louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06541366: Physical Capacity of Spina Bifida and Factors Affecting
Official title: Physical Capacity of Spina Bifida and Factors Affecting During Pregnancy: A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spina Bifida
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 2
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit between February 2019 and January 2020 (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children). The control group was formed through random selection among the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.

Brief summary: Objective: It was aimed to evaluate the physical characteristics of the cases with spina bifida and to review the factors that may affect the etiology of the disease.

Methods: 48 cases with spina bifida and 48 control groups in other disease groups evaluated. A physiotherapist physically evaluated the cases after their personal information was obtained. A survey form examining the possible factors in the etiology of spina bifida was applied to the families.

Detailed description: The study was carried out with the participation of 48 cases with spina bifida between the ages of 0 and 2 evaluated in XXXXXX Training and Research Hospital (XXXXX) Pediatric Clinics and 48 control groups in other disease groups in response to each case.

The case group consisted of patients who were diagnosed in the Neonatal Intensive Care Unit between February 2019 and January 2020 (39 children), and who applied to the Physiotherapy and Rehabilitation Department from the centers outside for physiotherapy needs (9 children).

Eligibility criteria: Inclusion Criteria:

* spina bifida between the ages of 0 and 2

Exclusion Criteria:

* control group was formed through random selection among the children who were at the same age group between the same dates, did not have any diseases related to the neuromuscular system, and hospitalized for any other reason.

Primary outcomes:
measure: Results of Groups
timeFrame: 1-2 month
measure: Antropomethric measures
timeFrame: 1-2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: University of Health Sciences, Diyarbakır Gazi Yaşargil Training and Research Hospital
Study officials:
References:
Clinical trial NCT01949766: Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Official title: Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Byler Disease
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2013-09-24
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.


Eligibility criteria: Inclusion Criteria:

* Byler Disease
* Cholestasis
* Tolerance of Buphenyl therapy

Exclusion Criteria:

* Allergy/Hypersensitivity to RAVICTI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01964066: Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Official title: Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Keywords: therapeutic ERCP
prevention of post-ERCP pancreatitis
thoracic epidural analgesia
Lead sponsor: Volgograd State Medical University
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 491
Sex: ALL
Minimum age (years): 15
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has been the most frequent adverse effect of endoscopic transpapillary interventions. We sought to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP pancreatitis.

Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491 patients was conducted. The first group of patients (N=247) received thoracic epidural analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a narcotic analgesic. To detect statistically significant differences between research groups adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.

Detailed description: Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind randomization) into two groups, 250 patients each.

The patients of the first group had TEA applied during the ERCP procedure; other methods of pain relief were applied to the patients of the second (control) group.

The first group (TEA group) of patients received the following premedication: atropine sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space.

The second group (control group) of patients received the following premedication: atropine sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml.

Eligibility criteria: Inclusion criteria:

* Patients with performed therapeutic ERCP;
* The ERCP procedure was performed in a patient for the first time;
* Prior to the ERCP procedure the patient didn't have any clinical signs of acute pancreatitis.

Exclusion criteria:

- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).

Primary outcomes:
measure: the prevention of post-ERCP pancreatitis
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Volgograd
country: Russian Federation
facility: Clinic №1 of Volgograd State Medical University
Study officials:
affiliation: Clinic №1 of Volgograd state medical university
name: Mihail Turovets, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03865966: Hepatitis B Virus Infection After Liver Transplantation in Children
Official title: Clinical Follow-up Study on Hepatitis B Virus Infection After Liver Transplantation in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B Infection
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage liver disease requires liver transplantation.

Brief summary: China is a highly prevalent area of hepatitis B virus（HBV） infection, with at least 75 million hepatitis B virus carriers, and 80% of primary hepatocellular carcinoma (HCC) is associated with chronic hepatitis B virus infection. Liver transplantation is currently the preferred method for end-stage liver disease such as biliary atresia and cirrhosis in children. In recent years, children's liver transplantation has developed rapidly and the number of developments has increased significantly. If there is chronic hepatitis B virus infection in the donor liver, it may cause HBV transmission, or the patient may have a low-load occult hepatitis B virus infection, and after immunosuppressive treatment, it may lead to hepatitis B virus infection after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with end-stage liver disease who require liver transplantation

Exclusion Criteria:

* Children without liver transplantation refer to children;
* Children who are unwilling to participate;

Primary outcomes:
measure: The rate of occult hepatitis b virus infection
timeFrame: 3-5 years
measure: The rate of overt hepatitis b virus infection
timeFrame: 3-5 years
Secondary outcomes:
measure: The levels and changes of anti-HBs after liver transplantation
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Children's Hospital of Chongqing Medical University
name: Yao Zhao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00786266: Sleep Enhancement Training Study for Novice Shiftworkers
Official title: Sleep Enhancement Training Study for Novice Shiftworkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Shift-Work Sleep Disorder
Keywords: shift-work
sleep
nurse
relaxation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2008-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in shiftwork-naive new nurse graduates.


Eligibility criteria: Inclusion Criteria:

* English-speaking nurses scheduled to work at least 2 consecutive night shifts per week in the next 2 months

Exclusion Criteria:

* \> 6 months experience working night-shift
* current diagnosis of sleep disorder or affective illness

Primary outcomes:
measure: actigraphy measures of sleep
timeFrame: 6 weeks
Secondary outcomes:
measure: subjective measures of sleep and well-being
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Inner Health, Inc.
name: Christopher R Alsten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04744766: Central Mammary Duct Excision; How to Improve the Outcome?
Official title: Central Mammary Duct Excision; How to Improve the Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duct Ectasia Breast
Benign Breast Disease
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 130
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study compares two surgical techniques in excision of the central duct system of the breast. known also as major duct excision

Detailed description: first technique used is the original Hadfield techniques. the other technique is Almasad technique published in 1999. in this technique, de-epithelialization of a supraareolar area of nearly 2cm is done and elevation of the nipple areola complex is done to support the retroareolar area.

Eligibility criteria: Inclusion Criteria:

females with nipple discharge / recurrent peri-ductal mastitis

-

Exclusion Criteria:

* suspicion or evidence of malignancy

Primary outcomes:
measure: patient satisfaction and sensation of nipple areolar complex complications
timeFrame: 6 months
Secondary outcomes:
measure: complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Main Univeristy Hospital
Study officials:
affiliation: Faculty of Medicine , Univeristy of Alexandria
name: Mahmoud A. Alhussini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05123066: Effect of Aquatic Training on Motor Function in Children With Autism Spectrum Disorder
Official title: Effect of Aquatic Training Versus Land Exercises on Motor Function in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Aquatic Therapy
Motor development
Land Exercises
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinically, infants with Autism Spectrum Disorder often display gross motor delays in supine, prone, and sitting skills in their first year of life . Studies reveal that motor abnormalities in Autism Spectrum Disorder can occur very early in developmental trajectory.

Detailed description: Hydrotherapy is an environment that may be conducive to encouraging physical activity in children with Autism Spectrum Disorder. The buoyancy of water can assist with movement, balance, and coordination .Water also provides an opportunity for social interaction through aquatic games and activities.Based on the literature, Aquatic therapy appears to be particularly beneficial for children with Autism Spectrum Disorder who need strong sensory stimulation.

Eligibility criteria: Inclusion Criteria:

* Age ranges from 3 to 5 years.
* Mild to moderate autistic features according to GARS (scores from 60 to 110).

Exclusion Criteria:

* Significant visual or auditory defects.
* History of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder).
* Open wound.
* Dermatological diseases

Primary outcomes:
measure: Autism Index
timeFrame: Treatment for 3 monthes
measure: Motor Development
timeFrame: Treatment for 3 monthes
measure: Pediatric Quality of life Inventory Scale
timeFrame: Treatment for 3 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Eman S Albadry
Study officials:
affiliation: Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: Amira M ABD-ELMONEM, PhD
role: STUDY_CHAIR
affiliation: Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
name: MAI E ABBASS, PhD
role: STUDY_DIRECTOR
affiliation: Pediatrics Department, Faculty of Medicine, Sohag University
name: AMR A OTHMAN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06598566: A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.
Official title: A Comparative Evaluation of Nottingham Hip Fracture Score (NHFS) and Acute Physiology and Chronic Health Evaluation (APACHE) II Score to Predict 30-day Mortality in Geriatric Patients Above 60 Years Undergoing Hip Fracture Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Hip Fracture
Keywords: Geriatrics
Hip Fractures
APACHE II
Mortality
Morbidity
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 182
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for elective surgery for fractures around the hip joint at at Tata main hospital, Jamshedpur, India

Brief summary: This study aims to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years old undergoing hip fracture surgery.

Detailed description: The study aim to compare the Nottingham Hip Fracture Score (NHFS) and the Acute Physiology and Chronic Health Evaluation II (APACHE II) score in predicting 30-day mortality in geriatric patients over 60 years undergoing hip fracture surgery. This study was conducted at the Tata Main Hospital in Jamshedpur, India. The study was designed as a prospective observational study, with data collected from June 2022 to June 2023. The study's primary objective was to predict mortality in patients undergoing hip fracture surgery. The study also investigated secondary outcomes such as the need for postoperative ventilator and ionotropic support, the occurrence of acute kidney injury, cardiac morbidity, and the presence of pulmonary embolism and deep vein thrombosis, as well as length of stay.

Eligibility criteria: Inclusion Criteria: Age more than or equal to 60 years, Underwent Hip fracture surgeries, of Either Sex

-

Exclusion Criteria: Age less than 60 years of age, Hip fractures not undergoing any invasive surgery, Implant removals planned for healed hip fractures, Re-explorations during the same admission in which primary surgery was conducted

-

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of Stay (LOS)
timeFrame: 30 days
Other outcomes:
Locations:
city: Jamshedpur
country: India
facility: Tata Main Hospital
state: Jharkhand
Study officials:
References:
Clinical trial NCT02576366: Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
Official title: Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Interactions
Kidney Transplantation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Single center, open label crossover study with 2 treatment phases in healthy volunteers.

The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.


Eligibility criteria: Inclusion Criteria:

* Male
* Age over 18 years
* Written informed consent

Exclusion Criteria:

* Female
* Medical comorbidities
* Use of concomitant medication

Primary outcomes:
measure: Change in tacrolimus area under the curve
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Dirk RJ Kuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03821766: Haemodynamic Abnormalities Recorded With Cardiac Catheterization Along With Body's Surface Micro-accelerometers (KT-KCG)
Official title: Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Pulmonary Hypertension
Keywords: Intracavitary pressure
Ballistocardiography
Seismocardiography
Microaccelerations
Kinetic energy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 0
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: Patients suffering from heart failure and undergoing a planned cardiac catheterization as required by their medical condition will be asked to participate to the study.

The inclusion criteria include heart failure regardless of its etiology. Patients with a left ventricle assistance device will not be enrolled because the high-frequency accelerations generated by the mechanical device and transmitted to the skin level will likely hamper the ballisto- and seismocardiographic signal.

Brief summary: The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording the vibrations at the skin level generated by the acceleration and displacement of the blood and cardiac mass at each cardiac contraction. The former records the acceleration near the subject's center of mass, the latter at the local chest wall. So far, the unclear physiological origin of those acceleration signals has led to important ambiguities in their scientific and clinical interpretation. Therefore, several ongoing studies would aim to highlight the physiological genesis of those acceleration-induced signals.

Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at the body surface with several haemodynamic parameters recorded invasively during a cardiac catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.

Detailed description: Patients suffering from severe heart failure regardless of the etiology will undergo a cardiac catheterization as required by their medical condition.

The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of an unintrusive and friendly device consisting of two houses, the first one placed on sternum and the second one in the lumbar column. The device will record a continuous tracing synchronized with the intracavitary pressure profiles recorded during the invasive procedure.

Eligibility criteria: Inclusion Criteria:

* Age 18 y.o. to 80 y.o.
* Heart failure

Exclusion Criteria:

* Left ventricle assistance device
* Refused participation

Primary outcomes:
measure: Micro-accelerations recorded at the body's surface
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: