell transfusions using magnetic resonance imaging (MRI).


Eligibility criteria: Inclusion Criteria:

* Male or Female patients will need documentation of diagnosis of Myelodysplastic Syndrome by previous bone marrow exam
* Male or female patients with MDS who have received at least 50 units of Red Blood Cell Transfusions.
* Serum ferritin \> 1,000
* Written informed consent by the patient.

Exclusion Criteria:

* Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia.

Primary outcomes:
measure: To evaluate the incidence of clinically significant cardiac iron overload in heavily transfused MDS patients using T2* MRI.
timeFrame: A single T2* MRI will be performed on eligible patients.
Secondary outcomes:
measure: Evaluate left ventricular ejection fraction as assessed by T2* MRI.
timeFrame: A single T2* MRI will be performed on eligible patients.
measure: Evaluate liver iron concentration as assessed by R2* MRI
timeFrame: A single T2* MRI will be performed on eligible patients.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Eric Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: