louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00319111: Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Official title: Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
bosentan
BENEFIT
CTEPH
inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.


Eligibility criteria: Inclusion Criteria:

* Patients having completed the 16-week treatment period of protocol AC-052-366 (NCT00313222)
* Signed informed consent

Exclusion Criteria:

* Any major violation of protocol AC-052-366 (NCT00313222)
* Pregnancy or breast-feeding

Primary outcomes:
measure: Change From Baseline to All Assessed Time Points in 6-minute Walk Test (6MWT) Distance
timeFrame: Until discontinuation of study drug, up to 3.3 years
measure: Change From Baseline to All Assessed Time Points in Borg Dyspnea Index
timeFrame: Until discontinuation of study drug, up to 3.3 years
measure: Disease Severity - Number of Patients Showing Improvement by One Class or More in World Health Organisation (WHO) Functional Classification of Pulmonary Hypertension (PH)
timeFrame: Until discontinuation of study drug, up to 3.3 years
measure: Time to Clinical Worsening up to End-of-study
timeFrame: Until discontinuation of study drug, up to 3.3 years
Secondary outcomes:
measure: Number of Patients With an Adverse Event(s) Leading to Premature Discontinuation of Study Medication
timeFrame: Until discontinuation of study drug, up to 3.3 years
measure: Number of Patients Experiencing a Serious Adverse Event(s) up to 28 Days After Study Medication Discontinuation
timeFrame: 28 days after discontinuation of study drug, up to 3.3 years
measure: Occurrence of Liver Function Test and Hemoglobin Abnormality
timeFrame: Until discontinuation of study drug, up to 3.3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04216511: Early Cancer Detection Test - Lung Cancer China
Official title: Clinic Validation of Autoantibody Panel for Lung Cancer Diagnosis in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Tumor Autoantibody
Early Detection
Indeterminate Pulmonary Nodule
Lead sponsor: Chinese Alliance Against Lung Cancer
Sponsor class: OTHER
Collaborators: name: Gene Tech (Shanghai) Company Limited
First posted: 2020-01-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with lung cancer, benign pulmonary nodule or identified as at-risk healthy volunteer in participating hospitals of this study, from the recruitment starting date, till the end of the study.

Brief summary: Lung cancer is the most common cancer in China from both incidence and mortality rate point of view, with significantly lower 5-year survival rate than average. Early detection is the recognized solution. LDCT is more and more popular accepted as an effective screening methodology but leads to numerous indeterminate pulmonary nodules for physicians to distinguish too. The value of autoantibody test in risk assessing of IPNs as well as early detection of lung cancer in high risk population has been demonstrated in clinical practice and trial but mainly in Caucasian. Purpose of this study is to understand the sensitivity, specificity and accuracy of candidate autoantibodies, and consequently explore the autoantibody combination with best clinical performance in Chinese population.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 or above.
* Individuals complying with either of the following

  1. diagnosed as lung cancer (histopathologically confirmed);
  2. diagnosed as benign pulmonary nodule (confirmed by pathology or by follow-up based on 2018 Chinese Consensus on Pulmonary Nodule Diagnosis and Treatment);
  3. without pulmonary nodule but with lung cancer risk factor, age \& gender matched recruited lung cancer patients.
* Participant is willing and able to provide necessary information required in CRF.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* History of any cancer;
* Lung cancer patient who received or is receiving any treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.

Primary outcomes:
measure: Autoantibody panel with best clinical performance in Chinese population
timeFrame: Oct.30, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Zhengzhou
country: China
facility: Henan Province People's Hospital
Study officials:
affiliation: Fudan University
name: Chunxue Bai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553111: Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission
Official title: Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syphilis
Keywords: syphilis
video education
knowledge
black
hispanic
Lead sponsor: Jacobi Medical Center
Sponsor class: OTHER
First posted: 2007-11-04
Enrollment: 168
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC Department of Health funded the Emergency Department of Jacobi Medical Center to further evaluate the effectiveness of the Syphilis and Men video in additional settings where men access STD related information and testing and where high-risk groups, such as MSM, frequent. The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited from a community-based organization, an ambulatory care setting, and a dance club.

Detailed description: The Solomon-four group design was applied to assess the effectiveness of the video in raising syphilis knowledge among participants, while controlling for the influence of the pre-test knowledge survey in skewing post-knowledge survey scores. Participants in Group 1 received a pre-test survey, the video intervention, and the post-test survey; Group 2 received the pre-test and post-test surveys; Group 3 received the video intervention and post-test survey; and Group 4 received the post-test survey only. A computer-generated randomization list was used to assign participants to one of the four groups.

Eligibility criteria: Inclusion Criteria:

* must speak english or spanish

Exclusion Criteria:

* excluded if hearing or visually impaired

Primary outcomes:
measure: The primary outcome was the score on a 10-question measure designed to assess knowledge attained from the syphilis educational video
timeFrame: 20 minutes
Secondary outcomes:
measure: A secondary outcome was the decision to be tested for syphilis and HIV
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: New York University Ambulatory Care Pavilion
state: New York
city: Manhattan
country: United States
facility: Gay Men of African Descent
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Chinazo Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: John Sanchez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084811: Chronic Rhinosinusitis: Biochemical Markers and Biofilm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Rhinosinusitis
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to sinonasal surgery at Ahus, Norway

Brief summary: The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis.

In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present.

The hypothesis here is that biofilm patients suffers a more severe disease.

In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period.

The purpose of this part of the study is to investigate candidates for the development of nasal polyposis.

The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis based on EPOS3
* Submitted to surgery
* Using nasal corticosteroids

Exclusion Criteria:

* Age below 18 years
* Using antibiotics at the time of surgery
* Using systemic corticosteroids
* Sempers triad

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Ahus
state: Akershus
Study officials:
References:
Clinical trial NCT02913911: Sit-to-stand With Feedback in SCI Patients
Official title: The Provision of External Feedback During Sit-to-stand in Ambulatory Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries, Spinal Cord
Keywords: feedback
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: * Does the utility of external feedback in terms of goal-directed LLL approach during STS training immediately improve functional ability relating to walking in ambulatory patients with SCI?
* Does the utility of LLL feedback improve functional ability relating to walking in ambulatory patients with SCI after 2-week training?

Detailed description: * To compare immediate effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI
* To compare 2 weeks effects of STS training with and without LLL feedback on functional ability relating to walking in ambulatory patients with SCI.

Eligibility criteria: Inclusion Criteria:

* Ambulatory spinal cord injury patients

Exclusion Criteria:

* Deformity of musculoskeletal system

Primary outcomes:
measure: 10MWT
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand
name: Sugalya Amatachaya, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510011: Allograft and Tantalum Cone Reconstruction in TKA Revision
Official title: Clinical and Radiological Outcomes of Composite Tibial and Femoral Allograft and Tantalum Cone Reconstructions in Total Knee Replacement Revision
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tantalum
Bone Loss
Allograft
Keywords: Tantalum
Allograft
TKA revision using tantalum cone and/or allograft
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 76
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: Pregnant women attending for 3rd timester scan

Brief summary: A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft.

Study of radiological and clinical outcomes.


Eligibility criteria: Inclusion criteria:

* \> 18 years old
* TKA revision using tantalum cone or allograft

Exclusion criteria:

* \<18 years old
* no reconstruction used in TKA revision

Primary outcomes:
measure: Rate of Survivorship of the implant
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Louis DAGNEAUX, PHU
role: STUDY_DIRECTOR
References:
Clinical trial NCT00918411: A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
Official title: Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: diarrhea
IBS
Colonic diseases
YM060
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 98
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).


Eligibility criteria: Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

* Patients having hyperthyroidism or hypothyroidism

Primary outcomes:
measure: IBS severity index (Japanese version)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient reported global assessment of relief of IBS symptoms
timeFrame: 12 weeks
measure: Patient reported assessment of relief of abdominal discomfort and/or pain
timeFrame: 12 weeks
measure: Patient reported assessment of improvement of abdominal bowel habits
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Randomized, placebo-controlled, phase IV pilot study of ramosetron to evaluate the co-primary end points in male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.
citation: Ida M, Nishida A, Akiho H, Nakashima Y, Matsueda K, Fukudo S. Evaluation of the irritable bowel syndrome severity index in Japanese male patients with irritable bowel syndrome with diarrhea. Biopsychosoc Med. 2017 Mar 11;11:7. doi: 10.1186/s13030-017-0092-x. eCollection 2017.
Clinical trial NCT01597011: Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
Official title: Long-term Follow-up After Laparoscopic Inguinal Hernia Repair Using Tisseel for Mesh Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Recurrence
Chronic Pain
Keywords: Hernia, Inguinal
Hernia repair
Fibrin Tissue Adhesive
Tisseel
Tissucol
Recurrence
Chronic Pain
Dysejaculation
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 2340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled based on their registration in the Danish Hernia Database. All patients in the database who have undergone laparoscopic inguinal hernia repair from January 2009 to September 2012 will be included.

Brief summary: In hernia repair a mesh is used to close the defect in the abdominal wall. This mesh is either secured with tissue penetrating devices (ex. staples,tacks or sutures) or fibrin glue (Tisseel/Tissucol) or left unfixated.

The investigators believe, and previous studies indicate, that the use of fibrin glue greatly reduces the amount of postoperative complications (ex. chronic pain, impaired ejaculation in men or recurrence of the hernia)when compared with the use of tacks or staples.

The aim of this study is to compare the recurrence rates and amount of postoperative complications in patients who have had inguinal hernia repair with fibrin glue and in patients who have had inguinal hernia repair with tacks, staples or sutures.

Detailed description: The study will use prospectively collected data from the Danish Hernia Database to find the patients. The patients will be contacted using a questionnaire.

Eligibility criteria: Inclusion Criteria:

inguinal hernia repair from January 2009-September 2012

Exclusion Criteria:

Patients lost to follow-up

Primary outcomes:
measure: Chronic pain
timeFrame: within period from one year after procedure until follow-up
Secondary outcomes:
measure: Recurrence
timeFrame: within period from procedure to follow-up
measure: dysejaculation
timeFrame: Debut within period from procedure to follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Herlev Hospital
name: Neel M Helvind, Researcher
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Jacob Rosenberg, professor
role: STUDY_CHAIR
affiliation: Herlev Hospital
name: Andreas Q Fenger, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053611: Composite Variability Index Versus Bispectral Index (BIS)
Official title: Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation During
Keywords: composite variability index
bispectral index
pain
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

Detailed description: Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Eligibility criteria: Inclusion Criteria:

* ASA class I and II patients requiring general anesthesia for elective surgical procedures

Exclusion Criteria:

* patient refusal
* weight less than 70% or more than 130% of ideal body weight,
* neurological disorder
* recent use of psycho-active medication, including alcohol.

Primary outcomes:
measure: BIS and CVI.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Sahinovic MM, Eleveld DJ, Kalmar AF, Heeremans EH, De Smet T, Seshagiri CV, Absalom AR, Vereecke HEM, Struys MMRF. Accuracy of the composite variability index as a measure of the balance between nociception and antinociception during anesthesia. Anesth Analg. 2014 Aug;119(2):288-301. doi: 10.1213/ANE.0000000000000274.
Clinical trial NCT06144411: Recording and Evaluating Preoperative Malnutrition in Electively Scheduled Adult Surgical Patients With the GLIM Criteria (GLIM-study)
Official title: Recording and Evaluating Preoperative Malnutrition in Electively Scheduled Adult Surgical Patients With the GLIM Criteria (GLIM-study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of electively scheduled adult surgical patients at the Amsterdam UMC, location AMC.

Brief summary: Data about the prevalence of preoperative malnutrition according to all the five GLIM criteria among the broad range of surgical patients are lacking. The current study will investigate the prevalence of malnutrition according to all of the five GLIM criteria in electively planned surgical patients in a large academic hospital, the Amsterdam University Medical Centres, location AMC, where over 11.000 patients are operated on yearly.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective surgery at the operating theatres of the AUMC, location AMC
* Patients ≥ 18 years
* Dutch speaking
* Willing and able to sign consent for re-use of care data
* The study can be combined with other studies

Exclusion Criteria:

* Patients \< 18 years
* Not speaking Dutch
* Patients who do not sign consent for re-use of care data

Primary outcomes:
measure: prevalence of preoperative malnutrition
timeFrame: preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-holland
Study officials:
affiliation: j.hermanides@amsterdamumc.nl
name: Jeroen Hermanides, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: