louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00967109: Establishment of Optimal Transfusion Threshold During Spine Surgery
Official title: Establishment of Optimal Transfusion Threshold During Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Spine Surgery
Keywords: Anemia
Tissue oxygenation
Spine surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2009-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patients undergoing spine surgery
* Be legally competent
* Read and understand Danish

Exclusion Criteria:

* Present malignant disease
* Previously apoplexia cerebri
* Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Primary outcomes:
measure: The change in subcutaneous oxygen tension from incision.
timeFrame: Every fifteen minutes throughout surgery
Secondary outcomes:
measure: Oxygenation of the brain
timeFrame: Every fifteen minutes throughout surgery
measure: The concentration of lactate in plasma
timeFrame: Every half an hour throughout surgery
measure: Variation in the ST-segment of the ECG
timeFrame: Every fifteen minutes throughout surgery
measure: Muscular saturation of the deltoid muscle
timeFrame: Every fifteen minutes throughout surgery
measure: The change in subcutaneous oxygen tension from incision.
timeFrame: Every fifteen minutes throughout surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kamilla Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520009: EHR Embedded Comparative Effectiveness Studies--CPS
Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disk Herniated Lumbar
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Trustees of Dartmouth College
name: Patient-Centered Outcomes Research Institute
First posted: 2020-08-20
Enrollment: 37
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: HEALTH_SERVICES_RESEARCH

Brief summary: Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

Detailed description: EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either activity restriction or no activity restriction following lumbar discectomy.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18) able to consent
* Sufficient fluency in English
* Indications for discectomy
* Able to restrict activities or to resume activities as tolerated

Exclusion Criteria:

* Pregnant women
* Prisoners
* Children (\<18).

Primary outcomes:
measure: Compliance Rate With Assigned Treatment
timeFrame: Upon completion of surgery approximately 24 days post-randomization
measure: Percentage Eligible Patients Participating in Study
timeFrame: 1 day, during the recruitment period from October 23 2020 to August 7, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-HItchcock
state: New Hampshire
Study officials:
affiliation: Dartmouth
name: Tor Tosteson, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05687409: Synbiotics Interventions for Managing Cirrhosis and Its Complications
Official title: Alterations in the Intestinal Microbiome and Metabolic Profile of Patients With Cirrhosis Supplemented With Lactulose, Clostridium Butyricum, and Bifidobacterium Longum Infantis: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis, Liver
Metagonimiasis
Keywords: Cirrhosis, Liver
Synbiotics
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.

Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.


Eligibility criteria: Inclusion Criteria:

* ① Hepatitis B cirrhosis was diagnosed by clinical biochemistry and imaging.

  * CTP rating is a-b.

    * There was a previous liver cirrhosis complication, including ascites, spontaneous peritonitis, massive gastrointestinal bleeding, liver coma, etc.

      * Over 18 years old. ⑤ Under 90 years old.

        * The patient or family member signs the informed consent form.

Exclusion Criteria:

* ① The CTP of liver cirrhosis was evaluated as grade C.

  * Other types of cirrhosis such as primary biliary cirrhosis.

    * Pregnancy status. ④ Have a history of diabetes, renal insufficiency, gastrointestinal surgery, etc.

      * Antibiotics, PPI preparations and microecological preparations (including yogurt) have been used in the past 8 weeks.

        * Have a history of narcotic drug abuse, drug abuse, or mental illness. ⑦ Patients and their families do not agree to sign the informed consent form. ⑧ Under 18 years old or over 90 years old.

Primary outcomes:
measure: Liver CT to assess cirrhosis in 70 cirrhotic participants
timeFrame: Up to 11 months
measure: Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
timeFrame: Up to 12 months
measure: Metabolomics to assess the metabolites of the 120 cirrhotic and healthy participants' intestinal microbiota including polyketides(Casimiroedine μmol/L),Benzenoids(Olmesartan μmol/L),Organoheterocyclic compounds(Amlexanox μmol/L) and etc.
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03859609: Comparison of GAP-score With Schwab-score
Official title: Failure Prediction of Adult Spinal Deformity Surgery Comparing GAP-score With Schwab-score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Adjacent Segment Degeneration
Keywords: GAP-score
Schwab score
Proximal Junctional Failure
Spinal Fusion
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had fusion operation with dorsal instrumentation on at least 3 spinal levels

Brief summary: The predictive value of two different score-systems with regard to failure rate following long extent spinal fusion is subject of evaluation.

Detailed description: The multilevel spinal fusion is associated with high rate of failure. This results from insufficient adaptation of the fused spine to the proper individual spinal alignment. In the recent years, comprehensive understanding of spinal alignment and definition of several parameters contributed to develop score systems to evaluate the alignment of the multilevel spinal fusion and to predict failure. In the following study the results of multilevel spinal fusion were evaluated retrospectively according to two scoring systems: GAP-score und Schwab-score. The predictive value of each score system is analyzed by the correlation of the failure rate with its corresponding score value.

Eligibility criteria: Inclusion Criteria:

* 3 and more fusion levels

Exclusion Criteria:

* Neuromuscular disease

Primary outcomes:
measure: Radiological Evaluation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Orthopaedic Surgery, University Hospital Frankfurt
Study officials:
affiliation: Goethe University
name: Mohammad Arab Motlagh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03542409: Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas
Official title: Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor Adult
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 60
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: This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.

Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.

Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Suspected glioma (grade II, III, or IV)
* Preoperative MR perfusion (enhancing tumors)
* Preoperative MR 2-HG spectroscopy (nonenhancing tumors)Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
* Karnofsky performance status ≥ 60
* Life expectancy \> 12 weeks
* Cohort 1: Ability to comply with study and follow-up procedures
* Cohort 2: Ability to comply with study procedures

Exclusion Criteria:

* Prior diagnosis of intracranial glioma
* Other malignancy with expected need for systemic therapy within 3 years
* Inability to have 6000 grays of radiation to the brain
* Need for urgent palliative intervention for primary disease (e.g., impending herniation)
* Evidence of bleeding diathesis or coagulopathy
* History of intracerebral abscess within 6 months prior to Day 0
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Pregnant females
* Subjects unable to undergo an MRI with contrast

Primary outcomes:
measure: Intraoperative Imaging Completion
timeFrame: 1 day
measure: Incidence of Patient Complications Following Tumor Resection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
References:
Clinical trial NCT02095509: Pharmacokinetics of Enoxaparin in Intensive Care Patients
Official title: Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2014-03-24
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily.

To investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin


Eligibility criteria: Inclusion Criteria:

* Body Mass Index between 18-30 kg/m2
* Critically ill patients requiring intensive care and pharmacological thromboprophylaxis
* Expected to remain in the ICU for at least 72 h
* Written informed consent obtained from the patient or his/her legal representative.

Exclusion Criteria:

* Other indications for anticoagulant therapy than thromboprophylaxis
* Intracranial haemorrhage or central neurosurgical operation within three months prior to the admission
* Disseminated intravascular coagulation (DIC) according to the international society on Thrombosis and Haemostasis criteria
* Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
* Treatment with enoxaparin or any other low-molecular weight heparin (LMWH) or heparin within 24 hours prior to ICU admission. If patient has received thromboprophylactic dose of LMWH within 24-72 hours before ICU admission inclusion can be done if measured anti-factor Xa level is \<0.1 IU/ml at the time of admission
* Any long-term anticoagulant medication, expect low-dose aspirin
* Major bleeding within the last week unless definitively treated
* Blood platelet count \<50, P-thromboplastin time (TT) \<40% , international normalized ratio (INR) \>1.7
* Glomerular filtration rate less than 50 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation or chronic dialysis
* HIV, hepatitis B virus, or hepatitis C virus infection
* Pregnancy

Primary outcomes:
measure: Plasma anti-factor Xa level
timeFrame: 72 hours
Secondary outcomes:
measure: Incidence of Venous thromboembolism
timeFrame: 90 days
measure: Incidence of Bleeding
timeFrame: 90 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Meilahti
state: Uusimaa
Study officials:
References:
Clinical trial NCT04958109: Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Official title: Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolic Diseases
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-07-12
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

Detailed description: Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.

Delivery of Interventions:

* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the inpatient study, the subjects will

  * Undergo a 16-hour kisspeptin infusion
  * Undergo an oral glucose tolerance test

Eligibility criteria: Inclusion Criteria:

History:

* over the age of 18,
* normal pubertal development
* stable weight for previous three months,
* normal body mass index (BMI between 18.5-25)
* regular menstrual cycles

Physical examination:

• systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg

Laboratory studies: (per Massachusetts General Hospital reference ranges)

* normal hemoglobin
* hemoglobin A1C \< 6.5%
* blood urea nitrogen, creatinine not elevated
* aspartate aminotransferase, alanine aminotransferase \< 3x upper limit of normal

Exclusion Criteria:

* active illicit drug use,
* history of a medication reaction requiring emergency medical care,
* difficulty with blood draws.
* history of chronic disease, except well controlled thyroid disease,
* recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
* history of diabetes in a first degree relative,
* use of contraceptive pills, patches or vaginal rings within last 4 weeks.
* hyperlipidemia by fasting lipid panel
* positive serum pregnancy test (for all women)

Primary outcomes:
measure: Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Margaret Lippincott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00551109: SA4503 8-Week Study in Major Depressive Disorder (MDD)
Official title: A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: M's Science Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.

Detailed description: Further study details as provided by M's Science Corporation:

Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 18 and 65 (inclusive)
* Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
* HAM-D17 score of \>/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
* Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.

Exclusion Criteria:

* Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
* Subjects who require psychotropic medication other than the study medication
* Subjects who started psychotherapy within 4 months prior to Screening
* Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
* Subjects who have a primary diagnosis of anxiety
* Subjects who regularly use sleeping medication more than 3 times per week
* Subjects who have major psychiatric or neurologic disorders other than MDD
* Subjects with depression secondary to stroke, cancer, or other severe medical illness
* Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Turku
country: Finland
Study officials:
affiliation: Helsinki University Central Hospital, Department of Psychiatry
name: Björn Appelberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03038607: Aspirin in Asymmetrically Intrauterine Growth
Official title: Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intrauterine Growth Restriction Asymmetrical
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications.

When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.


Eligibility criteria: Inclusion Criteria:

* The pregnant women
* 28-30 weeks
* Idiopathic asymmetrically intrauterine growth restriction
* Middle aged women (20-35 years)
* Women with abnormal umbilical artery Doppler flow indices ( \> +2 standard deviation above mean for gestational age)

Exclusion Criteria:

* Women less than 20 and more than 35 years
* hypertensive or diabetic women
* any type of smoking
* multiple pregnancies
* amniotic fluid index \<5 cm
* premature pre-labor rupture of membranes
* abnormal placenta
* any fetal congenital malformations.
* women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.

Primary outcomes:
measure: Estimated fetal weight
timeFrame: 6 weeks
Secondary outcomes:
measure: Birth weight
timeFrame: 6 weeks
measure: Changes in Doppler blood flow indices in umbilical artery
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: