louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03032549: Safety of a Ready to Drink Supplement
Official title: Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine a Ready to Drink (RTD) supplement.

Detailed description: This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and self-reported side effects.

Eligibility criteria: Inclusion Criteria:

* Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40

Exclusion Criteria:

* Participants are under 18 years old and above 40 years old
* Participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease
* Participants currently use any prescription medication (birth control is allowed)
* Participants are pregnant or lactating females or plan to become pregnant within the next month
* Participants have a history of smoking
* Participants drink excessively (12 drinks per week or more)
* Participants have a recent history of creatine supplementation within 8 weeks of the start of supplementation

Primary outcomes:
measure: The effects of ingesting an RTD immediately prior to exercise on the blood
timeFrame: 7 days
measure: The effects of ingesting an RTD immediately prior to exercise on heart rate
timeFrame: 7 days
measure: The effects of ingesting an RTD immediately prior to exercise on blood pressure
timeFrame: 7 days
Secondary outcomes:
measure: The effects of ingesting an RTD immediately prior to exercise on self-reported side effects
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Texas A&M University
name: Richard B Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03670849: Image Fusion in the OR
Official title: Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Liver Ablation
Keywords: Laparoscopic Ultrasound
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
name: IGI Technologies, Inc.
First posted: 2018-09-14
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.

Detailed description: Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.

We have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. For ablations, we further track the needle and overlay its path on the AR view for precise needle placement. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

Eligibility criteria: Inclusion Criteria:

1. Referred for laparoscopic cholecystectomy or liver ablation
2. Clinical indication for the use of laparoscopic ultrasound
3. Patient or an authorized guardian provides written consent

Exclusion Criteria:

Patients with pacemaker or any other ICD (intra-cardiac device) which may interfere with electromagnetic tracking

Primary outcomes:
measure: Usability
timeFrame: post surgery, an expected average of 5 minutes
measure: System set-up time
timeFrame: before surgery, an expected average of 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT04006249: Haemochromatosis and Periodontitis
Official title: Haemochromatosis and Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: to Evaluate the Prevalence of Periodontal Diseases in Patients With Hemochromatosis at the Time of Diagnosis and / or Their Usual Therapeutic
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 87
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Periodontitis is a chronic inflammatory disease that affects tissues surrounding the teeth. It is strongly associated with the major pathogenic "red complex", including Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola1 and thus is considered an infection. Recent advances in the pathogenesis of periodontal disease have suggested that polymicrobial synergy and microbiota dysbiosis together with a dysregulated immune response can induce inflammation-mediated damage in periodontal tissues2-4. Interestingly, currently periodontitis is associated with a growing number of systemic diseases, including cardiovascular diseases, adverse pregnancy outcomes, diabetes5-7 and hereditary haemochromatosis8.


Eligibility criteria: Inclusion Criteria:

* Patients aged 35 to 64 years with homozygosity hemochromatosis C282Y
* Patients regularly enrolled in a health insurance plan
* Patients with at least 10 natural teeth
* Patients who have given informed written, dated and signed consent

Exclusion Criteria:

* Diabetic patients
* Simultaneous participation in another study
* Pregnant or lactating women
* The incapacitated persons and persons deprived of their liberty
* Patients who do not speak French, both written and spoken
* Patients previously included in this trial
* Patients with heart valves or endovascular equipment (risk of infective endocarditis ...)
* Patients with a history of maxillofacial surgery
* Patients whose oral status is considered incompatible with entry into the study, at the discretion of the investigator
* Patients on drugs that can cause gingival hypertrophy, such as Hydantoins (phenytoin), Dihydropyridines, Diltiazem or Ciclosporin
* Patients on medication that can cause gingival bleeding (anticoagulants, antiplatelet agents and aspirin).

Primary outcomes:
measure: prevalence of periodontal diseases
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00333749: The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
Official title: Phase 1 1 Study Assesing the Benefit of Pasteurized Goat Milk in Reducing Disease Severity of Young Children With Oral Ulcer Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oral Ulcer
Keywords: children
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2006-06-06
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with acute diseases with oral ulcers (not included PRESENTATIONS OF SLE, IBD or IMMUNOCOMPRMIZED STATES)will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - signs and symptoms.

Detailed description: A prospective randomized controlled study that will include 110 previously health 6months - 5 years children (55 in each group) with acute oral ulcer disease (\< 48 hours). Children will receive several doses (drinking or mouth rinsing) of either pasteurized goat milk or cow milk. Children will than be followed for length of the disease - sings and symptoms by questioner to parents, and physical examination by there physicians. .

Eligibility criteria: Inclusion Criteria:

* Age \> 6 months or \< 5 years.
* Acute (\< 48 hours) oral ulcer disease.
* \> 5 ulcers.
* Cooperative parents .
* Signing inform consent.

Exclusion Criteria:

* All types of immunosuppression, IBD, SLE, recurrent oral ulcer, disease \> 48 hours, age , 6 \< months or \> 5 years.

Primary outcomes:
measure: Severity of disease
timeFrame: 3 years
measure: Length of disease
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dan Miron
Study officials:
affiliation: HaEmek Medicak Center, Afula, Israel
name: Dan Miron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02005549: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Official title: A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.


Eligibility criteria: Inclusion Criteria:

* female patients, 18-70years of age;
* histologically-proven invasive breast cancer;
* no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
* no distant disease/secondary cancer.

Exclusion Criteria:

* pregnant or lactating women;
* pre-operative local treatment for breast cancer;
* prior or concurrent systemic antitumor therapy;
* clinically significant cardiac disease.

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Secondary outcomes:
measure: Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)
timeFrame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
measure: Percentage of Participants Undergoing Breast-Conserving Surgery
timeFrame: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
Other outcomes:
Locations:
city: Salzburg
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT03410849: Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium
Official title: Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Detailed description: Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: the prevalence and causes of post-operative swallowing disorders and reflux disease are uncertain. Recently, independent study groups described a high incidence of Barrett oesophagus post LSG. Additional research is urgently needed.

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion Criteria:

* Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy as a secondary bariatric procedure (e.g. after gastric banding),
* Patients who received a secondary bariatric operation after laparoscopic gastric bypass or laparoscopic sleeve gastrectomy( e.g. biliopancreatic diversion)

Primary outcomes:
measure: Incidence of Barrett oesophagus after bariatric surgery
timeFrame: 5-7 years after bariatric surgery
Secondary outcomes:
measure: Prevalence of dysphagia after bariatric surgery
timeFrame: 5-7 years after bariatric surgery
measure: Prevalence of oesophageal motility disorders after bariatric surgery
timeFrame: 5-7 years after bariatric surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: Clinical Research St Claraspital
name: Bettina Wölnerhanssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06294249: Pain Severity in Flapless Dental Implant Placement Using Laser
Official title: The Evaluation of Pain Severity in Flapless Dental Implant Placement Using Laser-induced Incisions: A Split Mouth Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Jaw, Edentulous, Partially
Keywords: Jaw, Edentulous, Partially
Pain Measurement
Laser Therapy
Dental Implants
Randomized Controlled Trial
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser.


Eligibility criteria: Inclusion Criteria:

1. Adult human subjects agreed to participate in the study and return on follow-up times
2. Subjects eligible for receiving dental implants
3. Subjects with an edentulous area in the posterior of the mandible bilaterally 3- Subjects with sufficient bone width and height (\>5 mm width, and \>10 mm height) at the implant sites
4. Subjects with sufficient keratinization tissue at the implant sites

Exclusion Criteria:

1. Subjects refused to return for follow-up or refused study enrollment.
2. Subjects with uncontrolled systemic diseases
3. Subjects younger than 18 years
4. Subjects receiving psychotropic drugs

Primary outcomes:
measure: Pain Severity
timeFrame: Patients were visited at 24, 48, 72 hours, and 7 days after insertion.
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: shiraz University of medical sciences
state: Fars
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: +98-9125850829 Tabrizi, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942149: An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Official title: An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sepsis
Keywords: Infants
Daptomycin
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 48
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.


Eligibility criteria: Inclusion Criteria:

1. \> 48 hours and \<120 days of age at the time of daptomycin administration
2. Sufficient venous access to permit administration of study medication
3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

1. History of anaphylaxis attributed to daptomycin
2. Previous participation in the study
3. Exposure to daptomycin in the month prior to the study
4. Serum creatinine \>1.0 mg/dL
5. Concomitant administration of tobramycin

Primary outcomes:
measure: PK of Daptomycin
timeFrame: 24 hours
Secondary outcomes:
measure: Adverse Events Will be Monitored.
timeFrame: 7 days following last dose of study drug
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: P Brian Smith, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006449: Post-Treatment Effects of Naltrexone
Official title: Post-Treatment Effects of Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2000-11-07
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.


Eligibility criteria: Inclusion Criteria:

* Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
* Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
* Must be fluent in English.
* Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

* Severe hepatic disease or a liver function test greater than 4 times normal.
* Opiate use in the last 14 days or a history of opioid dependence in the past year.
* Pregnant or lactating females who are not using a reliable method of birth control.
* Inability to follow medication instructions and safety precautions.
* Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.
* Use of medications intended to decrease drinking.
* Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Institute of Psychiatric Research, Indiana University School of Medicine
state: Indiana
Study officials:
References:
Clinical trial NCT01957449: Propranolol in Severely Burned Children
Official title: Safety and Efficacy of Propranolol in Severely Burned Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2013-10-08
Enrollment: 63
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.

Detailed description: Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.

Eligibility criteria: Inclusion Criteria:

* Burns covering \>20% of the total body surface are
* Age of 0 to 18 years
* Patient arrival to the burn center within 96 hours (4 days) of burn injury
* Require \> 1 surgical procedure

Exclusion Criteria:

* Pregnancy
* Known history of AIDS, Aids Related Complex, or HIV
* History of cancer within 5 years
* Existence of pre-morbid conditions
* Asthma
* Congestive heart failure (measured ejection fraction \< 20%)
* Medical condition requiring glucocorticoid treatment
* Burn injury due to chemical burns
* Burn injury due to deep electrical injury (decision of hospital PI)
* Presence of anoxic brain injury that is not expected to result in complete recovery
* Decision not to treat due to burn injury severity

Primary outcomes:
measure: Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product
timeFrame: Measured during acute hospital stay, an average of 4 weeks.
Secondary outcomes:
measure: Number of deaths
timeFrame: time of randomization up to one year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospitals for Children
state: California
city: Boston
country: United States
facility: Shriners Hospitals for Children
state: Massachusetts
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children
state: Ohio
city: Galveston
country: United States
facility: Shriners Hospitals for Children
state: Texas
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: