louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02477189: Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
Official title: Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penile Implant
Lead sponsor: International Medical Devices, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-22
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men age 22 and older who had a penis implant from 2009-2014

Brief summary: This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.


Eligibility criteria: Inclusion Criteria:

* Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.

Exclusion Criteria:

* Medical records for the subject are not available for review or tabulation
* Subject did not comply with pre-operative or post-operative instructions.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Up to 4 years, with an average of 2 years
Secondary outcomes:
measure: Self-Esteem Score
timeFrame: 7 days pre-surgery to 90 days post-surgery
measure: Self-confidence score
timeFrame: 7 days pre-surgery to 90 days post-surgery
measure: Flaccid penile girth
timeFrame: 7 days pre-surgery to 90 days post-surgery
measure: Quality of Life Questionnaire
timeFrame: 7 days pre-surgery to 90 days post-surgery
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Allen Kamrava, MD, MBA
state: California
Study officials:
References:
Clinical trial NCT05617989: Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score
Official title: Role of Non-invasive Mechanical Ventilation and Diuretics in Improving Weaning Outcome of Patients With High Lung Ultrasound Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weaning Failure
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mechanical ventilated more than 48 h with high lung score

Brief summary: patients who succeeded in SBT with high lung scores by ultrasound, non-invasive ventilation, and diuretic may have a role.


Eligibility criteria: Inclusion Criteria:

* age ≥ 21 years of age
* mechanical ventilation for more than 48 hrs
* patients successfully passed according to the traditional weaning criteria
* lung ultrasound score ≥ 17.

Exclusion Criteria:

* Significant obstructive lung diseases
* Obstructive sleep apnea
* Interstitial lung disease
* Neuromuscular disorders

Primary outcomes:
measure: weaning failure ( number of patients)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Medicine Ain Shams University
Study officials:
References:
Clinical trial NCT04917289: CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients
Official title: Circulating Tumor Cell vs. Radiography as the Evidence of Disease Recurrence in Colorectal Cancer Patients Whose Tumor Underwent R0 Resection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Colorectal Cancer
Circulating Tumor Cell
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years;

Histologically proven colorectal cancer

All the lesion (s) has been R0 resected

Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests

More than 1 CTC has been detected (including 1)

ECOG 0-1

Hematology tests suggest that they can tolerate chemotherapy

Written informed consent for participation in the trial

Exclusion Criteria:

* Have any radiological evidence of recurrence

Other previous malignancy within 5 years

Primary outcomes:
measure: Overall Survival
timeFrame: 3 year
Secondary outcomes:
measure: Disease free survival
timeFrame: 3 year
measure: Adverse event
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01938989: Effect of Blue Light Filtration on Visual Performance
Official title: Effect of Blue Light Filtration on Visual Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
intraocular lens
IOL
blue light filter
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 158
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes \[ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery\]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.


Eligibility criteria: Inclusion Criteria:

* Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months;
* Good ocular health;
* 20/40 or better vision with best correction in both eyes;
* Willing to provide voluntary consent and sign informed consent form;
* Able to competently perform testing;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Photostress Recovery Time
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Stefani Smith, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02898389: Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients
Official title: Influence of Chronic Vascular Diseases on Transcranial Doppler Profiles in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Sedated
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All sedated patients under mechanical respiratory assistance will be included. These are further devided into 2 groups.

Brief summary: The primary objective of this study is to show that cardiovascular risk factors associated with the chronic elevation of arterial resistance may be associated with "false" profiles of intracranial hypertension during transcranial doppler ultrasound of the middle cerebral arteries in intensive care unit patients. A "false" profile of intracranial hypertension is defined by a high pulsatility index without any intracranial pathology.


Eligibility criteria: Inclusion Criteria for entry in the study:

* Sedated patient under mechanical respiratory assistance

Inclusion criteria for entry in group 1: the patient meets at least one of the following criteria:

* The patient is a man over the age of 50 or a woman over the age of 60
* Hypercholesterolemia (LDL \> 1.6 g/L, HDL \< 0.4 g/L)
* Arterial hypertension for over 10 years (treated or systolic arterial pressure \> 140 mmHG)
* Type 2 diabetes for over 10 years
* Active or former smoker in the past 3 years
* History of cardiovascular event (peripheral artery disease, heart attack, stroke/transient ischemic attack over 3 months ago)
* Chronic renal insufficiency with MDRD \< 30 ml/min/1.73m\^2

Inclusion criteria for entry in group 2:

* The included patient is not in group 1

Exclusion Criteria:

* acute neurological disorder (brain trauma, infectious or immune meningitis, meningoencephalitis, ischemic or hemorrhagic stroke \<3 months)
* pregnant woman
* person under guardianship
* prisoners
* recent carotid surgery (\<1 month)

Primary outcomes:
measure: Pulsatility index on the middle cerebral arteries
timeFrame: Day 0
measure: Diastolic velocity at the middle cerebral arteries
timeFrame: Day 0
measure: Mean velocity at the middle cerebral arteries
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Muller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135589: Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
Official title: Efficacy and Safety in Micafungin Sodium for Prophylaxis Against Invasive Fungal Disease During Neutropenia in Pediatric & Adolescent Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neutropenia
Hematopoietic Stem Cell Transplantation
Invasive Fungal Disease
Keywords: pediatric
adolescent
micafungin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2010-06-03
Enrollment: 145
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

Detailed description: The purpose of this study is to evaluate absence of proven, probable, possible, suspected invasive fungal disease (IFDs) through the end of prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis after allogeneic hematopoietic stem cell transplantation in pediatric and adolescent neutropenia patients. Patients will receive micafungin until the earliest of the following: 1) neutrophil engraftment; 2) development of proven, provable, possible or suspected invasive fungal disease; 3) development of unacceptable drug toxicity; 4) withdrawal from study participation or discontinuation of study treatment. Safety profile of micafungin is also evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients will receive allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

* Aspartate transaminase or alanine transaminase level \> 5 times UNL
* Bilirubin \> 2. 5 times UNL
* History of allergy, sensitivity, or any serious reaction to an echinocandin
* Invasive fungal disease at the time of enrolment
* Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
* Positive pregnancy test

Primary outcomes:
measure: Absence rate of IFDs assessed by physical examination and serum galactomannan test
timeFrame: during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis
Secondary outcomes:
measure: Survival rate
timeFrame: at day 100
measure: Safety assessed by lab-test and adverse events
timeFrame: during micafungin prophylaxis therapy
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Goyang
country: Korea, Republic of
city: Hwasun
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00204789: Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients
Official title: Phase 2b Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients (OTR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-solid Organ Transplant
Skin Neoplasms
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-20
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.


Eligibility criteria: Inclusion Criteria:

* \>1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney
* Adequate organ function
* Hearing age/gender appropriate
* At high risk for developing skin cancer
* Immunosuppressant levels and doses show stable graft function

Exclusion Criteria:

* Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA)
* Systemic therapy for cancer treatment or prophylaxis
* Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs \[NSAIDs\] (other than cardioprotective doses of aspirin)

Primary outcomes:
measure: To determine if DFMO at 500 mg daily will be well tolerated and not affect organ transplant viability
timeFrame: for 12 months
Secondary outcomes:
measure: To determine if DFMO will inhibit TPA-induced ODC in skin biopsies by approximately 50%
timeFrame: for the 12 months of therapy
measure: To determine if DFMO will be able to decrease polyamine levels in skin biopsies
timeFrame: for the 12 months of treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Howard H Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400489: Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
Official title: Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve or Aortic Valve Replacement
Keywords: Heart Valve Replacement Surgery
Perimount
Edwards
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 265
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with Perimount 6900PTFX or Perimount 2800TFX in three hospitals in China: Wuhan Asia Heart Hospital, Shandong Provincial Hospital, Tianjin Chest Hospital.

Patients need to complete two follow up visits after surgery in hospitals.

Brief summary: To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.

To track the patients'situations during one year after surgery and to collect the relevant clinical data.


Eligibility criteria: Inclusion Criteria:

* Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
* Patients sign the Inform Consent Form (ICF) and agree to join the study

Exclusion Criteria:

* Don't have any specific exclusion criteria.

Primary outcomes:
measure: Twice echocardiography to evaluate the performance of heart valve
timeFrame: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
measure: The recovery status of patients after surgery
timeFrame: The subjects will be followed for the duration of one year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Xufa Chen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Chengwei Zou, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Chest Hospital
name: Nan Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459289: Psychosocial Effect of HPV Positivity
Official title: The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papillomavirus
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
First posted: 2011-10-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of HPV testing in cervical screening has raised concerns about the effect of a positive HPV result on women's psychological well being. This is a nested psychosocial study of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects of educational intervention on such impact. Potential participants are identified among those who have joint the COCY trial. Participants will be randomized into two groups, namely the control group or intervention group. The control group participants will receive their smear results and an HPV leaflet by post. The intervention group will receive the leaflet and a counseling session on HPV. Self-administered questionnaires will be used to assess participants' psychological condition at the receipt of the smear results and at two months afterward. It is hypothesized that the level of emotional distress measured at smear result notification will be greater than that at two months afterward for all participants. Furthermore, participants in the intervention group will have lower psychological distress than those in the control group at two months after the receipt of their smear results.


Eligibility criteria: Inclusion Criteria:

1. Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
2. Women who are willing to attend colposcopy
3. Literate in the Chinese language
4. Have given a verbal consent to participate in this study

Exclusion Criteria:

* Women who are unable to provide a consent to participation.

Primary outcomes:
measure: Change from baseline in anxiety to 6 months
timeFrame: Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.
Secondary outcomes:
measure: Change from baseline in depression to 6 months
timeFrame: Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Obstetrics & Gynaecology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Hextan YS Ngan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353989: Hepatitis A Vaccination in the Elderly
Official title: Hepatitis A Vaccination in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis A
Keywords: hepatitis A
vaccination
elderly
protection to hepatitis A after vaccination
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 \>60 years, hepatitis A vaccination indicated 40 \< 40 years, hepatitis A vaccination indicated

Brief summary: A lot of elderly people travel to hepatitis A endemic areas. The prevalence of hepatitis A IgG positivity is declining in the Netherlands, also in the elderly. Studies show that people above 40 years of age have a slower immune response to hepatitis A vaccination. However, a lot of travelers seek pre-travel advice only shortly before their journey. More information about the time to adequate antibody response after hepatitis A vaccination is required to provide good protection during travelling. Alternative protection with immunoglobulins are available.

Study design: Observational, longitudinal pilot study Study population: 20 adults over 60 years of age with a negative hepatitis A IgG, (with a estimated 50% positivity for hepatitis A IgG in this age Group, 40 patients in this age group) 20 adults 18-40 years of age as controls.

Intervention (if applicable): When hepatitis A vaccination is indicated and informed consent is obtained, hepatitis A IgG wil be measured at day 0, 7, 14, 21 en 28.

Main study parameters/endpoints: Time to protective hepatitis A IgG. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: hepatitis A vaccination will be given also outside this study. In the study 5 venous punctures of 7 ml of blood.


Eligibility criteria: Exclusion Criteria:

* previous hep A vaccination
* known hepatitis A serology status
* immunodeficiency

Primary outcomes:
measure: How fast do patients> 60 year reach protective anti-HAV levels after vaccination?
timeFrame: 0, 1,2,3,4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
Study officials:
References: