louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01020864: Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer
Official title: Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Keywords: Platinum-resistent head and neck cancer
Cetuximab
Carboplatin
Navelbine
Phase II trial
Combination chemotherapy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2009-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.


Eligibility criteria: Inclusion Criteria:

* Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
* Measurable or non-measurable disease.
* Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence \< 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
* WHO Performance Status 0-2.
* Age ≥ 18 years.
* Neutrophil count (ANC) ≥ 1.5 x 10\^9/l and platelets ≥ 100 x 10\^9/l.
* Normal liver function with bilirubin \< 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
* Creatinin clearance ≥ 50 ml/min.
* Signed informed consent.

Exclusion Criteria:

* Other active malignant disease.
* Patients who are considered unable to follow the treatment plan or follow-up visits.
* Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
* Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
* Pregnant or lactating women.
* Known hypersensitivity towards one or more of the components of the treatment.
* Prior treatment with either cetuximab or other inhibitors of EGFR.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2.5 years
measure: Response rate
timeFrame: 3 years
Secondary outcomes:
measure: Toxicity
timeFrame: 2.5 years
measure: Median survival
timeFrame: 3 years
measure: Correlation between response and evolvement in tumor biology markers.
timeFrame: 3 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Per Pfeiffer, Professor, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03923764: High Protein and Energy Diet for Better Coughing in COPD Patients
Official title: Effects of a Diet High in Protein and Energy in Combination With Physical Activity for the Improvement of Coughing Capacity in COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Copd
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2019-04-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic Obstructive Lung Disease (COPD) is one of the leading death causes worldwide. COPD is a disease that is characterized by chronic inflammation which leads to irreversible damage of airways and lung tissue. This intervention investigates the effects of a diet high in protein and energy for the improvement of coughing capacity and lung function of COPD patients. The patients will be recruited as part of a lung rehabilitating programme which takes place in Bispebjerg and Hvidovre Hospital. The intervention group receives individual nutritional guidelines whereas the control group continues their usual diet. Blood tests will be performed at baseline and the end of the study. Other anthropometric measures include spirometry for lung function, hand grip strength and fat free mass to assess muscle waisting.

Detailed description: 40 patients with COPD randomized to diet with protein 1.3 g/kg/day or habitual intake:

Primary endpoint (before-after): Leicester Cough Questionnaire Secondary endpoints: ADL-score, no. daily cough periods, development in FEV1 and FVC, hand-grib-strenght, use of respiratory medications, smoking, appetite, admissions to hospital, antibiotics and/or steroids, oxygen saturation, FFM (BIA), Coughs tests in spirometer and peak-flow-meter

Study period: 2 months

Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD
* Participating in ongoing lung rehabilitating programme at Hvidovre and Bispebjerg Hospital
* over 18 years

Exclusion Criteria:

* Plasma creatinin over 200 mikrog/l
* dementia
* unable to read or speak danish

Primary outcomes:
measure: Improvement of coughing capacity of COPD patients
timeFrame: 8 weeks
Secondary outcomes:
measure: Weight change
timeFrame: 8 weeks
measure: Oxygen saturation before and after treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Pulmonary Medicine, Bispebjerg Hospital
Study officials:
affiliation: Associate Professor
name: Jens R Andersen, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00470964: Titanium-Sapphire Laser Trabeculoplasty in Glaucoma: A Randomized Study Comparing Titanium-Sapphire With Argon Laser Trabeculoplasty in Open-Angle Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: laser trabeculoplasty, glaucoma, argon, titanium-sapphire
IOP lowering effect
Adverse effects
IOP spikes
Lead sponsor: Goldschleger Eye Institute
Sponsor class: OTHER
First posted: 2007-05-08
Sex: ALL
Minimum age (years): 40
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Titanium Sapphire laser trabeculoplasty is effective in lowering intraocular pressure in glaucoma patients, and is comparable to argon laser trabeculoplasty

Detailed description: Objective: To compare the medium-term outcome of Titanium-Sapphire laser trabeculoplasty (TiSLT) vs. Argon Laser Trabeculoplasty (ALT) in uncontrolled Open-angle Glaucoma (OAG) patients.

Methods: Prospective, masked, randomized comparative clinical study. Thirty-seven OAG patients with uncontrolled IOP and no previous filtration surgery (22 females and 15 males, mean age of 68 years) participated. Eighteen were treated with TiSLT and 19 with ALT. All patients underwent a comprehensive eye examination including visual acuity, IOP, goniocscopy and slit-lamp biomicroscopy and visual field examinations. Patients were examined pre-operatively and then at 1 hour, 1 day, 1 week, 1, 3 and 6 months, 1 year and 18 months post-operatively.

Main outcome measures: Final IOP, delta IOP and number of anti-glaucoma medications.

Results: The 18 patients in the TiSLT arm had an average of 8.3(±2.7) mm Hg or 32% reduction from pre-operative IOP (P\<0.001). The 19 patients in the ALT arm had a mean IOP decrease of 6.5 (±4.3) mm Hg (P\<0.001) or a 25% IOP reduction. Patients in both groups achieved a similar decrease in IOP (P\>0.05). TiSLT patients had statistically significant fewer IOP spikes compared to the ALT group. (P=0.002). Two patients (1 in each arm) underwent trabeculectomy and were considered failures. Mean follow-up time was 15 months.

Conclusions: TiSLT provides similar efficacy to ALT in IOP reduction in OAG patients, and may offer better safety with fewer IOP spikes see post-operatively.

Application to clinical practice: If confirmed in additional studies, TiSLT may be used as an alternative to ALT in OAG patients.

Eligibility criteria: Inclusion Criteria:

* Uncontrolled open angle glaucoma patients

Primary outcomes:
measure: IOP
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Goldschleger Eye Institute
Study officials:
affiliation: Goldschleger Eye Institute
name: Shlomo Melamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02745964: A Comparison of LMA-Supreme and I-gel for the Incidence of Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 8
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate and compare the incidence of the postoperative sore throat between LMA supreme and I-gel.


Eligibility criteria: Inclusion Criteria:

- adult patients aged over 19 years who are scheduled for elective surgery under general anesthesia using the laryngeal mask airway

Exclusion Criteria:

* Anticipated difficult airway
* Expected duration of surgery more than 4 hours
* body mass index more than 35 kg/m2
* pregnancy
* Upper gastrointestinal surgery or open abdominal surgery.

Primary outcomes:
measure: Postoperative sore throat
timeFrame: within 24 hours after the end of surgery.
Secondary outcomes:
measure: Postoperative dysphagia
timeFrame: within 24 hours after the end of surgery
measure: Postoperative dysphonia
timeFrame: within 24 hours after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain MedicineSeverance Hospital, Yonsei University Health System
state: Korea
Study officials:
References:
Clinical trial NCT04042064: To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment
Official title: To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery and Anesthesia on Elderly
Comprehensive Geriatric Assessment
Aged
Keywords: CGA
Anesthesia for the elderly
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The elderly population requiring anesthesia.

Brief summary: Aging is a universal and progressive physiological phenomenon clinically characterized by degenerative changes in both the structure and the functional capacity of organs and tissues. A comprehensive geriatric assessment (CGA) has now become a standard assessment for caring for the elderly. CGA is a multidisciplinary team with the goal of improving the overall well-being of the elderly. It encompasses screening, diagnosis and treatment of the elderly. In this study, we use the comprehensive geriatric assessment to study the effects of surgery and anesthesia on elderly patients.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Participants receiving general anesthesia for longer than 1 hour.

Exclusion Criteria:

* Participants receiving local anesthesia.
* Participants receiving regional anesthesia.
* Participants receiving general anesthesia for less than 1 hour.
* Participants with psychiatric disorder.

Primary outcomes:
measure: Mini-Mental Status Examination
timeFrame: Before general anesthesia till 48-hours post-anesthesia.
measure: Geriatric Depression Scale - 15
timeFrame: Before general anesthesia till 48-hours post-anesthesia.
measure: Confusion Assessment Method
timeFrame: Before general anesthesia till 48-hours post-anesthesia.
measure: Barthel Index
timeFrame: Before general anesthesia till 48-hours post-anesthesia.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02424864: 4D FDG PET in Esophageal Cancer
Official title: 4D PET-CT Imaging in Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: 4D PET-CT
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.

Detailed description: Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.

Eligibility criteria: Inclusion Criteria:

* Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer
* \> 18 years
* Written informed consent

Exclusion Criteria:

* \<18 years
* Possibility of pregnancy

Primary outcomes:
measure: The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET
timeFrame: one year
Secondary outcomes:
measure: Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes
timeFrame: one year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: The Netherlands cancer Institute
state: Noord-Holland
Study officials:
affiliation: NKI-AvL
name: Francine Voncken, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voncken FEM, Vegt E, van Sandick JW, van Dieren JM, Grootscholten C, Bartels-Rutten A, Takken SL, Sonke JJ, van de Kamer JB, Aleman BMP. Motion-compensated FDG PET/CT for oesophageal cancer. Strahlenther Onkol. 2021 Sep;197(9):791-801. doi: 10.1007/s00066-021-01761-w. Epub 2021 Apr 7.
Clinical trial NCT02500264: The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Official title: The Effect of Non Invasive Electrical Stimulation Therapy on Gastroesophageal Reflux Disease (GERD) Symptoms - Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the study: To evaluate whether the use of a specific TENS technology can improve GERD symptoms and esophageal acid exposure.


Eligibility criteria: Inclusion Criteria:

* at least 3 episodes of heartburn and/or regurgitation in a week for at least 3 months.
* evidence for an abnormal esophagal acid exposure on impedance-pH monitoring (tested in the last 2 years off PPI)

Exclusion Criteria:

* gastric or esophagal surgery
* active peptic ulcer disease
* malignancy
* pregnancy
* uncontrolled diabetes mellitus
* severe cardiac conditions such as cardiac arrhythmia or ischemia or cardiac pacemaker/defibrillator
* allergy to adhesives/patches
* severe pulmonary disease
* obesity (BMI\>30)

Primary outcomes:
measure: Symptoms severity questionnaire (heartburn and regurgitation) before and after treatment
timeFrame: 34 days
Secondary outcomes:
measure: Esophageal acid exposure before and after treatment
timeFrame: 34 days
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: MD
name: ram dickman, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05673564: Anatomical Resection in Colorectal Liver Metastases Patients
Official title: Anatomical Resection in Colorectal Liver Metastases Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study was a retrospective cohort study based on our prospectively collected colorectal cancer database. All adult patients who underwent curative-intent liver resection for CRLM between June 2012 and May 2019 at Zhongshan Hospital in Shanghai and had available data on KRAS/NRAS/BRAF status, were eligible for inclusion.

Brief summary: The type of liver resection (anatomical resection, AR or nonanatomical resection, NAR) for colorectal liver metastases (CRLM) is subject to debate. The debate may persist because some certain prognostic factors, associated with aggressive biological behavior of tumor, have been overlooked. The aim of our study was to investigate the characteristics of patients who would benefit more from anatomical resection for colorectal liver metastases.

Detailed description: 729 patients who underwent hepatic resection of CRLM were retrospectively collected from June 2012and May 2019. Treatment effects between AR and NAR were compared in full subgroup analyses. Tumor relapse-free survival (RFS) was evaluated by a stratified log-rank test and summarized with the use of Kaplan-Meier and Cox proportional hazards methods.

Eligibility criteria: Inclusion Criteria:

(1)Age 18-79 years;(2) Histologically proven colorectal adenocarcinoma;

Exclusion Criteria:

(1) the histologic type of tumor was not called adenocarcinoma; (2) peritoneal metastasis; (3) number of liver metastasis \>3; (4) simultaneous anatomical and nonanatomical resections; (5) R2 resection; (6) history of previous hepatectomy; (7) incomplete data. The rest of patients were divided into 2 groups: patients undergoing an AR, and patients undergoing a NAR.

Primary outcomes:
measure: RFS
timeFrame: 2012.6.1-2022.6.1
Secondary outcomes:
measure: OS
timeFrame: 2012.6.1-2022.6.1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00849264: Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
Official title: a Randomized Controlled Study of Surgical Comprehensive Treatment for Different Types of Tumor Thrombi in the Portal Vein for Hepatocellular Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Portal Vein Tumor Thrombus
Keywords: hepatocellular carcinoma
portal vein tumor thrombus
surgical comprehensive treatment
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is working to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Detailed description: Primary liver cancer (PLC) has a great tendency to invade portal vein intravascularly, results in the formation of portal vein tumor thrombus (PVTT), which is a crucial factor that can worsen the prognosis of patients with PLC.

In clinical, various treatments have been applied to improve this short-term prognosis, but there was no identical indication for treatment of PLC patients with different PVTT.

The objective of this study is to evaluate the surgical comprehensive treatment for different types of tumor thrombi in the portal vein for hepatocellular carcinoma patients, to establish a standardized, unified, effective therapeutic program.

Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 30 years and \<=60 years of age.
* with a clinical diagnosis of primary liver cancer with PVTT, without any adjuvant therapy.
* resectable tumors in the liver.
* PVTT type for II or III (based on the PVTT type system established by our groups), confirmed through pre-operative imaging and pathologic examination.
* liver function grade A or B of the Child-Pugh classification.
* No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hb ≥95g/L,WBC ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³.
* Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

* have had an allergic reaction following iodine or chemotherapeutic drugs.
* with extrahepatic metastasis.
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
* liver function:Child C.

Primary outcomes:
measure: overall survival
timeFrame: 2010
Secondary outcomes:
measure: disease-free survival
timeFrame: 1,2 and 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Feng Shen, M.D.
role: STUDY_CHAIR
References: