louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02005705: Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Official title: Randomized Trial of Outpatient vs. Inpatient Management of Low-risk Patients With Upper Gastrointestinal Bleeding.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 17
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: Patients presenting to the emergency room with upper gastrointestinal bleeding and a Glasgow Blatchford score of zero will be randomly assigned to further care in the inpatient vs. outpatient setting. The hypothesis of this study is that patients who are managed as outpatients will require interventions at a rate not higher than those managed as inpatients and will have lower direct healthcare costs.


Eligibility criteria: Inclusion Criteria:

1. Blood Urea Nitrogen \< 18.2 mg/dl
2. Hemoglobin ≥ 13.0 g/dl for men and ≥ 12.0 g/dl for women
3. Systolic blood pressure ≥ 110 mm Hg
4. Heart rate \< 100 beats/min

Exclusion Criteria:

1. Inability to obtain informed consent
2. Pregnancy
3. History of liver disease
4. History of heart failure
5. Syncope that is temporally related to ongoing bleeding
6. Melena
7. Contraindication to proton pump inhibitor use
8. Other conditions that necessitate inpatient evaluation.
9. Inpatients with new onset of GI bleeding

Primary outcomes:
measure: The number of patients requiring intervention for UGIB (endoscopic therapy, blood transfusion, surgery, interventional radiology)
timeFrame: Within 7 days of the index presentation to the emergency room
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University, Section of Digestive Disease
name: Loren Laine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852605: Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment
Official title: A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Lung Injury
Keywords: Acute Lung Injury after allogeneic transplantation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Recent data (Hilbert et al.) suggested a beneficial effect of Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons including stem-cell transplantation.

The investigators study is designed to evaluate early markers of ALI after allogeneic transplantation. In case ALI is documented patients are randomized to either conventional therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation. The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic transplantation.


Eligibility criteria: Inclusion Criteria:

patients undergoing allogeneic transplantation presenting with at least two of the following criteria

* Respiratory rate \>25 / min
* Oxygenation Index \<300
* Continuous oxygen-saturation \<92% whilst breathing room air

Exclusion Criteria:

* Indication for Emergency intubation
* Hemodynamic instability
* Left ventricular failure
* GCS \<8
* No consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
name: Illmer Thomas, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05571605: Cerebrovascular Dysregulation in Chronic Kidney Disease
Official title: Cerebrovascular Dysregulation in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: exercise
brain blood flow
Lead sponsor: University of North Texas, Denton, TX
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two conditions:1) aerobic exercise training on a stationary bicycle, or 2) stretching and balance training.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether or not regular exercise training may improve brain blood flow regulation in patients with chronic kidney disease (CKD).

Detailed description: Prior research has shown that CKD patients have an increased risk of stroke and that impairments in brain blood flow regulation predict stroke in other chronic disease states. This study will test whether exercise training can improve brain blood flow regulation via improved dynamic cerebral autoregulation and cerebrovascular carbon dioxide reactivity in CKD. Participants will undergo exercise training on a stationary bicycle, or stretching exercises, 3 times per week for 12 weeks.

Eligibility criteria: Inclusion Criteria:

• Individuals with chronic kidney disease stages III-IV.

Exclusion Criteria:

* Heart failure
* Chronic obstructive pulmonary disease
* Uncontrolled hypertension or hypotension
* Pregnancy or plans to become pregnant
* Inability to exercise on a stationary bicycle
* Current participation in exercise more than 20 minutes twice per week

Primary outcomes:
measure: change in dynamic cerebral autoregulation
timeFrame: Mean arterial pressure-middle cerebral artery blood velocity transfer function phase (radians) and gain (cm/s/mmHg) will be compared at baseline (week 0) and after completing the 12-week intervention (week 13).
Secondary outcomes:
Other outcomes:
Locations:
city: Denton
country: United States
facility: University of North Texas
state: Texas
Study officials:
References:
Clinical trial NCT02534805: Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
Official title: Patient Buddy App for the Prevention of Avoidable Readmission in Cirrhosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-08-28
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic subjects who are hospitalized for non-elective reasons

Brief summary: To use the PatientBuddy App to reduce 30-day avoidable readmissions in cirrhotic patients using a patient and caregiver perspective.

Detailed description: Specific aim 1: To perform a pilot and feasibility study of disseminating current knowledge of readmission prevention in cirrhosis by using the Patient Buddy App with patient and caregiver interfaces. Eighty subjects (40 cirrhotic inpatients and 40 caregivers) will be enrolled and trained on the Patient Buddy at discharge. The App focuses on daily communication between patient/caregivers and the study team based on previously identified risk factors associated with readmission. The study team will initiate measures to prevent readmission using these communications. A detailed analysis of 30-day readmissions and input of the patients,caregivers and nurse manager will be performed to improve the App. Avoidable readmissions will be defined by a committee of hepatologists who is not part of the study at VCU.

Specific aim 2: To incorporate the opinion of key stakeholders (patients, caregivers and case managers) towards improving the Patient Buddy App in the prevention of avoidable readmission in cirrhosis. The input of the key stakeholders and the analysis of readmissions prevented during the pilot study will be used to update the App for preventing avoidable readmissions in future studies

Eligibility criteria: Inclusion Criteria:

* Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
* Adult caregiver and the patient living in the same house
* Both (caregiver and patient) should be able to complete the Patient Buddy training and evaluation
* Discharged home from the hospital
* Patients who have VCU as a primary hospital base

Exclusion Criteria:

* Elective hospitalization
* Lack of an adult caregiver
* Active alcohol/substance abuse within 1 month of the hospitalization
* Unable to perform training or give consent
* Patients discharged to hospice, nursing home or extended care facilities
* Patients on Hemodialysis

Primary outcomes:
measure: Readmission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VCU Medical Center
name: Jasmohan S Bajaj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329405: The Effects of PXR Activation on Hepatic Fat Content
Official title: PXR-aktivaation Vaikutus Maksan Rasvoittumiseen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2014-12-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effects of pregnane X receptor (PXR) activation on hepatic fat content in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers. Hepatic fat content is measured with magnetic resonance imaging and blood samples are collected at the end of each study arm. The investigators' hypothesis is that rifampicin causes accumulation of fat to the liver.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Body mass index (BMI) 18.5-25 kg/m2

Exclusion Criteria:

* Systolic blood pressure over 150 mmHg
* Any continuous medication (hormonal intrauterine device is permitted)
* Any significant medical condition
* Insensitivity to rifampicin
* Pregnancy and lactation
* Previous difficult venipuncture
* Alcohol and medicine abuse and drug use
* Participation to any other pharmaceutical trial within on month of screening
* Claustrophobia
* Metal and other implants which are contraindications to MRI

Primary outcomes:
measure: Hepatic fat fraction
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
Clinical trial NCT02151305: Different Hemostasis According to the Anesthetic Agents
Official title: The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Retina Detachment
Pterygium
Keratitis
Vitreous Hemorrhage
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.


Eligibility criteria: Inclusion Criteria:

* All patient scheduled for ophthalmic surgery under general anesthesia
* American Society of Anesthesiologist physical status I or II

Exclusion Criteria:

* hematologic disorder
* severe anemia
* liver disease
* kidney disease
* taking a medication interfering with hemostasis

Primary outcomes:
measure: Clotting time of ROTEM
timeFrame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
measure: Clot firmness time of ROTEM
timeFrame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
measure: Alpha angle of ROTEM
timeFrame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
measure: Maximum clot firmness of ROTEM
timeFrame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Secondary outcomes:
measure: Hemoglobin
timeFrame: 10 minutes before the induction of anesthesia
measure: Hematocrit
timeFrame: 10 minutes before the induction of anesthesia
measure: Platelet count
timeFrame: 10 minutes before the induction of anesthesia
measure: International normalized ratio of prothrombin time
timeFrame: 10 minutes before the induction of anesthesia
measure: Activated partial thromboplastin time
timeFrame: 10 minutes before the induction of anesthesia
measure: Fibrinogen
timeFrame: 10 minutes before the induction of anesthesia
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT01978405: Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
Official title: Short-Term Alpha Lipoic Acid Therapy for Prevention of Contrast-induced Acute Kidney Injury and Endothelial Dysfunction in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
The Changes of Plasma Creatinine
The Changes of Plasma Free Radicals
The Changes of Endothelium-dependent Arterial Dilation
Keywords: Type 2 diabetes
Nephropathy
Contrast medium
Alpha lipoic acid
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast-induced acute kidney injury (CIAKI) is a major complication with adverse outcomes after contrast media injection. Although the risk of developing CIAKI is low in patients with normal renal function, it is dramatically higher in patients with conditions such as diabetes mellitus (DM) or chronic kidney disease (CKD). More recently, our data showed that contrast agents can induce endothelial dysfunction partially via free radicals in diabetes. Therefore, strategies to prevent CIAKI and endothelial dysfunction in DM patients with CKD are urgently needed. Alpha-lipoic acid and its reduced form, dihydrolipoate, are potent antioxidants. We hypothesized that alpha lipoic acid can prevent the contrast-induced acute kidney injury and endothelial dysfunction in type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* nephropathy (stage 3 and 4)

Exclusion Criteria:

* recive alpha lipoic acid
* type 1 diabetes
* nephropathy (stagte 1, 2 and 5)
* hypersensitivity to contrast media
* IV heart failure
* lactic acidosis

Primary outcomes:
measure: Contrast induced acte kidney injury
timeFrame: 6 months
measure: The changes of endothelium-dependent arterial dilation before and after contrast administrated
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
affiliation: Wuhan General Hospital
name: Xiang Guangda, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04583605: The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors
Official title: Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Skin Cancer
Epidermoid Carcinoma
Neuroendocrine Carcinoma
Lymph Node Metastases
Keywords: vacuum assisted closure
PRENEVA
lymph node dissection
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: major patient affected by a metastatic skin tumors

Brief summary: In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

Detailed description: Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.

Eligibility criteria: Inclusion Criteria:

* major patient affected by a metastatic skin tumors
* the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor

Exclusion Criteria:

* lymph node dissection resumption

Primary outcomes:
measure: Is there a visible scar disunion ?
timeFrame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
measure: Is there lymphorrhoea from the scar ?
timeFrame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Secondary outcomes:
measure: Are there lymphocele punctures ?
timeFrame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
measure: Is there any lymphoedema ?
timeFrame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
affiliation: Visceral Surgery Department
name: Manuela PEREZ
role: STUDY_DIRECTOR
References:
Clinical trial NCT00350805: Measuring Time Windows in Patients With Schizophrenia and Healthy Controls
Official title: Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Time perception
Cortical synchronization
Electroencephalography
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National de la Recherche Scientifique, France
name: Institut de Physique Biologique de Strasbourg
First posted: 2006-07-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, residents of Strasbourg

Brief summary: Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia (DSM-IV criteria)
* Healthy controls matched with patients on age, sex and education level
* Age between 18 and 50
* Informed consent signed
* No severe somatic illness
* No invalidating sensory disease
* No drug abuse, as defined by DSM-IV criteria
* No general anesthesia in the past 3 months
* No intake of drug affecting the CNS, except for patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Service de Psychiatrie Adulte & INSERM U841, Hôpital Albert Chenevier et Henri Mondor (AP-HP)
city: Rouffach
country: France
facility: Centre Hospitalier de Rouffach
city: Strasbourg
country: France
facility: INSERM U666 - Département de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Anne GIERSCH, MD
role: PRINCIPAL_INVESTIGATOR
References: