louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00581763: Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies
Official title: Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 110
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young group of SLE and APS subjects

Brief summary: This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.

Detailed description: Aim:

1. Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.
2. Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.
3. Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.
4. Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.
5. Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods:

This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression.

Eligibility criteria: Inclusion Criteria:

Age: Less than 21 years at baseline exam

* Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.

The five diagnostic categories are:

* SLE with no aPL
* SLE with aPL, but without manifestations of APS
* SLE-like APS
* SLE with APS
* Primary APS.

Exclusion Criteria:

* none

Primary outcomes:
measure: thrombosis
timeFrame: Ten years
Secondary outcomes:
measure: lupus
timeFrame: 10 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Emily von Scheven
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671163: Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy
Official title: EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Cancer
Radiation therapy
Fiducial markers
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-08-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.

Brief summary: The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older,
* Scheduled to undergo fiducial placement,
* Subject must be able to give informed consent

Exclusion Criteria:

* Any contraindication to performing endoscopy,
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
* The subject is unable/unwilling to give informed consent

Primary outcomes:
measure: Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
timeFrame: approximately one week
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida/Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Peter V Draganov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Robert Zlotecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02172963: A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemorrhagic Cystitis
Keywords: Stem Cell Transplantation
Decidual Stromal Cells
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Detailed description: Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10\^6 cells/kg once or at weekly intervals dependent on clinical effect.

Eligibility criteria: Inclusion Criteria:

* Hemorrhagic cystitis grade 2-4

Exclusion Criteria:

* Urinary urge without macroscopic hematuria or clots

Primary outcomes:
measure: Response at day 28 after onset of hemorrhagic cystitis
timeFrame: 28 days after inclusion
Secondary outcomes:
measure: Actuarial survival at one year after onset of hemorrhagic cystitis
timeFrame: One year after inclusion
measure: Time to disappearance of pain or urges
timeFrame: Up to 6 months after inclusion
measure: Time to disappearance of microscopic hematuria
timeFrame: Up to 84 days after inclusion
measure: Transplant related mortality
timeFrame: Up to one year after inclusion
measure: Incidence of severe infections
timeFrame: Up to one year after inclusion
measure: Incidence of graft versus host disease
timeFrame: Up to one year after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Olle Ringdén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04824235: Alveolar Ridge Preservation Using Amniotic Chorion Membrane
Official title: Alveolar Ridge Preservation Using Amniotic Chorion Membrane Alone or Combined With Xenograft (A Randomized Controlled Clinical Trial With Histological Evaluation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Preservation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the present study is to compare the amniotic chorion membrane (ACM) alone versus the amniotic chorion membrane combined with xenograft for their efficacy in alveolar ridge preservation procedures regarding volumetric changes assessed by cone beam computed tomography (CBCT).


Eligibility criteria: Inclusion Criteria:

* Patients require extraction of a non-restorable (premolar or anterior tooth) located in the maxillary arch and needs implant restoration.
* Type two sockets will be selected as revealed by Cone beam computed tomography(CBCT)
* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified Cornell Medical Index
* Male and female within age range of 20-45 years.

Exclusion Criteria:

* Smokers.
* Patients with poor oral hygiene or non-compliant patients who are not willing to perform oral hygiene measures.
* Pregnant and breast-feeding females.
* Patients with acute peri-apical infection or sinus tract.
* Vulnerable group of patients as handicapped patients, orphans,prisoners,etc

Primary outcomes:
measure: Change in Bucco-lingual bone width
timeFrame: at baseline, 1 months and 4 months
measure: Change in Corono-apical bone height
timeFrame: at baseline, 1 months and 4 months
measure: total bone volume change
timeFrame: at baseline, and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00859235: The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With Percutaneous Endoscopic Gastrostomy Placement
Official title: Predicting Oral Care Before Percutaneous Endoscopic Gastrostomy (PEG). The Influence of Oral Hygiene on Local Wound and Systemic Infection in Patients With PEG Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dysphagia
Peristomal Wound Infection
Keywords: Percutaneous endoscopic gastrostomy
peristomal wound infection
antibiotic mouth wash solution
prophylaxis prior Percutaneous endoscopic gastrostomy (PEG)
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Percutaneous endoscopic gastrostomy (PEG) is commonly used for long term enteral feeding of patients with severe dysphagia. The most common complication is peristomal wound infection. The possible mechanism the bacterial from the oral cavity disseminate during the PEG insertion through the stomach to the abdominal wall, in spite the routine use of antibiotic prophylaxis, have reported low rates of wound infection in patients who were already receiving antibiotics at the time of PEG Our hypothesis that washing the oral cavity with antibiotic solution prior the insertion PEG , We planned a prospective, randomised, double blind, one centre study of antibiotic mouth wash solution (0.2% Chlorhexidine gluconate) as.prophylaxis in PEG


Eligibility criteria: Inclusion Criteria:

* All patients scheduled to undergo PEG

Exclusion Criteria:

* Previous GI surgery
* Coagulopathy
* Sepsis

Primary outcomes:
measure: Assess impact mouth wash (containing 0.2% Chlorhexidine gluconate) (Taro Pharmaceutical Industries Haifa Israel) prior PEG insertion.
timeFrame: One month
Secondary outcomes:
measure: Follow the peristomal wound infection in patients who had prepared by mouth wash to a group a patients without mouth washing.
timeFrame: One month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03871335: Work-related Musculoskeletal System Disorders Among Female Workers in Hazelnut Factory
Official title: Work-related Musculoskeletal Disorders Among Female Workers in a Hazelnut Factory: Prevalence, Working Posture and Relating Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Strain
Pain
Occupational Problems
Work-related Injury
Keywords: work-related musculoskeletal disorders
hazelnut factory
low back pain
neck pain
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
Collaborators: name: Giresun University
name: Hacettepe University
First posted: 2019-03-12
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of this study involved the female workers of a hazelnut factory.

Brief summary: The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor.


Eligibility criteria: Inclusion Criteria:

* age \>18 years,
* had at least 12 months of continuous working experience in hazelnut selection.

Exclusion Criteria:

* having pregnancy,
* working in a standing position or having a burden job,
* having joint disease, gout, diabetes, and trauma during the last one year

Primary outcomes:
measure: Nordic Musculoskeletal Questionnaire (NMQ)
timeFrame: 10 minutes
Secondary outcomes:
measure: Dutch Musculoskeletal Questionnaire short version (DMQ-s)
timeFrame: 10 minutes
measure: Assessment of the working posture
timeFrame: 2 minutes
measure: Rapid Upper Extremity Assessment
timeFrame: 5 minutes
measure: Short Form-12 Health Survey (SF-12 Health Survey)
timeFrame: 5 minutes
measure: Pain Severity
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Sevim ACARÖZ CANDAN
state: Altinordu
Study officials:
affiliation: Bayan
name: Sevim ACARÖZ CANDAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02235935: The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
Official title: The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any diabetic patient undergoing hyperbaric chamber treatment due to diabetic ulcers

Brief summary: Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non proliferative DR and proliferative DR. The damage is caused by either macular edema, macular ischemia that can be followed by vascular proliferation.

Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different wounds in diabetic patients but its effect hasn't been tested in diabetic retinopathy yet.

This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due to different indications such as chronic wounds or radiation damages and who also have diabetic retinopathy. These patients will undergo opthalmic physical examination including fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography). Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe Medical Center for all diabetic patients prior to their first treatment.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria:

1. Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR.
2. Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment.

Exclusion Criteria:

1. Patients with Carotid stenosis of more than 70%
2. Anemia of \< 10mg/Dl
3. Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment.
4. Patients with claustrophobia or that cannot decompress properly.
5. Patients with any malignant disease
6. Patients with inability to sign informed consent

Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen.

-

Primary outcomes:
measure: OCT results
timeFrame: 1 month
Secondary outcomes:
measure: Visual Acuity
timeFrame: 1 month
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf Harofe MC
name: Shai Efrati
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03122535: 70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
Official title: 70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operative Incision
Keywords: Femtosecond LASIK (FS--LASIK)
Visual acuity
Refractive errors
Side-cut angles
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare 70 and 110 degree side-cut angles on the same patient undergoing Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK).

Detailed description: LASIK has become the preferred corneal procedure to correct certain refractive errors. One of the major advancements in LASIK has been the introduction of Femtosecond Laser technology for flap creation. Several studies have compared microkeratome and femtosecond laser technology, showing superior accuracy and precision of flap dimensions in the latter.

The Femtosecond Laser technology provides different parameters and settings that can be changed according to the surgeon's preference. One of such parameters is the side-cut angle. Some of the most common side-cut angles used today include 45, 70, 90, and 110 degrees. Previous studies have reported on the visual outcomes of side-cut angles, but head to head comparisons are lacking. Currently, there are no studies comparing the safety and efficacy of the 70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and complication rates between these side-cut angles will provide an objective measure that can be used when deciding which one is more suitable in FS-LASIK.

One angle will be performed on the right eye and the other on the left eye. The study will evaluate uncorrected visual acuity, best corrected visual acuity, intraoperative, and postoperative complications. Performing different side-cut angles on the same individual will allow a direct comparison of outcomes, minimizing confounding variables.

Eligibility criteria: Inclusion Criteria:

* Subjects who are deemed suitable candidates for bilateral LASIK will be considered eligible for participation in this study. Correction will be distance for both eyes.

Exclusion Criteria:

* Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be included.

Primary outcomes:
measure: Uncorrected Visual Acuity at One Year
timeFrame: one year
Secondary outcomes:
measure: Best Corrected Visual Acuity at Year One
timeFrame: one year
Other outcomes:
Locations:
city: Murray
country: United States
facility: University of Utah John A. Moran Eye Center - Midvalley Location
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Mark D Mifflin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03195335: Turkish Version of LIFE Habits Assessment
Official title: Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Participation
LIFE Habits (life-H)
Validity
Reliability
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Cumhuriyet University
First posted: 2017-06-22
Enrollment: 98
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be recruited from children who lives in Ankara city and, attend special education centers.

Brief summary: Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.


Eligibility criteria: Inclusion Criteria:

* To be diagnosed as cerebral palsy

Exclusion Criteria:

* Children whose family didn't accept to participate to study

Primary outcomes:
measure: Life Habits Questionnaire (LIFE-H)
timeFrame: At baseline
Secondary outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: At baseline
measure: Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
timeFrame: At baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Prof. Dr.
name: Mintaze KEREM GÜNEL
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.
citation: Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.
Clinical trial NCT03723135: Expanded Access for CC-486
Official title: Expanded Access for CC-486
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Acute Myelogenous Leukemia (AML)
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-10-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to CC-486.


Eligibility criteria: Inclusion Criteria:

-Adult patients with documented acute myelogenous leukemia (AML) in their first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, who seek treatment with CC-486 as monotherapy to maintain their CR or CRi.

Exclusion Criteria:

* Patients with AML in CR/CRi who plan to proceed to or are waiting for a bone marrow transplant
* Patients who have received a bone marrow transplant for the treatment of AML
* Treatment of AML patients with relapse or refractory disease
* Pregnant or breast-feeding females
* Patient meets enrollment criteria and can participate in a disease-specific clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
References: