louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00601302: Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Chronic Stable Angina
Vasospastic Angina
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Twenty-one day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: Walter Parham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097302: Tomographic Analysis of Anterior, Posterior, Total Corneal Refractive Power Changes After Laser-assisted Keratotomy
Official title: Tomographic Analysis of Anterior, Posterior and Total Corneal Refractive Power Changes After Femtosecond Laser-assisted Keratotomy After Laser Lens Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Astigmatism
Keywords: laser-assisted keratotomy
anterior astigmatism
posterior astigmatism
total corneal refractive power
nomogram
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism during lens surgery

Brief summary: To analyze the effect of femtolaser-assisted keratotomy on corneal astigmatism (anterior, posterior and Total corneal refractive power) measured by Scheimpflug tomography after laser lens surgery.

Detailed description: This study investigated patients' eyes with low to moderate total corneal refractive power determined with Scheimpflug tomography (Pentacam HR) after penetrating femtosecond laser-assisted keratotomy (pFLAK) and laser lens surgery. The anterior corneal astigmatism, posterior corneal astigmatism and total corneal refractive power were determined before, 1 month and 3 months after lens surgery. Vector analysis according to the Alpins' method was used to calculate surgically induced astigmatism (SIA).

Eligibility criteria: Inclusion Criteria:

- Patients who received penetrating femtosecond laser-assisted lens surgery with low to moderate corneal astigmatism

Exclusion Criteria:

* Eyes with irregular corneal astigmatism such as keratoconus, previous corneal surgery, acute or chronic ophthalmic diseases of the anterior segment and intraoperative complications were not included in this study.

Primary outcomes:
measure: Change from Baseline Total corneal refractive power at 3 months
timeFrame: Before and 3 months after lens surgery
Secondary outcomes:
measure: Change from Baseline Anterior corneal astigmatism at 3 months
timeFrame: Before and 3 months after lens surgery
measure: Change from Baseline Posterior corneal astigmatism at 3 months
timeFrame: Before and 3 months after lens surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03665402: A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
Official title: Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Drug-Induced Liver Injury
Adverse Drug Event
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2018-09-11
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects


Eligibility criteria: Inclusion Criteria:

* Agreement with written informed consent
* Adult healthy male or female subject age 20 to 45

Exclusion Criteria:

* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
* Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days
* Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
* Subject with known for hypersensitivity reactions to isoniazid
* Subject who can not perform contraception during study periods
* Female woman who are pregnant or are breast feeding
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: Liver toxicity
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Drug exposure
timeFrame: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trials Center
Study officials:
References:
Clinical trial NCT00468702: Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
Official title: Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Abnormalities
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will measure the efficacy and safety of an early postoperative anticoagulation self-management program, using the CoaguChek S device, in patients undergoing mechanical valve replacements. Patients will be randomized into a study group (self-management) or a control group (physician management).


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* recipient of a mechanical heart valve (aortic and/or mitral), +/- CABG, +/- postoperative atrial fibrillation.

Exclusion Criteria:

* recipient of a bioprosthetic valve;
* post-operative thrombotic events;
* pre-operative utilization of oral anticoagulation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06037902: CPAP for Esophageal Cancer With Radiotherapy
Official title: Use of CPAP (Continuous Positive Airway Pressure) for Simulating Esophageal Cancer Patients Prior to Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Keywords: radiation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients undergo two simulations.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy.

The main questions it aims to answer are:

* does use of CPAP decrease exposure of normal lung to radiation?
* does use of CPAP decrease exposure of normal heart to radiation?

Participants will undergo simulation twice:

* with CPAP
* without CPAP


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of cancer, with a tumor (primary or secondary) in the esophagus including tumors in the esophagus-stomach junction.
2. Age ≥ 18
3. Planned RT treatment
4. The level of functioning ≥ 60 on the Karnofsky scale
5. Life expectancy ≥ two months
6. All patients must understand the informed consent form document and sign it of their own free will before any test/procedure related to the study is performed.
7. Able to undergo simulation and radiation with CPAP
8. Candidate patients can be recruited to receive definitive, palliative or pre-operative radiation, with or without chemotherapy.

Exclusion Criteria:

A person who meets any of the following exclusion criteria will not be able to participate in the study:

1. Pregnancy or breastfeeding
2. Significant comorbidity at the starting point that would prevent the use of CPAP
3. Hospitalized in an institution by virtue of an administrative order or a court order.
4. Special population
5. A history of a psychiatric problem that may impair the patient's ability to understand the research requirements or respond to them, or to give his consent

Primary outcomes:
measure: absolute mean heart radiation dose
timeFrame: on day of simulation (day 1)
Secondary outcomes:
measure: lung dose in Gy
timeFrame: on day of simulation (day 1)
measure: heart dose in Gy
timeFrame: on day of simulation (day 1)
measure: movement of tumor in cm
timeFrame: on day of simulation (day 1)
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT03158402: Preoperative Inspiratory Muscle Training Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery.
Official title: High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Prehabilitation
Respiratory Therapy
Keywords: Inspiratory muscle training
Systemic Inflammatory Response Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.


Eligibility criteria: Inclusion Criteria:

* Waiting for thoracic surgery with valve replacement
* Preoperative surgeon consultation between 3 and 6 weeks before surgery

Exclusion Criteria:

* Patient with antecedent of lung surgery
* Patient with neuromuscular or neurovascular disease
* Non anticipated surgery with a time between surgeon consultation and surgery inferior to 3 weeks.
* Inhability to do the preoperative exercises

Primary outcomes:
measure: Preoperative STNFr1 level
timeFrame: Outcome is evaluated at the training initiation and re evaluated 24hours before the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
References:
citation: Furon Y, Dang Van S, Blanchard S, Saulnier P, Baufreton C. Effects of high-intensity inspiratory muscle training on systemic inflammatory response in cardiac surgery - A randomized clinical trial. Physiother Theory Pract. 2024 Apr;40(4):778-788. doi: 10.1080/09593985.2022.2163212. Epub 2023 Jan 13.
Clinical trial NCT05684302: The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
Official title: The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Refractive Errors
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy myopic people between 18 and 50 years of age

Brief summary: A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.

Detailed description: A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.

Eligibility criteria: Inclusion Criteria:

* health volunteers
* their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter
* best corrected visual acuity (BCVA)≥ 20/20 in both eyes
* stable refraction (no change greater than 0.5 Diopter within two years)

Exclusion Criteria:

* if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.

Primary outcomes:
measure: The clarity score
timeFrame: baseline visit time
measure: The comfort score
timeFrame: baseline visit time
Secondary outcomes:
measure: Accuracy of foveal and peripheral visual acuity
timeFrame: baseline visit time
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
References:
citation: Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20.
citation: Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888.
Clinical trial NCT03757702: Trunk Position Sense, Postural Stability and Spinal Posture in Fibromyalgia
Official title: Investigation of Trunk Position Sense, Postural Stability and Posture in Fibromyalgia Patients and Healthy Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Postural Lordosis
Postural Kyphosis
Proprioception
Postural Stability
Balance
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women and Fibromyalgia patient

Brief summary: This study aims to investigate trunk position sense, postural stability and spine posture in fibromyalgia patients and healthy women.


Eligibility criteria: Inclusion Criteria:

* being women
* having FMS
* being volunteer

Exclusion Criteria:

* have neurologic, infectious, endocrine, and other severe psychological disorders
* malignancy,
* being pregnant
* any condition interfering with evaluation (advanced cardiac respiratory or orthopedic problems)
* spinal deformities such as scoliosis, spine surgery
* inflammatory rheumatic diseases

Primary outcomes:
measure: Joint Position Sense
timeFrame: 20 days
Secondary outcomes:
measure: Postural Stability
timeFrame: 20 days
measure: Spinal Posture
timeFrame: 20 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
affiliation: Research Assitant
name: Özge Çoban
role: STUDY_CHAIR
References:
Clinical trial NCT06262802: Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression
Official title: In Patients With Large Cystic Lesion Does Volume Reduction Occurs Faster by Using Active Decompression and Distraction Sugosteogenesis Than Using Passive Decompression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Odontogenic Cysts
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions


Eligibility criteria: Inclusion Criteria:

* any patient with large cystic lesion

Exclusion Criteria:

* any patient can't follow home instructions

Primary outcomes:
measure: Volume change
timeFrame: 2weeks/one and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03675802: Cervical Preparation in Hysteroscopy
Official title: Randomized Comparison of Vaginal Dinoprostone and Misoprostol for Cervical Ripening Before Diagnostic Hysteroscopy in Patients Who Have Undergone Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GYN Disorders
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-09-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hysteroscopy was performed in the proliferativephase of the menstrual cycle.

The patients were given generalintravenous anesthesia (propofol/fentanyl) after the vulvar and the vaginal area had been disinfected with a 7.5% Betadinesolution by the surgical nurse All operations were performed by the same surgeon to avoid possible discrepancies between different surgeons.

Detailed description: Astandard rigid30 hysteroscope (Karl Storz bettocchi hysteroscope) with a 30° viewing angleand an outer sheath diameter 5.5 mm, inner sheath diameter 4.3 mm and scope diameter 2.9 mmwas used in all procedures.

A speculum was introduced into the vagina, and the uterine cervixwas visualized. Initially, the surgeon attempted to passthrough the cervical canal with the tool directly. When thatwas not possible or when the cervical canal was too rigid ortoo tight, the cervix was grasped with a tenaculum.

Eligibility criteria: Inclusion Criteria:

1. patients of reproductive age
2. have undergone a cesarean section at least once
3. an indication for diagnostic hysteroscopy for menstrualproblems or suspected intrauterine lesions (suchas uterine polyps and ﬁlling defects in the uterine cavity) by abnormal ﬁndings from hysterosalpingography,ultrasonography, or saline infusion sonography.

Exclusion Criteria:

1. Patients who delivered vaginally
2. Had undergone any other transcervical or transabdominal uterine and cervical intervention other than cesareansection, such as loop electrosurgical procedures, cervical cryotherapy, cervical biopsies, and spontaneousabortions, previous dilation, and previous electiveabortions.
3. Patients with cervical pathology,e.g. tears or polyps.
4. The patients with a contraindicationto prostaglandins such as hypersensitivity, bronchial asthma, glaucoma, severeasthma, cardiac, liver or kidney diseases.

   -

Primary outcomes:
measure: The number of women who will require cervical dilatation
timeFrame: within an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03226002: Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
Official title: Which Nostril Should be Used for Nasotracheal Intubation With Airtraq NT®: the Right or Left? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasotracheal Intubation
Keywords: Airtraq NT
nasotracheal intubation
right
left
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: After Ethics committee approval investigators decided to enroll 40 patients ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. We primay aimed to compare the glottis visualization time, intubation time and total intubation times.

Detailed description: After Ethics committee approval, investigators decided to enroll 40 pateints ASA I-II, 18-60 years of age undergoing maxillofascial, oral and double chin surgery to determine which nostril is more suitable for nasotracheal intubation with nasotracheal Airtraq. In addition is the 90° anti-clockwise rotation of the tip of the tube helpful to insert the tube into the trachea. Patients were randomized into right and the left nostril groups. After standard anesthesia induction with propofol and fentanyl, rocuronium was used for muscle relaxation. Primary aim of this prospective study was to compare the glottis visualization time, intubation time and total intubation times. The Cormack-Lehane grades, the need for optimization, tube adjustment maneuvers, hemodynamic data, occurrence of epistaxis of the patients were recorded during the process.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age
* undergoing elective maxillofacial surgery
* dental surgery
* plastic surgery requiring nasotracheal intubation
* ASA I-II

Exclusion Criteria:

* \>18 years and \> 65 years
* BMI\> 35
* ASA III-IV
* fasted patients
* patients do not require nasotracheal intubation

Primary outcomes:
measure: insertion time of the device
timeFrame: 20 seconds
measure: nasotracheal intubation time with the device
timeFrame: 30 seconds
measure: total nasotracheal intubation time with the device
timeFrame: 40 seconds
Secondary outcomes:
measure: optimisation maneuvers during intubation with the device
timeFrame: 20 seconds
measure: minor complications related to the device
timeFrame: 40 seconds
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
affiliation: Anesthesiology and Reanimation
name: zehra I Arslan
role: PRINCIPAL_INVESTIGATOR
References: