louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00765206: A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Official title: Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Acid
Human Experimentation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2008-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

Detailed description: Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

Eligibility criteria: Inclusion Criteria:

* Normal subjects who are 18-65 years of age.
* Non-childbearing potential females or those using birth control.

Exclusion Criteria:

* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
* History of significant gastrointestinal disease
* Any significant medical illness
* Gastrointestinal disorder or surgery leading to impaired drug absorption
* Currently using gastrointestinal medications

Primary outcomes:
measure: Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
timeFrame: Baseline and 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03266406: Effect of Hyaluronidase on Intraocular Pressure
Official title: Effect of Hyaluronidase on Intraocular Pressure After Retrobulbar Anaesthesia During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Pressure Low
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate effect of retrobulbar local anaesthesia after addition of hyaluronidase on IOP during cataract surgery


Eligibility criteria: Inclusion Criteria:

* 1-Patients above the age of 50 years. 2-Patients with age related cataract. 3-Normal IOP.

Exclusion Criteria:

* 1History of trauma. 2-Patients with glaucoma. 3-Previous ocular surgery. 4-Patients with other ocular pathology. 5-Uncontrolled diabetes or hypertension. 6-hypersensitivity to lignocaine. 7-Uncooperative or epileptic patients.

Primary outcomes:
measure: reduction in IOP
timeFrame: within 10minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01412606: Endometrial Scratching in Couples With Unexplained Subfertility
Official title: Endometrial Scratching in Couples With Unexplained Subfertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Subfertility
Keywords: Unexplained infertility-endometrial scratching
effect of endometrial biopsy (scratching) on clinical pregnancy rates in women with unexplained infertility
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial scratching in luteal phase of a spontaneous menstrual cycle may increase pregnancy rate in women with unexplained infertility.


Eligibility criteria: Inclusion Criteria:

* women aged between 20 and 39 years with at least one year of infertility
* regular menstruation with the length of the cycle between 22-34 days and ovulation confirmed by appropriately timed mid-luteal progesterone
* fertile semen variables
* bilateral tubal patency (demonstrated by laparoscopy or hysterosalpingography).

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 months
Secondary outcomes:
measure: miscarriage rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Teaching Hospital Gynecology outpatient clinic
Study officials:
affiliation: Mansoura University
name: Ahmed Gibreel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibreel A, Badawy A, El-Refai W, El-Adawi N. Endometrial scratching to improve pregnancy rate in couples with unexplained subfertility: a randomized controlled trial. J Obstet Gynaecol Res. 2013 Mar;39(3):680-4. doi: 10.1111/j.1447-0756.2012.02016.x. Epub 2012 Oct 29.
Clinical trial NCT03232606: Physical Activity of Asthmatic Children
Official title: Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Asthma
Child Development
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2017-07-28
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatic cohort of the asthma clinic of the children hospital

Brief summary: Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children.

The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

Detailed description: Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the behaviour of children and its family with a significant reduction of exercise and practice of sports.

There no scientific argument to advice such a reduction of physical activity in asthmatic children.

The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

To evaluate the factors explaining this behaviour the investigator design an observational study, based on a questionnaire.

The evaluation of the number of sujets to complete this study is 50 asthmatic children. The whole population will be considered as the same group. This study may be further completed by a comparative and new study including asthmatic and non-asthmatic children.

Eligibility criteria: Inclusion Criteria:

* Asthmatic children coming for regular follow-up
* Good control of asthma

Exclusion Criteria:

* Previous pathologies with significant impact on physical activity

Primary outcomes:
measure: Physical activity of children
timeFrame: inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: University of Lorraine
name: Cyril E SCHWEITZER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872806: Electrophysiological Reactivity Due to Mobile Phone Radiation
Official title: Radiation Meter Controlled Electrophysiological Reactivity (EEG and ECG) Due to Mobile Phone Radiation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objective of this study is to investigate whether radiofrequency electromagnetic radiation, induced by a dialing mobile phone placed on the body, causes a change in electrophysiology.

Detailed description: The aim of this study is to investigate whether placement of a 3G dialing mobile phone causes direct changes in EEG activity compared to the placement of a sham phone. Furthermore, it is investigated whether placement of the mobile phone on the ear or the heart results in different outcomes. The subjects are measured twice: on one of the two days the mobile phone is attached to the ear, the other day to the chest. In this single-blind, cross-over design, assessments in the sham phone conditions are conducted directly preceding and following the mobile phone exposure. During each assessment, EEG activity and radiofrequency radiation are recorded jointly. Delta, theta, alpha, slowbeta, fastbeta, and gamma activity are computed. The association between radiation exposure and the EEG is tested using multilevel random regression analyses with radiation as predictor of main interest.

Eligibility criteria: Inclusion Criteria:

* female aged between 18 - 30 years

Exclusion Criteria:

* cardiac or brain disorder
* pregnancy

Primary outcomes:
measure: Changes in EEG and ECG
timeFrame: during mobile phone exposure (immediately)
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Mondriaan, locatie Vijverdal, Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Jim van Os
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039506: An Observational Study of CPT-11 Based Regimens and UGT1A1 Genotypes in Metastatic Colorectal Cancer (mCRC)
Official title: A Prospective Observational Study of the Efficacy and Safety of CPT-11 Based Regimens for UGT1A1 Genotype Guided Patients With Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: UGT1A1, irinotecan
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 1376
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 with metastatic colorectal cancer treated with CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) in clinical practice in Japan

Brief summary: The purpose of this study is to examine the correlation between UGT1A1 genotypes and the efficacy of CPT-11 based regimens (FOLFIRI, CPT-11+S-1, CPT-11) for patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer (adenocarcinoma)
* UGT1A1 genotyped patients
* Patients to receiving FOLFIRI, CPT-11+S-1 and CPT-11 alone therapy (with or without molecular targeted agents)

Exclusion Criteria:

* Contraindication of CPT-11
* Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) 3-4
* Patients to receiving CPT-11 as adjuvant chemotherapy
* History of pelvic irradiation

Primary outcomes:
measure: Progression free survival
timeFrame: Within 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: At 3 years
measure: Time to treatment failure
timeFrame: Within 3 years
measure: Response rate
timeFrame: from Day 1 (treatment) through disease progression (within 3 years)
measure: Disease control rate
timeFrame: Within 3 years
measure: Safety events
timeFrame: Within 3 years
Other outcomes:
Locations:
city: Tokorozawa-shi
country: Japan
facility: Department of Clinical Oncology, National Defense Medical College Hospital
state: Saitama
Study officials:
References:
Clinical trial NCT00376649: Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes
Official title: Development of Workshop for Lifestyle Changing for Crohn's Disease Patients and Its Affect on the Disease's Indexes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Crohn's Disease
Keywords: crohns
quality of life
lifestyle changing
remmision
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment

Detailed description: Participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. The workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. The study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an IBDQ , CDAI and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* diagnosed with CD
* Crohn's Disease Activity Index (CDAI) of under 170
* a minimum of 75% of the meetings

Exclusion Criteria:

* patients with a stoma
* and patients with a planned admission to the hospital for surgery or other treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: hadassah univercity hospital
name: Rifat safadi, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290249: Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq
Official title: Face-to-face Intubation With Glidescope or Airtraq
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation; Difficult
Edema of the Tongue
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.

Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.

Detailed description: Trauma victims mostly had to be intubated at the scene of the area with the paramedics. In a suspect of a cervical trauma, patients must be intubated with the least movement. Videolaryngoscopic techniques had several advantages at this condition. We want to investigate which can be used easily by novice personnel.

Eligibility criteria: Inclusion Criteria:

* medical students at their third year,
* novice personnel

Exclusion Criteria:

* anesthesists,
* anesthesia residents,
* skilled investigators of tracheal intubation

Primary outcomes:
measure: intubation success rates
timeFrame: 5 minutes
Secondary outcomes:
measure: intubation time
timeFrame: 5 minutes
measure: Esophageal intubation
timeFrame: 5 minutes
measure: need of optimisation maneuvers
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesiology and Reanimation
name: Zehra I ARSLAN, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557049: Global Postural Reeducation in Chronic Low Back Pain
Official title: Global Postural Reeducation in Chronic Low Back Pain: an Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Mechanical Low Back Pain
Keywords: chronic low back pain
Postural global reeducation
randomized
physical rehabilitation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a Global Postural Reeducation (GPR) program in subjects with chronic low back pain.

Detailed description: Approximately 80-85% of individuals will experience low back pain during their lifetime. It is one of the major concerns of current health care. There is evidence for the effectiveness of exercise therapy in patients with chronic low back pain. GPR is a physical therapy method developed in France by Philippe Emmanuel Souchard. Although this method is largely used as form of treatment in most countries, few studies showed its clinical effectiveness in chronic low back pain. This is the first randomized controlled trial, with assessor blind that evaluate the GPR effects in chronic low back pain. All outcome measurements are reliability, validated and sensitivity for statistical changes using the Visual Analogic Scale- VAS (0-10cm), Roland Morris Questionary, SF36 (Quality Life Questionary) and Beck Scale (Depression Symptoms).

Eligibility criteria: Inclusion Criteria:

* between 18-65 years age,
* low back pain (more than 12 weeks) without legs irradiation,
* pain between 3-8 cm on a visual Analogue scale (0-10cm).

Exclusion Criteria:

* fibromyalgia,
* pregnancy,
* osteoporosis severe,
* disc herniation,
* patients who had undergone spinal surgical or physiotherapeutic interventions within 3 months prior to baseline assessment.

Primary outcomes:
measure: Change from baseline in pain
timeFrame: baseline and two follow-up examinations - after 3 and 6 months from baseline
Secondary outcomes:
measure: Change from baseline in function
timeFrame: It was collected at baseline and two follow-up examinations after 3 and 6 months from baseline.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: São Paulo Federal University UNIFESP
Study officials:
affiliation: Federal University of São Paulo
name: Priscila Maria Lawand, Author
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691249: Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
Official title: Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Keywords: Diabetes
Diet
Fiber
Lead sponsor: Kansas State University
Sponsor class: OTHER
Collaborators: name: MGP Ingredients, Inc.
First posted: 2008-06-05
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.

Detailed description: To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. The investigators will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetics

Exclusion Criteria:

* Diagnosed with other metabolic disorders
* Allergies to wheat
* Non-smokers

Primary outcomes:
measure: Post-Prandial metabolism
timeFrame: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion
Secondary outcomes:
measure: Satiety
timeFrame: Early morning - Midafternoon
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Kansas State Univerity: Department of Human Nutrition
state: Kansas
Study officials:
affiliation: Department of Human Nutrition
name: Mark Haub, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: