louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03008876: IV Acetaminophen and Patent Ductus Arteriosus
Official title: The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: neonate
acetaminophen
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.


Eligibility criteria: Inclusion Criteria:

* preterm infants 23-30 weeks gestation,
* PDA requiring treatment

Exclusion Criteria:

* infection,
* congenital heart disease,
* genetic syndrome,
* NEC,
* pulmonary hypertension,
* hydrops,
* intestinal perforation,
* grade 3 or 4 IVH,
* serum creatinine \>1.5,
* previous treatment with a COX inhibitor.

Primary outcomes:
measure: Rate of PDA Closure
timeFrame: 3 days
Secondary outcomes:
measure: Change in PDA size
timeFrame: 3 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Neonatal Intesive Care Unit
state: New York
Study officials:
References:
Clinical trial NCT02614976: Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding
Official title: Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 273
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.

Detailed description: Objective Primary Outcome : incidences of skin crease or petichiae after noninvasive blood pressure measurement ievery 5 minutes for 1 hour Secondary Outcome : factor related truma after noninvasive blood pressure measurement.

Eligibility criteria: Inclusion Criteria:

* Health volunteer age \> 18 or patients

Exclusion Criteria:

* Peripheral vascular disease
* Difference of blood pressure both arms \> 15 mmHg
* Acute dermal cappillary rupture
* Phlebitis
* Skin necrosis
* Acute radial nerve injury
* Deep vein thrombosis
* Rumpel-Leede phenomenon
* Compartment syndrome

Primary outcomes:
measure: Complication of a non-invasive blood pressure cuff
timeFrame: 5 minutes after completion of non-invasive blood pressure measuring
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Mingkwan Wongyingsinn, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290376: Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture
Official title: Clinical Evaluation of RTX Locator Attachments for Implant-supported Mandibular Complete Overdenture Using Two Loading Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertical Alveolar Bone Loss
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTX locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol.
Primary purpose: TREATMENT

Brief summary: This study was conducted to clinically and radiographically evaluate locator RTx attachments for two implant-supported mandibular overdenture using two loading protocols

Detailed description: Thirty edentulous patients received two implants in the interformaninal region in the canine area . According to the loading protocol used for attaching mandibular overdenture, patients were randomly assigned into two equal groups. Group I (control): patients who would be delivered mandibular implant overdenture retained by two RTx locator attachments using conventional loading protocol. Group II (study): patients who would be delivered mandibular overdenture retained by two RTx locator attachments using early loading protocol. Peri-implant tissue health \[Plaque (PL) and (GI) gingival scores, pocket depth (PD), and crestal bone loss (CBL)\] were evaluated immediately after denture insertion (T0), 6 (T6), and 12 (T12) months after insertion.

Eligibility criteria: Inclusion Criteria:

* adequate bone quantity \[class III -V according to Cawood and Howell in the interforaminal area of the mandible to receive 2 implants (4×13 mm)
* adequate restorative space \[12-15 mm from the mucosa of the mandibular ridge to the occlusal plane, Class I according to Ahuja and Cagna for RTX supported implant overdenture.

Exclusion Criteria:

* systemic diseases that contraindicate implant placement
* bone metabolic diseases as diabetes mellitus
* irradiation of the head and neck region
* chemotherapy within the past 3 years
* smoking habits.

Primary outcomes:
measure: Marginal bone loss
timeFrame: one year
measure: plaque score
timeFrame: one year
measure: gingival index
timeFrame: one year
measure: pocket depth
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Christine Ibrahim
Study officials:
References:
Clinical trial NCT02247427: Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders
Official title: Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiomyopathy
Keywords: Heart failure
Super responder
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.


Eligibility criteria: Inclusion Criteria:

* super response to Cardiac Resynchronization Therapy
* near normal Left ventricular ejection fraction
* \>99% pacing

Exclusion Criteria:

* \<99% pacing
* atrial fibrillation
* ischemic cardiomyopathy

Primary outcomes:
measure: Clinical/Echocardiographic outcome
timeFrame: 12 months
Secondary outcomes:
measure: Mortality
timeFrame: 12 months
measure: Heart failure hospitalization
timeFrame: 12 months
measure: Cardiac Resynchronization Therapy Device intervention
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Yuksek Ihtisas Hospital
name: Serkan Cay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04207827: mHealth Intervention to Prevent Postpartum Smoking Relapse
Official title: An mHealth Intervention to Prevent Smoking Relapse After Pregnancy (RESPREMO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Pregnancy Related
Keywords: mHealth
smoking
postpartum
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project aims to develop an adapted and enhanced mHealth couple intervention to prevent post-partum smoking relapse.

Detailed description: The main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. So, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mHealth intervention. The scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the iCoach mobile application for the prevention of smoking uptake after birth. 2) The cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) The iCoach app intervention is enhanced with SMS-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* gave up smoking 6 months before or during pregnancy
* owns a smartphone
* has a stable partner/husband
* offers the partner's contact data
* signs the informed consent
* CO level (ppm) below 4

Exclusion Criteria:

* younger than 18 years
* smoker
* does not own a smartphone
* does not have a stable partner/husband
* refuses to offer the partner's contact data
* refuses to sign the informed consent
* refuses the CO level measurement or the CO level (ppm) is above 4

Primary outcomes:
measure: Seven-day point prevalence abstinence (PPA)
timeFrame: At 3 months post-birth
measure: Prolonged abstinence (PA)
timeFrame: At 3 months post-birth
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
affiliation: Babes-Bolyai University
name: Cristian I Meghea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612827: Development of Tumor Organoids from Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions
Official title: Development of Tumor Organoids from Undifferentiated Primary Carcinomas to Guide Therapeutic Decisions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Undifferentiated Carcinoma
Keywords: tumoroid
organoid
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with undifferentiated primary carcinoma (UPC) with indication for 1st-line treatment

Brief summary: The study is based on the constitution of a collection of tumor and blood samples for the development of tumoroid for functional tests to predict clinical response to treatment.


Eligibility criteria: Inclusion Criteria:

* Patient with undifferentiated primary carcinoma (UPC) with histological and immunohistochemical evidence, validated in a local and/or national UPC multidisciplinary consultation
* Patient with indication for 1st-line treatment at the time of inclusion.
* Patient with life expectancy greater than 3 months
* Patient of legal age
* Patient affiliated to a social security scheme
* Signature of informed consent prior to any specific study procedure

Exclusion Criteria:

* Persons deprived of their liberty or under guardianship (including curatorship)
* Pregnant or breast-feeding patient

Primary outcomes:
measure: Rate of establishment of exploitable tumor organoids
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT01496027: Cerebral Tissue Oxygenation Values in Newborns Measured Using Laser and LED NIRS Oximeters
Official title: A Comparison of Cerebral Tissue Oxygenation Values in Newborns Measured Simultaneously Using Laser and LED NIRS Oximeters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Oxygenation
Keywords: cerebral oxygenation
NIRS
tissue oximeters
near infrared spectroscopy
newborn
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically stable, spontaneously breathing newborns will be included in the study. Enrolled patients will be divided into two groups: 15 term (≥37 weeks GA) and 15 preterm (32-37 weeks GA) newborns. NIRS measurements will be performed on the 1st and 3rd day of life.

Brief summary: The aim of the study is to compare the values of cerebral tissue oxygenation measured simultaneously using laser light (FORE-SIGHT) and LED (INVOS) cerebral oximeters.


Eligibility criteria: Inclusion Criteria:

* Clinically stable
* Spontaneously breathing newborns

Exclusion Criteria:

* Congenital heart defects or anomalies of central nervous system
* Prematurity below 32 GA
* Respiratory distress

Primary outcomes:
measure: Comparison of variability and repeatability of the recorded cerebral tissue oxygenation signals between two groups of patients (clinical stable preterm and term newborns)
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Katedra Neonatologii
state: Wielkopolskie
Study officials:
References:
citation: MacLeod D; Ikeda K; Vacchiano C Simultaneous Comparison of FORE-SIGHT and INVOS Cerebral Oximeters to Jugular Bulb and Arterial Co-Oximetry Measurements in Healthy Volunteers ANESTH ANALG 2009; 108(SCA Suppl);1-104
Clinical trial NCT06286527: Quality of Sexual Life of PrEP Users
Official title: Quality of Sexual Life of PrEP Users
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Pre-exposure Prophylaxis Use
Adult
Keywords: PrEP (HIV pre-exposure prophylaxis)
quality of life
sexual life
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: current PrEP users in sexual health centers or other PrEP facilities

Brief summary: The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.

PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life.

Detailed description: PrEP aims to protect against HIV; more broadly, PrEP is a holistic process, addressing vaccination (hepatitis A, hepatitis B, human papillomavirus, MPox), sexually transmitted infection diagnosis, mental health, issues related to psychoactive substance use, etc.

This process is likely to impact not only "classical" health areas, but also fields concerning more widely the quality of life.

In particular, the investigators emit the hypothesis that PrEP is associated with an increase of the quality of sexual life.

the investigators have therefore designed a study based on a self-administered anonymous questionnaire to explore how PrEP user evaluate their quality of sexual life and how they perceive the impact of PrEP on this topic.

Adult PrEP users will be recruited through billboard in sexual health center or another PrEP facility in France. A QR (quick response) code will be displayed, giving access to the questionnaire.

Participation to the study is limited to fill once the questionnaire.

Eligibility criteria: Inclusion Criteria:

* current PrEP use
* adult

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: quality of sexual life as assessed by a set of questions
timeFrame: inclusion
measure: perceived influence of PrEP use on the quality of sexual life
timeFrame: inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Olivier EPAULARD
state: Is
Study officials:
References:
Clinical trial NCT01146327: A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
Official title: A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Multiple Dose Study in Overweight Healthy Subjects
body weight
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2010-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.

Primary outcomes:
measure: To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
timeFrame: Day 1 to Day 13
measure: To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.
timeFrame: Day 6 and Day 14
Secondary outcomes:
measure: To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
timeFrame: Baseline to 2 weeks
measure: To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.
timeFrame: Baseline to 2 weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06707727: Characteristics and Prognostic Outcomes of Diaphragmatic Ultrasound in Myasthenia Gravis
Official title: Characteristics and Prognostic Outcomes of Diaphragmatic Ultrasound in Myasthenia Gravis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myasthaenia Gravis
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors; Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins; Repeated electrical stimulation examination showed a decrease in wave amplitude.

Brief summary: The goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. The main question it aims to answer is:

Does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? Participants diagnosed as myasthenia gravis will take the diaphragm ultrasound examinations.


Eligibility criteria: Inclusion Criteria:

* 1: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors

  2: Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins

  3: Repeated electrical stimulation examination showed a decrease in wave amplitude.

Exclusion Criteria:

* 1: Patients with lung disease or heart failure, or a history of non-invasive ventilator or tracheotomy

Primary outcomes:
measure: QMG changes
timeFrame: 6 months
Secondary outcomes:
measure: Changes in medication type or dose
timeFrame: 6 months
measure: respiratory infection
timeFrame: 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05332327: Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Official title: Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Peri-implant Mucositis
Lead sponsor: Malmö University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In 50 patients with a screw-retained prosthetic restoration the peri-implant pocket registration will be recorded with 3 different types of periodontal probes; measurements will be performed in patients for baseline assessment (i.e., before surgical intervention) as well as in patients for annual post-operative controls to include a wide range of shallow, average, and deeper peri-implant pocket depths.

Brief summary: Various types of periodontal probes (e.g., metal probes, plastic/bendable probes, electronic periodontal probes) are used for peri-implant pocket depth registration; however, depending on the shape and size of the prosthetic restoration an accurate peri-implant pocket registration might be impeded with standard metal probes. There is currently no systematic assessment of which probe is more accurate in peri-implant pocket registration. Therefore, peri-implant pocket registration of 50 patients with a screw-retained prosthetic restoration will be recorded with 3 different periodontal probes; i.e., with a metal probe, with a plastic probe, and with an automatic periodontal probe, before and after removal of the prosthetic restoration.


Eligibility criteria: Inclusion Criteria:

* screw-retained prosthetic implant restoration

Exclusion Criteria:

- cemented prosthetic implant restoration

Primary outcomes:
measure: peri-implant probing pocket depth
timeFrame: 1 day (single measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Periodontology, Malmö University
Study officials:
References: