louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02881359: SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
Official title: SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anastomotic Leakage
Lead sponsor: LifeBond Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who are treated with LifeSeal® and comply with the eligibility criteria will be offered to participate in the study.

Brief summary: This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate

Detailed description: The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age at screening visit
2. Written informed consent obtained
3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis\* created within 15 cm from the anal verge.
4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU

Exclusion Criteria:

1. Subject with American Society of Anesthesiology (ASA) status \> 3.

Primary outcomes:
measure: Incidence of post-operative clinical anastomotic leaks at discharge
timeFrame: discharge from hospital 3-14 days post surgery
Secondary outcomes:
measure: Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery
timeFrame: up to 4 weeks post surgery
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Antwerpen
country: Belgium
facility: ZNA Antwerpen Campus
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Mol
country: Belgium
facility: H. Hartziekenhuis
city: Roeselare
country: Belgium
facility: AZ Delta
city: Almelo
country: Netherlands
facility: ZGT
Study officials:
References:
Clinical trial NCT00793559: Terlipressin Administration in Septic Shock Refractory to Catecholamines
Official title: Terlipressin Administration in Septic Shock Refractory to Catecholamines Bolus vs. Continuous Drip-Phase II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Septic Shock
Keywords: septic shock refractory to catecholamines
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: terlipressin is given to refractory septic shock patients who do not respond to noradrenalin in Israel and Europe. It is given by bolus injection. we attempt to investigate weather it is better to give it by continuous drip and avoid abrupt changes in BP and heart function


Eligibility criteria: Inclusion Criteria:

* septic shock patients receiving above 0.5 mcg/kg NA

Exclusion Criteria:

* allergy to terlipressin, CHF, IHD, pregnancy

Primary outcomes:
measure: CI, SVR,HR,BP, noradrenalin administration,renal function
timeFrame: 6 mo
Secondary outcomes:
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Asaf Harofeh MC
Study officials:
affiliation: Asaf Harofeh
name: Tal Mann, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04069559: Migrant Health Promotion Program for University Students
Official title: Developing Nursing Students Attitudes Towards Refugees Based on Contact Hypothesis: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refugees
Keywords: Refugees health
Contact hypothesis
Nursing students
Attitudes
Randomized controlled trial
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and control group
Primary purpose: PREVENTION

Brief summary: The aim of the study is to determine effect of program about developing nursing students' attitudes towards refugees based on contact hypothesis on Xenophobia, Attitude towards Refugees and Intercultural Sensitivity.

Detailed description: This Randomized Controlled Trials has been conducted with Bachelor's degree in nursing. Ninety students selected and randomly assigned to the intervention and control group as 45 students. Intervention group received a program about developing refugees health for 12 weeks. The content of this program consists of education and practices for refugees health.

Primary Outcome Measure: Xenophobia, Attitude towards Refugees and Intercultural Sensitivity Scale.

Eligibility criteria: Inclusion Criteria:

* The university students in the fourth year of nursing education

Exclusion Criteria:

* Refugees or immigrants students

Primary outcomes:
measure: Xenophobia,
timeFrame: 12 weeks
measure: Attitude towards Refugees
timeFrame: 12 weeks
measure: Intercultural Sensitivity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Belgin Akin, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00403559: A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Official title: A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seborrheic Dermatitis
Keywords: seborrheic dermatitis
Lead sponsor: Dermatology Specialists Research
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-11-23
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis

Detailed description: This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Must be 18 or older and sign written informed consent.
* Must be wiling and able to comply with protocol.
* Must have active seborrheic dermatitis of the face.

Exclusion Criteria:

* No history of overt bacterial, viral or fungal infection of the head/neck.
* No history or presence of compromising dermatosis elsewhere on the skin
* No Parkinson's disease, HIV, infections or disorders of the central nervous system
* No actinically damaged skin

Primary outcomes:
measure: The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
timeFrame: One week from Baseline
Secondary outcomes:
measure: Key Secondary Efficacy Will be the % of Patients With Facial Clearance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
Study officials:
affiliation: Associated Skin Care Specialists
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Associates
name: Bernard Goffe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati - Dermatology
name: Debra Breneman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06491459: Predicting Postoperative Pulmonary Infection in Elderly Patients Undergoing Major Surgery: a Study Based on Logistic Regression and Machine Learning Models
Official title: Predicting Postoperative Pulmonary Infection in Elderly Patients Undergoing Major Surgery: a Study Based on Logistic Regression and Machine Learning Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pulmonary Infection in Elderly Patients
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 9481
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients underwent surgery at the tertiary hospital Hospital from January 2014 to December 2019.

Brief summary: Although a number of clinical predictive models were developed to predict postoperative pulmonary infection, few predictive models have been used in elderly patients. In this study, the researchers aim to compare different algorithms to predict postoperative pulmonary infection in elderly patients and to assess the risk of postoperative pulmonary infection in elderly patients.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 65 years
2. patients who were mechanically ventilated under major surgery

Exclusion Criteria:

1. preoperative tracheal intubation
2. preoperative pneumonia
3. organ transplantation
4. missing data

Primary outcomes:
measure: the incidence of postoperative pulmonary infection during hospitalization
timeFrame: through study completion, an average of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT03631459: A Multicenter Real World Study of Kanglaite for Cancer Cachexia
Official title: Safety and Effectiveness of Kanglaite Injection/Capsules for Treatment of Cancer Cachexia: A Prospective, Multicenter Real World Study of a Large Cohort of Chinese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Cachexia
Keywords: Kanglaita Injection/Capsule
Cancer cachexia
Real-world evidences
Overall survival
Lead sponsor: Zhejiang Kanglaite Pharmaceutical Co.Ltd
Sponsor class: OTHER
Collaborators: name: NanJing PLA 81 Hospital
name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2018-08-15
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting international diagnostic criteria for cachexia:

1. Weight loss \> 5% over past 6 months or
2. BMI\<20 kg/m2 and weight loss \> 2% or
3. Sarcopenia and weight loss \>2%;

Brief summary: A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia

Detailed description: This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.

Eligibility criteria: Inclusion Criteria:

Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.

Exclusion Criteria:

None

Primary outcomes:
measure: Overall survival
timeFrame: 2018 - 2020
Secondary outcomes:
measure: Lean body mass
timeFrame: 2018 - 2020
measure: Body weight
timeFrame: 2018 - 2020
measure: Grade of cachexia
timeFrame: 2018 - 2020
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30
timeFrame: 2018 - 2020
measure: Karnofsky performance status
timeFrame: 2018 - 2020
measure: Patient-generated subjective global assessment (PG-SGA)
timeFrame: 2018 - 2020
measure: Numeric rating scale for pain
timeFrame: 2018 - 2020
measure: Numeric rating scale for appetite
timeFrame: 2018 - 2020
measure: Synergistic antitumor effect: Overall response rate
timeFrame: 2018 - 2020
measure: Synergistic antitumor effect: Disease control rate
timeFrame: 2018 - 2020
Other outcomes:
measure: Adverse events
timeFrame: 2018 - 2020
measure: Serious adverse event
timeFrame: 2018 - 2020
Locations:
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
city: Nanjing
country: China
facility: NanJing PLA 81 Hospital
state: Jiangsu
Study officials:
affiliation: NanJing PLA 81 Hospital
name: Shukui Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267459: Can Pretreatment MRI be Used to Predict Intra-arterial Chemotherapy Response in Retinoblastoma?
Official title: Prediction of the Response Using Dynamic Contrast-enhanced Magnetic Resonance Imaging Before Intra-arterial Chemotherapy in Children With Retinoblastoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinoblastoma
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-08-30
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with retinoblastoma, undergoing intra arterial chemotherapy

Brief summary: Retinoblastoma is the most frequent intraocular tumor in children and represents 6% of all pediatric cancers before the age of 5 years-old. The outcome is now excellent with 95 to 97% of 5-years survival rate. Conservative treatments are being more and more used, and intra arterial chemotherapy is one of the adjuvant treatments proposed to the children. The treatment is efficient in most cases, but a small proportion of children will have an early progression after treatment. MRI is used for the diagnosis of retinoblastoma. We aim to find prognostic factors using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for early identification of children response to intra arterial chemotherapy.


Eligibility criteria: Inclusion Criteria:

* grade B to D retinoblastoma
* prescription of intra arterial chemotherapy

Exclusion Criteria:

* none

Primary outcomes:
measure: response to chemotherapy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A De Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Augustin Lecler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484559: The Assessment of Survival After In-hospital Cardiac Arrest for 2 Years in Tertiary Hospital
Official title: The Assessment of Survival After In-hospital Cardiac Arrest for 2 Years in Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Keywords: In-hospital Cardiac Arrest
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include all patients who develop in-hospital cardiac arrest. (Adnan Menderes University Training and Research Hospital).

Brief summary: Define the frequency and survival pattern of cardiac arrests in relation to the hospital day of event and etiology of arrest.

Detailed description: Define the frequency and survival pattern of cardiac arrests in relation with event and etiology of arrest.

Investigators aims to evaluate the outcome of in-hospital cardiac arrests, focusing on the relationship between etiology and outcome.

Eligibility criteria: Inclusion Criteria:

* Cases where the cardiac arrest team is called

Exclusion Criteria:

* Lack of data records of patients

Primary outcomes:
measure: Incidence of in-hospital cardiac arrest
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
Study officials:
affiliation: Aydin Adnan Menderes University
name: Sinan Yilmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03392259: Usefulness of Cardiovascular Disease (CVD) Management Solution
Official title: Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 666
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Patients with atherosclerotic cardiovascular diseae

  1. history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)
  2. history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery
  3. history of stroke
  4. history of peripheral arterial disease presumed to be of atherosclerotic origin
* Patients who have smartphone and can use app by themselves
* Patients who can speak and read Korean language

Exclusion Criteria:

* Patients with evidences of delirium, confusion or impaired consciousness
* Patients who are not familiar to smartphone or app
* Patients who are not supposed to follow the study protocol adequately.

Primary outcomes:
measure: Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
timeFrame: 6 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 3 & 6 months
measure: Diastolic blood pressure
timeFrame: 3 & 6 months
measure: lipid profiles (total cholesterol, LDL, HDL)
timeFrame: 6 months
measure: body mass index
timeFrame: 6 months
measure: smoking rate
timeFrame: 6 months
measure: degree of moderate physical activity
timeFrame: 6 months
measure: depression scale questionnaire
timeFrame: 6 months
measure: drug compliance
timeFrame: 6 months
measure: App service satisfaction survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-Won Suh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang SH, Baek H, Cho J, Kim S, Hwang H, Lee W, Park JJ, Yoon YE, Yoon CH, Cho YS, Youn TJ, Cho GY, Chae IH, Choi DJ, Yoo S, Suh JW. Management of cardiovascular disease using an mHealth tool: a randomized clinical trial. NPJ Digit Med. 2021 Dec 3;4(1):165. doi: 10.1038/s41746-021-00535-z.
Clinical trial NCT00203359: TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Official title: Etanercept for Alzheimer's-Type Memory Loss Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Tobinick, Edward Lewis, M.D.
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Detailed description: Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.

Eligibility criteria: Inclusion Criteria:

* NINCDS-ADRDA Criteria for Alzheimer's disease
* CT or MRI consistent with AD

Exclusion Criteria:

* active infection
* CHF
* demyelinating disease
* uncontrolled diabetes mellitus
* vascular dementia
* clinically significant neurologic disease other than AD
* Hachinski \>4
* history of lymphoma
* TBC
* wbc\<2500
* platelets\<100,000
* HCT\<30
* pregnancy
* premenopausal, fertile not on acceptable birth control
* change in neuroactive medication within 4 weeks of study initiation

Primary outcomes:
measure: ADAS-Cog
measure: SIB
measure: MMSE
Secondary outcomes:
measure: Category fluency
measure: other neuropsychological tests
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Edward Tobinick, MD (private medical office)
state: California
Study officials:
affiliation: unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
name: Edward L Tobinick, MD
role: PRINCIPAL_INVESTIGATOR
References: