louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04191252: Genetic Mutation in Epithelial Ovarian Cancer
Official title: Overall Perspective on the Characteristics of Genetic Mutation in Chinese Patients of Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Nucleotide Variant
Copy Number Variation
Insertion-deletion Variation
Genomic Structural Variation
Total Mutation Burden
Microsatellite Instability
PD-1
PD-L1
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 500
Sex: FEMALE
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: Patients of pathology confirmed of epithelial ovarian cancer and aged 18 years or older

Brief summary: Little is known about the characteristics of genetic mutation in a large multi-gene panel in epithelial ovarian cancer. This study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. The mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. The total mutation burden (TMB) will be calculated. The status of microsatellite instability, expression of PD-1 and PD-L1 antibodies are also tested. These findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma
* With available materials for analysis
* With detailed clinicopathological information
* Given consent to participate the trial

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequency of genetic mutations
timeFrame: Two years
Secondary outcomes:
measure: Total mutation burden
timeFrame: Two years
measure: Frequency of microsatellite Instability
timeFrame: Two years
measure: Expression rates of PD-1 and PD-L1 antibodies
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05194852: Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
Official title: In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Capsulitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.

Detailed description: patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.

Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.

A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.

Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.

Eligibility criteria: Inclusion Criteria:

* patients aged 35 to 60 years,
* patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
* patients who had restriction of passive motion.

Exclusion Criteria:

* patients with previous trauma,
* patients with neurological
* patients with endocrinal diseases
* patients with shoulder tumor
* patients with arthritis
* people who had received intra-articular shoulder injection within the last 6 months.
* Patients with tendon tear

Primary outcomes:
measure: visual analoge state
timeFrame: 3 months
measure: shoulder pain and disability index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine
state: Gharbia
Study officials:
References:
Clinical trial NCT04344652: Photoscreening for Retinoblastoma
Official title: Prospective Evaluation of a Smartphone Application, GoCheckKids TM, as a Screening Tool for Leukocoria in the Infant and Pediatric Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinoblastoma
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 76
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single visit cross sectional prospective study
Primary purpose: DIAGNOSTIC

Brief summary: Retinoblastoma is the most common pediatric eye malignancy and manifests between 1 and 5 years of age. The tumor is most often diagnosed by leukocoria ( white reflex in the pupil). There is often a significant delay in diagnosis and early diagnosis enables good life prognosis and better vision outcome.There is currently not a standardized screening protocol for detection of retinoblastoma. Vision screening methods are recommended for children 3-5 years of age. The investigators are attempting to use instrument based screening started from birth to detect leukocoria.


Eligibility criteria: Inclusion Criteria:

* Age birth to 10 years
* Informed consent given by parent or legal guardian

Exclusion Criteria:

* None

Primary outcomes:
measure: Reliability to detect leukocoria
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03975452: Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer
Official title: Phase II Study on Volume De-escalation in Neoadjuvant Radiochemotherapy of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Toxicity
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study outlines a clinical prospective protocol consisting of preoperative chemoradiation in locally advanced rectal cancer, without elective pelvic nodal irradiation. The proposal to exclude lateral spaces from the target volume is based on the assumption that the radiological evidence of recurrence in the lateral lymph nodes is shown to be below 5%. In the study all patients underwent an accurate pre-treatment work-up including total body CT, pelvic MRI and 18-fluorodeoxyglucose PET/CT, in order to include patients without evidence of disease in lateral lymph nodes. The primary endpoint of the study was the reduction of gastrointestinal toxicity; secondary endpoints were the pathological complete response (pCR), the local control (LC) rate, the overall survival (OS) and the disease-free survival (DFS).

Detailed description: Patients affected by histologically proven rectal cancer were considered for enrollment in a prospective protocol that included preoperative CRT and surgical treatment. All patients underwent pre-treatment work-up (clinical examination, pancolonoscopy with biopsy, total body CT scan, pelvic MRI, and whole body 18-fluorodeoxyglucose PET/CT scan). Eligible patients had primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes. Additional eligibility criteria included performance status as well as liver, kidney, and bone marrow function that allowed for long-course CRT, older than 18 years, and no distant metastases.

Eligibility criteria: Inclusion Criteria:

* Primary resectable cT2-low lying-T3, N0-N1 adenocarcinoma of the rectum, without evidence of disease in lateral lymph nodes
* No distant metastases

Exclusion Criteria:

* Evidence of disease in lateral lymph nodes
* Distant metastases

Primary outcomes:
measure: The reduction of gastrointestinal (GI) toxicity
timeFrame: 36 months
Secondary outcomes:
measure: Pathological complete response (pCR)
timeFrame: 36 months
measure: The local control (LC) rate
timeFrame: 36 months
measure: The overall survival (OS)
timeFrame: 36 months
measure: The disease-free survival (DFS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Michele Fiore
Study officials:
affiliation: Campus Bio-Medico University
name: Lucio Trodella, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06219252: Intraoperative Aberrometry vs Conventional Intraocular Lens Calculation, a Prospective Study.
Official title: Intraoperative Aberrometry vs Conventional Introcular Lens Calculation ( Barrett Universal II / Barrett True K ), Refractive and Visual Outcomes, a Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraocular Lens Implantation
Cataract
Humans
Ocular, Refraction
Keywords: biometry
aberrometry
prospective study
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal of this intervention study is to compare prospectively the accuracy of the power calculation between both groups, the intraoperative aberrometry (ORA) vs barrett universal II preoperative calculation (control group) .

Researchers will compare ORA group vs control to see changes in spherical equivalent and uncorrected distance visual acuity

Detailed description: Studies have described a small difference between ORA (intraoperative aberrometer) and preoperative calculation with latest generation formulas ( Barrett Universal II ), the investigators intend to compare both groups prospectively, during the process randomization and blinding of the participants will be made.

The investigators will report spherical equivalent and uncorrected distance visual acuity values at 90 days of the postoperative period.

Eligibility criteria: Inclusion Criteria:

* patients with senile cataract, patients undergoing phacoemulsification, complete biometric profile, axial length calculated by interferometer.

Exclusion Criteria:

* glaucoma, uncontrolled diabetic retinopathy, pseudoexfoliation syndrome, aged macular degeneration , dry eye syndrome, other ocular pathologies.

Primary outcomes:
measure: spherical equivalent
timeFrame: 90 days of the postoperative period
Secondary outcomes:
measure: uncorrected distance visual acuity
timeFrame: 90 days of the postoperative period
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto de oftalmología Fundación Conde de Valenciana
state: Cuauhtemoc
Study officials:
affiliation: INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA
name: ANGEL NAVA - CASTAÑEDA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00426452: A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female Volunteers
Official title: A Phase IB, Open Label, Single Center, Drug-drug Interaction Study of Oral 1250 mg of PTK787/ZK 222584 Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor (Omeprazole) in Healthy Sterile or Postmenopausal Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Vascular endothelial growth factor receptor (VEGF-R) tyrosine kinase inhibitor
Vatalinib
Proton-pump inhibitors
Omeprazole
Healthy Postmenopausal Female Volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2007-01-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of acidic drugs such as proton-pump inhibitors on the pharmacokinetics of Vatalinib under fasting and fed conditions.


Eligibility criteria: Inclusion criteria

* Healthy female
* Surgically sterile or post-menopausal
* At least a weight of 50 kg and have a body mass index (BMI) ≤33.0
* Non-smokers or those who smoke 25 cigarettes or less per day Exclusion criteria
* Use of certain prescription and over the counter drugs
* Having received an investigational drug within 30 days prior to dosing
* Donation of plasma or donation or loss of whole blood prior to administration of the study medication
* Any clinically significant laboratory tests
* Abnormal cardiac function
* A positive test for HIV, Hepatitis B or C
* A positive alcohol test or drug test
* Known allergy to Vatalinib or Omeprazole
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism and excretion or drugs.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.
Secondary outcomes:
measure: Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT00756652: Mentor MemoryGel Post-Approval Study
Official title: MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Breast Augmentation
Breast Revision
Lead sponsor: Mentor Worldwide, LLC
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 42491
Sex: FEMALE
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: MemoryGel™ PAS uses a current cohort design of 41,900 gel participants and 1,000 saline participants.

Brief summary: In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.


Eligibility criteria: Inclusion Criteria:

1. Female, age 18 years or older (22 or older for breast augmentation patients)
2. U.S. resident

Exclusion Criteria:

1. If a saline participant, current or past, unilateral or bilateral, silicone breast implants
2. Active infection anywhere in her body
3. Existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
4. Currently pregnant or nursing

Primary outcomes:
measure: Kaplan Meier Estimated Cumulative Incidence of Reported Complications
timeFrame: 10 years
measure: Kaplan Meier Estimated Cumulative Incidence of Explantation
timeFrame: 10 years
Secondary outcomes:
measure: Reasons for Reoperations
timeFrame: 10 Years
Other outcomes:
Locations:
Study officials:
affiliation: Mentor Worldwide, LLC
name: John Canady, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01661452: Development of Post Traumatic Stress Disorder After Natural Disaster
Official title: Development of Post Traumatic Stress Disorder After Natural Disaster
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development of PTSD After Natural Disaster
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 629
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to UAB emergency room, outpatient trauma clinics and substance abuse center.

Brief summary: A survey (patient self-report) of patients presenting to UAB emergency room, outpatient trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and maladaptive coping responses after the widespread tornado disaster that occurred in Alabama in April 2011.


Eligibility criteria: Inclusion Criteria:

* 19 and older Able and willing to complete a questionnaire

Exclusion Criteria:

* Younger than 19 Unwilling or unable to complete a questionnaire

Primary outcomes:
measure: Development of PTSD
timeFrame: June 2011-December 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT01493700: Changes of Body Temperature During Shoulder Arthroscopy
Official title: Effect of Heated Humidifier on the Body Temperature During Shouler Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: heated circuit
body temperature
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the effect of electrically heated humidifier on the body temperature during shoulder arthroscopy.

Detailed description: On the control group, use only routine anesthetic respiratory circuit for mechanical ventilation On the comparative group, use electrically heated humidifier for mechanical ventilation And compared the changes of body temperature durgin shoulder artheroscopy.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologist physical status 1 or 2
* 20-60 years old

Exclusion Criteria:

* body mass index over 30 kg/m2
* peripheral vascular disease
* uncontrolled cardiovascular disease

Primary outcomes:
measure: changes of body temperature
timeFrame: every 15 minutes from base line
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Kyung Cheon Lee
Study officials:
affiliation: Gachon University Gil Medical Center
name: Kyung Cheon Lee, MD.PhD
role: STUDY_DIRECTOR
References:
citation: Lee HK, Jang YH, Choi KW, Lee JH. The effect of electrically heated humidifier on the body temperature and blood loss in spinal surgery under general anesthesia. Korean J Anesthesiol. 2011 Aug;61(2):112-6. doi: 10.4097/kjae.2011.61.2.112. Epub 2011 Aug 23.
Clinical trial NCT06446700: Correlation Between Neck Pain and Visual Disturbances in Smartphone Users
Official title: Correlation Between Neck Pain and Visual Disturbances in Smartphone Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Visual Disturbances
Keywords: neck pain
vision
smartphone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants from universities and local population

Brief summary: the goal of this study is to Investigate the correlation between neck pain and visual disturbances in smartphone users.

Detailed description: Study design:

Cross-sectional observational analytical study design conducted on smartphone users 2- Subject selection 141 subjects (who are smartphone users) according to sample size calculation will be selected randomly to complete the neck disability index and visual functional questionnaire 25 version 2000

Eligibility criteria: Inclusion Criteria:

* 141 subjects who are smartphone users
* Age between 18 to 50 years
* Both genders are included
* Subjects Who put in more than 4 hours a day using smartphone
* Participants without systemic illnesses or physical deformities were also included
* Consent: Participants who provide informed consent to participate in the study.
* Neck disability index will be used to assess how your neck pain has affected your ability to manage in everyday life.
* Visual Functioning Questionnaire version 2000 will be used to assess vision-related quality of life

Exclusion Criteria:

* People with head and neck injuries
* eye diseases
* People with diabetic retinopathy
* who had refractive correction surgery
* psychiatric problems (depression)
* people with systemic illnesses or physical deformities
* people who have vision impairments and disabilities

Primary outcomes:
measure: Neck disability index
timeFrame: 1 month
measure: Visual functional questionnare
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yasmin Saeed Atallah
Study officials:
affiliation: Professor
name: Mohamed H Elgendy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01375400: Effect of Aspirin at the Acute Phase of Cerebral Ischemic Event.
Official title: Laboratory Effect on Platelet Activity of the First 300 mg Oral Dose Aspirin at the Acute Phase of Cerebral Ischemic Event.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: aspirin
platelet
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin, given at hospital, after an ischemic event.

The principal hypothesis is that platelet activity would be able to recover during this day and could lead to ischemic recurrences.

Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23 hours after. Photometric aggregometry are performed with arachidonic acid and collagen induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.


Eligibility criteria: Inclusion Criteria:

* Adult men and women
* Ischemic stroke less than 48 hours
* Signed consent

Exclusion Criteria:

* Danger to prescription of aspirin (haemorrhagic risk...)
* Prescription of heparin or VKA

Primary outcomes:
measure: Measure of platelet activity recovery within 24 hours after the first 300 mg oral dose of aspirin given at hospital at the acute phase of ischemic stroke
timeFrame: 1 month
Secondary outcomes:
measure: Measure of effect of the first 300 mg oral dose of aspirin given at the acute phase of cerebral ischemic stroke for already aspirin treated
timeFrame: 1 month
Other outcomes:
Locations:
city: Nancy
country: France
facility: Hopital central
Study officials:
References: