louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04022096: Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Official title: A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healed Erosive Esophagitis
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-16
Enrollment: 351
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

Detailed description: This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Eligibility criteria: Inclusion Criteria:

1. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
2. Healed erosive esophagitis within 7 days prior to Randomization
3. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy
2. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
3. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
4. History of acid-suppressive, esophageal or gastric surgeries

Primary outcomes:
measure: Endoscopic remission rate of EE at 24-week
timeFrame: 24-week
Secondary outcomes:
measure: Endoscopic remission rate of EE at 12-week
timeFrame: 12-week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University Seoul Hospital
name: Oh Young Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00752596: Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
Official title: Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Congestive Heart Failure
Keywords: patients
with ICD
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 1
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.


Eligibility criteria: Inclusion Criteria:

* No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy

Exclusion Criteria:

* Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
* Is unwilling or unable to give or understand informed consent.

Primary outcomes:
measure: There was no outcome measure in this compassionate use
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
Study officials:
affiliation: Procter and Gamble
name: Stephen R Marcello, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00293696: Casodex/Zoladex Biomarkers in Localised Prostate Cancer
Official title: A Randomised Pilot Study to Evaluate the Effect(s) of Casodex 150 mg and Zoladex 3.6 mg on Pathological and Genomic Tumour Markers in Subjects Undergoing Radical Prostatectomy for Localised Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: biomarker study
Patients with clinically localised prostate cancer
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2006-02-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed localised prostate biopsy specimen that contains sufficient tumour for evaluation of cell proliferation and apoptosis markers
2. Patients who are scheduled for radical prostatectomy with curative intents

Primary outcomes:
measure: Proliferation by Ki67,
measure: apoptosis marker (TUNEL assay),
measure: Gleason score
Secondary outcomes:
measure: expression of known androgen-regulated genes,
measure: biomarkers of apoptotic pathway,
measure: (novel) genomic transcripts
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: TUCH
Study officials:
affiliation: Tampere University Hospital
name: Teuvo L Tammela, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800796: Transfer of Standard Operating Procedures in Anesthesiology
Official title: Evaluation From Didactic and Structural Transfer of Standard Operating Procedures in Anesthesiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesia physicians who participating in a Scenario training

Brief summary: Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.

Detailed description: The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.

Eligibility criteria: Inclusion:

* anesthesia residents
* anesthesia consultants

Exclusion:

* nurses
* students

Primary outcomes:
measure: Rate of SOP deviations
timeFrame: 12 minutes after start scenario
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University JG, Mainz
name: Marc Kriege, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06226896: Effects of Dapagliflozin on Progression of Alport Syndrome
Official title: Effects of Dapagliflozin on Progression of Alport Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alport Syndrome
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 222
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Alport syndrome who are at risk for kidney disease progression

Brief summary: Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.


Eligibility criteria: Inclusion Criteria:

* Histologic or genetic confirmation of Alport syndrome;
* eGFR ≥ 30 ml/min/1.72m2;
* Proteinuria \> 0.5 g/24 h;
* Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;

Exclusion Criteria:

* Concurrence of other types of kidney disease;
* type 1 or type 2 diabetes;
* use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs;
* ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists;
* Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening);
* Patients undergoing renal transplantation or maintenance dialysis treatment;
* Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases;
* Patients who are participating in clinical trials of other drugs;
* Pregnant or lactating women, or patients who do not want to receive contraception.

Primary outcomes:
measure: Change of eGFR
timeFrame: 24 months
Secondary outcomes:
measure: Change of proteinuria
timeFrame: 24 months
measure: Progression of kidney disease
timeFrame: 24 months
Other outcomes:
measure: Change of eGFR in different subgroups
timeFrame: 24 months
measure: Change of proteinuria in different subgroups
timeFrame: 24 months
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: National Clinical Research Center of Kidney Diseases
name: Yu An, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02969096: Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Official title: Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Neoplasms
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.

Detailed description: A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of liver cancer based on histology or the current accepted radiological measures.
* Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
* Life expectancy: Greater than 3 months.
* Patients' liver function is Child-pugh A or B.
* Ability to understand the study protocol and a willingness to sign a written informed consent document.
* Unable to receive operative surgery.

Exclusion Criteria:

* Patients with other primary tumor except liver cancer.
* History of coagulation disorders or anemia.

Primary outcomes:
measure: Rate of complete tumor ablation
timeFrame: Up to 4 weeks post surgery
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 4 weeks post surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Longhua Hospital
name: qing wu, Bachelor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05736796: Effects of Complex Training On Pain and Posture In School Going Children With Heavy Bags Packs
Official title: Effects of Complex Training On Pain and Posture In School Going Children With Heavy Bags Packs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posture Disorders in Children
Keywords: Abnormal posture
Back pain
Improper backs use
Physical exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As the issues of related to heavy bag packs are increasing with every day so the complex training program along with postural training may prove to be an effective protocol in dealing with issues


Eligibility criteria: INCLUSION CRITERIA:

* Children with age between 12 to 15 years.
* Children with normal BMI (5th - 85th percentile).
* Students carrying bags with 15% of body weight.

EXCLUSION CRITERIA:

* Children with any physical disability ( Spinal cord injury, Cerebral palsy, Multiple sclerosis, and Epilepsy)
* Children using single-strap bags.
* One-sided shoulder elevation.
* Children using handbags or trolley bags.

Primary outcomes:
measure: Numeric Pain Rating scale.
timeFrame: 8 weeks
measure: Visual Analog scale
timeFrame: 6weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: EFA school Adalat garha branch
state: Punjab
Study officials:
affiliation: Riphah International University
name: Shabna Ashraf
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125796: Analgesic Use for Pain Relief in Scorpion Sting
Official title: Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scorpion Stings
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In scorpion stings, patients mostly apply with the complaint of pain. Emergency physicians need to relieve this pain quickly.

Detailed description: Aim: In this study, the analgesic efficacy of intravenous (IV) paracetamol, IV dexketoprofen trometamol and topical lidocaine will be compared in patients presenting with pain after scorpion sting.

Methods: This study is a double-blind, randomized, placebo-controlled study conducted in a tertiary emergency department. Adult patients who applied to the study with no systemic findings after scorpion sting and especially with pain will be randomly assigned to one of 4 groups: IV paracetamol, IV dexketoprofen trometamol, topical lidocaine or placebo. In order to determine the intensity of pain, Visual Analog Pain Score (VAS) will be measured at the time of admission to the emergency department, at the 30th minute and at the 60th minute. Afterwards, the VAS score changes between the groups will be compared.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over
* Scorpion sting with pain
* The diagnostic criteria of Grade 1 for Scorpion sting

Exclusion Criteria:

* Patients who denied to give informed consent
* Taking analgesic treatment (ice application or drugs etc.) in the last 6 hours
* Any symptoms and findings of systemic toxicity of scorpion sting
* Pregnant women
* Hemodynamically unstable patients
* Known allergy to drugs of the study
* Patients with renal disease
* The cases that passed more than 6 hours after the bite

Primary outcomes:
measure: Change of the intensity of pain
timeFrame: 30 minutes and 60 minutes after the study drug administered
Secondary outcomes:
measure: Adverse events
timeFrame: 60 minutes after the study drug administered
measure: need to rescue medication
timeFrame: 60 minutes after the study drug administered
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University of Medical Faculty
name: Umut Gülaçtı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01874496: Iron Absorption From GDS Capsules
Official title: Iron Absorption Mechanism From a Slow Release Iron Capsule Using the Gastric Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Slow release iron capsules have been designed based on the gastric delivery system. Iron absorption from those capsules administered with and without meals will be measured using stable iron isotopes.


Eligibility criteria: Inclusion Criteria:

* female,
* age 18-50 years,
* max. body weight 65 kg,
* serum ferritin \< 35µg/l

Exclusion Criteria:

* pregnancy,
* lactation,
* regular intake of medication,
* blood donation or significant blood losses over the past 4 months

Primary outcomes:
measure: fractional iron absorption
timeFrame: 2, 4, 6, and 8 weeks
Secondary outcomes:
measure: serum isotope appearance
timeFrame: day 1, 15, 29 and 33
Other outcomes:
measure: Serum non transferrin bound iron
timeFrame: day 1, 15, 29 and 33
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
References:
Clinical trial NCT02742896: Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
Official title: Evaluation for Restoration of Erectile Dysfunction After Cardioversion Treatment Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
cognitive function
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to rhythm control of persistent atrial fibrillation.

Brief summary: Erectile and Cognitive function by using the questionnaire and assessment form before sinus conversion

Detailed description: Sinus conversion by electrical cardioversion increase cardiac output and systemic perfusion. According to recent reports, maintenance of sinus rhythm increase systemic perfusion which leads to improve renal function. Therefore, we hypothesized that sinus conversion of patients with atrial fibrillation will increase systemic perfusion which might improve the erectile dysfunction and cognitive dysfunction.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to electrical cardioversion

Exclusion Criteria:

* Patients have taken any medication for erectile dysfunction or who have got any operation already or are scheduled to do.
* More than moderate degree of cognitive dysfunction

Primary outcomes:
measure: The changes of erectile function
timeFrame: Erectile dysfunction 1 year after conversion to sinus rhythm.
Secondary outcomes:
measure: The changes of cognitive function
timeFrame: cognitive dysfunction 1 year after conversion to sinus rhythm
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: Seoul St Mary hospital
name: Yong Seog Oh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01299896: Connect to Quit for Smoking
Official title: Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoking Cessation
Keywords: Cigarette Smoking
Smoking, Tobacco
Tobacco Smoking
Smoking Cessation
Tobacco Dependence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2011-02-18
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care "Connect to Quit (CTQ)" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.

Detailed description: Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older
* Veterans seen by a primary care physician within the VAPHS
* Household income not more than $36,000 annually
* Smoke at least 1 cigarette per day

Exclusion Criteria:

* Smokeless tobacco (snuff or chew) users
* Non-cigarette (e.g., pipe) smokers
* Non-English speaking patients
* Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment

Primary outcomes:
measure: Effectiveness of CTQ vs UC
timeFrame: Two (2) year period
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
Study officials:
affiliation: Vanderbilt University
name: Hilary A. Tindle, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: