louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03825172: Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
Official title: Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Caudal
Anatomy
Ultrasonography
Pediatrics
Keywords: Caudal block
Ultrasound
Children
Regional block anatomy
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Pinar Kendigelen
name: Ayse Cigdem Tutuncu
name: Kaya, Guner, M.D.
First posted: 2019-01-31
Enrollment: 348
Sex: ALL
Minimum age (years): 1
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients who are admitted to operating room for any pediatric surgery

Brief summary: Detailed study of ultrasonographic caudal epidural anatomy

Detailed description: Caudal epidural block is one of the most common methods to provide analgesia for an infraumbilical surgery in children. Although it can be carried out safely and easily, many complications have been described so far, because of inaccurate needle injections. To perform a successful block, a good caudal epidural anatomic assessment is essential. Ultrasonography is an important tool to perform pediatric regional blocks, including caudal blocks. We believe that caudal epidural ultrasound evaluation can be an important option to decrease complications and to achieve a successful attempt; due to that we will try to describe caudal epidural ultrasound imaging and changes from one month to 84 months.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients who applied for any pediatric surgery from 20 january to 20 july

Exclusion Criteria:

* Premature patients
* Patients who have any sendromic diagnosis
* Patients who have any musculoskeletal abnormalities
* Patients who have any spinal abnormalities

Primary outcomes:
measure: Definition Of Dural Sac Termination Level By Ultrasonography
timeFrame: 5 minutes
measure: Distance Between Dural Sac Termination Level And Placement Of Caudal Epidural Needle
timeFrame: 5 minutes
measure: Definition Of Average Caudal Epidural Depth By Ultrasonography
timeFrame: 5 minutes
Secondary outcomes:
measure: Determination Of Sacral Cornua As An Anatomic Landmark And Confirmation By Ultrasonography
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University
name: Celal Kaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02166372: Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
Official title: Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients in Taiwan

Brief summary: T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia.

The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.

Detailed description: This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c \< 7%, LDL cholesterol \< 100 mg/dl and systolic blood pressure \< 140 mmHg.

Eligibility criteria: Inclusion Criteria:

* Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
* BMI over 25
* age between 20 and 67

Exclusion Criteria:

* Diagnosed with cancer within past five years
* HIV positive
* Active TB patients
* CV events in past six months
* serum cretinine over 2.0 mg/dl
* C-peptide bellow 1.0 ng/ml in past three months
* Diabetic retinopathy; vision bellow 0.1
* Cushing's syndrome
* History of organ transplant
* History of bariatric surgery
* History of alcohol or drug dependency in past five years
* Psychological problems likely to interfere with adherence to protocol

Primary outcomes:
measure: Evaluate the natural course of the diabetes of obese patients over a period of 10 years
timeFrame: ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Min-Sheng General Hospital
Study officials:
affiliation: Min-Sheng General Hospital; National Taiwan University Hospital
name: Wei-Jei Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01443572: The Comparison of Desflurane and Sevoflurane on Postoperative Recovery and Hepatic Function of Biliary Atresia Patients During Kasai Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kasai Operation
Biliary Atresia
Keywords: Kasai operation under general anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-09-29
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biliary atresia (BA) is a perinatal disease of unclear etiology, characterized by inflammation and obliteration of intrahepatic and extrahepatic bile ducts, leading to cholestasis and cirrhosis. Kasai operation remains as the first line operative treatment in BA. In the previous studies, inhalation anesthetics might induce liver damage. The choice of inhalation anesthetic that minimally affects hepatic function is important. Therefore, the purpose of this study is to compare the postoperative recovery and hepatic function between desflurane and sevoflurane, two most frequently used inhalational anesthetics in patients undergoing Kasai operation.


Eligibility criteria: Inclusion Criteria:

* patients with biliary atresia undergoing Kasai operation

Exclusion Criteria:

* patients with congenital anomalies at major organs

Primary outcomes:
measure: Change in postoperative recovery
timeFrame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days.
measure: Change in hepatic function
timeFrame: after operation, and on the 1st, 2nd, 3rd, 5th, 7th and 15th postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02735772: Transobturator Approach for Paravaginal Repair
Official title: Transobturator Approach for Paravaginal Repair a New Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystocele
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
Primary purpose: TREATMENT

Brief summary: A new technique for Applying sutures to the white line in paravaginal repair.

Detailed description: A new trial for transobturator repair of the paravaginal defect.

Eligibility criteria: Inclusion Criteria:

* paravaginal defect cystocele
* midline and paravaginal defect cystocele

Exclusion Criteria:

* uterine descent
* previous cystocele surgery

Primary outcomes:
measure: success rate
timeFrame: 6 months
Secondary outcomes:
measure: lateral vaginal fornices elevation
timeFrame: 3 month
measure: Operative time
timeFrame: 1 day
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Complications rate
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urogynecology Unit
Study officials:
affiliation: Ain Shams Universty
name: Hazem SH Samoor, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04155372: Effect of Different Fluid Ingestion Rate on Post-exercise Rehydration
Official title: Effect of Different Fluid Ingestion Rate on Post-exercise Rehydration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dehydration
Keywords: sports nutrition
dehydration
sports medicine
rehydration
ingestion rate
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2019-11-07
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to investigate the effect of different rate of fluid consumption on post-exercise rehydration.

Detailed description: The body water deficits equivalent to 2% body mass might impair performance. Due to high exercise intensity, thermal environment, or rule limitation, athletes often in dehydration status post-exercise. Thus, how to rehydrate effectively to prepare the next game is important. The participants arrived to the lab euhydrated and were dehydrated to 2% of body weight by running. After a rest, they will ingest sports drink in a volume equivalent to 150% of BW loss in 30 min, 60 min, or 90 min. Urine and blood sample will be collected to evaluate hydration status.

Eligibility criteria: Inclusion Criteria:

* 20\~35 years old male
* Exercise 150 min per week
* Without chronic disease or gastrointestinal surgery

Exclusion Criteria:

* Injury
* Answer "Yes" in part 1 of the Physical Activity Readiness Questionnaire(PAR-Q+)
* Participate in other studies within one month

Primary outcomes:
measure: specific gravity of urine(SG)
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure: Osmolality(Urine)
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure: Osmolality(Blood)
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure: Vasopressin
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure: sodium(blood)
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
measure: Body weight change
timeFrame: Change from baseline outcome measure at dehydration and 1st and 2nd hour in recovery period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: JIAN-YU LIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06322368: Myofunctional and Respiratory Intervention on Phonation in Stroke
Official title: Effects of a Combined Myofunctional and Respiratory Intervention on Phonation in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.

Detailed description: Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of chronic stroke (duration above 6 months).
* Age over 18 years

Exclusion Criteria:

* Communication or cognitive deficits that prevented them from following verbal commands.

Primary outcomes:
measure: Volume during monologue
timeFrame: Baseline, 6 weeks
measure: Frequency during monologue
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Volumen during sustained phonation of /s/ sound
timeFrame: Baseline, 6 weeks
measure: Communication effectiveness Index
timeFrame: Baseline, 6 weeks
measure: Frequency during sustained phonation of /s/ sound
timeFrame: Baseline, 6 weeks
measure: Volumen during sustained phonation of /a/ sound
timeFrame: Baseline, 6 weeks
measure: Frequency during sustained phonation of /a/ sound
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: UGR
name: Irene Cabrera Martos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06757972: Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas (RCT)
Official title: Effect of Tele Rehabilitation in Breaking Barriers With Mobility Impairments in Rural Areas: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobility Limitation
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Tele-rehabilitation offers remote healthcare services via telecommunication technology to patients who face challenges in accessing traditional in-person rehabilitation. This randomized controlled trial investigated the effectiveness of tele-rehabilitation in overcoming mobility impairments in rural Pakistan.

Detailed description: A total of 92 participants, equally divided into intervention and control groups, were assessed. The intervention group received a 6-month tele-rehabilitation program, including video consultations, home visits, structured calls, and text messages.

Eligibility criteria: Inclusion Criteria:

* People will be eligible for participation if they have had any disorder causing mobility impairment,
* Lives in rural areas,
* Are over the age of 20,
* Have been discharged from inpatient, outpatient and community physiotherapy living in their home, (Saywell, Vandal et al. 2012)
* Have medical approval from their general practitioner to engage in low to medium level exercise programs,
* At least 3 score on telephone cognitive screening questionnaire (Callahan, Unverzagt et al. 2002)
* Have limitation in mobility, physical function of arm, leg or both.

Exclusion Criteria:

* If they have confirmed cerebellar or brain stem stroke,
* Tele rehabilitation involvement require frequent communication with physiotherapist so using interpreter is considered impractical,
* Participants enrolled in other rehabilitation programs,
* Lack of necessary devices (e.g, internet, smartphone, tablet, computer) for tele rehabilitation.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 12 Months
measure: Quality of Life (QOL)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Superior University CRC
state: Punjab
Study officials:
References:
Clinical trial NCT06175572: Comprehensive Functional Assessments for NOCAD
Official title: The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Ischemia
Coronary Microvascular Dysfunction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population enrolled from Zhongshan Hospital, Fudan University (Shanghai, China)，with coronary angiography and available cadmium zinc telluride - single photon emission computed tomography imaging (CZT-SPECT).

Brief summary: To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.


Eligibility criteria: Inclusion Criteria:

1. visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
2. CZT-SPECT was successfully conducted within three days of CAG

Exclusion Criteria:

1. had flow-limiting epicardial stenosis (DS% \>50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
2. severe valvular heart disease;
3. chronic heart failure and/or left ventricular ejection fraction (LVEF) of \< 50%;
4. cardiomyopathy and myocarditis;
5. severe renal or hepatic insufficiency;
6. failure in detecting SPECT;
7. failure in computing Angio-IMR, and -FFR.

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 5 years
Secondary outcomes:
measure: Individual components of MACE
timeFrame: 5 years
measure: the change in Seattle Angina Questionnaire (SAQ) summary score
timeFrame: 5 years
measure: the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Chenguang Li
role: STUDY_DIRECTOR
References:
Clinical trial NCT01843972: Safety of Single Rising Doses and Relative Bioavailability of BI 691751
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. Subjects must be able to understand and comply with study requirements
3. Age from 18 to 55 years
4. BMI range: from 18.5 to 29.9 kg/m2
5. Known genotype as specified in the study protocol

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: AUC0-72h (Part II)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration
measure: Cmax (Part II)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration
measure: Frequency of Subjects With Drug-related Adverse Events (Part I)
timeFrame: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7
Secondary outcomes:
measure: Cmax (Part I)
timeFrame: for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
measure: AUC0-infinity (Part I)
timeFrame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
measure: AUC0-tz
timeFrame: Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h
measure: t1/2 (Part I)
timeFrame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
measure: Tmax (Part I)
timeFrame: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1334.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: