louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02042066: Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension
Official title: Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Resistant Hypertension
RH
RHT
Blood Pressure
Kidney
Shockwave
Lead sponsor: Medispec
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2014-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.


Eligibility criteria: Inclusion Criteria:

* Subjects who have provided written informed consent.
* Age ≥18 and ≤80 years old.
* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).
* Able and willing to comply with the required follow-up schedule.

Exclusion Criteria:

* Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
* Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.
* Prior renal artery intervention (balloon angioplasty or stenting).
* Pregnancy.
* Uncompensated heart failure.
* Chronic Liver Disease.
* Patients with skin wound / infection at the treatment area.
* Subjects who take oral anti-coagulants.
* Local tumor of treatment area.

Primary outcomes:
measure: Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: 6 Months
measure: Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: 3 Months
Secondary outcomes:
measure: Office Blood Pressure
timeFrame: 6 Months
measure: Serum Urea and Creatinine
timeFrame: 3 Months
measure: Ultrasound
timeFrame: 3 Months
measure: Serum Urea and Creatinine
timeFrame: 6 Months
measure: Adverse Events
timeFrame: 6 Months
measure: Office Blood Pressure
timeFrame: 3 Months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ayelet Shauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01389466: Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
Official title: Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza
Keywords: Avian influenza
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Korean Center for Disease Control and Prevention
First posted: 2011-07-08
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

Detailed description: MG1109 is purified, inactivated influenza viral antigen.

Eligibility criteria: Inclusion Criteria:

* Healthy adults who are available for follow-up during the study

Exclusion Criteria:

* Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
* Subjects with immune system disorder including immune deficiency disease

Primary outcomes:
measure: Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group
timeFrame: 42 days after vaccination
measure: Number of subjects with Solicited / Unsolicited adverse events
timeFrame: With in 24 weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Catholic University Of Korea ST. Vincent's Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376466: Impact of CT on Diagnosis of Acute Appendicitis
Official title: The Impact Of Computed Tomography On The Diagnoses Of Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: acute appendicitis
diagnosis
computed tomography
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Herning Hospital
First posted: 2011-06-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted patients with acute appendicitis.

Brief summary: The purpose of this study is to determine whether computed tomography is reliable investigation in the diagnosis of acute appendicitis.

Detailed description: The aim of this study is to

1. evaluate CT scan validity for the diagnosis of acute appendicitis.
2. compare the difference in evaluation of CT-scan result between radiologist on call and consultant radiologist with CT experience.
3. illustrate difficulties associated with practical implementation of CT-scan in relation to other activities in radiology department and O.R. (logical \& organizational).
4. illustrate patients experiences about the study (pain, discomfort \& other information

Eligibility criteria: Inclusion Criteria:

* Patients who have been admitted and diagnosed as having acute appendicitis

Exclusion Criteria:

* Patients under the age of 18 years.
* Pregnancy.
* Uncooperative patients (senile dementia, mentally ill).
* Not speaking Danish.
* Does not wish to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Herning Hospital
Study officials:
affiliation: Consultant surgeon
name: Mogens R Madsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06831266: Effects of Exercise Prediabetic Individuals
Official title: Comparison of the Effects of High-Intensity Interval Exercise Training and Moderate-Intensity Continuous Exercise Training in Prediabetic Individuals: Single-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes / Type 2 Diabetes
Keywords: exercise
anti-inflammatory markers
aerobic capacity
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effects of two different exercise protocols on body composition, aerobic capacity, blood lipid profile, some biomarkers, quality of life and exercise beliefs in participants at risk of diabetes.

Detailed description: After being informed about the study and possible risks, all participants who gave written informed consent and met the eligibility requirements will be randomly assigned to 2 separate groups.

Eligibility criteria: Inclusion Criteria:

* Being between 18-60 years old
* HbA1c value between 5.7%-6.4%
* BMI\>24,9 kg/m²
* Being sedentary
* Not on any diet

Exclusion Criteria:

* Insulin and derivative drug use
* Uncontrolled hypertension
* History of heart disease
* History of MI or stroke

Primary outcomes:
measure: HbAc
timeFrame: 12 weeks
Secondary outcomes:
measure: HDL
timeFrame: 12 weeks
measure: LDL level LDL
timeFrame: 12 weeks
measure: CRP
timeFrame: 12 weeks
measure: Total cholesterol
timeFrame: 12 weeks
measure: Triglyceride
timeFrame: 12 weeks
measure: Irisin
timeFrame: 12 weeks
measure: Adiponectin
timeFrame: 12 weeks
measure: IL-6
timeFrame: 12 weeks
measure: Resistin
timeFrame: 12 weeks
measure: Kemerin
timeFrame: 12 weeks
measure: Osteocalcin
timeFrame: 12 weeks
measure: Leptin
timeFrame: 12 weeks
measure: TNF-alpha
timeFrame: 12 weeks
measure: Cardiometabolic risk level
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Aerobic capacity
timeFrame: 12 weeks
measure: Exercise Health Belief Model Scale
timeFrame: 12 weeks
measure: Short Form-36 Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: University of Kyrenia Hospital
state: Kyrenia
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Mehtap Malkoç
role: STUDY_DIRECTOR
References:
Clinical trial NCT01303666: Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
Official title: Tidal Irrigation Versus Intra-articular Steroid Injection in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2011-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. The KIVIS study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). At study entry any preference expressed by the patient for each of the treatment interventions was recorded. This study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of knee OA
* Knee pain for most days of the prior month
* Radiographic evidence consistent with knee OA
* Aged between 40 and 90 years old

Exclusion Criteria:

* Symptomatic hip OA
* Co-existent inflammatory or crystal arthritis
* Prior knee surgery
* Injury to the knee in the preceding 6 months
* Any intra-articular injection in the preceding 3 months
* Inability to provide informed consent

Primary outcomes:
measure: WOMAC pain (WP)score
timeFrame: Weeks 0
measure: Visual Analogue Scale
timeFrame: Weeks 0
measure: WOMAC pain (WP)score
timeFrame: Weeks 2
measure: WOMAC pain (WP)score
timeFrame: Weeks 4
measure: WOMAC pain (WP)score
timeFrame: Weeks 12
measure: WOMAC pain (WP)score
timeFrame: Weeks 26
measure: Visual Analogue Scale
timeFrame: Weeks 2
measure: Visual Analogue Scale
timeFrame: Weeks 4
measure: Visual Analogue Scale
timeFrame: Weeks 12
measure: Visual Analogue Scale
timeFrame: Weeks 26
Secondary outcomes:
measure: WOMAC physical function score (WF)
timeFrame: Weeks 0,2,4,12,26
measure: Overall assessment of the impact of the procedure by the patient (five point scale) (PA)
timeFrame: Weeks 0,2,4,12,26
measure: Overall assessment of the impact of the procedure by the blinded clinician (five point scale)(CA)
timeFrame: Weeks 0,2,4,12,26
measure: Time to walk fifty metre
timeFrame: Weeks 0,2,4,12,26
measure: Analgesic intake
timeFrame: Weeks 0,2,4,12,26
measure: Side effects of the procedure
timeFrame: Weeks 0,2,4,12,26
Other outcomes:
Locations:
Study officials:
affiliation: MRC Epidemiology Resource Centre, Southampton General Hospital, Southampton, UK
name: Nigel K Arden
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05149066: #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
Official title: #KindGirlsInACTion: A School-based Intervention to Promote Compassive Competences and Psychological Flexibility in Female Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Eating Disorders
Eating Behavior
Psychological
Emotion Regulation
Body Image
Relations, Interpersonal
Keywords: Intervention Programme
School-based
Adolescence
Girls
Psychological well-being
Compassion
Psychological flexibility
Positive body image
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Joana Marta-Simões
First posted: 2021-12-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The #KindGirlsInACTion project started in 2017 and developed and implemented a psychotherapeutic intervention program in Portuguese female adolescents. This program aimed to improve the overall quality of life and well-being of the participants, and specifically to promote a qualitative improvement in body image and interpersonal relationships, through the promotion of self-compassion, compassion and psychological flexibility. #KindGirlsInACTion is a school-based program, with 9 sessions over 9 weeks. It is essentially practical and interactive, with exercises created specifically for the program, as well as the regular practice of mindfulness.


Eligibility criteria: Inclusion Criteria:

* being a female adolescent;
* being aged between 12 and 18;
* being a part of a classroome with immediate availability to attend the sessions.

Exclusion Criteria:

* Having a clinical condition that could compromise the completion of self-report questionnaires;
* Having a significant score on screening measures administered pre-intervention.

Primary outcomes:
measure: Psychological Well-being
timeFrame: 5 months
measure: Psychological Well-being
timeFrame: 3 months
measure: Psychological Wel--being
timeFrame: Baseline
Secondary outcomes:
measure: Eating Disorders
timeFrame: Baseline
measure: Eating Disorders
timeFrame: 3 months
measure: Eating Disorders
timeFrame: 5 months
measure: Positive body image
timeFrame: Baseline
measure: Positive body image
timeFrame: 3 months
measure: Positive body image
timeFrame: 5 months
measure: Social safeness
timeFrame: Baseline
measure: Social safeness
timeFrame: 3 months
measure: Social safeness
timeFrame: 5 months
measure: Body image shame
timeFrame: Baseline
measure: Body image shame
timeFrame: 3 months
measure: Body image shame
timeFrame: 5 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: CINEICC
Study officials:
References:
Clinical trial NCT03843866: Sutures Versus Glue in Laparoscopic Port Site Closure.
Official title: The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cosmetic Outcome
Infection
Cost
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 200
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: Cosmesis postoperatively is an important consideration for both patients and surgeons and consequently surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds.

Therefore the investigators are using two different close techniques for laparoscopic wounds. These are; 1. sutures with steri-strips and 2. adhesive bond.


Eligibility criteria: Inclusion Criteria:

* Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.

Exclusion Criteria:

* Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.

Primary outcomes:
measure: Cosmesis
timeFrame: 6 months
Secondary outcomes:
measure: Surgical site infection (SSI).
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James Hospital
Study officials:
References:
Clinical trial NCT02344966: Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and During Treatment or Thereafter in Acute Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Leukemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 1100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sampling is performed in patients diagnosed with acute leukemia in Severance Hospital.

Every eligible patients in peroid of study are enrolled. Patients must have the ability and willingness to sign a written informed consent document. Planned number of patients is 1100 considering annual incidence rate.

Brief summary: The objective of this study is to evaluate the prognostic factors of acute leukemia patients and to invent the molecular genetic test for sensitive detection of minimal residual disease, and thereby this study would contribute to plan the risk adapted treatment. Patients will have samples of blood and/or bone marrow collected during diagnosis process, treatment and/or thereafter


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with acute leukemia in Severance Hospital.
* Both genders of 16 Years and older
* sign a written informed consent document

Exclusion Criteria:

* No comprehension or willingness to sign a written informed consent document.

Primary outcomes:
measure: Overall survival
timeFrame: 10years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 10years
measure: Treatment-related mortality
timeFrame: 10years
measure: Complete remission rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06553066: Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
Official title: Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuromuscular Blockade
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery

Exclusion Criteria:

* ASA 4 patients
* Maternal population
* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.
* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.
* Patients with neuromuscular diseases
* Patients who refuse to participate in the study.

Primary outcomes:
measure: impact of a deep neuromuscular blockade on surgical conditions
timeFrame: During surgery
Secondary outcomes:
measure: the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.
timeFrame: in the first six postoperative hours
measure: Postoperative pain
timeFrame: first postoperative day
measure: Mean arterial pressure (mmHg)
timeFrame: intraoperative and in Postanesthesia care unit
measure: PIPcmH20 ( Peak inspiratory pressure)
timeFrame: intraoperative
measure: duration of surgery (hr)
timeFrame: intrapostoperative
measure: The first flatus time (min)
timeFrame: up to 5 days
measure: duration of anesthesia time (min)
timeFrame: intraoperative
measure: Postoperative nausea and vomiting (PONV)
timeFrame: until first postoperative day
measure: Hospitalization time ( days)
timeFrame: up to 2 weeks
measure: cumulative analgetid dose (mg)
timeFrame: until 2 PM the next day of the surgery
measure: oxygen saturation (SpO2) %
timeFrame: intraoperative and in Postanesthesia care unit
measure: tidal volume (ml)
timeFrame: Intraoperative
measure: Pplat cmH20 ( plateau pressure),
timeFrame: Intraoperative
measure: dynamic compliance ml/cmH20,
timeFrame: Intraoperative
measure: DP cmH20( Driving pressure)
timeFrame: Intraoperative
measure: Resistance cmH20/L/sec
timeFrame: Intraoperative
measure: PEEP cmH20
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
References: