louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04430881: A National Study in Patients With Unexplained Splenomegaly
Official title: The SMS Study, a National Study on Prevalence of Unexplained Splenomegaly Etiologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gaucher Disease
Splenomegaly
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-06-12
Enrollment: 506
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams

Brief summary: Primary Objective:

To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes)

Secondary Objective:

To describe the exams and tests conducted for diagnosis purpose and the more frequent associations

Detailed description: Study duration per participant is between 1 and 12 months

Eligibility criteria: Inclusion criteria:

* Participants referred for the first time for splenomegaly exploration defined as :

  * Either a palpable mass on left upper abdominal quadrant, further confirmed by a ≥ 13 cm craniocaudal length on abdominal Imaging
  * Or a non palpable splenomegaly discovered on abdominal imaging and with a craniocaudal length ≥ 13 cm
* Participants with splenomegaly (as defined above) of unknown origin

Exclusion criteria:

* Participants with obvious diagnostics based on clinical exam, patient's interview and the previous initial routine biological tests :

  * Diagnosis of portal hypertension
  * Diagnosis of hemolytic anemia
  * Diagnosis of hematological malignancy
  * Known diagnosis of Gaucher Disease

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

Primary outcomes:
measure: Percentage of patients diagnosed with Gaucher disease in the included population of patients with unexplained splenomegaly
timeFrame: between 1 and 12 months
Secondary outcomes:
measure: Percentage of patients with other than Gaucher disease-etiologies in the included population
timeFrame: between 1 and 12 months
measure: Number of participants by type of exams and tests conducted for diagnosis purpose
timeFrame: between 1 and 12 months
Other outcomes:
Locations:
city: France
country: France
facility: Investigational site France
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05205681: The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic
Official title: The Role of Imaging in the Diagnosis of Acute Appendicitis During the COVID-19 Pandemic: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Keywords: appendicitis
COVID-19
negative appendicectomy rate
computer tomography
ultrasonography
pre-operative imaging
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 313
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients operated at a tertiary centre

Brief summary: This is a retrospective observational study in the form of a cohort study evaluating the use of pre-operative imaging for the diagnosis of acute appendicitis in a tertiary centre during the first and second waves of the COVID-19 pandemic in the United Kingdom. The study group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2020 and February 2021, while the control group includes all patients who underwent emergency appendicectomy for suspected acute appendicitis between March 2019 and February 2020. The final histology will be used as primary outcome, as the study hypothesis is that increasing the use of pre-operative imaging will reduce the negative appendicectomy rate.


Eligibility criteria: Inclusion Criteria:

* Patients of all ages who underwent emergency appendicectomy (either laparoscopic or open) for suspected acute appendicitis
* Patients of all ages who underwent partial ileo-caecectomy or right hemicolectomy for suspected acute appendicitis

Exclusion Criteria:

* Patients who underwent elective interval appendicectomy for a previous appendiceal phlegmon
* Patients who underwent appendicectomy or right hemicolectomy for appendiceal tumours
* Patients who underwent diagnostic laparoscopy for suspected acute appendicitis, where the appendix was not removed

Primary outcomes:
measure: Negative Appendicectomy Rate (NAR)
timeFrame: Up to 3 weeks post-operatively (when final Histology is ready)
Secondary outcomes:
measure: Post-Operative Length of Stay
timeFrame: Assessed on day 30 after the completion of the study
measure: Post-Operative Complications Rate
timeFrame: Within 30 post-operative days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
affiliation: University College London Hospitals
name: Gerardo Perrotta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855581: The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children Requiring Sedation for MRI/CT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 3739
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring sedation for MRI/CT

Brief summary: Sedation and anesthesia for diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea.

The investigators reviewed 3739 charts of pediatric patients sedated for MRI/CT between January and November 2012.

In this study, the investigators will report the nature and frequency of adverse events associated with sedation for MRI/CT between January and November 2012.


Eligibility criteria: Inclusion Criteria:

* Requiring sedation for MRI/CT, aged 0- 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Srinivasan M, Turmelle M, Depalma LM, Mao J, Carlson DW. Procedural sedation for diagnostic imaging in children by pediatric hospitalists using propofol: analysis of the nature, frequency, and predictors of adverse events and interventions. J Pediatr. 2012 May;160(5):801-806.e1. doi: 10.1016/j.jpeds.2011.11.003. Epub 2011 Dec 16.
Clinical trial NCT01187381: An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Official title: Multicenter, Single-Arm, Observational Study of Mean Duration of Trastuzumab (Herceptin) Treatment in Patients With HER2-Positive Early or Metastatic Breast Cancer in Romanian Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 250
Sex: FEMALE
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: Female participants with early or metastatic HER2-positive breast cancer

Brief summary: This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.


Eligibility criteria: Inclusion Criteria:

* HER2-positive breast cancer
* Treated with trastuzumab in accordance with Summary of Product Characteristics and local protocols
* Written informed consent to data collection

Exclusion Criteria:

* Any contraindication to trastuzumab
* Clinically relevant cardiovascular disorder or disease

Primary outcomes:
measure: Treatment Duration With Trastuzumab in the Routine Clinical Practice
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
timeFrame: Baseline up to 5 years
measure: Percentage of Participants Who Received Previous Neoadjuvant Therapy
timeFrame: Baseline up to 5 years
measure: Percentage of Participants Who Had Surgical Procedure for Breast Cancer
timeFrame: Baseline up to 5 years
measure: Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
timeFrame: Baseline up to 5 years
measure: Progression Free Survival
timeFrame: Baseline uo tp 5 years
measure: Percentage of Participants by the Site of First Disease Progression
timeFrame: Baseline up to 5 years
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Cluj Clinical County Hospital; Oncology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06973681: A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Clinical Study to Evaluate the Safety, Tolerability, PK/PD Profile, and Efficacy of Multiple Doses of BGM0504 Injection in Overweight or Obese Subjects Without Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight or Obesity
Lead sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* 1. BMI ≥ 28.0 kg/m2 or 24.0 ≤ BMI \< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit; 2.Controlled by diet and exercise alone for at least 12 weeks prior to Screening with \<5.0% change in body weight and able to continue the original diet and exercise for weight control during the trial.

Exclusion Criteria:1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.

Primary outcomes:
measure: Percentage change in body weight
timeFrame: Week 0 to Week 24
Secondary outcomes:
measure: Proportion of Subjects with weight loss of ≥5%
timeFrame: Week 0 to Week 24
measure: Change from baseline in waist circumference
timeFrame: Week 0 to Week 24
measure: Change from baseline in BMI
timeFrame: Week 0 to Week 24
measure: Change from baseline in fasting plasma glucose (FPG)
timeFrame: Week 0 to Week 24
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
Study officials:
References:
Clinical trial NCT03320681: Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
Official title: Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Neurostimulator
Lead sponsor: Inventram
Sponsor class: INDUSTRY
Collaborators: name: Koç University
First posted: 2017-10-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind
Primary purpose: OTHER

Brief summary: Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Detailed description: Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 2
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria:

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy-

Primary outcomes:
measure: fMRI - Activation level comparison of the motor and supplementary cortex
timeFrame: Baseline and PostStim (right after the stimulation is terminated)
measure: fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)
timeFrame: Baseline and PostStim (right after the stimulation is terminated)
measure: fMRI - STN, PPN and cortical connectivity alterations
timeFrame: Baseline and PostStim (right after the stimulation is terminated)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koc University Hospital
Study officials:
affiliation: Otago University
name: Yusuf O Cakmak, Phd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inventram
name: Burak Ozsoy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02411981: Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis
Official title: Short-term Effects of Chest Physiotherapy on Ventilation Inhomogeneity in Non-CF Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Lung Clearance Index
Non cystic fibrosis Bronchiectasis
Multiple Breath Nitrogen Washout
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.

Detailed description: This is a before-after intervention study.

Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy.

The chest physiotherapy technique used will be autogenic drainage during 30 minutes. A resting period of 5 minutes will be given to the participant before the following tests.

Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.

Eligibility criteria: Inclusion Criteria:

* Non cystic fibrosis bronchiectasis in stable state

Exclusion Criteria:

* Not in stable state
* Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)

Primary outcomes:
measure: Change of Lung Clearance Index (LCI)
timeFrame: up to 80 minutes
Secondary outcomes:
measure: Change of Spirometry
timeFrame: up to 40 minutes
measure: Sputum weight
timeFrame: 35 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Sophie Gohy, MD, PhD
role: STUDY_DIRECTOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: William Poncin, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Grégory Reychler, PhD
role: STUDY_CHAIR
References:
citation: Poncin W, Reychler G, Leeuwerck N, Bauwens N, Aubriot AS, Nader C, Liistro G, Gohy S. Short-Term Effect of Autogenic Drainage on Ventilation Inhomogeneity in Adult Subjects With Stable Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2017 May;62(5):524-531. doi: 10.4187/respcare.05194. Epub 2017 Feb 21.
Clinical trial NCT03995381: Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis
Official title: Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Haemostatic Adverse Reaction
Keywords: Haemostasis
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.


Eligibility criteria: Inclusion Criteria:

* Patients who needs an angiographic examination or treatment.
* Patients with angiographic indications
* Patients who were able to give consent and complete the interview

Exclusion Criteria:

* The angiographic procedure uses patients with a catheter size more than 7fr.
* Patients in critical situations requiring urgent treatment
* Patients had cognitive impairment
* Patients were physically unfit to be interviewed
* Patients were non-Mandarin or -Taiwanese

Primary outcomes:
measure: Decisional conflict
timeFrame: 1 hour before Angiography
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuang Ho Hospital, Taipei Medical University
Study officials:
References:
Clinical trial NCT04874181: Use of Virtual Reality Game in Rehabilitation of Stroke Patients in Tan Tock Seng Hospital
Official title: A Proof Of Concept Single Arm Study To Use Virtual Reality in Rehabilitation of Stroke Patients in Neuro Intensive Care Unit in Tan Tock Seng Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: virtual reality
Silverfit 3D
rehabilitation
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Arm study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Use of SIlverfit 3d to aid in rehab of stroke patients focusing on their shoulder and knee strength

Detailed description: Either 1 of 3 physiotherapists will recruit the patient from NICU if the GCS is 14 - 15. Silverfit 3D will then be used for 20 minutes each day to train the knee and arm strength until the patient's discharge from ICU. Baseline muscle strength will be measured and graded by the physiotherapist using Medical Research Council grading then followed up by the same physiotherapist on discharge from ICU and on discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* Patients 21 - 90 years old
* Diagnosis of stroke of pure motor/sensory type affecting the limbs, all levels of severity and at all stages post stroke, defined by the WHO as "a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than that of vascular origin" (WHO 1989), diagnosed by imaging or neurological examination
* GCS 14 - 15
* RASS -1 to +1
* Blood pressure within 20% of patient's baseline
* Muscle power at least 2 out of 5 on the affected side, as assessed by the physiotherapist or clinician

Exclusion Criteria:

* Age less than 21 or more than 90 years old
* Neurological instability
* Poor prognosis/expected withdrawal of treatment/palliative care patient
* Visual loss/hearing loss
* Active delirium with inability to cooperate as determined by CAM-ICU positivity
* Severe cognitive impairment/dementia
* Haemodynamic instability

Primary outcomes:
measure: To estimate an improvement in muscle strength using the Medical Research Council (MRC) grading following the intervention.
timeFrame: 3 months
measure: estimate how much a patient can do compared to his/her baseline in terms of ability to stand/ambulation/reaching out for objects based on the physiotherapist who first saw the patient.
timeFrame: 3 months
measure: increase frequency and intensity of rehab activities in stroke patients
timeFrame: 6 months
Secondary outcomes:
measure: reduce length of stay in ICU
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References: