louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03184623: Muscle Mass and Body Composition
Official title: Time Course of Changes in Muscle Mass and Body Composition During ICU Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Loss
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to the ICU with an expected lenght of stay \> 48 hours

Brief summary: ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

Detailed description: The weakness and disability that result from these neuromuscular disorders can dominate the lont-term course and impede recovery.

In this observational study we try to measure muscle mass and body composition by echocardiography and BIVA at admission and on day 2, 5

Eligibility criteria: Inclusion Criteria:

* all acute admitted patients in ICU

Exclusion Criteria:

* age \< 18
* stay on ICU \< 48 hours
* use of corticosteroids
* neurological diseases
* acute kidney injure / nead of CVVH

Primary outcomes:
measure: change in muscle mass measurements during ICU stay
timeFrame: baseline, day 2 and day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
Study officials:
affiliation: MCL
name: Matty Koopmans, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196723: Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites
Official title: TIPS Improve Survival in Patients With Cirrhosis and Recurrent Ascites: a Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Ascites
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This retrospective study included patients with cirrhosis and recurrent ascites who were treated with TIPS or large volume paracenteses plus albumin at 11 tertiary level A hospitals in China

Brief summary: Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A） to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.


Eligibility criteria: Inclusion Criteria:

Definite diagnosis of recurrent ascites in cirrhosis (based on clinical symptoms, laboratory and imaging studies, or liver biopsy) TIPS or LVP+A therapy, -

Exclusion Criteria:

Malignant neoplasm, including hepatocellular carcinoma with extrahepatic metastasis Prior liver transplantation Severe heart and lung dysfunction Recurrent hepatic encephalopathy Concomitant active infection TIPS with the use of uncovered stents Complete portal vein thrombosis

-

Primary outcomes:
measure: One year transplant free survival
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: Tangdu hospital
state: Shaanxi
city: Xian
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Xian
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT02669550: Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope
Official title: A Comparison of Disposcope Endoscope and Fiberoptic Bronchoscope During Awake Orotracheal Intubation in Obese Patients With Anticipated Difficult Airway : A Prospective, Randomised and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Procedural Complication
Keywords: Fiberoptic bronchoscope
Disposcope endoscope
Awake orotracheal intubation
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2016-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The fiberoptic bronchoscope (FOB) has been the preferred instrument for many years in the management of difficult tracheal intubation, and it is considered as a gold standard. The disposcope endoscope (DE) is a medical device for endotracheal intubation used in clinical practice recently.This study compares FOB and DE for awake orotracheal intubation in obese patients with anticipated difficult airway.

Detailed description: Forty obese patients with anticipated difficult airways were randomised to undergo awake orotracheal intubation by FOB(group F) or DE(group D) after conscious sedation. The conditions of orotracheal intubation, the time needed to view the vocal cords and to complete the orotracheal intubation, the hemodynamic changes and the adverse events including bradycardia, respiratory depression during orotracheal intubation, throat pain, hoarseness and memory after surgery were recorded. The ease of view the vocal cords and passing the tracheal tube through the glottis were also evaluated by using a visual analogue scale (VAS) by operator.

Eligibility criteria: Inclusion Criteria:

* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria:

* Exclusion criteria included age younger than 18 yr,
* ASA class IV or V,
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Primary outcomes:
measure: Intubation Time
timeFrame: 36 months
Secondary outcomes:
measure: Occurrence of throat pain measured by VAS
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: Ximing Qi, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00144950: Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Empyema
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.


Eligibility criteria: Inclusion Criteria:

* patients under the age of 16 referred to GOSH for management of empyema

Exclusion Criteria:

-

Primary outcomes:
measure: length of hospital stay
Secondary outcomes:
measure: radiological changes at follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Adam Jaffe, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaffe A, Calder AD, Owens CM, Stanojevic S, Sonnappa S. Role of routine computed tomography in paediatric pleural empyema. Thorax. 2008 Oct;63(10):897-902. doi: 10.1136/thx.2007.094250. Epub 2008 May 20.
Clinical trial NCT06782750: EFFECT of PHYSIOTHERAPY in STROKE
Official title: The EFFECT of PHYSIOTHERAPY on CORPUS CALLOSUM VOLUME in STROKE PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Corpus Callosum
Hemiplegia
Physiotherapy
Stroke
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with stroke, had unilateral hemiplegia, practiced a rehabilitation program at the Physical Medicine and Rehabilitation Clinic of XXX University, and had no other neurological disease, were selected for the right and left groups.

Brief summary: The study was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.

Detailed description: Physical therapy after stroke contributes to the physical and social recovery of the paralyzed person. Corpus callosum is the commissural fibers consisting of white matter connecting the cortical areas between hemispheres. Its main function is to provide information exchange and coordination by establishing interhemispheric connections between areas in the right and left hemispheres. Inactivity and decreased physical activity may cause a decrease in the volume of the corpus callosum in patients with stroke. It was aimed to determine the volumetric change in the corpus callosum after the rehabilitation program in patients with stroke. A total of 42 patients (22 males, 20 females), 21 right hemiplegic and 21 left hemiplegic patients with unilateral hemiplegia were enrolled in the rehabilitation program. Traditional physiotherapy treatment was applied 5 days in a week, 1 hour in a day for 6 weeks. The corpus callosum volumes were measured and evaluated on Magnetic Resonance Imaging (MRI) images before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stroke
* Patients had unilateral hemiplegia
* Patients practiced a rehabilitation program at the Physical Medicine and Rehabilitation

Exclusion Criteria:

* Patients had other neurological disease
* Patients had mental disorders

Primary outcomes:
measure: Corpus Callosum Volume
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Firat University
state: University
Study officials:
affiliation: Firat University
name: Songul Baglan Yentur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750150: Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Official title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trauma
Coagulopathy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.


Eligibility criteria: Inclusion Criteria:

* Emergency
* Trauma patient admitted in participating trauma care centers
* Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
* Inclusion performed within the first 6 hours after trauma.

Exclusion Criteria:

* Patient taking anticoagulants
* Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
* Minor Patient
* Pregnant or breastfeeding women

Primary outcomes:
measure: fibrinogen concentration (clauss)
timeFrame: 45 minutes after the admission on day 1 after trauma
Secondary outcomes:
measure: time frame of transfusion of 4 plasma
timeFrame: time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission
Other outcomes:
Locations:
city: Lille
country: France
facility: Emergency unit, Salengro hospital,
Study officials:
affiliation: University Hospital, Lille
name: Sophie Susen, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06925750: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-031/LIGHTRAY EXTENSION)
Official title: An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 130
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: Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.

A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.

This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
* Has not started treatment with commercially available sotatercept

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)

Primary outcomes:
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 28 months
measure: Number of Participants who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital-Cardiology ( Site 2000)
state: Guangdong
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1502)
city: London
country: United Kingdom
facility: Hammersmith Hospital ( Site 1801)
state: London, City Of
city: Glasgow City
country: United Kingdom
facility: Golden Jubilee National Hospital ( Site 1800)
state: Scotland
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01945450: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
Official title: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometritis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 300
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta.

Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams\*4, Gentamycin 240 mg\*1, Clindamycin 600 mg\*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg\*1, Clindamycin 600 mg\*3.

Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.


Eligibility criteria: Inclusion Criteria:

* suspected retained placenta

Exclusion Criteria:

* Intrapartum fever

Primary outcomes:
measure: Endometritis rate
timeFrame: 3 years
Secondary outcomes:
measure: Puerperal fever
timeFrame: 3 years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT00791050: Examine the Effects of Maintaining Body Core Temperature During CABGs
Official title: To Examine the Effects on Patients Outcomes of Maintaining Body Core Temperature During CABGs With Thermowrap
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Hypothermia
Coronary Artery Bypass Grafting
Keywords: Hypothermia/complications/etiology
coronary artery bypass/adverse effects
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although data on cardioprotective effects (as profile of troponin I)of perioperative maintenance of normothermia during CABGs are already known, little is known about the effects of maintaining normothermia on clinical outcomes of patients submitted to coronary surgery. Being acute renal failure (ARF) and atrial fibrillation (AF) the two most frequent complications of this surgery, this study compare as primary end point the rate of postoperative ARF and AF in two group of patients, one actively warmed with Thermowrap and the control group receiving standard institutional care.


Eligibility criteria: Inclusion Criteria:

* Isolated on pump CABGs
* Age 18 - 85
* Preoperative core temperature 36- 37.5 °C

Exclusion Criteria:

* History of fever in the last week
* Severe renal, hepatic,hematologic or pulmonary disease
* Chronic Atrial fibrillation
* History of acute MI in the last week
* Previous neurologic abnormalities

Primary outcomes:
measure: Rate of atrial fibrillation
timeFrame: First 48 postoperative hours
measure: Rate of acute renal failure
timeFrame: First 48 postoperative hours
Secondary outcomes:
measure: Rate of Myocardial infarction and low output syndrome
timeFrame: First postoperative 48 hours
measure: Rate of Type I neurological injury
timeFrame: First 48 postoperative hours
measure: Total units of RBCs transfused
timeFrame: First 48 postoperative hours
measure: Length of mechanical ventilation
timeFrame: First 48 postoperative hours
measure: Rate of in-hospital mortality
timeFrame: 30 postoperative days
measure: Intensive Care Unit length of stay
timeFrame: 30 postoperative days
measure: Hospital length of stay
timeFrame: 30 postoperative days
measure: Cardiac Troponin I (cTnI) curve
timeFrame: First postoperative 24 hours
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino
Study officials:
affiliation: Dept. of Anesthesia & ICU, IRCCS Centro Cardiologico Monzino. Milano, Italy
name: Luca Salvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nesher N, Zisman E, Wolf T, Sharony R, Bolotin G, David M, Uretzky G, Pizov R. Strict thermoregulation attenuates myocardial injury during coronary artery bypass graft surgery as reflected by reduced levels of cardiac-specific troponin I. Anesth Analg. 2003 Feb;96(2):328-35, table of contents. doi: 10.1097/00000539-200302000-00007.