louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03479619: Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Official title: Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Keywords: lancing device
lancet
Lead sponsor: HTL-Strefa S.A.
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Lodz
First posted: 2018-03-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.


Eligibility criteria: Inclusion Criteria:

* patients with diagnosed diabetes type 1 or 2 ,
* aged 18 - 50,
* period of suffering from diabetes \>2 years,
* performing on average 3-8 daily measurements of glycaemia,
* glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.

Exclusion Criteria:

* glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
* previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
* anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
* non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
* patients with signs of dehydration,
* patients who are currently participating in another clinical study,
* currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.

Primary outcomes:
measure: Volume (uL) of blood in the capillary tube
timeFrame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Secondary outcomes:
measure: The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).
timeFrame: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Nzoz Magmed
Study officials:
affiliation: Medical University of Lodz
name: Agnieszka Szadkowska, PhD,Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mianowska B, Mlynarski W, Szadkowska I, Szadkowska A. Evaluation of Three Lancing Devices: What Do Blood Volume and Lancing Pain Depend On? J Diabetes Sci Technol. 2021 Sep;15(5):1076-1083. doi: 10.1177/1932296820949930. Epub 2020 Aug 17.
Clinical trial NCT03123419: Gardasil Administration
Official title: Gardasil Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vaccine Administration Rates
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the Gardasil study is to increase the rates of Gardasil vaccination at a maternal fetal Care Center. This will be done by reminding patients via text to come for follow up vaccine appointments.

Detailed description: Patients will be screened in center for history of Gardasil vaccination. If the patient has not received the vaccination series they will be counseled/educated (standard of care \[SOC }) and offered the vaccine series. If the patient agrees to the vaccination, they will then be offered participation in this study, (consent will be reviewed and signed) and they will receive the first vaccination at this visit, administered according to standard protocol. The patient will then be scheduled for two follow up vaccination appointments. The second vaccination will be given 2 months after the first vaccine and the third will be given 4 months after the second vaccination in accordance with the Gardasil vaccine guidelines. -SOC

The patients will receive a total of two texts during the study entirety. The two texts will be appointment reminders for the second and third vaccination, sent 1 week prior to the next appointment. This is study related.

Data collection Data will be collected using a data collection sheet. The investigators will record date of first vaccine administration and adherence to follow up.vaccinations.

Eligibility criteria: Inclusion criteria

* Patient receiving gynecological or postpartum care at the Maternal Fetal Care Center
* Females age 9-26 years per manufacturer's recommendation
* Having a cell phone that will allow texting
* Willing to accept any texting charges that may occur for receiving the reminder text.

Exclusion criteria

* Allergy to HPV-4 or HPV-9 vaccine
* Prior completion of the HPV-4/9 series,
* Pregnancy
* Patients older than 26 years old

Primary outcomes:
measure: Increase HPV-9 vaccine administration rates
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Sarah Hostetter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01134419: Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
Official title: Implementing a Comprehensive Handoff Program to Improve Pediatric Patient Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety
Resident Workflow
Resident Experience
Keywords: Patient Safety
Medical Errors
Handoff
Sign-out
Resident
Intern
Graduate Medical Education
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Risk Management Foundation
First posted: 2010-06-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for pediatric residents on inpatient units at Children's Hospital Boston - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Detailed description: Following collection of baseline data on two inpatient pediatric wards, teamwork training is to be provided to all pediatric residents. On our primary intervention unit, this will be accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the primary intervention ward as compared with the historical control unit and the concurrent unit that received teamwork training without the computerized tool.

Eligibility criteria: Inclusion Criteria:

* all residents working on study units during study period, except as below

Exclusion Criteria:

* residents on the teamwork only unit who have previously been on the primary intervention unit

Primary outcomes:
measure: Rates of resident-related communication and total medical errors
timeFrame: July 2010
Secondary outcomes:
measure: Rates of total medical errors
timeFrame: July 2010
measure: Minutes residents spend updating the signout; minutes spent in direct patient care; minutes spent working at computer
timeFrame: July 2010
measure: Resident reported experience of care
timeFrame: July 2010
measure: Rates of verbal miscommunications
timeFrame: July 2010
measure: Rates of written miscommunications
timeFrame: July 2010
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher P Landrigan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063219: Study Evaluating MAC-321 in Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
Official title: A Phase 2, Open-label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Non-small Cell Lung Cancer Refractory to Platinum-based Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Keywords: Non-Small-Cell Lung Carcinoma
Lung Cancer
Cancer of Lung
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-06-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This non-randomized, open-label clinical trial is designed to determine safety and clinical activity of a new chemotherapeutic agent, MAC-321, when given intravenously to patients with non-small cell lung cancer. Clinical activity will be evaluated by determining the percentage of patients with an objective tumor response after treatment with MAC-321. Patients must have been previously treated with a platinum-containing chemotherapy regimen.

A total of 96 patients will be enrolled in this trial. Eligible patients will receive MAC-321 intravenously every 3 weeks for up to a total of 6 courses of treatment. All patients will receive MAC-321 at the same dose. MAC-321 is an experimental drug, and is not offered outside of this research trial.


Eligibility criteria: Inclusion Criteria:

* Recurrence of non-small cell lung cancer after at least 1 prior chemotherapy regimen containing a platinum agent
* Recovery from all acute side effects of prior therapies (with the exception of hair loss)
* Adequate bone marrow, liver, and kidney function

Exclusion Criteria:

* More than 2 prior chemotherapy regimens for treatment of advanced or metastatic non-small cell lung cancer. (Treatment given in conjunction with surgery will not be included in the maximum of 2 prior regimens)
* Radiation therapy, chemotherapy or any other anticancer therapy within 28 days of beginning study
* Symptomatic brain metastases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03761719: The Influence of HDL Function on Cognitive Function
Official title: The Influence of HDL Function on Cognitive Function and Brain Structures in Older People With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Older People With Diabetes Mellitus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 145
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DM patients

Brief summary: Older people with diabetes mellitus are at risk of cognitive decline and dementia. We therefore propose to examine the potential influence of HDL function on global cognitive function and brain structures in older people with DM.


Eligibility criteria: Inclusion Criteria:

Participants with DM

Exclusion Criteria:

Participants refuse blood taking

Primary outcomes:
measure: Neurocognitive test domain scores
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT00284219: High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Smoking
Keywords: rTMS, smoking, dopamine, acotinine
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction.

The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS.

Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.


Eligibility criteria: Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

-

Primary outcomes:
measure: number of cigarettes smoked
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Revital A Amiaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weizmann Institute of Science
name: Abraham Zangen, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02429219: Saline With Alcohol in TransUrethral Resection aNd Photoselective Vaporisation of the Prostate
Official title: Prospective Study of Monitoring the Alcohol Concentration in Breathing Air During Transurethral Prostate Resection of Benign Prostate Hyperplasia (BPH) Assessing the Uptake of Irrigation Fluids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hypertrophy
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transurethral therapy (TURiS / PVP) of benign prostatic hyperplasia (BPH) using an ethanol-containing saline irrigating fluid, prospective detected by breath alcohol measurement.

Detailed description: Aim was to evaluate the amount of absorbed saline irrigation fluid during transurethral therapy of benign prostatic hyperplasia (BPH). We want to differentiate two different methods of the surgical therapy: the TransUrethral Resection in Saline (TURiS) and the Photoselective Vaporisation of the Prostate (PVP). Both methods using saline irrigation. To measure the amount of absorbed saline irrigation fluid, we added pure Ethanol to the Irrigation fluid resulting in am 0,02% ethanol containing saline irrigation fluid. The conventional TransUrethral Resection of the Prostate (TUR) method is using electrolyte free irrigation. In the literature this method is well known for the occurence of the transurethral resection syndrome ("TUR syndrome"). This is caused by absorption of electrolyte-free irrigating fluid, followed by a hyponatraemic hyperhydration, and consists of symptoms from the circulatory and nervous Systems.

Eligibility criteria: Inclusion Criteria:

* Patients in which a TURiS or PVP to be performed

Exclusion Criteria:

* Alcoholics,
* Patients with severe hepatic impairment,
* Epilepsy,
* Existing metabolic acidosis.

Primary outcomes:
measure: last breath alcohol measurement
timeFrame: Every 10 minutes, the breath alcohol is measured to 2 hours after the operation. Of these unnoticed, the intervention (surgery) is carried out until the end. It's all about the detection; the patient's treatment does not change.
Secondary outcomes:
measure: Surgical abortion with significant Absorption of irrigation fluid
timeFrame: Surgery will be last on average 1 hour
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
state: Sachsen-Anhalt
Study officials:
affiliation: Urologic Faculty University Magdeburg
name: Markus Porsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermanns T, Grossmann NC, Wettstein MS, Fankhauser CD, Capol JC, Poyet C, Hefermehl LJ, Zimmermann M, Sulser T, Muller A. Absorption of irrigation fluid occurs frequently during high power 532 nm laser vaporization of the prostate. J Urol. 2015 Jan;193(1):211-6. doi: 10.1016/j.juro.2014.07.117. Epub 2014 Aug 7.
Clinical trial NCT02269319: MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Official title: A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Infections
Keywords: ABSSSI
MRX-I
Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 120
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 purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections


Eligibility criteria: Inclusion Criteria:

* Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
* Prior systemic antibiotics within 96 hours of randomization

Primary outcomes:
measure: Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
timeFrame: 48-72 hours
Secondary outcomes:
measure: Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
timeFrame: Day 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06992219: Impact of Minimally Invasive Non-surgical Periodontal Treatment on Infrabony Defects
Official title: Effects of Minimally Non-surgical Periodontal Treatment Versus Quadrantwise Subgingival Instrumentations on Infrabony Defects and Analysis of Defect Morphology on the Effectiveness of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Intrabony Defect
Keywords: periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI for infrabony defects
Primary purpose: TREATMENT

Brief summary: Fifty-two periodontitis patients (26 per group) were randomly assigned to the test (Minimally invasive non-surgical therapy - MINST) or the control group (Quadrantwise Subgingival Instrumentation - Q-SI) NPT protocols.

Detailed description: Clinical periodontal parameters, the number of pocket sites, x-ray of the infrabony defects characteristics and a composite outcome measure (COM) on the combined assessment of intrabony defect were recorded at baseline, and -3, 6- and at 12-months after treatment

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Periodontitis

Exclusion Criteria:

* Periodontal treatment
* Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
* Pregnancy

Primary outcomes:
measure: Probing Pocket Depth Reduction
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: Università degli Studi di Catania
name: Gaetano Isola, DDS
role: PRINCIPAL_INVESTIGATOR
References: