louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01180166: Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
Official title: Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Concurrent Chemoradiotherapy
Keywords: Gastric cancer
concurrent chemoradiotherapy
target therapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2010-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.

Detailed description: There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

Eligibility criteria: Inclusion Criteria:

* 18-75 years old, male or female
* Gastric cancer with measurable lesions, and the diameter is at least 1 cm
* Karnofsky score: at least 70
* Estimated survival: at least 6 months
* No prior target therapy or radiotherapy
* No severe hypertension, cardiac disease, or diabetes mellitus
* Normal blood routine and chemical tests
* Signed consent

Exclusion Criteria:

* Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
* Extensive distant metastases
* Pregnancy or in lactation
* Allergic to 5-Fluorouracil

Primary outcomes:
measure: progression-free survival
timeFrame: 1 year progression-free survival
Secondary outcomes:
measure: overall responses
timeFrame: 1 month after treatment
measure: overall survival time
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Acedemy of Medical Sciences
name: jing jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02519166: Characterisation of Biofilm of the Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wounds
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic wounds (period \> 6 weeks) \> 10 cm2
* Patient age \>18 for the 3 French centres
* Patient participation in a follow-up program for treatment of their wound \> 1 month
* Availability of patient information and written informed consent from them or their legal representative

Exclusion Criteria:

* Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
* Patients deprived of freedom or under guardianship

Primary outcomes:
measure: Clinical examination
timeFrame: 1 month
measure: characterisation of biofilm by fluorescence microscopy and confocal
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chu Montpellier
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Rothschild
Study officials:
References:
Clinical trial NCT01834066: Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Muscular Dystrophy.
Official title: Safety and Efficacy of Bone Marrow Autologous Cells in Muscular Dystrophy. It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Muscular Dystrophy
Duchenne Muscular Dystrophy,
Keywords: muscular Dystrophy stem cell
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Study is single arm, single centre trial to check the safety and efficacy of Bone Marrow derived autologous cell(100 million per dose) for the patient with Duchenne Muscular Dystrophy.

Detailed description: Muscular dystrophy is a group of inherited disorders that involve muscle weakness and loss of muscle tissue, which get worse over time. Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition. slowly progress diseases.it causes Muscle weaknesses, Difficulty with motor skills ,Progressive difficulty walking.Breathing difficulties and heart disease,Frequent falls,weak limbs,lose motor Function.Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body.Trouble getting up from a lying position or climbing stairs.

Eligibility criteria: Inclusion Criteria:

* Patient with Diagnose of Duchenne Muscular Dystrophy.
* Aged in between 6 to 25 Years.
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient who is not Diagnose of Duchenne Muscular Dystrophy.
* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+,Tumor Markers+
* History of Life threatening allergic or immune -Mediated Reaction.
* the site of bone marrow aspiration potentially limiting Procedure.
* Alcohol and drug abuse / dependence.
* Patients with History of Hypertension and Hypersensitive.

Primary outcomes:
measure: Significant Improvement in Muscle strength by using Kinetics Muscle testing or by using MMT( manual muscle test }score
timeFrame: 6 Months
Secondary outcomes:
measure: -Improvement of daily living scale and baseline in EMG(electromyography)
timeFrame: 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitnany Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, MS ORTHO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02348866: Bacterial Contamination on Obstetric Resident Surgical Scrubs
Official title: Bacterial Contamination on Obstetric Resident Surgical Scrubs: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Contamination
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital.

Detailed description: An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting.

Eligibility criteria: Inclusion Criteria:

* ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks

Exclusion Criteria:

-

Primary outcomes:
measure: difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2)
timeFrame: 4 days
Secondary outcomes:
measure: Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting
timeFrame: 4 days
Other outcomes:
Locations:
Study officials:
affiliation: Prisma Health-Upstate
name: Kacey Y Eichelberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470466: Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser for Enlarged Facial Pores
Official title: Short Pulse and Q-switched ND-YAG Laser With Topical Carbon Versus Fractional CO2 Laser in Treatment of Enlarged Facial Pores: A Split-face Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Lesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Facial pores are visible topographic features of the skin that reflect openings of pilosebaceous follicles, that may be enlarged causing distress to some individuals. Many patients desire treatment for this condition, which can be an early sign of skin aging. Therapeutic modalities include intense pulsed light, radiofrequency, dermabrasion, oral and topical retinoids, as well as chemical peeling. Lasers, as fractional CO2, short pulse and Q-switched Nd-YAG, can potentially be used in treatment of wide pores.

This study aims at the assessment and comparison of therapy with short pulsed and Q-switched Nd-YAG laser plus topical carbon with fractional CO2 laser in the management of wide facial pores.

Detailed description: topical carbon cream will be applied to one side of the face in patients with wide facial pores, followed by 2 passes of short pulse 1064 ND:YAG laser, then one pass of Q-switched ND-YAG laser.

fractional CO2 laser will be performed to the other half of the face. the patients will receive 2 treatment sessions

Eligibility criteria: Inclusion Criteria:

* Participants who are more than 18 years old with the large facial pores and are aware of their problem and seeking treatment

Exclusion Criteria:

* • Previous laser therapy, chemical peeling, microdermabrasion or cosmetic procedure for the face.

  * Patients with any contraindication to laser therapy such as photosensitive diseases, skin malignancies, patients on oral retinoids.
  * Keloid-forming tendency.
  * Local or systemic treatment for skin pores in the previous 3 months
  * Connective tissue disease or the use of immunosuppressive medications.
  * Pregnancy.
  * Present or past history of herpes labialis.

Primary outcomes:
measure: the percentage of decrease in size of enlarged facial pores assessed clinically and by dermoscopy
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy
Study officials:
References:
Clinical trial NCT00378066: Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer
Official title: A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2006-09-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented colorectal adenocarcinoma
* ECOG performance status of 2 or lower
* Adequate bone marrow function
* Adequate kidney function
* Adequate liver function
* Informed consent

Exclusion Criteria:

* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
* Known allergy to study drugs

Primary outcomes:
measure: time to progression
timeFrame: 6 months
Secondary outcomes:
measure: overall survival, safety, response
timeFrame: 1 year
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Hospital
city: Sungnam
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
Study officials:
affiliation: Asan Medical Center
name: Tae Won Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598466: Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa
Official title: Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Hexor, South Africa
First posted: 2015-11-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP).


Eligibility criteria: Inclusion Criteria:

* The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP

Primary outcomes:
measure: Patterns of change in patient assessments of physical function with scores of the Health Assessment Questionnaire (HAQ) among users of SC Abatacept for RA since the commencement of a CUP in South Africa's private sector
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Demographic characteristics (age, gender, education and population group) of patients
timeFrame: Approximately 2 years
measure: Clinical characteristics (comorbidities including Tuberculosis, medication use, and adverse events) of patients
timeFrame: Approximately 2 years
measure: Reasons for discontinuation based on the reasons mentioned in Questionnaire
timeFrame: Approximately 2 years
measure: Reasons for skipping treatment based on the reasons mentioned in Questionnaire
timeFrame: Approximately 2 years
measure: Association of demographic and clinical characteristics based on Standard Disability Index of the Health Assessment Questionnaire (HAQ-DI) scores
timeFrame: Approximately 2 years
measure: Changes in physical functioning against clinical trial and long-term extension phase data based incidence of adverse events
timeFrame: Approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03721666: Medical Dispatchers' Perception of Visual Information in Real Out-of-hospital Cardiac Arrest
Official title: Medical Dispatchers' Perception of Visual Information in Real Out-of-hospital Cardiac Arrest: A Qualitative Interview Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Dispatcher-assisted cardiopulmonary resuscitation
Out-Of-Hospital Cardiac Arrest
Emergency Medical dispatcher
Lead sponsor: Emergency Medical Services, Capital Region, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: TrygFonden, Denmark
name: Danish Heart Foundation
First posted: 2018-10-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Medical dispatchers

Brief summary: Dispatcher-assisted cardiopulmonary resuscitation is a complex, nonvisual procedure that is challenging for the dispatcher. The aim was to explore the medical dispatchers' perception of bystanders' responses and dispatchers' reflections about the added value of visual information in out-of-hospital cardiac arrests (OHCA) situations.

Detailed description: Ten individual interviews with medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV) were conducted. First, the medical dispatcher listened to the emergency call and described their perception of the scenario. Afterward, the CCTV recording was shown to the dispatcher, who was then interviewed. The interviews were videotaped, and the audio files were transcribed verbatim. Thematic content analysis was conducted.

Eligibility criteria: Inclusion Criteria:

* Emergency Medical dispatchers who had previously handled an emergency call concerning OHCA captured on closed-circuit television (CCTV)

Exclusion Criteria:

* None

Primary outcomes:
measure: The added value of visual information to the medical dispatcher in out-of-hospital cardiac arrests (OHCA) situations.
timeFrame: One hour interview with earch of the emergency medical dispathers
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Doris Oestergaard
role: STUDY_DIRECTOR
affiliation: Emergency Medical Services, Capital Region, Denmark
name: Freddy K. Lippert
role: STUDY_CHAIR
References:
Clinical trial NCT02333266: Bio-assay Development and Implementation for Fungal Infection Detection
Official title: Bio-assay Development and Implementation for Fungal Infection Detection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Candidemia
Keywords: Candida bloodstream infection
Detection fungal cells
Fiber-Optic Surface Plasmon Resonance (FO-SPR)
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients laying in the hospital that suffer from a candidemia.

Brief summary: The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.

Detailed description: The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
* Candidemia

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
timeFrame: Blood samples will be collected at baseline from patients directly after informed consent is given
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Jeroen Lammertyn, Prof.
role: STUDY_DIRECTOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Katrien Lagrou, Prof.
role: PRINCIPAL_INVESTIGATOR
References: