louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01560494: Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery
Official title: Validation of a Structured Training and Assessment Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Education
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study describes the development and validation of a structured training and assessment curriculum (STAC) for a basic laparoscopic procedure. The investigators hypothesized that residents trained using the STAC curriculum would demonstrate superior technical skills in the operating room compared to residents that were trained using a traditional curriculum.

Detailed description: The objective of this study was to develop and validate an ex-vivo comprehensive curriculum for a basic laparoscopic procedure. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex-vivo training on learning curves in the operating room (OR), nor the effect on non-technical proficiency has been investigated. This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured-curriculum (STAC) group or conventional residency training. The STAC curriculum consisted of: case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to: learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and non-technical skills.

Eligibility criteria: Inclusion Criteria:

* post graduate year 1 and 2 general surgical residents
* completed less than 10 laparoscopic cholecystectomies or appendectomies as the primary surgeon

Primary outcomes:
measure: Technical skills
timeFrame: 6 months
Secondary outcomes:
measure: cognitive knowledge
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Teodor Grantcharov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palter VN, Orzech N, Reznick RK, Grantcharov TP. Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial. Ann Surg. 2013 Feb;257(2):224-30. doi: 10.1097/SLA.0b013e31827051cd.
Clinical trial NCT01643694: Individualized Electronic Intervention to Promote Work Engagement
Official title: Randomized Controlled Trial Evaluating the Effect of An Individualized Electronic Intervention to Promote Resilience, Meaning, and Engagement for Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Meaning in Work
Engagement at Work
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 288
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine if physicians who complete brief tasks intended to promote meaning in work and job satisfaction, foster teamwork and social support at work, nuture personal relationships and work-life balance, recognize and build on personal strengths, encourage effective problem solving, and promote positive emotions have improved resilience, meaning in work, and engagement at work.


Eligibility criteria: All physicians at Mayo Clinic

Primary outcomes:
measure: Job satisfaction
timeFrame: baseline to 3 month
Secondary outcomes:
measure: Well-being
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Liselotte Dyrbye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
Clinical trial NCT00300794: Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opiate Dependence
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2006-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).


Eligibility criteria: Inclusion Criteria:

* Diagnosed opiate dependence according to ICD 10 and/or DSM 4;
* Duration of substance abuse more than 1 year
* No or minor co-morbidities;
* Grade I-II according to physical status classification system of American Society of Anesthesiologists.

Exclusion Criteria:

* Current history of long acting opiate or poly-substance abuse;
* Acute medical or surgical condition;
* Pregnancy;
* Breastfeeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Emergency Hospital
Study officials:
affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care
name: Juozas Ivaskevicius, Prof.
role: STUDY_DIRECTOR
affiliation: Vilnius University Clinic of Anaesthesiology and Intensive Care
name: Tomas Jovaisa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ivaskevicius J, Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R. [Safety and effectiveness of opiate antagonist detoxification under general anesthesia]. Medicina (Kaunas). 2005;41(12):1011-8. Lithuanian.
citation: Jovaisa T, Laurinenas G, Vosylius S, Sipylaite J, Badaras R, Ivaskevicius J. Effects of ketamine on precipitated opiate withdrawal. Medicina (Kaunas). 2006;42(8):625-34.
Clinical trial NCT02383394: Factors Associated With Pregnancy Loss in IVF Women
Official title: Factors Associated With Second-Trimester Pregnancy Loss in Women With Normal Uterine Anatomy Undergoing In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invitro Fertilization
Keywords: second trimesteric pregnancy loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 500
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Brief summary: Maternal and clinical characteristics associated with spontaneous second-trimester pregnancy loss (between 12 1/7 and 23 6/7 weeks of gestation) will be assessed.

Detailed description: Maternal characteristics as age , parity, body mass index, previous abortion,previous failed IVF cycles, weight gain during pregnancy, physical activity, sexual relation and frequency, adherence to treatment, residency, medical history,surgical pelvic history, fever during pregnancy.

Clinical characteristics as multiple pregnancy, site of implantation, day of transfer, serum HCG day 14.

Eligibility criteria: Inclusion Criteria:

* Women aged 21-44 years with ongoing in vitro fertilization pregnancy (at least one fetus with fetal heart tones at 12 weeks of gestation)

Exclusion Criteria:

* abnormal uterine cavity induced abortion for medical problem

Primary outcomes:
measure: second trimester abortion
timeFrame: between 12 1/7 and 23 6/7 weeks of gestation)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maged
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097760: Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Official title: Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2004-12-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS as defined by McDonald et al., criteria # 1-4
* Between the ages of 18 and 55, inclusive
* Baseline EDSS score between 0.0 and 5.0, inclusive
* Have been treated with GA for at least the 12 months prior to randomization

Exclusion Criteria:

* Primary progressive, secondary progressive or progressive relapsing MS
* MS relapse has occurred within the 50 days prior to randomization
* A clinically significant infectious illness
* History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.

Primary outcomes:
measure: Rate of development of new active lesions on MRI scans.
timeFrame: Week 20
Secondary outcomes:
measure: Incidence and severity of adverse events.
timeFrame: Week 20
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Biogen Idec, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05126160: Immune Score Based Radiomics in Nasopharyngeal Carcinoma
Official title: Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Renmin Hospital of Wuhan University
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo Medical Center Lihuili Hospital
name: Ningbo No. 1 Hospital
First posted: 2021-11-18
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-metastatic NPC patients receive radical radiotherapy with/without induction or concurrent chemotherapy. De novo metastatic NPC patients would receive at least 4 cycles of platinum-based therapy.

Brief summary: In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.


Eligibility criteria: Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.

ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC \>4\*109/L, HGB\>90G/L, and PLT\>100\*109/L. Written informed consent

Exclusion Criteria:

Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), or emotional disturbance.

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: Median follow-up time of 5 years for the whole group
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Ningbo
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Ningbo
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Wenzhou
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Department of Radiation Oncology, Zhejiang Cancer Hospital
name: Xiaozhong Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558960: Intravitreal Injections of Melphalan for Retinoblastoma
Official title: Intravitreal Injections of Melphalan for Retinoblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinoblastoma
Keywords: Retinoblastoma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 10
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials.

Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan.

In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

Detailed description: Intravitreal injections of Melphalan will be given to cases unresponsive to chemotherapy or with vitreal seeding of the disease.

Eligibility criteria: Inclusion Criteria:

* Retinoblastoma that has not responded to chemotherapy
* Retinoblastoma that has vitreal seeding

Exclusion Criteria:

* previous failure of IVit Melphalan

Primary outcomes:
measure: treatment response
timeFrame: 1 year
Secondary outcomes:
measure: complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Shahar Frenkel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517660: Source Profiling of Biohazardous Aerosols in Hospitals
Official title: Source Profiling of Biohazardous Aerosols in Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Keywords: Healthy subjects
Lower Respiratory Tract Infections
Upper Respiratory Tract Infections
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Hong Kong University of Science and Technology
First posted: 2007-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 from each groups. Healthy subjects - recruited from voluntary basis. LRTI - recruited from patient wards with consent. URTI - recruited from out-patient clinic with consent.

Brief summary: To characterise the physical parameters (number concentration, size distribution and their trajectories) of aerosols (droplets) generated in high risk procedures.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (\>18 years old) that can give valid consent
2. URTI: with symptoms such as coryza, sore throat, nasal discharge, cough and sputum +/- fever. Amongst these, cough should be a major complaint.
3. LRTI (CAP): acute lower respiratory illness of no other known cause which is usually associated with fever, symptoms and signs of the chest and abnormalities on the CXR. (BTS 1993).

Exclusion Criteria:

1. Pneumonia developed at or after 48 hours, or history of hospital admissions within 1 month of the present admission (to exclude hospital-acquired infections)
2. Patients who are unable to cooperate with the study protocols (such as mentally confused, dementia) or are physically unable to sit or stand independently to carry out the tests optimally.
3. Patients with TOCC associations with infections such Avian Flu or SARS (travel to endemic areas, at-risk occupations, close contacts with index cases, especially with compatible clinical features) or NPA revealed positivity of influenza A/B
4. Patients who are clinically or haemodynamically unstable, such as the need for inotropes, oxygen supplement of \>2L/min, any types of shock, etc.
5. Underlying diseases that might affect the coughing effort (such as musculoskeletal diseases, or severe kyphoscoliosis)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Institute for the Environment, The Hong Kong University of Science and Technology
name: Ming Fang, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06472960: Relationships Between Physical Activity and Inhibitory Control Among College Students
Official title: Relationships Between Physical Activity and Inhibitory Control Among College Students: fNIRS and Fundus Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognition
Lead sponsor: Shenzhen University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to explore the impact of a 20-minute aerobic exercise on inhibitory control, microvascular diameters, and brain function. The main questions it aims to answer are:

1. Is there a correlation among the level of physical activity, performance in inhibitory control, and the diameter of retinal microvasculature, and do retinal microcirculation parameters mediate this relationship?
2. Does short-term aerobic exercise (moderate and high intensity) improve inhibitory control and physiological markers, such as retinal diameter and frontal brain activation, compared to a sedentary control group?


Eligibility criteria: Inclusion Criteria:

* right-handed (how was handedness assessed; i.e., "What hand do you write with?") with normal or corrected-to-normal vision and normal color vision

Exclusion Criteria:

* reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.

Primary outcomes:
measure: Cognitive function
timeFrame: 21 weeks
measure: Retinal Vessel Diameter
timeFrame: 21 weeks
measure: Brain Connectivity
timeFrame: 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Body-Brain-Mind Laboratory, School of Psychology, Shenzhen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00724360: Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
Official title: A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsed/Refractory Leukemia
Keywords: relapsed/refractory
HER2
positive
B-ALL
trastuzumab
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-07-29
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: TREATMENT

Brief summary: This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* B-ALL in relapse
* refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
* adequate hepatic and renal functions (AST or ALT \<= 5 times the upper limit of normal creatinine \< 2 times the upper limit of normal)
* \> 20% blasts in bone marrow,
* \> 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping

Exclusion Criteria:

* Previous treatment by trastuzumab
* FEVG \< 50%

Primary outcomes:
measure: Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary outcomes:
measure: Trastuzumab efficiency concerning transfusional needs
measure: Overall survival
measure: Leukemia free survival
measure: cytogenetic response rate
measure: Trastuzumab tolerance profile
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
city: Créteil
country: France
facility: Mondor Hospital
city: Grenoble
country: France
facility: Grenoble Hospital
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: St Louis Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
Study officials:
References:
citation: Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.