louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04025983: Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
Official title: Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Helicobacter Pylori Infection
Peptic Ulcer
Keywords: Helicobacter pylori
peptic ulcer
Lactobacillus johnsonii
immunoglobin Y
Lead sponsor: Institute of Gastroenterology and Hepatology, Vietnam
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 190
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with gastritis, duodenitis, or peptic ulcer.
* Tested positive with Helicobacter pylori using C13- or C14-urea breath test or urease test.
* Indicated for Helicobacter pylori eradication.

Exclusion Criteria:

* Suspected malignant lesions.
* Children under 10 years of age; pregnant or lactating women.
* Allergic to chicken egg.

Primary outcomes:
measure: Proportion of patients with negative urea breath test after 6-8 weeks
timeFrame: Six to eight weeks after recruitment
Secondary outcomes:
measure: Proportion of patients with clinical improvement after 6-8 weeks
timeFrame: Six to eight weeks after recruitment
measure: Proportion of patients with adverse effects
timeFrame: Six to eight weeks after recruitment
measure: Proportion of patients with improvement of lesions on endoscopy
timeFrame: Six to eight weeks after recruitment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Institute of Gastroenterology and Hepatology
Study officials:
References:
Clinical trial NCT06701383: Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
Official title: Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Medisch Spectrum Twente
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 30
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: Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.


Eligibility criteria: Inclusion Criteria:

- All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines

Exclusion Criteria:

* Persistent, long-standing persistent or permanent AF
* Left atrial diameter \> 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)
* Previous PVI ablation (epicardial or endocardial).

Primary outcomes:
measure: Fluoroscopy time
timeFrame: Procedure time
measure: radiation exposure
timeFrame: Procedure time
measure: Contrast
timeFrame: Amount of contrast during procedure
Secondary outcomes:
measure: Recurrence
timeFrame: one year
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: OV
Study officials:
affiliation: Medisch Spectrum Twente
name: Jurren van Opstal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802683: Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypotension
Keywords: Hypotension
cesarean section
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.


Eligibility criteria: Inclusion Criteria:

* pregnant woman scheduled for elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* patients who refuse involved
* patients who have pre-eclampsia
* patients who have heart disease
* patients who fetal distress is suspicious

Primary outcomes:
measure: Number of hypotension events with treatment related
timeFrame: during 30min after spinal anesthesia
Secondary outcomes:
measure: total dose of phenylephrine
timeFrame: during the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital Seoul, Korea, Republic of
name: Bahk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236183: Evaluation of Learning Curve of Manual Skills in Anesthesia Residents
Official title: Evaluation of Learning Curve of Manual Skills in Anesthesia Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Skill
Laryngeal Mask Airway Insertion Skill
Spinal Anesthesia Skill
Epidural Anesthesia Skill
Radial Artery Cannulation Skill
Internal Jugular Vein Cannulation Skill
Keywords: manual skill
anesthesia residents
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new anesthesia residents

Brief summary: To determine number of cases need to perform in new anesthesia residents to be proficient in manual skills.

Detailed description: Manual skills in anesthesia are complex and unique to learn. The adequate cases need to be done to reach optimal success rate for each procedure is still varied from data available from the publications.

This study is designed to evaluate the number of cases need to perform in new anesthesia residents to be proficient in anesthesia skills, which are intubation, laryngeal mask insertion, spinal anesthesia, epidural anesthesia, radial artery cannulation and internal jugular vein cannulation.

Eligibility criteria: Inclusion Criteria:

* new anesthesia residents

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Kasana Raksamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01485783: Improving Outcomes for Hypertensive Children
Official title: Improving Outcomes for Hypertensive Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 200 children age 6 - \<18 years receiving medications for essential HTN will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit.

Brief summary: Approximately 200 children age 6 - \<18 years receiving medications for essential hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained with the ABPM will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. Kappa statistic will be utilized to compare differences in documented BP control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the ABPM readings. The overall goal is to confirm that ABPM leads to an increased detection of uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive medication regimens.


Eligibility criteria: Inclusion Criteria:

1. Age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit
2. Arm circumference measurement of 15-50 cm (limits of SpaceLabs ABPM cuffs).

Exclusion Criteria:

1. Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study.
2. Secondary HTN from all causes (excluding obesity-related HTN). This includes but is not limited to renovascular HTN, chronic kidney disease, coarctation of the aorta, and monogenic forms of HTN.
3. Physical limitations prohibiting placement of the ABPM monitor.
4. Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Karen Redwine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03307083: Operating Check List During Consultation for Dental Implant
Official title: Operating Check List During Consultation for Dental Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Various studies showed how extent elements not directly linked to the state of the patient were involved in the failures in particular in surgery. That's why it's common to use check list system to avoid human mistakes or any other situation which could impact on the surgery.

Here the study 's aim is to assess a tool set up by the Foundation for Oral Rehabilitation ; it's a check list which cover all the treatment phases concerning dental implant surgery.


Eligibility criteria: Inclusion Criteria:

* patient with dental implant surgery

Exclusion Criteria:

* refusing the participation

Primary outcomes:
measure: number of adverst events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT06986083: A Study of Changes to Prostate Procedures
Official title: A Randomized Controlled Trial of Modifications to Prostate Needle-Based Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Needle-Based Procedures
IV sedation
Local anesthesia
25-085
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 800
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is an ongoing, rolling phase III study. This is a surgical trial. Any agents administered to patients during the trial are part of routine care.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look whether using local anesthesia during a transperineal prostate biopsy, while put to sleep by IV sedation, helps reduce the number of people who feel significant pain in the recovery room. The researchers will also look at how local anesthesia affects the amount of pain medication used, how quickly people can go home after the biopsy, and how well they recover after leaving the hospital.


Eligibility criteria: Inclusion Criteria:

Local anesthesia versus no local anesthesia during transperineal biopsy, while the patient is under IV sedation:

* Patients scheduled for transperineal prostate biopsy at the JRSC.

Standardization of a periprocedural pathway versus usual care for focal gland ablation:

* Patients scheduled for a partial prostate gland ablation procedure at the JRSC.

Exclusion Criteria:

Local anesthesia versus no local anesthesia during transperineal biopsy, while patient is under IV sedation:

* None

Standardization of a periprocedural pathway versus usual care for focal gland ablation:

* None

Primary outcomes:
measure: Change in the proportion of patients experiencing significant pain
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonathan Fainberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03017183: Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy
Official title: Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Heinrich-Heine University, Duesseldorf
First posted: 2017-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.

Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.

The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.

Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.


Eligibility criteria: Inclusion criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Informed consent: a signed and dated written informed consent prior to study participation.
2. Type of subject: inpatient
3. Age: subjects of more than 18 years and less than 85 years.
4. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
5. Central lesion has to be accessible by the biopsy techniques under investigation

Exclusion criteria:

Subjects meeting any of the following criteria must not be enrolled in the study:

1. Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
2. Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR\>2, thrombocytopenia \<40/nl)
3. Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
4. Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.

Primary outcomes:
measure: Number of detected mutations
timeFrame: within 7 days after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
state: NRW
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Winfried J Randerath, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358083: Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
Official title: Attitudes Toward Human Papillomavirus and Influenza Vaccination Among Mothers of Early Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Vaccines
Influenza Vaccines
Attitude to Health
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 1165
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine whether messages about 1. relative risk of vaccination vs. other activities and 2. strength of doctor's recommendation influenced parental intention to get own child vaccinated against human papillomavirus (HPV) or Influenza.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Lives in United States
* Mother or female legal guardian of at least one child aged 9-13
* Able to understand English
* For HPV condition: Target child must not have received any doses of HPV vaccine
* For Flu condition: Target child must not have received the flu vaccine during the prior flu season

Exclusion Criteria:

* Under 18 years of age
* Not mother or female legal guardian of at least one child ages 9-13
* Not living in United States
* Not able to understand English and Spanish
* For HPV condition: Target child had already received at least 1 dose of the HPV vaccine
* For Flu condition: Target child received the influenza vaccine during the previous flu season

Primary outcomes:
measure: Willingness to vaccinate child with target vaccine
timeFrame: During survey administration, at approximately 15 minutes into the survey.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Indiana University
name: Gregory D Zimet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279083: Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 147
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: To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description: This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Eligibility criteria: Inclusion Criteria:

* Provide signed, written informed consent
* 18 yeas of age and older
* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
* Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy
* Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 29 days
Secondary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 29 days
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT06199583: Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy
Official title: Diagnostic Value of Shear-Wave Elastography for Patellar Tendinopathy in Female Volleyball and Basketball Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar Tendinopathy
Keywords: Patellar tendinopathy
shear-wave elastography
ultrasound
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 67
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: female athletes between the ages of 17-35 playing professional basketball or volleyball.

Brief summary: To investigate the accuracy of shear-wave elastography (SWE) in diagnosing patellar tendinopathy in female volleyball and basketball players. In addition, we want to compare different parts of the patellar tendon and investigated the effects of different knee angles.


Eligibility criteria: Inclusion Criteria were:

* being a female athlete between the ages of 17-35 playing professional basketball or volleyball and agreeing to participate in the study

Exclusion Criteria were:

* to have a history of partial or full-thickness patellar tendon tear,
* if they received an injection in or around the patellar tendon within the past 12 months,
* undergone patellar tendon graft repair for anterior cruciate ligament, had a ligament or meniscus operation within the past six months,
* have a chronic disease (such as diabetes, heart disease, or rheumatic disease),
* are actively using oral contraceptives,
* have an active infection in the knee or surrounding tissues

Primary outcomes:
measure: Shear-wave elastography
timeFrame: Through study completion, an average of 3 months
measure: Ultrasound
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine Sports Medicine Department
Study officials:
References: