louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01956682: Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Official title: Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Regurgitation, Gastric
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 132
Sex: ALL
Minimum age (years): 5
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.

Detailed description: The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.

Eligibility criteria: Inclusion Criteria:

* Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
* Age of infant between 5 days and 5 months
* NGA
* Infant exclusively formula-fed at enrollment
* Presenting regurgitation/spitting-up according to the parents' perception
* Vandenplas score of at least 2 and maximum 5
* Having obtained the subject's legal representative's written informed consent

Exclusion Criteria:

* Previous antireflux treatment
* Previous consumption of AR infant formula or external thickener
* Previous consumption of a formula with L. reuteri
* Cow's milk allergy symptoms according to medical decision
* Congenital illness or malformation that may affect growth
* Significant pre-natal and/or post-natal disease
* Newborn whose parents / caregivers cannot be expected to comply with study procedures
* Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Primary outcomes:
measure: Regurgitation
timeFrame: four weeks of treatment
Secondary outcomes:
measure: Growth
timeFrame: Four weeks of treatment
measure: Regurgitation score
timeFrame: Four weeks treatment
measure: Gastric empty rate
timeFrame: Four week treatment
measure: Digestive tolerance
timeFrame: Four weeks treatment
measure: Stool frequency
timeFrame: Four weeks treatment
measure: compliance
timeFrame: four weeks intervention
measure: Financial and non-financial burden
timeFrame: Four week treatment
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Ospedale Pediatrico Giovanni XXIII
state: BA
Study officials:
affiliation: University of Bari
name: Flavia Indrio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859482: Differential Immune Effects of Natalizumab
Official title: A Phase IV Study to Investigate Differential Immune Effects of Natalizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing Remitting
Keywords: natalizumab
multiple sclerosis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients initiating natalizumab for treatment of relapsing remitting MS

Brief summary: Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

Detailed description: Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs).

Eligibility criteria: Inclusion Criteria:

* relapsing remitting MS
* indication for natalizumab treatment

Exclusion Criteria:

* other disease modifying agents within 2 weeks

Primary outcomes:
measure: Function of T regulatory cells
timeFrame: at month 3
Secondary outcomes:
measure: Change in distinct immune cell lines
timeFrame: month 3
Other outcomes:
Locations:
Study officials:
affiliation: KSSG, 9007 St. Gallen, Switzerland
name: Norman Putzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622882: Early Infectious Disease Consultations in Staphylococcus Aureus Bacteremia
Official title: Early Infectious Disease Consultation for Better Outcomes From Staphylococcus Aureus Bacteremia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Staphylococcus Aureus Bacteremia
Keywords: Staphylococcus aureus
Bacteremia
Outcome
Mortality
Recurrence
Infectious Diseases specialists
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective is to determine if early infectious disease (ID) consultation (defined as within 48 hours of a positive blood culture) will reduce mortality rates from Staphylococcus aureus bacteremia (SAB). This study will also determine if such consultations could reduce the duration of hospitalisation, recurrence and financial costs in patients with this infection.

Detailed description: Bacteremia is a serious manifestation of Staphylococcus aureus infection with an attributable mortality as high as 25% in MRSA bacteremia. More than a third of patients end up with complications such as endocarditis, osteomyelitis or pneumonia.

Overall the outcome of patients with respect to mortality or recurrence is better in patients who have an eradicable focus and have received an appropriate antibiotic dose and duration. Also complicated bacteremia is more common in patients with

* persistent bacteremia or fever
* prosthetic device
* new murmur
* skin findings of a systemic infection

Based on this evidence, an ID consultation could improve the outcomes of patients with SAB by

* Advising adequate antibiotic dosage and duration
* Sourcing out and counselling eradication of any focus of infection

Eligibility criteria: Inclusion Criteria:

* All inpatients at the National University Hospital with Staphylococcus aureus (both methicillin sensitive and methicillin resistant) bacteremia isolated within the defined time period

Exclusion Criteria:

* Patients who died or were discharged before the notification from the laboratory
* Neonates
* Polymicrobial bacteremia

Primary outcomes:
measure: mortality
timeFrame: 1 year
Secondary outcomes:
measure: recurrence
timeFrame: 2 year
measure: duration of hospitalisation
timeFrame: 1 year
measure: financial costs of hospitalisation
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University of Singapore
name: Paul A Tambyah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03737682: Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study.
Official title: Hemostasis Achievement Reflecting Inflammatory Status of the Pulp Based on Cytokine Levels: A Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 41
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * primary teeth with carious pulp exposures during caries removal will be included in the study.
* primary molars with the presence of exudate, purulence or necrotic pulp tissue around the exposure site will be excluded

Brief summary: Assessment of pulp inflammation by hemostasis achievement after pulp exposure

Detailed description: The possibility has been raised of diagnosing pulpal pathological status using the cytokines that are released during the inflammation process in healthy as well as infected tooth pulp. Cytokines are small polypeptides secreted by leucocytes and other inflammatory cells and are known to play important roles in the intensity and duration of the immune response

Eligibility criteria: Inclusion Criteria:

1. healthy children
2. patients had not used any inflammatory medications
3. primary molar teeth of these children were included based on the following clinical and radiographic criteria:

   1. no clinical symptoms or evidence of pulp degeneration (pain on percussion, history of swelling or sinus tract
   2. no spontaneous pain
   3. no radiographic signs of internal or external resorption, widened periodontal ligament space, or furcal/periapical radiolucency
   4. physiological root resorption of no more than one third the root length
   5. a deep caries lesion with a likelihood of pulp exposure during caries removal

Exclusion Criteria:

* patients used any anti-inflammatory medication

Primary outcomes:
measure: Measuring interleukin 2 (IL-2)
timeFrame: After 5 minutes
Secondary outcomes:
measure: Measuring interleukin 6 (IL-6) and interleukin 8 (IL-8)
timeFrame: After 5 minutes
measure: Postoperative pain, Bifurcation/periapical radiolucency and Internal/external root resorption Or other pathological changes
timeFrame: 3,6,9,12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT05105282: Comparison of Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block
Official title: Comparison of the Effects of Ultrasound-Guided Deep Serratus Anterior Plane Block and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Serratus Anterior Plane Block
Thoracic Surgery, Video-Assisted
Keywords: Postoperative Pain
Serratus Anterior Plane Block
Video-Assisted Thoracic Surgery
VATS
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB) and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, in this study, the analgesic efficacy of two different methods, DSAPB and SSAPB, will be compared.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* American Society of Anesthesiologists physical status I-II-III
* Body mass index between 18-30 kg/m2
* Patients undergoing elective video assiste thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* History of chronic analgesic therapy
* History of local anesthetic allergy
* Infection in the intervention area
* Patients with bleeding disorders
* Emergency surgery

Primary outcomes:
measure: Pain Scores
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT02776982: Influence of Central Obesity on the Esophageal Epithelial Barrier
Official title: Influence of Central Obesity on the Esophageal Epithelial Barrier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
GERD
Keywords: Gastroesophageal reflux disease
GERD
Barrett's Esophagus
Esophageal adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to help understand why some people with an increased amount of central obesity, without gastroesophageal reflux, develop changes to the lining of their esophagus that can potentially lead to esophageal adenocarcinoma (cancer).


Eligibility criteria: Inclusion Criteria:

Participants who are undergoing clinically indicated upper endoscopy with Bravo ambulatory pH capsule (off reflux medications for 7 days), in the Esophageal Clinic at Mayo Clinic.

Exclusion Criteria:

1. Pre-existing or suspected Barrett's Esophagus (\> 1cm of columnar mucosa in esophagus on endoscopy
2. Oral anticoagulation precluding endoscopic biopsies
3. Patients with known hypersensitivity to fluorescein sodium.

Primary outcomes:
measure: Compare intercellular space dilation as a marker for apical junction complex integrity in esophageal squamous epithelium by using transmission electron microscopy in those patients with/without gastroesophageal reflux and with/without central obesity.
timeFrame: One year
Secondary outcomes:
measure: Compare paracellular permeability of esophageal squamous epithelium by measuring mucosal impedance and IV fluorescein leak using a confocal laser endomicroscope in those patients with/without gastroesophageal reflux and with/without central obesity.
timeFrame: One year
measure: Compare the prostaglandin E2 level as measured by enzyme immunoassay in esophageal squamous epithelium in those patients with/without gastroesophageal reflux and with/without central obesity.
timeFrame: One year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Prasad G Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbens YY, Lansing R, Johnson ML, Blevins CH, Katzka DA, Iyer PG. Effects of Central Obesity on Esophageal Epithelial Barrier Function. Am J Gastroenterol. 2021 Jul 1;116(7):1537-1541. doi: 10.14309/ajg.0000000000001196.
Clinical trial NCT03064282: Prostatic Hyperplasia Treatment and Cancer Prevention
Official title: Treatment of Prostatic Hyperplasia With Topical Papaverine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostatic Hyperplasia
Lead sponsor: Manchanda Medical Clinic
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of patients with prostatic hyperplasia with topical papaverine.

Detailed description: Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Eligibility criteria: Inclusion Criteria:

* patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA

Exclusion Criteria:

* patients on chemotherapy
* abnormal lab values e.g. liver function, GFR and CAD

Primary outcomes:
measure: Laboratory tests to measure regression of symptoms
timeFrame: every 4 weeks up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.
Clinical trial NCT01317082: Use of the Pressure Right Device After Laparoscopic Surgery
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Nausea
Vomiting
Keywords: Postoperative Nausea & Vomiting.
Lead sponsor: Therapeutics: 101 Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: The primary objective is to test the hypothesis that the use of the Pressure Right device in combination with ondansetron and dexamethasone would result in a lower incidence of postoperative vomiting (emesis) than the combination of antiemetic therapy alone.

Detailed description: The study design is a randomized, double-blinded and sham-controlled evaluation of the adjunctive Acupressure on the P6 point with Pressure Right to reduce the incidence of PONV and the need for rescue antiemetics leading to an improve quality of recovery after laparoscopic and ENT surgery. The two proposed study groups are: Group 1 (Sham-Control) 50 patients, will receive the sham Pressure Right (without acupressure button)30-45 min before induction of anesthesia and will be kept in place for 24h after discharge, and Group 2 (Pressure Right) 50 patients, will receive the Pressure Right device 30-45 min before induction of anesthesia and will be kept in place for 24h after discharge. In addition, all 100 study patients will receive a combination of antiemetics (ondansetron and dexamethasone) during the surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo major laparoscopic and ENT surgery procedures under genertal anesthesia.
* ASA Class I-III adults of either sex
* Willingness and ability to sign an informed consent document.

Exclusion Criteria:

* Patients with known allergy, hypersensitivity or contraindications to 5-HT3 antagonist.
* Patients experienced vomiting or retching within 24 h before surgery.
* Patients with clinically-significant medical conditions.
* Pregnant and lactating women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00867282: A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing females.
* A positive urine drug screen.

Primary outcomes:
measure: Plasma pharmacokinetic parameters: AUClast & Cmax.
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04755582: SMARTHEART Validation Study
Official title: SMARTHEART Validation Study. A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: wearable ecg
electrocardiogram
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from cardiology wards across the University Hospitals of Leicester trust.

Brief summary: To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

Detailed description: Assess the effect of the following on the accuracy of the recorded ECG compared to a gold standard ECG:

* Posture or position of the patient
* Movement
* Amount of hair on the ECG site
* Skin condition (tone/dryness) Ability to detect a paced rhythm accurately A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Must have an adequate understanding of written and spoken English
* Able (in the Investigators opinion) and willing to comply with study requirements.
* Must be over 18 years of age
* Must be deemed clinically stable by their direct care team.

Exclusion Criteria:

* Subjects who do not have an adequate understanding of written and spoken English
* Patients who are medically unstable, as defined by the patient's direct care team.
* Patients who are unable to give informed consent
* Patients who are deemed clinically unstable by their direct care team

Primary outcomes:
measure: Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices
timeFrame: 2 hours
Secondary outcomes:
measure: Assessing the effects on the ECG of: - Posture or position of the patient
timeFrame: 2 hours
measure: Assessing the effects on the ECG of: • Movement
timeFrame: 2 hours
measure: Assessing the effects on the ECG of: • Amount of hair on the ECG site
timeFrame: 12 months
measure: Assessing the effects on the ECG of: • Skin condition (tone/dryness)
timeFrame: 12 months
measure: Ability to detect a paced rhythm accurately.
timeFrame: 2 hours
measure: A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device.
timeFrame: 12 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital, University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: G. Andre Ng
role: PRINCIPAL_INVESTIGATOR
References: