louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01177293: Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: biological availability
bioavailability
amlodipine
orally disintegrating tablet
ODT
tablets
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Aurobindo Pharma Ltd
name: Trident Life Sciences Ltd.
First posted: 2010-08-06
Enrollment: 14
Sex: ALL
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 is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female literate subjects (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 26.4 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 time of dosing).
* A positive urine drug screen.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
measure: Plasma Decay Half-life (t1/2)
timeFrame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose
Other outcomes:
Locations:
city: Hydrabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02720393: Impact of No-carrageenan Diet on Glucose Tolerance in Prediabetes
Official title: Impact of no Carrageenan Diet on Glucose Tolerance in Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 48
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: Participants will be randomly assigned to either regular or no-carrageenan prepared diets to determine whether the no-carrageenan leads to improvement in glucose tolerance. Hemoglobin A1c is the primary outcome measure.

Detailed description: Subjects will be randomly assigned to a diet. They will at onset have hemoglobin A1c values between 5.7% and 6.4%. Baseline glucose tolerance test will be performed, as well as measures of inflammation and fecal microbiome. Interim tests will be performed at six weeks. Subjects will participate for 12 weeks, at which time they will be re-evaluated.

Eligibility criteria: Inclusion Criteria:

* per diabetes, ability to follow diet and study procedures

Exclusion Criteria:

* on any medications that affect glucose, medical conditions or allergies that affect adherence to study diet, pregnancy

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change in serum Interleukin-8
timeFrame: baseline, 12 weeks
measure: Impact on glucose tolerance test
timeFrame: 12 weeks
measure: Impact on insulin level
timeFrame: 12 weeks
measure: Change in leukocyte subsets
timeFrame: baseline, 12 weeks
measure: Change in Tumor Necrosis Factor-alpha in serum
timeFrame: baseline, 12 weeks
measure: Change in insulin signaling pathway
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Change in fecal microbiome
timeFrame: baseline, 12 weeks
measure: Change in fecal calprotectin
timeFrame: baseline, 12 weeks
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT06344793: Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
Official title: A Multi-center Study of the Clinical Outcomes Between Initial CDK 4/6 Inhibitor Plus Endocrine Therapy and Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer in Real World Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: chemotherapy
CDK 4/6 Inhibitor
HR Positive
HER2 Negative
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023.

Brief summary: A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between June 2020 to October 2023;
3. Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: OS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165893: Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
Official title: Comparison of Internal Disc Decompression (IDD) vs. a Standardized Non-surgical Treatment Program for Chronic Low Back Pain Secondary to Mild to Moderate Degenerative Disc Disease (DDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Degenerative Disc Disease
Keywords: low back pain
DDD
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: North American Medical Corporation
First posted: 2005-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is looking at a new machine called the Accu-Spina which administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.

Detailed description: This study is a randomized trial where out of every 3 people, 2 will receive IDD therapy and 1 will have standardized physical therapy. Patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. If at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.

Eligibility criteria: Inclusion Criteria:

* Chronic low back pain for \> 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies
* Over 18 years old
* Able to provide written informed consent

Exclusion Criteria:

* Infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system
* Evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc
* Uncontrolled mood disorder
* History of drug or substance abuse
* Lumbar spine pathology requiring surgical intervention
* Previous spine surgery of the lumbar spine, except discectomies \>12 months
* Improvement with similar non-surgical treatments in the last 3 months
* Active litigation, workers compensation
* Females whom are pregnant

Primary outcomes:
measure: Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.
Secondary outcomes:
measure: Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: Michael K Schaufele, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03423693: Small Airway Obstruction in Asthma, COPD, ACOS
Official title: Comparative Study on Sputum Anti-inflammatory Mediators in Patients With Asthma or Asthma and COPD Overlap (ACOS) Syndrome, and COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Asthma-COPD Overlap Syndrome
Keywords: Small airway obstruction
Asthma
COPD
ACOS
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from Asthma Clinics and OPD in Siriraj Hospital

Brief summary: This study was designed as retrospective chart review to test our hypothesis whether there are the differences in inflammatory and anti-inflammatory mediators between asthmatic and ACOS patients with small airway obstruction, and COPD

Detailed description: The data including spirometry, lung volume, impulse oscillometry, sputum data, demographic characters within 6 months are collected for later analysis. Sputum supernatants and cytospins are used to determine inflammatory and anti-inflammatory responses in those patients.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma, ACO, and COPD
* Their spirometric, IOS, lung volume, demographic data and sputum samples are available

Exclusion Criteria:

* Concomitant diseases requiring immunosuppressive therapy
* Being on treatments with NSAIDs, macrolides, statins

Primary outcomes:
measure: Lipoxin A4, ,
timeFrame: 1 day (single time point)
Secondary outcomes:
measure: IL-33
timeFrame: 1 day (single time point)
measure: Thymic stromal lymphopoietin (TSLP)
timeFrame: 1 day (single time point)
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Kittipong Maneechotesuwan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04297293: Ramosetron OD Tablet and Postdischarge Nausea and Vomiting
Official title: Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Day Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patients who are taking other serotonin receptor antagonists
* Patients who have galactose intolerance or Lapp lactase deficiency
* patients who have glucose-galactose malabsorption

Primary outcomes:
measure: The change in the occurrence of postoperative nausea
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
measure: The change in the occurrence of postoperative vomiting
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Secondary outcomes:
measure: The change in the severity of postoperative nausea
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
measure: The change of patient's satisfaction score
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
measure: The change in the number of postoperative administration of rescue antiemetic drug
timeFrame: Postoperative 30 minute, 3 hour, 24 hour, and 48 hour
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun-Jung Shin, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.
Clinical trial NCT03415893: High-resolution Esophageal Manometry
Official title: High-resolution Esophageal Manometry in Teenagers With Esophageal Atresia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Atresia
Keywords: high-resolution manometry
esophageal atresia
teenagers
Lead sponsor: Hospital El Cruce
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: teenagers with esophageal atresia and surgically repaired

Brief summary: EA is one of the most frequent birth defects, with an incidence of 1 in 3000 live births1. Until the 1950s, these patients had 100% mortality; nowadays, the survival rate is greater than 90%, and only those with associated severe malformations die1-5.

Type C EA (atresia of the esophageal proximal segment with tracheoesophageal fistula between the trachea and the distal segment) is the most common variant, since it is present in 85% of the cases6-8. There is evidence that the esophageal motor disorder present in these children is secondary to a congenital neuromuscular disorder and a postoperative disorder9-14. Patients that survive the operation have greater risk of developing gastroesophageal reflux disease (GERD), caused by anomalies in the esophageal motility and its resulting delay in the evacuation of acid of the esophageal lumen.

There was a hypothesis that suggested that motility alteration could contribute to dysphagia and to the high prevalence of gastroesophageal reflux in these patients15-18. Also, there were reports of a greater incidence of severe esophagitis with requirement of fundoplication, which shows a larger failure rate17-18. Esophageal dysmotility has been proved in children with EA through performance of conventional perfusion manometry.

Lemoine C et al described three motility alteration patterns with HRM in children with repaired EA. Said study allowed a more precise knowledge of segmental esophageal motility19. Currently, there are no reports exclusively made about teenagers with repaired EA that describe segmental esophageal motility with HRM.


Eligibility criteria: Inclusion Criteria:

teenagers of more than 12 years old, with repaired EA, orally fed during the last 6 months, with no history of esophageal blockage or dilations, who underwent a HREM

Exclusion Criteria:

* patients under 12 years old

Primary outcomes:
measure: Patterns of High Resolution Manometry in teenagers with esophageal atresia
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
state: Buenos Aires
Study officials:
affiliation: Hospital El Cruce
name: cecilia curvale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06342193: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial
Official title: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystoscopy
Virtual Reality
Anxiety
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* 18 years of age or older
* Male gender
* undergoing a rigid cystoscopy procedure for the first time
* Application of local anaesthesia

Exclusion Criteria:

* Cognitive or physical disabilities that may prevent the use of virtual reality glasses.
* Premedication before the procedure

Primary outcomes:
measure: anxiety
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Usak Training and Research Hospital
state: Center
Study officials:
affiliation: Usak University Training and Research Hospital
name: Yucel Can Danisman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02507193: Fibular Fixation in Ankle Fractures:Plate Verses Nail.
Official title: Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Fibula Fracture
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation.

Detailed description: The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation. This objective will be accomplished using the Olerud-Molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. It is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (ADL) level. It does not involve physician-measured outcomes. The best possible score is a total of 100. Patients will be given a form to complete throughout follow-up and be utilized for data analysis. Functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.

Eligibility criteria: Inclusion Criteria:

* Distal fibula fracture
* Pilon fractures
* Open fractures
* Ipsilateral foot

Exclusion Criteria:

* Weber A distal fibula fractures
* Pathologic fractures

Primary outcomes:
measure: Functional outcome using the Olerud-Molander score.
timeFrame: One year.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Kenneth J. Koval, MD
role: STUDY_DIRECTOR
References: