louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01348035: Efficacy Study of Water Drinking on PKD Progression.
Official title: Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autosomal Dominant Polycystic Kidney Disease
Disease Progression
Keywords: Autosomal Dominant Polycystic Kidney Disease.
Arginine vasopressin
Total Kidney Volume
Glomerular Filtration Rate
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who visit Kyorin University Hospital.

Brief summary: This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.

Detailed description: Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)

Eligibility criteria: Inclusion Criteria:

* The patients with ADPKD
* The patients who consent to the study protocol
* Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2

Exclusion Criteria:

* Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
* The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
* The patients who is considered inappropriate by physicians.

Primary outcomes:
measure: Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
timeFrame: One year (12 months) and pre-study period.
Secondary outcomes:
measure: Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.
timeFrame: One year (12 months)
measure: Plasma arginine vasopressin (AVP, Copeptin) level.
timeFrame: 4-8-12 months
measure: Quality of life (QOL) questionnaire.
timeFrame: 4-8-12 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Department of Urology, Kyorin University Hospital
state: Tokyo
Study officials:
affiliation: Kyorin University
name: Eiji Higashihara, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04915235: Prevalence and Prognosis of Cardiac Amiloidosis in Turkey
Official title: Prevalence and Prognosis of Cardiac Amiloidosis in Turkey- Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Lead sponsor: Turkish Society of Cardiology
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 2087
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with left ventricular hypertrophy

Brief summary: Patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis


Eligibility criteria: Inclusion Criteria:

* Patients with left ventricular hypertrophy without left ventricular pressure or volume (IVS≥13mm)
* Patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (IVS\>15mm)

Exclusion Criteria:

* Patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension
* Patients with sigmoid septum and their hypertrophy limited in sigmoid area
* Patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with LV morhpology and genetic testing

Primary outcomes:
measure: Cardiac Amyloidosis
timeFrame: Upon screening
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Medicine
Study officials:
References:
Clinical trial NCT02139735: Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients
Official title: Therapeutic Response of Ultrasound and Muscular Stretching in Temporomandibular Disorder Patients: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Joint Disorders,
Ultrasonics,
Electromyography,
Pain Measurement,
Muscle Stretching Exercise
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 18
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.

Detailed description: This study aimed to evaluate the therapeutic response of ultrasound (US) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in Temporomandibular Disorder (TMD) patients . The study included 18 women with TMD diagnosed by the instrument Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD). The pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. The volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.

Eligibility criteria: Inclusion Criteria:

* diagnosis of myogenic or mixed TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD)
* women aged 20 to 35 years.

Exclusion Criteria:

* psychomotor impairment ;
* history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ;
* analgesics , anti-inflammatories , muscle relaxants , antidepressants ;
* presence of acute TMJ pain ( last 3 months) ;
* have perform physical therapy or speech therapy for the past 6 months;
* periods of the end of the menstrual cycle (7 days prior to menstruation ) and onset of menstruation ( first 2 days ) were excluded for conducting evaluations of volunteers who did not use oral contraception and those who used it to break.

Primary outcomes:
measure: pressure pain threshold
timeFrame: 10 minutes
Secondary outcomes:
measure: surface electromyography
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Universidade Federal de Santa Maria
state: Rio Grande do Sul
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Eliane C. Corrêa, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05823935: Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
Official title: Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Diseases
Keywords: TLH
Bakay purse string
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.

Detailed description: The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.

Eligibility criteria: Inclusion Criteria:

* Benign uterine lesions e.g fibroid, adenomyosis,...etc.
* Patient acceptance to undergo laparoscopic hysterectomy.

Exclusion Criteria:

* Gynecological malignancy.
* Low corporeal myoma obsecuring cervicovaginal junction.
* History of extensive abdominal surgery other than cesarean section.

Primary outcomes:
measure: Total operative time
timeFrame: From start to end of operation
measure: Operative time for colpotomy and vaginal cuff closure
timeFrame: From start colpotomy to end of vaginal cuff closure
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed M Elashry, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Hamed M Youssef, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Maged R Elshamy, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mahmoud M Awad, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00802035: ALK29-002: A Study of Baclofen Formulations in Healthy Adults
Official title: A Phase 1, Single-Center, Open-Label Study of the Pharmacokinetics of Baclofen Formulations Administered to Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Keywords: ALK29
Alcohol Dependence
Pharmacokinetics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 65 years
* Body mass index of 19 to 30 kg/m2 at screening
* If subject is female and of childbearing potential, she must agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Pregnancy and/or currently breastfeeding
* Clinical significant medical condition or observed abnormalities
* Acute gastrointestinal disorder or history of chronic gastrointestinal disease or surgery
* Participation in a clinical trial within 30 days before screening
* Known intolerance and/or hypersensitivity to baclofen or its excipients
* Use of alcohol-, caffeine-, or xanthine-containing products
* Clinically significant illness within 30 days of first study drug administration
* Dietary restrictions that conflict with required study meals

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 5 weeks
Secondary outcomes:
measure: Time to Cmax
timeFrame: 5 weeks
measure: Significant abnormal laboratory findings
timeFrame: 5 weeks
measure: Area under the plasma concentration curve (AUC)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Frederick A. Bieberdorf, MD, CPI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04652635: Management of Nailbed Injuries
Official title: Management of Nailbed Injuries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nail Bed Injury
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.


Eligibility criteria: Inclusion Criteria:

* any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present

Exclusion Criteria:

* nail plate absent over the nailbed injury

Primary outcomes:
measure: Number of participants who experience complications over time
timeFrame: 6 months
measure: Change in pain score over time as measured on a pain scale
timeFrame: 6 months
measure: Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score
timeFrame: 6 months
measure: Change in upper extremity function over time as measured by the QuickDash score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Anna Luan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jeffrey Yao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050435: Early Cardiac Extubation After Cardiac Surgery
Official title: Early Cardiac Extubation After Cardiac Surgery: a Retrospective Single-center Non-inferiority Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-operative Cardiac Surgery
Keywords: post-operative complications
on table extubation
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included all the patients who have had minimally invasive valve replacement surgery in our service

Brief summary: The management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability This evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. In particular, immediate postoperative extubation appeared feasible. The investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. The investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.


Eligibility criteria: Inclusion Criteria:

* Minimally invasive valve replacement intervention (thoracotomy or J-hemisternotomy)

Exclusion Criteria:

* Combined surgery

Primary outcomes:
measure: Post-operative complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: ULiege - CHU
Study officials:
References:
Clinical trial NCT02434835: Study of Absorption, Metabolism and Excretion Following a Single Oral Dose of [14C]KWA-0711 to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subject
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-05
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT

Brief summary: The purpose of this study is to evaluate the absorption, metabolism and excretion following a single oral dose of \[14C\]KWA-0711 to healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who are male, caucasian, and between 35 and 55 years of age, inclusive.
* Subjects who have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive.
* Subjects who have a body weight between 50 and 100 kg, inclusive.
* Subjects must have regular bowel movements.

Exclusion Criteria:

* Subjects who have an abnormality in heart rate, blood pressure , temperature or 12-lead ECG.
* Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the 3 months prior to dose administration.
* Subjects who have had a clinically significant illness within 4 weeks of dose administration as determined by the Investigator.
* Subjects who have any clinically significant abnormal laboratory safety findings.
* Subjects who have had an X ray or who have participated in any clinical trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of total radioactivity, unchanged drug substance and its major metabolites
timeFrame: 240 hours
measure: Maximum observed plasma concentration (Cmax) of total radioactivity, unchanged drug substance and its major metabolites
timeFrame: 240 hours
measure: Cumulative radioactivity recovery in urine and feces
timeFrame: 240 hours
measure: Profiles of metabolites in plasma, urine and faeces
timeFrame: 240 hours
Secondary outcomes:
measure: Number of adverse events
timeFrame: 240 hours
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
Study officials:
References:
Clinical trial NCT02636335: Light, Exercise Intensity and Mood in Overweight
Official title: Light, Exercise Intensity and Mood in Overweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight, Obesity Grade I
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index 25 - 35 kg/m2

Exclusion Criteria:

* Women who are pregnant or breast feeding,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Participation in other studies in the last four weeks
* Systolic blood pressure \> 170 mmHg, diastolic blood pressure \> 100 mmHg
* Shift work in the last two months
* Travels across time zones in the last four weeks
* Use of photosensitisation drugs
* Clinical manifest depression
* Cardiovascular diseases which reduce age-appropriate exercise capacity

Primary outcomes:
measure: Mean power output in watts
timeFrame: Power output during the first 30 minute time-trial on a bicycle ergometer.
Secondary outcomes:
measure: Subjective sleepiness
timeFrame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
measure: Subjective Mood
timeFrame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
measure: Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.
timeFrame: Mean of the 30 minutes of the exercise from the first, second and third time-trial.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Departement of Sport, Exercise and Health
Study officials:
affiliation: University of Basel
name: Arno Schmidt-Trucksäss, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04081935: Distraction Using VR for Children During IV in an Emergency Department
Official title: Distraction Using Virtual Reality for Children During Intravenous Injections in an Emergency Department: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Keywords: school-age children, emergency treatment, intravenous placement, virtual reality, pain, fear
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 136
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Exploring the use of virtual reality as a distracting intervention strategy for school-age children to receive intravenous placement in emergency department, and further understand the effectiveness of reducing pain and fear during the invasive procedure.


Eligibility criteria: Inclusion Criteria:

* Children ages 7-12
* Children who were clearly conscious
* Children who agreed and were required to receive intravenous injections after physicians' diagnoses
* Children and their primary caregivers who could communicate in Mandarin or Taiwanese
* Children and their primary caregivers who could read Chinese that agreed to participate in this study and sign written consent forms

Exclusion Criteria:

* Children with developmental delay, epilepsy, or heart diseases
* Children undergoing chemotherapy; children who were visually or hearing impaired
* Children who were nearsighted with more than 8.0 diopters or farsighted with 5.0 diopters
* Children who had sustained head trauma in the past month
* Children who were confirmed to be obese according to the recommended body mass index values for children and adolescents
* Children who required blood transfusions and blood preparation to be performed according to physician diagnoses
* Children who received two or more intravenous injections and had their blood drawn only one time

Primary outcomes:
measure: The degrees of pain experienced by the children.
timeFrame: The posttests 8 min after the tourniquets were worn.
measure: The degrees of fear experienced by the children.
timeFrame: The posttests 8 min after the tourniquets were worn.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
References:
citation: Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.