louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05440565: Evaluation of Different Colorectal Cancer Screening Strategies
Official title: Evaluation of Different Colorectal Cancer Screening Strategies: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 20000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies.


Eligibility criteria: Inclusion Criteria:

* 50-74 years old
* Informed consent is available

Exclusion Criteria:

* Previous colorectal cancer
* Previous colorectal resection
* Previous received cancer-related treatment (except non-melanoma skin cancer)
* Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
* Fecal occult blood or fecal DNA was performed within one year
* Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (\> 10% of baseline weight)
* Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)

Primary outcomes:
measure: Detection rate
timeFrame: up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01812265: Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects
Official title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Crossover Study To Investigate The Effects Of Pf-06305591 On Cold Pain In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-18
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the pharmacological activity of PF-06305591 in healthy male volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects unable to tolerate pre-study Cpressor testing at screening.
* Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to 20.
* Broken skin on hands or forearms

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval
timeFrame: 24h
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 24h
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 24h
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03647865: Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
Official title: Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macrogenia
Microgenia
Miniplate
Keywords: Computer Guided,
Osseous Genioplasty
Custom Made Titanium Plates
Orthognathic Surgery
Genioplasty
patient Specific device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients with chin deformeties, will using a custom made titanium plate in the positioning of the genial segments give an accurate results in comparison to the preoperative planned osteotomy and move of the Genioplasty.


Eligibility criteria: Inclusion Criteria:

* Patients with genial deformeties that require surgical correction.
* Patients with chin asymmetry.
* Patients older than 18 years old.

Exclusion Criteria:

* Patients with uncontrolled systemic disease (Diabetes Mellitus).
* Previous Radiotherapy to the area of interest.
* Patients on bisphosphonates therapy.
* Patients underwent previous or concomitant mandibular orthognathic surgery.

Primary outcomes:
measure: Accuracy Of the Custom Made Miniplate
timeFrame: one year
Secondary outcomes:
measure: Patient Satisfaction (Esthetics)
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Manial
Study officials:
affiliation: Cairo University
name: Nader Na Elbokle, Phd Holder
role: STUDY_DIRECTOR
References:
Clinical trial NCT00419965: Measuring G Protein-coupled Receptor Kinase-2 (GRK2) in the Blood to Diagnose and Treat Patients With Heart Failure
Official title: Measuring GRK2 in the Blood to Diagnose and Treat Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2007-01-09
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population subjects includes individuals in a range of age groups with a diagnosis of heart failure or at least one cardiovascular risk factor along with a subset of normal control subjects.

Brief summary: The primary objective of this study is to determine the utility of GRK2 to differentiate between normal patients and patient groups that differ by the presence/absence of HF symptoms, systolic or diastolic left ventricular dysfunction, and risk factors; and to evaluate if a new assay provides similar values as traditional methods for measuring GRK2 levels.

Detailed description: This study seeks to define a beta-adrenergic receptor kinase molecule in the blood and its role as an improved biomarker to be used for the diagnosis, assessment and management of patients with heart failure. We will test blood cell samples for the levels of this molecule, called "G protein-coupled receptor kinase-2" (GRK2) using both the existing method of GRK2 quantification in the Koch laboratory and using a prototype enzyme immunoassay (EIA) method being developed by Johnson \& Johnson, Ortho-Clinical Diagnostics (OCD).

Eligibility criteria: Inclusion Criteria:

* Normal Controls: Individuals without HF, hypertension, diabetes, hyperlipidemia, coronary artery disease or obesity;
* Group I: Symptomatic Subjects with Reduced LV Function, HF symptoms, EF ≤ 40%.
* Group II: Asymptomatic Patients with LV dysfunction, no HF symptoms (NYHA class I and ATS score 0 or 1, EF ≤ 40%.
* Group III: Symptomatic Subjects with Preserved LV Function, HF symptoms, EF ≥ 50%, and diastolic dysfunction.
* Group IV: Asymptomatic High Risk Subjects - Individuals with normal heart function, no HF symptoms (NYHA class I and ATS score 0 or 1), Preserved LV function (EF ≥ 50%), no diastolic dysfunction. Also possess one or more cardiovascular high risk factors: diagnosis of diabetes; hyperlipidemia; coronary artery disease; renal insufficiency; hypertension; age \>70 years

Exclusion Criteria

* Pregnancy
* Not providing consent
* Inability to provide consent
* Participation in a clinical study involving an experimental therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Walter J. Koch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05858866: The Effects of Smartphone Addiction on Physical Activity, Fatigue and Sleep Quality of University Students
Official title: The Effects of Smartphone Addiction on Physical Activity, Fatigue and Sleep Quality of University Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addictive Behavior
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University Students

Brief summary: The increasing rate of usage of smartphones ushers in various health problems and smartphone addiction. In the literature, the research focused mainly on the relationship between smartphone addiction and depression, anxiety and musculoskeletal system problems; however, the number of studies on fatigue was limited. We believe that this paper will be of interest to the readers of your journal because it adds information about the effect of smartphone addiction on physical activity, on sleep quality and especially on fatigue.

Detailed description: This cross-sectional study was conducted with the participation of 322 students attending the Faculty of Health Sciences at Süleyman Demirel University. The participants were given the socio-demographic characteristics form, developed by the researchers according to the literature review. They were also given the evaluation form, which surveys some variables related to smartphones, as well as the short version of the Smartphone Addiction Scale Short Version (SAS-SV), the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the Pittsburgh Sleep Quality Index (PSQI), and the Piper Fatigue Scale (PFS).

Eligibility criteria: Inclusion Criteria:

* The students who volunteered to participate in the study after being informed about the aims and procedures of the study.

Exclusion Criteria:

* The students who didnot volunteered to participate in the study after being informed about the aims and procedures of the study.

Primary outcomes:
measure: Short Version of the Smartphone Addiction Scale Short Version
timeFrame: 02.01.2021
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Süleyman Demirel Üniversitesi
state: Merkez
Study officials:
References:
Clinical trial NCT04463966: Prevention of Postpartum Haemorrhage
Official title: Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Partum Hemorrhage
Keywords: tranexamic acid
postpartum hemorrhage
cesarean section
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Detailed description: This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Eligibility criteria: Inclusion Criteria:

* Women at high risk for postpartum hemorrhage after cesarean section

Exclusion Criteria:

* women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.

Primary outcomes:
measure: blood loss
timeFrame: immediately after deliver
Secondary outcomes:
measure: blood pressure
timeFrame: immediately after delivery
measure: pulse
timeFrame: immediately after delivery
measure: temperature
timeFrame: immeditely after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Police Hospital
Study officials:
affiliation: Police Hospital
name: Shaimaa Ezzat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05869266: Tuned App Self-Fitting vs. Professional Fitting
Official title: A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: self fitting
Lead sponsor: Tuned Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.


Eligibility criteria: Inclusion Criteria:

* Adult males and females, 18 years and older.
* Mild to moderate sensorineural hearing loss.
* Own and able to use a smart phone (Android or iOS).
* Able to read and understand Hebrew.

Exclusion Criteria:

* Conductive mixed hearing loss.
* Unilateral hearing loss.
* Any external or inner ear malformations.
* Symptoms of ear disease or excessive cerumen.

Primary outcomes:
measure: Comparison of self fitting and professional fitting by COSI scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison of self fitting and professional fitting by IOI-HA scores
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ozen-Kashevet Hearing Clinic
Study officials:
affiliation: Ozen-Kashevet Hearing Clinic
name: Leonid Kriksunov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769166: Prevalence Of Deleterious Oral Habits Among a Group of School Children in Cairo, Egypt: Cross-Sectional Study
Official title: Prevalence Of Deleterious Oral Habits Among a Group of School Children in Cairo, Egypt: Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Habits
Bruxism
Sucking Behavior
Nail Biting
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: school children aged from five to seven years

Brief summary: This study aims to detect the prevalence of practicing oral habits among a group of school children in Cairo, Egypt.

Detailed description: An online questionnaire utilizing the third domain of Nordic Orofacial Test screen will be distributed among school children (aged five to seven years) parents to measure the prevalence of oral habits.

Eligibility criteria: Inclusion Criteria:

* school children
* accept to participate
* children within the age group

Exclusion Criteria:

* special health care needs children

Primary outcomes:
measure: oral habits (presence / absence)
timeFrame: baseline record
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06476366: Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
Official title: Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Chronic Actinic Dermatitis
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms of the study will be as follows:

Group A: Methotrexate 10mg/week Group B: Azathioprine 0.3mg/kg daily
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy and safety of AZT and MTX in patients with Chronic Actinic Dermatitis (CAD). These drugs have been used successfully as steroid-sparing alternatives in a variety of related dermatoses and this trial may help in paving the path towards the ubiquitous use of these cost-effective and relatively safer drugs in CAD patients of our population. The researchers will try to answer the following questions:

1. Is methotrexate safe and efficacious in treating CAD?
2. Is there a difference in efficacy of methotrexate and azathioprine in the treatment of this disease?

After the enrollment of patients and taking consent, participants will be divided in two treatment groups via lottery method. Group A will be administered oral methotrexate 10mg/week after a test dose while group B will be administered tablet azathioprine at a dose of 0.3mg/kg daily after. Both group of patients will be advised regarding strict sun protection measures (sunblock, hats, sunglasses etc.). The baseline investigations for both groups will include complete blood picture (CBC), liver function tests (LFTs), renal function tests (RFTs), electrocardiogram, chest X-ray and urine analysis while thiopurine methyltransferase (TPMT) levels will be assessed specifically for group B patients. The patients will be followed up at week 4, 12 and 24. CBC, RFTs and LFTs will be done at each follow-up and EASI score will be calculated,


Eligibility criteria: Inclusion Criteria:

* All newly diagnosed as well as patients with an established diagnosis of CAD presenting to the outpatient department or the emergency department of PEMH or CMH will be included in the study.

Exclusion Criteria:

* Patients with coexisting conditions requiring immunosuppressants will be excluded from the study. Patients with dementia or any other neuropsychiatric disorder will also be excluded.

Primary outcomes:
measure: EASI-50
timeFrame: 6 months
Secondary outcomes:
measure: An IGA score of 0-2
timeFrame: 6 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pak Emirates Military Hospital
state: Punjab
Study officials:
affiliation: Pak Emirates Military Hospital
name: Ahsan Tameez-ud-din
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01900366: Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
Official title: Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Healthy Volunteers
Lead sponsor: Rockefeller University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2013-07-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteer and obese subjects

Brief summary: This study will test the potential of two techniques using light properties of adipose tissue to diagnose crown-like structures and inflammation to be compared with pathologic examination of adipose tissue biopsies from ongoing clinical studies.

Detailed description: Adipose tissue (fat) inflammation is emerging as an important harbinger of disease development including Type 2 diabetes, heart disease and potentially cancer. The hallmark feature of adipose tissue inflammation is the crown-like structure, a dying fat cell surrounded by immune cells attempting to clear the damage. Current methods for detecting adipose tissue inflammation rely on invasive procedures such as fat biopsies. We propose developing methods that use the light reflection properties of inflamed adipose tissue as a potential non-invasive method to detect adipose tissue inflammation.

Eligibility criteria: Inclusion Criteria:

-Subjects currently enrolled in a current Rockefeller University study who will be undergoing adipose tissue biopsies as part of the study protocol

Exclusion Criteria:

-History of any skin disease

Primary outcomes:
measure: Classification of adipose tissue as healthy or inflamed by Raman Spectroscopy
timeFrame: 1 day
Secondary outcomes:
measure: Steady state oxygenation at the site of tissue biopsy by Diffuse Reflectance Spectroscopy
timeFrame: 1 day
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rockefeller University
state: New York
Study officials:
affiliation: Rockefeller Univesrity
name: Jose Aleman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: