louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05291741: Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
Official title: Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Very Low Calorie Diet
Weight Loss
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Detailed description: In this project the investigators want to develop an effective Very Low Calorie Diet (VLCD) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. Thus the investigators will randomize 500 patients to either VLCD or standard care prior to bariatric surgery. The investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Eligible for bariatric surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Weight loss
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient quality of life measured using the Short Form-12 (SF-12) questionnaire
timeFrame: 8 weeks and 1 year
measure: Positive and negative consequences of the two weight loss treatments identified by the surgeon, using a questionnaire developed for the purpose
timeFrame: 30 days after surgery
measure: Use of health care services assessed by a medical chart review
timeFrame: 30 days after surgery
measure: Severity of complications assessed by a medical chart review.
timeFrame: 30 days after surgery
measure: Presence of eating disorders
timeFrame: At baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Steno Diabetes Center Aarhus
Study officials:
References:
Clinical trial NCT01142141: Manual Therapy in Postoperative Breast Cancer
Official title: Manual Therapy in Postoperative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Axillary Lymph Node Dissection
Shoulder Joint Limitation
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.


Eligibility criteria: Inclusion Criteria:

* surgery of breast cancer at University of Campinas
* axillary lymph node dissection
* injury of shoulder range of motion

Exclusion Criteria:

* bilateral surgery
* previous radiotherapy
* bone metastasis in homolateral upper limb
* axillary web syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: São Paulo
Study officials:
References:
Clinical trial NCT04245241: Effects of High-Flow Nasal Cannula Therapy Assessed by Electrical Impedance Tomography
Official title: Effects of High-Flow Nasal Cannula Therapy on Lung Recruitment and Lung Strain Change Assessed by Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-flow Nasal Cannula
Electrical Impedance Tomography
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult critically ill patients, who received a HENC therapy within 24 h after the extubation, were enrolled.

Brief summary: This study aimed to determine the effects of HFNC therapy on lung recruitment and lung strain change assessed by electrical impedance tomography (EIT)


Eligibility criteria: * Inclusion Criteria:
* Patient who received a HENC therapy within 24 h after the extubation

Exclusion Criteria:

* Aged \<18 years
* Pregnancy
* Body mass index (BMI) over 50 kg/m2
* ribcage malformation .any contraindication of using EIT monitoring (automatic implantable cardioverter defibrillator, chest skin injury, etc.).

Primary outcomes:
measure: lung regional ventilation distribution
timeFrame: minute 80
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
state: Beijing
Study officials:
References:
citation: Zhang R, He H, Yun L, Zhou X, Wang X, Chi Y, Yuan S, Zhao Z. Effect of postextubation high-flow nasal cannula therapy on lung recruitment and overdistension in high-risk patient. Crit Care. 2020 Mar 6;24(1):82. doi: 10.1186/s13054-020-2809-7.
Clinical trial NCT03916341: Smoking and Ventricular Repolarization
Official title: Smoking and Ventricular Repolarization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Cardiac Death
Prolonged QTc Interval
Keywords: e-cigarettes
tobacco cigarettes
nicotine
ventricular repolarization
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2019-04-16
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover with 4 week washout
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization.

Detailed description: Non-user or chronic electronic cigarette (EC) users will use an EC or control on three occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).

Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw (control). The electrocardiogram will be recorded before and after acute exposures and analyzed for parameters representative of ventricular repolarization.

Eligibility criteria: Inclusion Criteria:

* Healthy non-smokers chronic TC smokers (non-e-cig users) Chronic EC smokers (Non-TC smokers)

Exclusion Criteria:

* Cardiac disease, respiratory disease, diabetes

Primary outcomes:
measure: Tpe
timeFrame: Change in Tpe 5 minutes before and 5 minutes after cigarette use
measure: Tpe/QT
timeFrame: Change in Tpe/QT 5 minutes before and 5 minutes after cigarette use
measure: Tpe/QTc
timeFrame: Change in Tpe/QTc 5 minutes before and 5 minutes after cigarette use
Secondary outcomes:
measure: QT
timeFrame: Change in QT 5 minutes before and 5 minutes after cigarette use
measure: QTc
timeFrame: Change in QTc 5 minutes before and 5 minutes after cigarette use
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
References:
Clinical trial NCT02082041: Measurement of Blood Perfusion in Response to Loading in Patients With Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Formation
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wounds on their legs, wound clinic patients

Brief summary: The purpose of this study is to monitor the skin blood flow in the lower leg, with different levels and types of applied loads. These loads will not be placed over the patient's wound nor will they be higher than loads the skin normally experiences in daily activities. The results of this research will help investigators understand the development of pressure ulcers, commonly known as bedsores and stasis ulcers.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible if he/she has a wound on one or both legs.

Exclusion Criteria:

* under the age of 18
* individuals with mental illness
* individuals who are unable to sit for an hour
* individuals whose wound care method prohibits testing

Primary outcomes:
measure: Changes in perfusion
timeFrame: Cross-sectional, evaluation time frame is approximately 2 hours occuring at the time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Sparrow Wound Clinic
state: Michigan
Study officials:
affiliation: Michigan State University
name: Tamara Bush, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00950417: Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer
Official title: Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Esophageal
Keywords: nimotuzumab esophageal chemo-radiotherapy
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.


Eligibility criteria: Inclusion Criteria:

* Informed consent form signed before performing any of the study's specific procedures.
* ECOG performance status 0-2.
* Age \> 18 and \< 75.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
* Histologically confirmed diagnosis of locally advanced esophageal.
* Life expectancy of more than 3 months.
* Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
* No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
* Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion Criteria:

* Previous radiotherapy or chemotherapy
* Pregnant or breast-feeding women
* Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
* Evidence of distant metastasis
* Participation in other clinical trials
* Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
* Uncontrolled psychiatric disease or seizure
* Patients not fit for the clinical trial judged by the investigators

Primary outcomes:
measure: Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
timeFrame: within study period
Secondary outcomes:
measure: To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fu Dan University Cancer Hospital
name: Xi-Chun Hu
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Dan University Cancer Hospital
name: Guo-Liang Jiang
role: STUDY_CHAIR
References:
Clinical trial NCT05250817: A Study of Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer
Official title: Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Preference
Advanced/Metastatic NSCLC
Discrete choice experiment (DCE)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-22
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational study includes pretest interviews with 15 participants diagnosed with non-small cell lung cancer (NSCLC) and 15 participants selected from the general population following the study inclusion criteria. The final survey will be administered online to 150 participants with NSCLC and 500 participants from the general population.

Brief summary: The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE).


Eligibility criteria: Inclusion Criteria:

The following is the inclusion criteria for pretest interviews and final online survey.

Participants:

* Must be 18 years of age or older
* Must be a US resident.
* Lung cancer participants with a physician diagnosis of NSCLC. Global Perspectives will be involved to suggest alternative strategies to a physician-confirmed diagnosis to ensure that actual cancer participants are recruited.

Exclusion Criteria:

* Not applicable

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Set of relative preference weights for all attribute levels included in the Discrete Choice Experiment (DCE)
timeFrame: At Baseline
measure: Respondents' baseline understanding of attribute descriptions
timeFrame: At Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: RTI Health Solutions
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03875417: Multidisciplinary Management of HCC in Elderly Patients
Official title: Multidisciplinary HCC Treatment in Elderly : QoL and Survival Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Quality of Life
Keywords: HCC
HCC in elderly
recurrent HCC
Liver resection
Quality of Life
intervention radiology
RF
TACE
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 126
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients submitted to surgery for HCC nodules resection between 2002 and 2017

Brief summary: Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Detailed description: Introduction- Hepatocellular carcinoma (HCC) is the most common primary liver malignancy. It usually develops in cirrhotic liver with high recurrence rates. More than 2/3 of patients are elderly, often excluded from surgery and follow-up protocols. Aim of this study is to evaluate whether treating HCC recurrences in resected elderly patients is advantageous or not.

Materials and methods- 126 patients, aged between 65 and 90 years, submitted to liver resection for HCC were enrolled. They were divided into three classes. Class 1 included patients submitted to major resections, Class 2 to minor resections and Class 3 to minor resections associated with thermoablation. All of them were clinically and radiologically followed up. Patients who developed recurrences (Group A) were referred to further treatments (surgery, interventional radiology or pharmacological therapy). Mortality, disease-free survival (DFS), overall survival (OS) and quality of life (QoL) were evaluated and compared with non-recurrent patients (Group B).

Used interventional radiology means were Radiofrequency ablation (RF), microwaves ablation (MWA) or transcatheter arterial chemoembolization (TACE).

Eligibility criteria: Inclusion Criteria:

* HCC patient
* eligible for surgery

Exclusion Criteria:

* non eligible for surgery at first HCC diagnosis

Primary outcomes:
measure: Overall survival
timeFrame: follow up time 1-16 years
measure: Disease free survival
timeFrame: follow up time 1-16 years
Secondary outcomes:
measure: Karnofsky performance scale
timeFrame: follow up time 1-16 years
measure: Activity of Daily living
timeFrame: follow up time 1-16 years
measure: Instrumental Activity of Daily living
timeFrame: follow up time 1-16 years
measure: Blood Haemoglobin
timeFrame: follow up time 1-16 years
measure: serum Albumin
timeFrame: follow up time 1-16 years
measure: Geriatric Depression Scale
timeFrame: follow up time 1-16 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Department of Surgery "Pietro Valdoni"
Study officials:
affiliation: Policlinico Umberto I - Sapienza università di Roma
name: Stefania Brozzetti, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02817217: The DDI Study of SP2086 and Valsartan
Official title: The Drug Interaction Study of SP2086 and Valsartan in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2.

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or Valsartan or any of the excipients of the formulation of SP2086 or Valsartan

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of Valsartan
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of Valsartan
timeFrame: up to Day 9
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 9
Other outcomes:
Locations:
city: Chengdu
country: China
facility: People's Liberation Army General Hospital of Chengdu Military Region
state: Sichuan
Study officials:
References:
Clinical trial NCT04617717: Personalized Treatment for Patients With Premature Ventricular Beats
Official title: Personalized Treatment for Patients With Premature Ventricular Beats
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Premature Complexes
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2020-11-05
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to PVC ablation

Brief summary: Frequent premature ventricular beats (PVBs) are common, negatively affects the quality of life for many patients, and can lead to impaired contractile function. Rule-out of structural heart disease is key in the assessment of PVBs. Cardiac MR has a high sensitivity for structural heart disease, but the diagnostic gain from this resource-demanding procedure in the work-up of patients with PVBs is unknown. There is a need to establish the role of MR in the evaluation of patients with PVBs to improve diagnostic efficacy, establish treatment strategies, and promote further research. This project will answer three key questions: 1) What is the diagnostic gain from cardiac MR in patients with PVBs? 2) Is MR the real gold standard to rule-out structural heart disease in patients with PVBs? 3) Can non-invasive heart rate parameters guide the strategy for induction of PVBs during invasive electrophysiological procedures?


Eligibility criteria: Inclusion Criteria: Patients referred for PVC ablation

Primary outcomes:
measure: MRI-based evidence of structural heart disease
timeFrame: 3-5 years
measure: PVC induction vs PVC/HR-relationship
timeFrame: 3-5 years
measure: EPS-based evidence of structural heart disease
timeFrame: 3-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Mathis K Stokke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: