louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01024257: Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pterygium
Keywords: beta-irradiation;conjunctival autograft;pterygium;recurrence; clinical trial
Lead sponsor: Marilia Medicine School
Sponsor class: OTHER
First posted: 2009-12-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.


Eligibility criteria: Inclusion Criteria:

* Fresh pterygium without previous treatment.
* Adult patients with age higher than 18 years.

Exclusion Criteria:

* Diagnosis of glaucoma.
* Previous treatment of pterygium.
* Patients with age less than 18 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marilia
country: Brazil
facility: Gustavo Viani Arruda
state: Saop Paulo
Study officials:
References:
Clinical trial NCT03530657: Assessment of Liver Fibrosis and Prognosis in Chinese Patients With CHB Infection Using STE/STQ Elastography
Official title: the Department of Medical Ultrasound, Third Affiliated Hospital of Sun Yat-Sen University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 460
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are recruited from primary care clinic

Brief summary: This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.

Detailed description: Ultrasound liver elasticity measurement and imaging has not only been proposed as an alternative to evaluate the severity of chronic liver fibrosis, but also as a mean to stratify patients with advanced fibrosis according to risks of occurrence of clinical complications of end-stage liver diseases.

Sound touch elastography (STE）and sound touch quantify (STQ) developed by Mindray Resona 7 imaging system provide both two-dimensional and point shear-wave elastography of tissue elasticity with stronger penetration and easy operation.

This analysis will study the diagnositic performance of STE/STQ elastography for lver fibrosis and the prognostic value of STE/STQ elastography for the prediction of clinical complications of chronic liver diseases.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
* Patients having reached the age of majority in China,
* Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the STE/STQ measurement date, and having the recommended quality criterion:

minimal length of biopsy samples of 15 mm, stored in paraffin minimal number of portal tracts of 6 per biopsy samples

* Patients of Chinese ethnic origin.

Exclusion Criteria:

Any of the conditions below will exclude patients from the study:

* Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
* Any patient presenting with a co-infection of HIV
* Any patient presenting with combined liver tumor
* Any patient ever received liver transplantation
* Pregnant women
* Acute hepatitis

Primary outcomes:
measure: Degree of Liver Fibrosis
timeFrame: 1-2 years
Secondary outcomes:
measure: Complication rates depending on liver STE/STQ measurement values at baseline
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05497557: A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Official title: An Open-label Study to Evaluate the Impact of Omeprazole, A Proton Pump Inhibitor, on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Sotorasib
AMG 510
Omeprazole
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 16
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: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.


Eligibility criteria: Inclusion:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Sotorasib
timeFrame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
measure: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Sotorasib
timeFrame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of Sotorasib
timeFrame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Days 1 and 9
Secondary outcomes:
measure: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
timeFrame: Day 1 to Day 11
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Clinical Research Unit Inc.
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03044457: Forgotten Joint Score After Reversed Gap Technique
Official title: Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Clinical Outcome
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: "reversed gap technique" vs. "gap technique", randomized
Primary purpose: TREATMENT

Brief summary: A new operation technique was established ("reversed gap technique" for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional "gap technique" as control in a RCT study.


Eligibility criteria: Inclusion Criteria:

* indication for implantation a total knee arthroplasty

Exclusion Criteria:

* indication for a constrained implant
* secondary type of arthritis (rheumatoid, post traumatic, post infectious)
* former "open" surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)

Primary outcomes:
measure: Forgotten Joint Score 12
timeFrame: one year after operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06176157: Vitamin D Supplementation in Pediatrics. Oral or Parenteral! D2 or D3
Official title: Vitamin D Supplementation in Vitamin D Deficient/Insufficient Children Oral or Parenteral! D2 or D3, A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: Vitamin D, ergochalciferol, cholecalciferol, oral, parenteral
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A study will be performed on Vitamin D deficient/ insufficient Egyptian children to compare the efficacy of oral and parenteral forms of Ergocalciferol and cholecalciferol in raising serum 25(OH) D levels in these subjects


Eligibility criteria: Inclusion Criteria:

* laboratory evidence of vitamin D deficiency or insufficiency without clinical signs of rickets

Exclusion Criteria:

* vitamin D or calcium supplementation within the last 6 months before inclusion, patients with diabetes mellitus, chronic liver disease and kidney disease, congenital or rheumatic heart disease, malabsorption syndromes, thyroid disease, juvenile rheumatic diseases, or other bone disorders.

Primary outcomes:
measure: serum 25(OH) D level after 1,2,3 months of supplementation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Marwa M Nawar, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867957: Efficacy and Safety of Anthrax Vaccine, GC1109
Official title: A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anthrax
Keywords: anthrax
vaccine
bioterrorism
efficacy
safety
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
name: LSK Global Pharma Services Co. Ltd.
First posted: 2013-06-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
2. OBJECTIVE

   - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
3. STUDY DESIGN

   * single-blinded
   * randomized
   * placebo controlled
   * phase 1 study


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects between 18 and 45 years of age at the time of screening visit
2. 18.5kg/m2 ≤BMI \< 30kg/m2 at the time of screening visit
3. Subjects without congenital or chronic disorder

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse Event
timeFrame: 0 - 28 Days
Secondary outcomes:
measure: Anti-protective antigen(PA) antibody level (by TNA)
timeFrame: Day 14, Day 28
measure: Anti-PA Immunoglobulin G (IgG) (by ELISA)
timeFrame: Day 14, Day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Myoung-don Oh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00740857: Study Comparing the Efficacy of Two Ibuprofen Formulations
Official title: A Study Comparing the Efficacy of Two Ibuprofen Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Dental pain analgesia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 211
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.


Eligibility criteria: Inclusion criteria :

* Outpatients with post-operative pain following surgical extraction of third molars,
* examined by the attending dentist or physician and medically cleared to participate in the study,
* in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

* any serious medical condition,
* acute localized dental infection at the time of surgery ,
* females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.

Primary outcomes:
measure: Time to Meaningful Pain Relief
timeFrame: 0-6 hours
Secondary outcomes:
measure: Pain Intensity Difference (PID) Scores at Each Individual Time Points
timeFrame: 0-6 hours
measure: Pain Relief (PR) Scores at Individual Time Points
timeFrame: 0-6 hours
measure: Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours
timeFrame: 0-2 and 0-6 hours
measure: Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points
timeFrame: 0-6 hours
measure: Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours
timeFrame: 0-2 and 0-6 hours
measure: Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours
timeFrame: 0-2 and 0-6 hours
measure: Time to First Perceptible Relief
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03573557: Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
Official title: Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Surgery
Laparoscopic Surgery
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.

Detailed description: Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center
* Patients must not be pregnant

Exclusion Criteria:

* Pregnancy
* Patients unable to give consent

Primary outcomes:
measure: Length of displacement when in Trendelenburg
timeFrame: 1 day
Secondary outcomes:
measure: Cost of device
timeFrame: 1 day
measure: Rank of ease of use by physician
timeFrame: 1 day
measure: Number of adverse events
timeFrame: 1 day
measure: Erythema score
timeFrame: 1 day
measure: Patient BMI
timeFrame: 1 day
measure: Patient age
timeFrame: 1 day
measure: Patient weight
timeFrame: 1 day
measure: Patient height
timeFrame: 1 day
measure: Patient Hip circumference
timeFrame: 1 day
measure: Patient Waist circumference
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Sherif El-Nashar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03047057: Lidocaine Infusion in Radical Cystectomy
Official title: Effect of Lidocaine Infusion on Acute Rehabilitation After Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Ileus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radical cystectomy (RC) remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. Nowadays, enhanced recovery pathway is used to decrease morbidity and improve acute rehabilitation after RC. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy.

Detailed description: Radical cystectomy remains the gold standard for treatment of patients with muscle invasive bladder cancer, or recurrent high grade non-muscle invasive bladder cancer. The high rates of morbidity and mortality reflect the fact that the majority of patients undergoing this procedure are elderly patients with multiple comorbidities. Postoperative ileus is the most frequent reason for prolonged hospital stay following cystectomy. To reduce the risk of ileus, prokinetics such as metoclopramide should be used postoperatively. Local anesthetics exert their actions as local anesthesia and antiarrhythmic through Na channels blocking but still have many other important actions through other receptors (e.g., m1 muscarinic receptors) that occur at very low plasma levels compared to levels needed for Na channels blocking, one of these actions is the anti-inflammatory effect against surgical stress response. Several randomized studies found that i.v. lidocaine shortens duration of postoperative ileus and some of it reported decreased postoperative pain with i.v. lidocaine, so they recommended i.v. lidocaine as a safe, simple, and less invasive method for management of postoperative ileus and equal to postoperative epidural analgesia.

Eligibility criteria: Inclusion Criteria:

* 45-75 yr ASA class I,II, and III Elective radical cystectomy

Exclusion Criteria:

* Allergy to the study medication, pre-existing chronic pain at any site requiring treatment, Psychiatric disease, hepatic or renal impairment, seizure disorder requiring medication within the previous 2 years

Primary outcomes:
measure: Postoperative return of gastrointestinal (GI) function
timeFrame: 15 day
Secondary outcomes:
measure: Postoperative Pain
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Seham Mohamed Moeen Ibrahim
Study officials:
References:
citation: Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80.
Clinical trial NCT01253057: A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure
Official title: A Research on the Hospital Pollution Control and Hygine Intervention of Chemotherapy Drugs Exposure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sister-chromatic-exchange(SCE)
Micronuclei(MN)
Keywords: cleaning staff
antineoplastic agents
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: cleaning staff

Brief summary: Several epidemiological studies found that exposure to antineoplastic agents were associated with some reproductive, carcinogenic effects, higher rates of advance micronuclei (MN), sister-chromatic-exchange (SCE) and spontaneous abortion. Cleaning staff were potentially exposed to these agents while cleaning ward, ward toilet or other area.

One medical center and one area hospitals in Taipei.Surface wipe samples were collected in the cleaning staff work area, such as ward environment and ward toilet. Urine and blood samples of subjects were collected for exposure examinations. Platinum-containing drugs (Cisplatin, Carboplatin, Oxaliplatin) were used as indicator drugs in environmental (surface wipe samples) and biological (urine and blood samples) samples.

A self-administered questionnaire was used to collect demographic data, working practices, medical and contact history, and perceived work-related symptoms of cleaning staff.

The results of this study will be to reduce exposure to cleaning staff.


Eligibility criteria: Inclusion Criteria:

* Only included those who signed the consent study

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Taipei Medical University
name: Ruey-Yu Chen
role: PRINCIPAL_INVESTIGATOR
References: