louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00579995: A Prospective, Randomized TrialComparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate
Official title: A Prospective, Randomized Trial Comparing Oral N-Acetylcysteine and Intravenous Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nephropathy
Keywords: contrast induced nephropathy
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the efficacy of oral N-acetylcysteine and intravenous sodium bicarbonate for the prevention of Contrast-Induced Nephropathy (CIN) after cardiac catheterization.

Detailed description: It is thought that N-acetylcysteine may reduce the ability of generated oxygen free radicals to damage cells by scavenging them. N-acetylcysteine may also increase the biologic effects of nitric oxide by combining with nitric oxide to form S-nitrosothiol, a more stable form and potent vasodilator. It also increases the expression of nitric oxide synthesis and may improve blood flow. Oxidants activate a signal-transduction cascade and molecular response that may initiate the cell-death pathway. These pathways seem to be sensitive to the redox state of the cell and are inhibited by N-acetylcysteine, which promotes pathways that lead to repair and survival whenever cells are under oxidant stress.

Eligibility criteria: Inclusion Criteria: 19 years of age

* Baseline serum creatinine or
* Calculated creatinine
* Stable Renal Function
* Left Ventricular ejection fraction
* Non-pregnant, non-lactating females (all women of childbearing potential must have a negative serum pregnancy test. No contraception will be required
* Able to sign informed consent

Exclusion Criteria:

* Acute renal failure
* History of Kidney transplant
* Currently receiving N-acetylcysteine

  _ Contraindication of hypersensitivity to N-acetylcysteine or sodium bicarbonate
* Left ventricular ejection fraction
* Pregnant, lactating females
* Allergy to contrast dye

Primary outcomes:
measure: Compare the Effectiveness of Two Medications for Prevention of Contrast-induced Nephropathy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Scott Shurmur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02921295: A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation Stumps
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: College Park Industries
First posted: 2016-10-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.


Eligibility criteria: Inclusion Criteria:

* bilateral transfemoral amputee
* own a pair of conventional stubby prosthesis with standard adaptation

Exclusion Criteria:

* dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
* use of prosthesis that do not allow change of feet with standard adapters
* any medical condition that may put an individual in greater risk of injury than normal daily activity.

Primary outcomes:
measure: Average Speed for 10 Meter Walk Test
timeFrame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
Secondary outcomes:
measure: Timed up and go Test Time
timeFrame: 6 times throughout study completion (3 every 1 hour during the 2 hour protocol)
measure: Gait Symmetry Index
timeFrame: 2 times throughout study completion (every 1 hour during the 2 hour protocol)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Bakery Square MSPO labs
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00300495: Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection
Official title: Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Lung Cancer
Keywords: Atrial fibrillation
Lung cancer
Pulmonary resection
Post-operative complications
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2006-03-09
Enrollment: 19
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: Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Detailed description: Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation.

We propose a study to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Eligibility criteria: Inclusion Criteria:

* Resectable lung nodule or mass

Exclusion Criteria:

* Allergy to amiodarone
* Currently taking amiodarone
* Documented atrial fibrillation within past 12 months
* Known pulmonary fibrosis
* Known hepatic dysfunction
* Thyroid disease
* 2nd or 3rd degree heart block
* Severe SA node disease
* Bradycardia-induced syncope
* Pregnancy

Primary outcomes:
measure: Incidence of Post-operative Atrial Fibrillation
timeFrame: 30 days
Secondary outcomes:
measure: Length of Post-operative Hospital Stay
timeFrame: 1 week on average
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Malcolm M DeCamp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02563795: Low Dose Spinal Anesthesia in Cesarean Surgery
Official title: Does the Reduction of Local Anesthetic Dose Provide Surgical Anesthesia While Avoiding Maternal Hypotension in Obese Pregnant for C/S by Single Shot Spinal Anesthesia?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal Hypotension
Anesthesia
Keywords: Spinal anesthesia
Cesarean
Maternal hypotension
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cesarean section under spinal anesthesia in obstetric clinic

Brief summary: Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.


Eligibility criteria: Inclusion Criteria:

* Pregnant patients

Exclusion Criteria:

* Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.

Primary outcomes:
measure: VAS score < 6 with only spinal anesthesia
timeFrame: Approximately 30 min, during surgery
Secondary outcomes:
measure: Maternal hypotension
timeFrame: Approximately 30 min, during surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Cigdem Yildirim Guclu
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIM GUCLU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06617195: Mechanisms of Anabolic Resistance in Older Humans
Official title: Mechanisms of Anabolic Resistance in Older Humans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women age 21-35 years or 70-85 years of age

Brief summary: The purpose of this research is to understand how chronic inflammation affects muscle function and responses to exercise in older adults.

Detailed description: Inflamed adipose tissue may contribute to blunted exercise response in skeletal muscle of older adults. The objective of this project is to evaluate a hypothesis that inflamed adipose secretes factors that activate inflammatory cascades in skeletal muscle, which may interfere with exercise-responsive molecular pathways and contribute to dysfunctional muscle phenotypes with aging. This project determine how adipose tissue influences skeletal muscle function and anabolic response to exercise in older adults. Young and older adults will complete studies to assess molecular response to acute exercise from protein synthesis rates, mRNA of exercise-responsive genes, and activation of signaling proteins in skeletal muscle. Adipose tissue will be assessed using a combination of non-invasive imaging and biopsy-based molecular phenotyping. The project will determine if acute exercise response is attenuated in older adults with inflamed adipose tissue phenotype.

Eligibility criteria: Exclusion Criteria:

1. Diabetes or fasting plasma glucose 126 mg/dL
2. Body mass index (BMI) 30 kg/m2
3. Anemia (female subjects hemoglobin of \&lt;11 g/dl and male subjects hemoglobin \&lt;12 g/dl)
4. Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
5. Renal failure (serum creatinine \&gt; 1.5mg/dl)
6. Chronic active liver disease (AST\&gt;144IU/L or ALT\&gt;165IU/L)
7. Oral warfarin group medications or history of blood clotting disorders.
8. Smoking
9. Pregnancy or breastfeeding
10. Alcohol consumption greater than 2 glasses/day or other substance abuse
11. Untreated or uncontrolled hypothyroidism
12. Debilitating chronic disease (at the discretion of the investigators)

Primary outcomes:
measure: Anabolic response
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ian Lanza
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06996795: Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction
Official title: Investigating the Effects of Music Therapy on Sensory Processing, Adaptive Behavior and Social Interaction in Children With Autism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Music Therapy
Keywords: autism
sensory integration
music therapy
sensory processing
social interaction
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with an intervention group and a control group
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of our study is to examine the effects of music therapy on sensory processing, adaptive behavior, and social interaction in individuals with autism.

Detailed description: The study was designed as a randomized controlled trial. A simple randomization method will be used to randomly assign individuals to two groups (intervention and control groups). A simple randomization method will be used where the intervention and control group papers are selected from a sealed envelope. Following the initial assessment of each participant, one of the papers labeled "intervention" or "control" will be randomly selected. This decision will determine whether the individual will be assigned to the intervention or control group. The study will be conducted at Hacettepe University. The study group and the control group will receive sensory integration training for 45 minutes per day, 2 days per week, for 6 weeks. The children in the control group will receive only sensory integration training, while the study group will receive music therapy training for 30 minutes per day, 2 days per week, for 6 weeks in addition to sensory integration training. Sociodemographic information of the children will be collected before the research and sensory processing problems of the children will be assessed with the Sensory Profile and adaptive behavioral skills will be assessed with the Adaptive Behavior Scale (ADS).

Eligibility criteria: Inclusion Criteria:

Having been diagnosed with autism spectrum disorder (ASD) by a child psychiatrist Being between the ages of 6-10 being able to cooperate

Exclusion Criteria:

Having any neurological, orthopedic or psychiatric diagnosis in addition to autism diagnosis Having undergone any surgical intervention in the last 3 months Being inadequate in understanding visual and auditory commands Having a visual and hearing impairment recorded in the health report

Primary outcomes:
measure: sensory profile
timeFrame: 1 month
Secondary outcomes:
measure: Adaptive Behavior Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT06752655: Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer
Official title: The Effect of Photodynamic Therapy Using Curcumin As a Photosensitizer on Postoperative Pain After Non-Surgical Root Canal Retreatment: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periapical Diseases
Postoperative Dental Pain
Irrigation Solution
Photodynamic Therapy (PDT)
Keywords: postoperative pain
endodontics
root canal irrigation
curcumin
photodynamic therapy
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. However, no research has specifically examined their effect on postoperative pain. The aim of this study is to investigate the impact of using a curcumin solution in combination with photodynamic therapy as the final irrigation solution on postoperative pain.

Detailed description: Fifty patients were randomly assigned to two groups using a web-based program, according to the selected final irrigation procedure: curcumin-photodynamic therapy or a control group (routine root canal final irrigation with NaOCl and EDTA). The teeth will be isolated with a rubber dam, and access cavities will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will then be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.

Eligibility criteria: Inclusion Criteria:

* healthy patients with aged between 18-60.
* Incisor, canine, and premolar teeth that had previously undergone root canal treatment
* Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
* teeth with only 1 root canal
* the patients had not used any antibiotics for 3 months before treatment

Exclusion Criteria:

* the presence of a root fracture
* teeth with any swelling
* ankyloses,
* periodontal pockets deeper than 4 mm.
* teeth which a rubber dam could not be performed
* patients with allergy to ibuprofen or ciprofloxacin were also excluded.

Primary outcomes:
measure: postoperative pain levels
timeFrame: one week
Secondary outcomes:
measure: dependent variables-sex
timeFrame: one week
measure: dependent variable-age
timeFrame: one week
measure: dependent variables-teeth number
timeFrame: one week
measure: dependent variables-smoking habit
timeFrame: one week
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
state: Yakutiye
Study officials:
References:
Clinical trial NCT00000455: Naltrexone for Early Problem Drinkers
Official title: Targeted Naltrexone for Early Problem Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.

Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.


Eligibility criteria: Inclusion Criteria:

* Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).
* Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.
* Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
* Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.
* A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.
* Willing to provide a signed informed consent to participate in the study.

Exclusion Criteria:

* Have a current clinically significant physical disease or abnormality.
* Have a serious psychiatric illness.
* Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.
* A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.
* Used opioids or other psychoactive medications regularly in the month prior to study enrollment.
* History of hypersensitivity to naltrexone (Revia).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Department of Psychiatry, University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00881855: To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotics
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: