louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02124200: High Cessation Rates in Smokers Using Personal Vaporizers
Official title: High Cessation Rates in Smokers Using Personal Vaporizers: A Prospective 6-month Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Addiction
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Eligibility criteria: Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

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Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmHg systolic and/or \>90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

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Primary outcomes:
measure: reducers
timeFrame: week-24 from baseline
Secondary outcomes:
measure: heavy reducers and quitters
timeFrame: week-24 from baseline
Other outcomes:
Locations:
city: Catania
country: Italy
facility: 1Centro per la Prevenzione e Cura del Tabagismo (CPCT), Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", Università di Catania,
Study officials:
References:
citation: Polosa R, Caponnetto P, Maglia M, Morjaria JB, Russo C. Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit. BMC Public Health. 2014 Nov 8;14:1159. doi: 10.1186/1471-2458-14-1159.
Clinical trial NCT05973500: Effect of Mediterranean Diet in Inflammatory Bowel Disease
Official title: Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of diet on inflammatory bowel disease is an under-studied area of research. The investigators are interested in further investigating the role that diet contributes to inflammatory bowel disease severity. The investigators will collect blood and stool samples from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. The investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including C-reactive protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* Meet classification criteria for inflammatory bowel disease including those with mild to moderate Crohn's Disease as defined by a Crohn's disease activity index between 150-450, with fecal calprotectin\>250, within 1 month of enrollment.

Exclusion Criteria:

* Unable to provide informed consent
* History of or current drug abuse
* Pregnancy
* Start or change in dose of standard-of-care treatment within 12 weeks of the screening
* Known allergy to any component of the proposed diet
* Subjects with significant other medical or psychiatric comorbidities and /or medication use which in
* physician's clinical judgment might difficult the interpretation of the results
* Patients that are not on a stable dose of medications, for instance, steroids, in between samples collection
* Patients on antibiotics
* Patients with C difficile infection within 4 weeks of enrollment

Primary outcomes:
measure: short Crohn's Disease Activity Index (sCDAI)
timeFrame: 42 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT06134700: Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy
Official title: Low Pressure Versus Standard Pressure Pneumoperitoneum in Laparoscopic Nephrectomy: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Functioning Kidney
Renal Cell Carcinoma
Lead sponsor: Institute of medicine, Maharagjung medical campus
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Laparoscopic nephrectomies are commonly performed these days and are considered gold standard for both benign and malignant diseases as well as for donor nephrectomies. Despite being a widely performed surgery worldwide still there are areas of uncertainties due to lack of evidences. One of such area of dilemma is the optimum pressure of pneumoperitoneum. This study aims to identify if lower pressure of pneumoperitoneum is safe during laparoscopic nephrectomies.

This is a hospital based prospective randomized control study. All the patients undergoing laparoscopic nephrectomies at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into low pressure or standard pressure pneumoperitoneum by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety of low pressure pneumoperitoneum


Eligibility criteria: Inclusion Criteria:

* All patients undergoing laparoscopic nephrectomy

Exclusion Criteria:

* Age \<18 years
* History of previous abdominal surgeries
* Laparoscopic donor nephrectomies

Primary outcomes:
measure: To compare the safety of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
timeFrame: 30 days perioperative period
measure: To compare the efficacy of low pressure versus standard pressure pneumoperitoneum in laparoscopic nephrectomy
timeFrame: 30 days perioperative period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04946500: Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)
Official title: Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prosthetic Joint Infection
Staphylococcus
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Prosthetic Joint Infections caused by Staphylococccus treated with Clindamycin

Brief summary: The alternatives to the combination of Fluoroquinolone and Rifampicin in prosthetic joint infections (PJI) caused by staphylococcus are currently unclear. Clindamycin is prescribed as dual therapy in this indication, and provides many advantages. We conducted a multicenter retrospective observational study evaluating the efficacy and safety of Clindamycin in prosthetic joint infections due to staphylococcus between January 2013 and December 2019.


Eligibility criteria: Inclusion Criteria:

* Patients with PJI defined according to the IDSA.
* Infection must be mono-microbial or multi-microbial with Staphylococcus spp sensitive to Clindamycin.
* Infection may be acute or chronic, nosocomial or community-acquired.
* Patient having received a curative treatment with Clindamycin.

Exclusion Criteria:

* Patients with osteitis, osteomyelitis, septic arthritis in native joints, diabetic foot infections, spondylodiscitis, infections in external fixator, surgical site infections following neurosurgical management, bedsores, skin and soft tissue infections.
* Patients with mono-microbial infections other than Staphylococcus, multi-microbial infections including other bacteria than Staphylococcus, suspected Osteoarticular Infection without microbial identification.
* Patients with clindamycin-resistant Staphylococcal PJI, constitutive MLSb phenotype.
* Patients having received suspensive treatment with Clindamycin.
* Patients treated with Clindamycin as last line of treatment for a duration of less than 14 days.
* Patients refusing to participate
* Patients under legal protection (guardianship, curatorship, ..)

Primary outcomes:
measure: Failure of Clindamycine
timeFrame: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
Secondary outcomes:
measure: Safety of Clindamycin
timeFrame: During the treatment and 6 month after
measure: Correlation between failure of Clindamycin and blood level of Clindamycin
timeFrame: within 2 years of the diagnosis (within one year for patients diagnosed in December 2019)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
References:
Clinical trial NCT00193700: Pharmacokinetic Evaluation of Testosterone Gel (1%)
Official title: Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)
Keywords: Hypogonadism
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Unimed Pharmaceuticals
First posted: 2005-09-19
Sex: MALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

* Clinically significant uncontrolled medical condition or psychiatric disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 208
state: Alabama
city: Torrance
country: United States
facility: Site 203
state: California
city: Jacksonville
country: United States
facility: Site 204
state: Florida
city: Kansas City
country: United States
facility: Site 201
state: Missouri
city: Morristown
country: United States
facility: Site 206
state: New Jersey
city: Brooklyn
country: United States
facility: Site 207
state: New York
city: Cincinnati
country: United States
facility: Site 209
state: Ohio
city: Philadelphia
country: United States
facility: Site 202
state: Pennsylvania
city: Seattle
country: United States
facility: Site 205
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT00885300: Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Official title: Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Double Lumen Infection
Hemodialysis
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.

Detailed description: Double lumen infection is one of the causes of morbidity and mortality in hemodialysis patients. Many strategies used to prevent it and one of them is antibiotic lock. Thus we select chronic hemodialysis patients and divided them into 2 groups. One group received cloxacillin and heparin as catheter lock and the second group received only heparin lock.

Eligibility criteria: Inclusion Criteria:

* hemodialysis for 3 months
* at least 2 time dialysis/week

Exclusion Criteria:

* active infection
* acute renal failure

Primary outcomes:
measure: catheter infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University Hemodialysis Center
state: Fars
Study officials:
affiliation: Shiraz nephro-urology research center
name: maryam pakfetart, assistant professor
role: STUDY_CHAIR
References:
citation: Unver S, Atasoyu EM, Evrenkaya TR, Ardic N, Ozyurt M. Risk factors for the infections caused by temporary double-lumen hemodialysis catheters. Arch Med Res. 2006 Apr;37(3):348-52. doi: 10.1016/j.arcmed.2005.07.010.
Clinical trial NCT06472700: Endoscopic Extirpation of Benign Breast Tumors Using a Lateral Chest Wall Incision
Official title: The Feasibility Analysis of Endoscopic Extirpation of Benign Breast Tumors Using Lateral Chest Wall Incision: The Feasibility Analysis of Minimally Invasive Excision for Benign Breast Tumors Via Lateral Chest Wall Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Breast Surgery
Benign Breast Tumors
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 42
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 42
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients diagnosed with benign breast tumors. The demographic characteristics included:

Age: Patients aged 14-42 years old Gender: Female Ethnicity: Diverse ethnic backgrounds, primarily Han Chinese

Inclusion Criteria:

1. Female breast benign tumor patients
2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach.

Exclusion Criteria:

Patients who are unable to comply with follow-up requirements

Sample Size:

A total of 42 patients were included in the study

Geographical Location:

Patients were recruited from Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Brief summary: 1. A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
2. The feasibility of this surgery, key technical points, and potential complications have been analyzed.


Eligibility criteria: Inclusion Criteria:

1. Female breast benign tumor patients
2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach.

Exclusion Criteria:

1. Patients who are unable to comply with follow-up requirements
2. Patients with a history of breast sugery
3. Breast cancer patients

Primary outcomes:
measure: Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection
timeFrame: 1-3 months post-surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02787200: Identification of Time-invariant EEG Signals for Brain-Computer Interface
Official title: Identification of Time-invariant EEG Signals for Brain-Computer Interface
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EEG Data Analysis
Healthy Subjects
Keywords: electroencephalogram (EEG),Human brain,Brain-Computer Interface
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers that understands Mandarin instructions.

Brief summary: This study aims to identify various time-variant and time-invariant components of EEG signals using advanced signal processing techniques, such as machine learning. The investigators' ultimate goal is to develop universal or customised brain-computer interface that are stable across days or even years.


Eligibility criteria: Exclusion criteria:

1. Severe vision disorders which prevent volunteers to recognize instructions on the screen
2. Severe psychiatric disorders
3. Severe sleep disorders which keep volunteers awake for two hours
4. Volunteers with claustrophobia
5. Patients who underwent stroke and brain surgery
6. Patients with neuromuscular diseases

Primary outcomes:
measure: Time invariant components of EEG signals
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Tsung-Ren Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638100: Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation
Official title: Efficacy and Safety of Different Doses of Rivaroxaban in Elderly Chinese Patients With Nonvalvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients aged ≥75 years with nonvalvular atrial fibrillation

Brief summary: From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up.

Detailed description: To explore the appropriate dose of rivaroxaban to prevent stroke in elderly Chinese patients with nonvalvular atrial fibrillation in order to improve the effectiveness and safety of anticoagulation therapy. From January 2023 to December 2025, 300 elderly patients with nonvalvular atrial fibrillation in Drum Tower Hospital Affiliated to Medical Scholl of Nanjing University will be enrolled to compare the efficacy and safety of rivaroxaban-H, rivaroxaban-M and rivaroxaban-L dose in elderly patients after 24-month follow-up. The efficacy indexes include stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack and myocardial infarction, and the safety indexes include major bleeding, non-major clinically relevant bleeding, minor bleeding events.

Eligibility criteria: Inclusion Criteria:

* Age≥75 years
* Chinese patient: male or female
* Patients had to be diagnosed as nonvalvular atrial fibrillation (NVAF)

Exclusion Criteria:

* Patients with anemia (hemoglobin\<100g/L), known human immunodeficiency virus infection, female patients who were pregnant or lactating and patients for whom warfarin was contraindicated, were also excluded
* Patients with calculated creatine clearance vulue\<30ml/min
* Patients expected to chronically use a non-steroidal anti-inflammatory agent (except for external preparations) and those treated with a strong cytochrome P4503A4 inhibitor (eg, ketoconazole, clarithromycin, or protease inhibitors) or a strong cytochrome P450 3A4 inducer (eg, rifampicin) during the trial

Primary outcomes:
measure: incidence of stroke, non-CNS systemic embolism, fatal stroke, transient ischemic attack,myocardial infarction
timeFrame: January 2023-December 2025
measure: incidence of major bleeding, non-major clinically relevant bleeding, minor bleeding events
timeFrame: January 2023-December 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00881400: To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb Company (Cefzil) 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose In Healthy Adults Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antibiotic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 24
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: To demonstrate the relative bioavailability of Cefzil 250 mg/5 ml oral suspension 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: Magdy L. Shenouda, M.D.
role: PRINCIPAL_INVESTIGATOR
References: