louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02640781: Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction
Official title: Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.


Eligibility criteria: Inclusion Criteria:

* 20\~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy
* Patients with clinical obstructive symptoms confirmed by CT or colonoscopy

Exclusion Criteria:

* Patients with evidence of bowel perforation or peritonitis
* Cause of obstruction other than malignancy (bowel adhesion or benign stricture)
* Multiple stricture
* Lower rectal cancer obstruction (AV \<5cm)

Primary outcomes:
measure: Duration of stent patency between stent insertion and recurrence of obstructive symptoms
timeFrame: 2 years after the procedure
Secondary outcomes:
measure: Number of patients with technical success
timeFrame: 2 years after the procedure
measure: Number of patients with clinical success
timeFrame: 2 years after the procedure
measure: Number of patients with complications
timeFrame: 2 years after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04450381: Noninvasive Hemoglobin Testing, Prospective Blood Donors
Official title: Noninvasive Hemoglobin Testing in Prospective Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Anemia
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2020-06-29
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this clinical investigation is to evaluate the pulse oximeter devices for screening prospective blood donors. The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer in a blood donation setting.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Weight at least 110 pounds
* Subjects with the intention of being screened for eligibility to donate blood
* The subject has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, infections, abnormalities, etc.
* Subjects unwilling and/or unable to remove nail polish or acrylic nails
* Subjects with blood cancers such as leukemia
* Subjects with hemoglobin disorders such as sickle-cell anemia and thalassemia
* Subjects with known history of infectious diseases such as HIV/AIDS, syphilis, hepatitis, etc.
* Subjects with self-disclosed/known pregnancy at the time of enrollment
* Subjects deemed not suitable for the study at the discretion of the investigator
* Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.

Primary outcomes:
measure: Rad-67 Sensitivity
timeFrame: Up to one hour per subject
measure: Rad-67 Specificity
timeFrame: Up to one hour per subject
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Blood Bank - Site 1
state: California
Study officials:
References:
Clinical trial NCT06578481: The Effectiveness of Postural Stabilization Exercises in Patients With Chronic Neck Pain
Official title: The Effect of Postural Stabilization Exercises on Craniovertebral Angle, Disability and Quality of Life in Patients With Chronic Neck Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effect of postural stabilization exercises given in addition to cervical stabilization on craniovertebral angle, neck disability index, and quality of life in people with chronic neck pain.Sixty women with chronic neck pain between the ages of 20-60 were included in the study and the individuals were randomly divided into two groups. Individuals in the first group underwent cervical stabilization (CS) exercises and additional scapular and lumbopelvic stabilization (SLPS) exercises three times a week for 6 weeks. The second group was treated with only CS exercises for the same period. In addition, stretching exercises and a 20-minute hot pack were applied to the muscles around the neck of all patients. Craniovertebral angle (CVA) was measured by photogrammetry. Disability level was measured by the Neck Disability Index (NDI). The Turkish version of the Short Form-36 (SF-36) was used to assess quality of life.


Eligibility criteria: Inclusion Criteria:

* The study included females between the ages of 20-60 years, with moderate pain intensity (3 cm and above according to the Visual Pain Scale) and neck pain lasting more than 3 months.

Exclusion Criteria:

* Participants who had undergone any shoulder or neck surgery complained of fibromyalgia and myofascial pain syndrome, had a neurological disease, cervical radiculopathy, and serious systemic disease that would interfere with treatment, and who were pregnant were excluded from the study

Primary outcomes:
measure: Craniovertebral Angle Measurement
timeFrame: 6 weeks
measure: Neck Disability Index
timeFrame: 6 weeks
measure: Health Related Quality of Life
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lefka
country: Cyprus
facility: European University of Lefke
state: Gemikonağı
Study officials:
References:
Clinical trial NCT00212381: Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia
Official title: Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dysplasia
Keywords: cervical dysplasia, diindolylmethane, pap smear
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind intervention trial
Primary purpose: TREATMENT

Brief summary: To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.

Detailed description: To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation

Eligibility criteria: Inclusion Criteria:

* Non pregnant women greater than or equal to 18 years of age able to consent
* CIN II or III confirmed by histology
* Karnofsky performance status \>= 80
* No prior treatment for dysplasia in the past 4 months

Exclusion Criteria:

* Incompletely visible lesion
* Diethylstilbestrol (DES) exposure
* HIV seropositive

Primary outcomes:
measure: Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
timeFrame: 3 months
Secondary outcomes:
measure: HPV colonization by commercial ELIZA test
timeFrame: 3 months
measure: Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
timeFrame: one year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NY Downtown Hospital
name: Giuseppe Del Priore, M.D., M.P.H.
role: STUDY_DIRECTOR
affiliation: NYU School of Medicine
name: Alan Arslan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24.
Clinical trial NCT01123681: Intubation and Extubation Over 48 Hours Mechanical Ventilation
Official title: Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia, Ventilator-Associated
Critical Illness
Keywords: Respiration, Artificial
Pneumonia, Ventilator-Associated
Critical Illness
Lead sponsor: Okayama Research Investigator Organizing Network
Sponsor class: NETWORK
First posted: 2010-05-14
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients in an intensive care unit

Brief summary: The purpose of this study is to determine how often ventilator associated pneumonia happens in the current intensive care units, and how types of endotracheal tube affect its occurrence.


Eligibility criteria: Inclusion Criteria:

* Age \> 20 years old
* Mechanically ventilated over 48 hours in the ICU

Exclusion Criteria:

* Mask ventilation
* Tracheostomy

Primary outcomes:
measure: Occurrence and timing of ventilator associated pneumonia
timeFrame: one month
Secondary outcomes:
measure: Ventilator-free days
timeFrame: one month
measure: Duration of ICU stay and hospital stay
timeFrame: three months
measure: ICU and hospital mortality
timeFrame: three months
Other outcomes:
Locations:
city: Himeji
country: Japan
facility: Intensive Care Unit, Himeji Red Cross Hospital
state: Hyogo
city: Hiroshima
country: Japan
facility: Intensive Care Unit, Hiroshima City Hospital
city: Kochi
country: Japan
facility: Intensive Crae Unit, Kochi Medical School Hospital
city: Marugame
country: Japan
facility: Intensive Care Unit, Kagawa Rosai Hospital
city: Okayama
country: Japan
facility: Intensive Care Unit, Okayama University Hospital
city: Tsuyama
country: Japan
facility: Intensive Care Unit, Tsuyama Chuo Hospital
Study officials:
affiliation: Okayama University
name: Hiroshi Morimatsu, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04187781: Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
Official title: Quality Control of CE-Certified Phonak Hearing Aids - 2019_34
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed description: This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.

The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).

The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.

This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility criteria: Inclusion Criteria:

* experienced hearing aid user
* severe hearing loss
* willingness and interest in testing an external microphone healthy outer ear
* willingness to wear behind the ear hearing aids
* Informed Consent as documented by signature

Exclusion Criteria:

* the audiogram is not in the fitting range of the intended hearing aid
* limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* participant is not able to describe experiences and hearing impressions

Primary outcomes:
measure: Rating of the subjective comfort for the old and the new setting
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluation of the speech intelligibility in noise
timeFrame: 2 weeks
measure: Subjective Sound Quality rating
timeFrame: 6 weeks
measure: Subjective rating of natural sounds
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
References:
Clinical trial NCT04866381: An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Official title: An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Progression to PD-1 Antibody
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 87
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: This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as esophageal squamous cell carcinoma by histopathology with at least one measurable lesion according to RECIST 1.1 criteria.
* Must have had progressive disease after previous treatment with PD-1 inhibitor
* ECOG score 0-2
* The expected survival time is ≥ 12 weeks
* Previous permanent discontinuation did not occur due to adverse events associated with immunotherapy, or the immunotreatment-related adverse events recovered to ≤1 grade

Exclusion Criteria:

* Had other active malignant tumors within 5 years before entering the study
* Had abnormal swallowing function or dysfunction of gastrointestinal absorption
* The first study drug treatment was less than 28 days or 5 half-lives (in terms of longer) from the last radiotherapy, chemotherapy, targeted therapy or immunotherapy
* Patients who have already received surgery within 28 days (biopsy for diagnosis is permitted)
* Pregnant or lactating women

Primary outcomes:
measure: Objective Response Rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression-Free-Survival
timeFrame: Up to 1 year
measure: Overall survival
timeFrame: Up to 1 year
measure: Subject safety
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT05890781: Engineering Immune Organoids to Study Pediatric Cancer
Official title: Engineering Immune Organoids to Study Pediatric Cancer (IMMUNE-ORGANOIDS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Kidney Tumor
Neuroblastoma
Sarcoma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 44
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To engineer immune organoids from pediatric patient tissues using induced-pluripotent stem cells (iPSC)


Eligibility criteria: Inclusion Criteria:

* Age at diagnosis ≤ 25 years except for patients with malignant gliomas and renal tumors for whom no upper age limit is applied
* Medical suspicion or diagnosis of one of the following diseases, regardless of stage:
* Brain tumors
* Renal tumors
* Neuroblastoma
* Sarcomas
* Adult patient or parents or guardians should understand, sign and date the appropriate written informed consent from prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* Affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

* Any histology not mentioned in the inclusion criteria
* Adult patient or parents/guardians incapable/incapable of giving its/their consent
* Patients deprived of their liberty by a judicial or administrative decision

Primary outcomes:
measure: Proportion of viable and exploitable immune organoids with engrafted tumor cells
timeFrame: until 5 years after enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
References:
Clinical trial NCT05620381: Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Official title: Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders
Disorders Post-Traumatic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥ 18 years old) having been exposed to the attacks of December 11, 2018 in Strasbourg directly or indirectly (presence at the scene or close relative present at the scene)

Brief summary: Evaluation of the prevalence of post-traumatic stress disorder (PTSD), associated risk factors, health care consumption, and sleep disorders in a civilian population exposed to the December 11, 2018, attacks in Strasbourg. Terrorist attacks have unfortunately become all too frequent on our territory in recent years. A better knowledge of the psychological and psychiatric repercussions on exposed populations is essential in order to better prevent and treat disorders that can have a major functional impact on the lives of exposed individuals and to adapt care during future similar events


Eligibility criteria: Inclusion criteria:

* Major subject (≥ 18 years old),
* Having been exposed to the attacks of December 11, 2018 in Strasbourg directly or indirectly (presence at the scene or close relative present at the scene)
* Subject who has not expressed his opposition, after information, to the reuse of his data for the purpose of this research

Exclusion Criteria:

* Subject who has expressed opposition to participating in the study
* Subject under guardianship, curatorship or legal protection

Primary outcomes:
measure: Retrospective evaluation of the prevalence of post-traumatic stress disorder (PTSD) in a population exposed to the attacks of December 11, 2018 in Strasbourg
timeFrame: Files analysed retrospectively from February 11, 2018 to November 30, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie d'Urgences, de Liaison et de Psychotraumatologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02931981: Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor
Official title: Serum Dickkopf-4 as a Biomarker for the Diagnosis and Treatment of Gastrointestinal Stromal Tumor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Stromal Tumor
Keywords: DKK4
Gastrointestinal Stromal Tumor
Biomarker
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal stromal tumor.

Brief summary: Our study aims to evaluate the role of Dickkopf-4 as biomarkers in the treatment of gastrointestinal stromal tumor.

Detailed description: To identify whether Dickkopf-4 (DKK4) could be a potential biomarker for diagnosis and prognosis in patients with gastrointestinal stromal tumor (GIST). Serum was collected from 50 patients with GIST. Serological levels of DKK4 were examined by enzyme-linked immunosorbent assay (ELISA). The sensitivity and specificity was compared with modified NIH risk criteria. A 3-year follow-up was monitored to evaluate the correlation between DKK4 serum levels and relapse-free or overall survival. The expression of DKK4 in GIST tumor tissues was also evaluated using immunohistochemistry staining.

Eligibility criteria: Inclusion Criteria:

* Primary gastrointestinal stromal tumor confirmed pathologically by surgery or biopsy
* Age from 18 - 70 years
* No serious organic and mental illness;

Exclusion Criteria:

* Pregnancy
* No pathologic result
* Suffering other malignancies at the same time.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Relapse-free Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
Study officials:
References: