louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03472742: An Follow-Up Study of Liver Cirrhosis
Official title: An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decompensated Liver Cirrhosis
Lead sponsor: Rohto Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Decompensated Liver Cirrhosis

Brief summary: This is a follow-up study to assess safety and preliminary clinical activity of ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already participated in the ADR-001-01 study and completed the last evaluation after 24 weeks of administration will be eligible to this study.

Patients registered will continue follow-up observation and evaluate long-term safety and exploratory efficacy.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis patients enrolled in ADR-001-01 study and completed the last observation of the study
* Voluntary signed informed consent

Exclusion Criteria:

* Patients evaluated by investigators as inappropriate

Primary outcomes:
measure: Number of patients with adverse events (AEs) and serious AEs (SAEs)
timeFrame: Change from Baseline (Day 0) until 80 weeks
Secondary outcomes:
measure: Change of liver function evaluated by Child-Pugh Score
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Improvement rate of Child-Pugh score
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Improvement rate of Child-Pugh grade
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) findings
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal pulse rate findings
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal body temperature findings
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal electrocardiogram (ECG) findings
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal clinical chemistry parameters
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal clinical hematology parameters
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
measure: Number of patients with abnormal urinalysis parameters
timeFrame: Day 0, 28 weeks and 80 weeks (optional 12 weeks and 54 weeks)
Other outcomes:
Locations:
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
Study officials:
References:
Clinical trial NCT04870242: Studding the Implementation of ERAS Protocols in Pediatric Surgery
Official title: Enhanced Recovery After Surgery in Pediatric Surgery in Jordan: A Retrospective Cohort Study in a Tertiary University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Pediatric Disorder
Appendicitis
Hydrocele
Keywords: Enhanced recovery after surgery (ERAS)
enhanced recovery protocol
fast-track surgery
pediatric surgery
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 178
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution

Brief summary: this is a retrospective cohort, descriptive study, investigating the role of ERAS protocols, in pediatric surgery and evaluate the feasibility and effectiveness of implementing these protocols


Eligibility criteria: Inclusion Criteria:

* all patients aged 6months -18 years, who underwent pediatric surgeries at a single tertiary institution

Exclusion Criteria:

* patients who had co-morbidities that might affect the outcome of the enhanced recovery and those who were younger than 6 months.

Primary outcomes:
measure: Duration of Hospital stay,
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
measure: Total Hospital expenses
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
measure: readmission within 30 days
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
measure: reoperation within 90 days
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
measure: post op ER visits
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
measure: Pain control, according to a scale from 0-10, post-operative pain after implementation of ERAS protocols
timeFrame: retrospectively studied. data collection done at least 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University Of Jordan
state: Amman, Jordan
Study officials:
affiliation: University of Jordan
name: Raed Al-Taher, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176942: Probiotics and Endotoxemia
Official title: Probiotics and Endotoxemia in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Endotoxemia
Metabolic Syndrome
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 90
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 study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 27 kg/m2; above 18 years of age
* Used to eat high fat diet (more than 40% of total energy intake)

Exclusion Criteria:

* Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia
* Severe illnesses
* Artificial heart valve
* Immunosuppression
* Regular consumption of probiotics
* History of bariatric surgery
* Consumption or wish to consume Orlistat
* Participation in other research
* Pregnancy or wishing/trying to get pregnant
* Inability to follow protocol.

Primary outcomes:
measure: Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Volunteer weight before and after the 12 week intervention.
timeFrame: 12 weeks
measure: Volunteer waist perimeter before and after the 12 week intervention
timeFrame: 12 weeks
measure: Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention
timeFrame: 12 weeks
measure: Brachial blood pressure of the volunteers before and after the 12 week intervention.
timeFrame: 12 weeks
measure: Blood lipids in the volunteers before and after the 12 week intervention.
timeFrame: 12 weeks
measure: Serum inflammatory markers of volunteers before and after the 12 week intervention.
timeFrame: 12 weeks
measure: Intestinal microbiota composition measured from stool samples before and after the 12 week intervention.
timeFrame: 12 weeks
measure: Gut function questionaire as a measure of tolerability
timeFrame: Symptoms during last 6 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse Hospital
state: Cedex 9
Study officials:
References:
Clinical trial NCT00212342: Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea
Official title: Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.


Eligibility criteria: Inclusion Criteria:

* dysmenorrhea associated with endometriosis

Exclusion Criteria:

* severe hepatopathy
* pregnant woman

Primary outcomes:
measure: patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS
Secondary outcomes:
measure: changes in the VAS of dysmenorrhea.
measure: changes in the VRS of non-menstrual pain.
measure: changes in the VAS of non-menstrual pain.
measure: changes in the clinical evaluation of pelvic induration.
measure: changes in the size of ovarian endometrioma.
Other outcomes:
Locations:
Study officials:
affiliation: Tottori University,Tottori,Japan
name: Naoki Terakawa, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04837742: The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Official title: The Effect of Ultrasound-guided Erector Spinae Plane Block on Postoperative Analgesia in Radiofrequency Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
radiofrequency ablation
erector spinae plane block
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blind, randomized controlled trial to evaluate the efficacy of ESPB(Erector Spinae Plane Block) on postoperative analgesia in RFA( Radiofrequency Ablation therapy). We will include 80 patients, and randomly assign to ESPB(Chirocaine) group and control group(normal saline).We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma.

Detailed description: Computed tomography guided radiofrequency ablation of hepatocellular carcinoma(HCC) has became a popular way to treat HCC. Although the wound is small and the patients can discharge on the next day, they have to suffer from moderate to severe pain. Nowadays Erector spinae plane block has been applied to many surgery as a postoperative analgesic strategy. We deduce Erector spinae plane block can be use as a postoperative analgesic way for patients who receive radiofrequency ablation of hepatocellular carcinoma. Besides, we will add contrast medium to evaluate the spread area of local anesthetics.

Eligibility criteria: Patients undergoing computed tomography guided radiofrequency ablation of hepatic tumor under scheduled general anesthesia, and fulfilled one of following inclusion criteria:

1. diameter of hepatic tumor is larger than 2 cm
2. distance of tumor site is near the hepatic surface \< 2cm

Exclusion criteria:

1. A history of allergic reaction to local anesthetics or iohexol
2. Renal insufficiency, creatinine clearance \< 30mL/min
3. Coagulopathy or other bleeding disorder that cannot perform nerve block
4. Under pregnancy or lactation
5. Opioid tolerant patient

Primary outcomes:
measure: Visual analogue pain scale at postoperative day one
timeFrame: approximately 12-24 hrs
measure: Drug spread level of erector spinae plane block
timeFrame: approximately 2-3 hrs
Secondary outcomes:
measure: Visual analogue pain scale at post-anesthesia care unit
timeFrame: approximately 3 hours
measure: Postoperative recovery quality
timeFrame: approximately 2 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Shiang Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03602742: Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
Official title: Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Keywords: Atrial Fibrillation
Arrhythmias, Cardiac
EZYPRO ECG Recorder
ECG monitor
Long term ECG monitor
14-day ECG monitor
Lead sponsor: Sigknow Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written informed consent before enrollment into the study
* Are able to communicate with the investigators
* With suspected arrhythmia related signs and symptoms, judged by the investigators
* Patients intend to wear ECG moniotrs
* Males and females, 20 years of age or older

Exclusion Criteria:

* Patients with skin allergies or injury, judged by investigators
* Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
* Pregnant women
* Currently participating in another trial or who participated in a previous clinical trial

Primary outcomes:
measure: Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time
timeFrame: Up to14 days
Secondary outcomes:
measure: The wearing time of 14-day continuous ECG patch (Study Compliance)
timeFrame: Up to14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Taiwan
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou
Study officials:
affiliation: Chang Gung Medical Foundation, Linkou
name: Ming-Shien Wen
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans General Hospital
name: Shih-Lin Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03958942: Bilateral Ultrasound Guided Quadratus Lumborum Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response in Abdominal Surgery
Official title: Effect of Bilateral Ultrasound Guided Quadratus Lumborum Block Versus Lumbar Epidural Block on Postoperative Analgesia, and Inflammatory Response Following Major Lower Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Inflammatory Response
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims at comparing the effects of bilateral ultrasound-guided quadratus lumborum block versus lumbar epidural block on postoperative analgesia and inflammatory response following major lower abdominal cancer surgery.


Eligibility criteria: Inclusion Criteria:

* ASA II, III
* Weight 50 - 85 kg.
* Scheduled for major lower abdominal cancer surgery (radical cystectomy, total abdominal hysterectomy).

Exclusion Criteria:

* Patients with a history of relevant drug allergy.
* Coagulation disorders.
* Opioid dependence.
* Sepsis.
* Local infection at the vicinity of the block site.
* Patients with psychiatric illnesses that would interfere with perception and assessment of pain

Primary outcomes:
measure: postoperative pain
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: postoperative inflammatory response
timeFrame: first 24 hours postoperatively
measure: side effects
timeFrame: first 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
References:
Clinical trial NCT00933842: Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DESILSTY_FL (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDESILSTYFL.

Secondary Objective:

None.


Eligibility criteria: Inclusion criteria:

* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 03 months before volunteers selection
* Use of Antihistamines 30 days before selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.
timeFrame: From the treatment start to the end of the study (treatment duration 5 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03108742: Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
Official title: Randomized Control Study of Dermal Staples vs Subcuticular Sutures on Postoperative Scar After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroidectomy
Pain
Esthetic
Dermal Stapler
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 37
Sex: ALL
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: In this study, a randomized controlled study was conducted between two groups of 20 classic recipients of intradermal sutures and 20 recipients of intradermal staple methods for patients undergoing the same cervical incision. This is a study to see if there is any difference in pain and esthetics in scar formation of these groups.


Eligibility criteria: Inclusion Criteria:

* Patient who will have thyroid surgery

Exclusion Criteria:

1. done thyroid surgery before
2. done any radiotherapy on neck
3. who needs neck dissection
4. laparoscopic ot robotic surgery
5. under 18 years old or over 70 years old
6. bad general condition, high American Society of Anesthesiologists (ASA) score (over 3)
7. who used immunosuppressive drugs in 6 months
8. breast feeder or pregnancy
9. who disagrees to do this trial

Primary outcomes:
measure: Modified Stony Brook Scar Evaluation Scale (SBES)
timeFrame: Change from Baseline scar at 6 months
measure: Manchester Scar Scale (MSS)
timeFrame: Change from Baseline scar at 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline pain at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongsik Bae
Study officials:
References: