louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04479865: Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
Official title: An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 49
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults


Eligibility criteria: Inclusion Criteria:

* Health Voulunterrs (Age : 19\~55 years)
* Body Weight : Male≥55kg, Female≥50kg
* 18.5 ≤BMI≤ 25.0

Exclusion Criteria:

* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
* Heavy alcohol intake (more than 210g/week)
* Heavy smoker (more than 10 cigarettes/day)
* Heavy caffeine intake

Primary outcomes:
measure: AUC
timeFrame: 29-36 days
measure: Css,max
timeFrame: 0-36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Clinical Trial Center
Study officials:
References:
Clinical trial NCT00925665: Intubation of Patients With Odontogenic Abcesses
Official title: Intubation of Patients With Odontogenic Abcesses Glidescope vs. Macintosh Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Odontogenic Abscess
Keywords: Intubation
Glidescope
Macintosh
Abscess
Difficult intubations in patients with odontogenic abscesses
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We want to study patients, who present with a odontogenic abscess for surgical treatment.

Brief summary: This study is a comparison of two techniques for endotracheal intubation (Glidescope versus Macintosh) in patients with odontogenic abscesses.

Detailed description: Patients with odontogenic abcesses have to be treated by surgical drainage of the abscess under general intubation with endotracheal intubation. Because of a limited mouth opening and swelling within the oral cavity, intubation can be difficult and sometimes impossible with conventional direct laryngoscopy. Therefore, alternative techniques are desirable. We want to compare the success rate of intubation in these patients using the Glidescope technique vs. conventional Macintosh technique.

Eligibility criteria: Inclusion Criteria:

* Patients have to have an abscess which has to be treated surgically.
* Mouth opening (Inter-incisor gap) has to be less than 3.5 cm and more than 1.4 cm.

Exclusion Criteria:

* Age under 18 years.

Primary outcomes:
measure: Success rate of endotracheal intubation
timeFrame: 18 months
Secondary outcomes:
measure: Time for intubation
timeFrame: 18 months
measure: View of the laryngeal entrance (according to the classification of Cormack and Lehane)
timeFrame: 18 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
Study officials:
affiliation: Kliniken Essen-Mitte
name: Harald Groeben, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.
Clinical trial NCT01553565: Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyps
Keywords: 10 mm in diameter
antithrombotic agents
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Background: The ideal method to remove small colorectal polyps in patients who are taking antithrombotic agents is unknown.
2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete retrieval rate after the removal by colon snare transection without electrocautery for small polyps in patients who are taking antithrombotic agents.
3. Design: A prospective, consecutive study.
4. Setting: Municipal hospital outpatients.
5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for colorectal polyps up to 10 mm in diameter in patients who continue to take antithrombotic agents. The primary outcome measure was bleeding within two weeks after polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal polyps based on the pathological examination.


Eligibility criteria: Inclusion Criteria:

* Patients with colorectal polyps up to 10 mm in diameter. The patients continue to take antithrombotic agents.

Exclusion Criteria:

* patients are less than 20 years old,
* pregnant,
* American Society of Anesthesiologists class III and IV,
* overweight (body weight \> 100 kg), or
* allergic to propofol used or its components (soybeans or eggs),
* with previous colorectal surgical resection.

Primary outcomes:
measure: Postpolypectomy bleeding
timeFrame: 2 weeks
Secondary outcomes:
measure: Complete retrieval rate of colorectal polyps
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horiuchi A, Nakayama Y, Kajiyama M, Tanaka N, Sano K, Graham DY. Removal of small colorectal polyps in anticoagulated patients: a prospective randomized comparison of cold snare and conventional polypectomy. Gastrointest Endosc. 2014 Mar;79(3):417-23. doi: 10.1016/j.gie.2013.08.040. Epub 2013 Oct 11.
Clinical trial NCT01922765: Concomitant Therapy of H. Pylori
Official title: Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastritis, Gastric Ulcer, and Duodenal Ulcer
Keywords: Helicobacter
Eradication
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Bucheon St. Mary's Hospital
name: St Vincent's Hospital
First posted: 2013-08-14
Enrollment: 540
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.

Detailed description: * Subject: The patient of gastritis, gastric ulcer, and duodenal ulcer infected with Helicobacter pylori
* 170 subjects per group
* Eradication regimens are as follows: AOC group, treated with amoxicillin, rabeprazole, clarithromycin for 7 days; AOM group, treated with amoxicillin, rabeprazole, metronidazole for 7 days; sequential group, treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days; concomitant group, treated with amoxicillin, clarithromycin, metronidazole, rabeprazole for 7 days

Eligibility criteria: Inclusion Criteria:

* patients infected with Helicobacter pylori

Exclusion Criteria:

* cancer
* pregnancy
* formerly treated with eradication

Primary outcomes:
measure: Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori
timeFrame: 6 months (Feb 2014)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
Study officials:
References:
citation: Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, Chung WC, Kim BW, Kim SS. Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol. 2015 Jan 7;21(1):351-9. doi: 10.3748/wjg.v21.i1.351.
Clinical trial NCT05317065: The Effect of Mindfulness-Based Stress Reduction Program (MBSR) in Risky Pregnants
Official title: The Effect of Mindfulness-Based Stress Reduction Program (MBSR) on Stress, Anxiety and Prenatal Attachment in Risky Pregnants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Pregnancy, High Risk
Keywords: prenatal attachment
Anxiety
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 94
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.

Detailed description: Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.

Eligibility criteria: Inclusion Criteria:

risky pregnant women

Exclusion Criteria:

mental disabilities

Primary outcomes:
measure: Prenatal Distress Scale
timeFrame: At the end of the 1 months
measure: Pregnancy-Related Anxiety Scale
timeFrame: At the end of the 1 months
Secondary outcomes:
measure: The Prenatal Attachment Inventory
timeFrame: At the end of the 1 months
Other outcomes:
Locations:
city: Amasya
country: Turkey
facility: Amasya University
Study officials:
References:
Clinical trial NCT04583865: Feasibility and Quality of TeleConsultation in Pediatric Anesthesia
Official title: Assessment of the Feasibility and Quality of the Consultation by TeleConsultation in Pediatric Anesthesia in the Context of the Covid 19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Keywords: Teleconsultation-anesthesia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under the age of 18 requiring an anesthesia consultation for an act requiring anesthesia

Brief summary: Teleconsultation (TLC) being a new method of anesthesia consultation, deployed as an emergency in healthcare facilities in the Covid context, it has never been evaluated either in terms of feasibility or in terms of quality. An initial assessment will highlight the pitfalls and difficulties encountered and suggest areas for improvement.

Detailed description: The evaluation of teleconsultation in pediatric anesthesia, a new consultation method developed in the context of COVID for several weeks, appears necessary and will be a first inventory after its implementation in France. Analysis of the data collected in this study will allow us to propose technical, medical and organizational solutions to optimize the positioning and practical use of TLC for patients and care facilities. This assessment step seems imperative if the Covid context persists over time but could also be useful for the development of TLC outside the Covid context.

Eligibility criteria: Inclusion Criteria:

* All patients under the age of 18 requiring an anesthesia consultation for an act requiring anesthesia
* whose deprogramming in the context of the Covid 19 pandemic would lead to a loss of opportunity for the patient,
* Or whose programming in the context of the Covid 19 pandemic is in accordance with the recommendations made in field of the Professional Practice Recommendations
* And for which the family and the anesthetist have agreed to carry out the consultation by telemedicine

Exclusion Criteria:

* Patient whose anesthesia consultation is performed face-to-face as a first-line decision
* Family refusing teleconsultation

Primary outcomes:
measure: assess the feasibility of teleconsultation (TLC) in pediatric anesthesia in France in the context of the COVID 19 pandemic.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: KERN Delphine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743665: Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome (CVS)
Official title: Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vomiting Syndrome
Keywords: Youth
consensus
criteria
CVS
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2008-08-29
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Youth who meet consensus criteria for CVS as determined by Dr. B. Li and their parents will be recruited from those being seen in the weekly outpatient CVS clinic at Children's Hospital of Wisconsin

Brief summary: The primary aim of this study is to characterize the quality of life of youth with Cyclic Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at risk youth. The impact of CVS on the child's parent and family will also be assessed.

A second aim is to evaluate the associations among coping strategies, personal strengths and vulnerabilities and the frequency and intensity of CVS attacks to determine if particular coping styles and personal characteristics are associated illness severity, psychiatric co-morbidity and quality of life


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CVS

Exclusion Criteria:

* Children and parents who are not English speaking
* Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Sally E Tarbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01501565: Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery
Official title: Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Postoperative pain
Transverse abdominal blockade
Efficacy
Safety
Urology
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.


Eligibility criteria: Inclusion Criteria:

* \> 18 yrs.
* Patients undergo laparoscopic urologic surgery
* Physical status ASA \< 3
* Surgical procedure without complications
* Signed informed consent

Exclusion Criteria:

* Allergy to bupivacaine chlorhydrate
* Patients with chronic pain treatment
* Alcoholism
* Decompensated hepatic disease
* Coagulation disorders
* BMI \> 35
* Patient involved in another clinical trial

Primary outcomes:
measure: Pain level
timeFrame: Change in pain from admittance to 24 hours postoperatively
Secondary outcomes:
measure: Analgesic consumption as a rescue therapy
timeFrame: within 24 postoperative hours
measure: Incidence of postoperative nausea and vomiting (PONV) related to therapy
timeFrame: within 24 postoperative hours
measure: Incidence of urethral/bladder spasm
timeFrame: within 24 postoperative hours
measure: Assessment of oral intake tolerance
timeFrame: within 24 postoperative hours
measure: Patient satisfaction
timeFrame: within 24 postoperative hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació Puigvert
Study officials:
affiliation: Fundació Puigvert (IUNA)
name: Juan Francisco Mayoral, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04143165: Ultrasound Guided Epidural Block in Axial SPA
Official title: Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidural Block in Axial Spondyloarthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Design: A randomized, prospective, pilot, controlled trial. Setting: Rheumatology and rehabilitation department Minia University and Sohag University Objectives: To evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial SPA.

Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip), whereas Group II patients did not receive. Both groups were age and sex matched and both were under treatment with anti TNF and NSAIDs with or without sDMARDs.


Eligibility criteria: Inclusion Criteria:

* all participants fulfilled the ASAS criteria for axial SPA
* all participants under treatment including bDMARDS and sDMARDs beside NSAIDs

Exclusion Criteria:

* Naive patients not under treatment
* limitation of spine flexion due to non inflammatory causes

Primary outcomes:
measure: change in pain
timeFrame: Baseline, after 2 weeks and after 8 weeks
measure: Change in functional ability of the patient
timeFrame: Baseline, after 2 weeks and after 8 weeks
measure: Change in spinal mobility
timeFrame: Baseline, after 2 weeks and after 8 weeks
measure: Change in ASDAS- CRP score
timeFrame: Baseline, after 2 weeks and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
citation: Elsaman AM, Hamed A, Radwan AR. Ultrasound-guided epidural block in axial spondyloarthritis patients with limited spine mobility: a randomized controlled trial. Korean J Pain. 2021 Jan 1;34(1):114-123. doi: 10.3344/kjp.2021.34.1.114.
Clinical trial NCT01606865: Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery
Official title: Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Non-Cardiac Surgery During Dual Antiplatelet Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Bleeding
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2012-05-28
Enrollment: 207
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 taking Clopidogrel, Prasugrel, or Ticagrelor within at least 7 days

Brief summary: The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.


Eligibility criteria: Inclusion Criteria:

* intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
* spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)

Exclusion Criteria:

* concomitant medication with warfarin
* renal insufficiency needing dialysis
* concomitant therapy with GPIIB/IIIA Antagonists
* expected duration of operation \>30min

Primary outcomes:
measure: increased risk of bleeding (according to TIMI definition)
timeFrame: 24hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Anesthesiology and Intensive Care Medicine, Medical University Graz
Study officials:
affiliation: Medical University of Graz
name: Helfried Metzler, Prof. Dr.
role: STUDY_CHAIR
References: