louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01225718: Ceftriaxone in Non-neutropenic Fever
Official title: Ceftriaxone in Non-neutropenic Fever
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Histiocytosis
Pediatric Patients With Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-10-21
Enrollment: 463
Sex: ALL
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with and treated for malignancy, Langerhans cell histiocytosis ,or Hemophagocytic lymphohistiocytosis between 2007 through 2010 at Monroe Carrell Jr. Children's Hospital at Vanderbilt under the age of 23 at diagnosis.

Brief summary: This is a retrospective chart review of all patients cared for at Monroe Carell Jr. Children's Hospital at Vanderbilt including the following:

* patients between 2007-2009 with malignancy, Langerhans cell histiocytosis (LCH) or hemophagocytic lymphohistiocytosis (HLH) and a central venous catheter who were under 23 years of age at time of diagnosis in order to ascertain the associated symptoms, management and outcome of all episodes of non-neutropenic fever.
* to identify a subset of low-risk patients that can be safely managed without use of empiric antibiotics.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis from 2007 through 2010
* Under 23 years at time of diagnosis of malignancy, Langerhans cell histiocytosis,or hemophagocytic lymphohistiocytosis
* Treated at Monroe Carell Jr. Children's Hospital at Vanderbilt for aforementioned diagnosis from 2007 through 2012
* While on immunosuppressive therapy with a central venous line in place had at least one documented episode of fever (defined as ≥ 38.0°Celsius orally for over 30 minutes or ≥ 38.3°Celsius orally x1).

Exclusion Criteria:

* Does not meet all inclusion criteria as stated above

Primary outcomes:
measure: Incidence of catheter-associated blood stream infections from all episodes of non-neutropenic fever in pediatric oncology, Langerhans cell histiocytosis or Hemophagocytic lymphohistiocytosis patients diagnosed and treated at Vanderbilt
timeFrame: 12 months
Secondary outcomes:
measure: Identify risk factors associated with increased risk for catheter-associated blood stream infections in non-neutropenic pediatric oncology and histiocytosis patients with unexplained fever by collecting data for all eligible medical records.
timeFrame: 12 months
measure: Effectiveness of administering empiric cefepime or ceftriaxone in a non-neutropenic oncology or histiocytic patient is estimated, using available microbiologic and antimicrobial susceptibility data from blood cultures
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carrell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
References:
Clinical trial NCT03477318: Accuracy of Endoscopists in Predicting Polyp Pathology
Official title: Accuracy of Endoscopists in Predicting Polyp Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resected Polyp
Keywords: colonoscopy, polyp, endoscopist
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 159
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 50 years or older undergoing first-time screening colonoscopy

Brief summary: The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. Patients 50 years or older undergoing first-time screening colonoscopy will be included in this observational study.

Detailed description: The study purpose is to assess the accuracy of experienced endoscopists at a community hospital in predicting histological types of polyps resected at colonoscopy using white light. The study will be conducted at Good Samaritan Hospital and TriHealth Surgery Center West. Study participants include patients 50 years or older undergoing first-time screening colonoscopy. This is an observational study and does not involve any patient interventions. After completing the colonoscopy, the endoscopist will document their prediction of the polyp type. The polyp type predicted by the endoscopist will be compared to the polyp type documented in the pathology report to determine accuracy. It is estimated that study enrollment will take 6 months.

Eligibility criteria: Inclusion Criteria:

* Males and females

Exclusion Criteria:

* first degree relative diagnosed with colorectal carcinoma at age 59 or under
* New onset of iron deficiency anemia (within past 3 months)
* Abnormal imaging of colon within past 3 months
* Pregnant women
* Inadequate visualization reported by endoscopist

Primary outcomes:
measure: Polyp prediction accuracy
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT05925218: Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Official title: Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: High Grade Glioma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected or pathologically-proven, previously untreated high grade gliomas

Brief summary: Improved outcomes for high-grade gliomas (HGG) require advances in our ability to monitor changes to tumour biology using non-surgical approaches. "Liquid biopsy" is a term used to describe a technique whereby tumour DNA, which has been shed off and then circulates through the blood stream, is detected and analyzed. Our goal is to develop a new type of liquid biopsy that is suitable for primary brain tumours that uses a method that is highly sensitive and allows for ongoing analysis of these tumours.

Detailed description: The study objective is to determine the feasibility of measuring both the burden and key molecular features of HGG through profiling of plasma circulating tumour DNA (ctDNA). This will be determined by detecting ctDNA in samples from HGG patients, and measuring changes in ctDNA levels over time following HGG treatment. 50 eligible patients will be enrolled in the study at University Health Network, and up to 10 blood samples will be obtained; up to 2 blood samples prior to their radiotherapy treatment, and 8 blood samples after their radiotherapy treatment. If available, tissue samples that are stored at UHN will also be collected for DNA extraction.

Eligibility criteria: Inclusion Criteria:

* Patients can be enrolled either prior to a planned surgery/biopsy for a suspected HGG or after biopsy/surgery of pathologically proven, previously untreated HGG, prior to adjuvant radiotherapy
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Age ≥18 yrs

Exclusion Criteria:

* History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years.

Primary outcomes:
measure: Feasibility of measuring both the burden and key molecular features of high- grade gliomas (HGG) through profiling of plasma circulating tumour DNA (ctDNA)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT03944018: Rehabilitation Coordinators in Orthopedic Care
Official title: Rehabilitation Coordinators in Orthopedic Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Problems or Pain
Foot Problems or Pain
Shoulder Problems or Pain
Keywords: Back pain
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: REKO-O is a study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic.

Detailed description: REKO-O is a randomized controlled intervention study that addressed women and men on sick leave in Uppsala County. Participants which are enrolled in orthopedic care clinic

Eligibility criteria: Inclusion Criteria:

* Not recovered in accordance with care plan or cannot be operated and wants an extension of his sick leave

Exclusion Criteria:

* Obvious medical complications for surgery (wound infection, prosthetic dislocation, stopper or the like)
* Permanent disability pension

Primary outcomes:
measure: RTW
timeFrame: 0.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university
Study officials:
References:
Clinical trial NCT06879418: Comparison Between Low and Medium Dose Radial Extracorporeal Shock Wave Therapy on Patients with Cervicogenic Headache: a Randomized Controlled Trial
Official title: Comparison Between Low and Medium Dose Radial Extracorporeal Shock Wave Therapy on Patients with Cervicogenic Headache: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Keywords: shock wave therapy
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized double blinded controlled trial will be conducted to determine and compare the effects of low and medium dose radial extracorporeal shock wave therapy on upper trapezius trigger points in patients with cervicogenic headache. Data will be collected at base line and at the end of the treatment program. Participants will be assigned randomly into three groups Group (A) will receive 2000 shock waves at frequency 10 MHz and 0.02mj/mm2 flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (B) will receive 2000 shock waves at frequency 10 MHz and 0.178 mj/mm2 energy flux density plus strengthening and stretching exercise for upper trapezius muscle.

Group (C) will receive sham shock wave therapy plus strengthening and stretching exercise for upper trapezius muscle.


Eligibility criteria: Inclusion Criteria:

* Symptoms of mechanical neck pain lasting for more than three months
* Skeletal muscle with a palpable taut band
* Hypersensitive point inside the taut band with the ability to reproduce referred pain when the sensitive spot is palpated,
* Joint soreness in at least one of the upper cervical spine's joints (c1-c3)
* Unilateral discomfort that originates in the neck and radiates to the frontotemporal area
* Pain that is made worse by moving the neck
* Headaches that occur at least once a week for a duration longer than three months.

Exclusion Criteria:

* Other primary headaches (i.e., migraine, tension-type headache)
* Bilateral headaches,
* Other defined cervical problem such as fracture, dislocation, skin disease, illness that is inflammatory, neural illness, vertebrobasilar insufficiency, a birth defect, tumor, or infection.

Primary outcomes:
measure: Henry Ford Hospital Headache disability inventory (HDI)
timeFrame: before the first session and after the last session (Four weeks)
measure: Upper trapezius electromyographic activity
timeFrame: before the first session and after the last session (Four weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02463318: The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Oxidative Stress
Keywords: Multiple sclerosis
SIRT1
MnSOD
Catalase
Oxidative stress
Antioxidant enzyme
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.


Eligibility criteria: Inclusion Criteria:

patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.

-

Exclusion Criteria:

* The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.

Primary outcomes:
measure: Relative gene expression by real-time PCR (polymerase chain reaction)
timeFrame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Secondary outcomes:
measure: MnSOD enzyme activity assay
timeFrame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
measure: Catalse enzyme activity assay
timeFrame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
measure: SIRT1 enzyme activity assay
timeFrame: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Solaleh Emamgholipour
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Ali Sahraian, Neurologist
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Solaleh Emamgholipour, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904018: Validation Study of Oral Teleconsultation
Official title: Validation Study of Oral Teleconsultation - Study EDENT2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People who are in long-term care home with oral telemedicine activity

Brief summary: In this study we want to evaluate the oral care pathway after an oral teleconsultation.

Detailed description: An oral teleconsultation was proposed to the 461 residents of the public hospital of Uzès. A specifically trained nurse recorded 4 videos (1 per quadrant) per mouth with an intra-oral camera using fluorescent light (Soprocare®) and keyed in information about the resident (general state, identification,...). These data were recorded and sent onto a central secured server, through a specific piece of software (e-DENT®). The dentists from the University Hospital of Montpellier were then able to analyse the videos remotely, make a diagnosis and organise each resident's oral care.

Eligibility criteria: Inclusion Criteria:

* The subject is aged at least 18 years
* Patients cared for in their host institution

Exclusion Criteria:

* NA

Primary outcomes:
measure: Diagnostic of caries
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic of caries
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02566018: Treatment of Proximal Humerus Fractures in the Elderly
Official title: Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humeral Fractures
Keywords: elderly
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients fulfilling all of the following inclusion criteria

Brief summary: This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

Detailed description: This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Eligibility criteria: Inclusion Criteria:

* Age of 65 years or above
* Proximal humerus fracture
* Informed consent by the patient or legal representatives to participate in the study

Exclusion Criteria:

* More than one fracture, polytrauma
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Previous surgery of the proximal humerus on the same side
* High energy trauma
* Open Fracture
* Insufficient German language skills

Primary outcomes:
measure: personal dependency status
timeFrame: 6 months
Secondary outcomes:
measure: range of motion
timeFrame: 6 months
measure: Shoulder pain and disability index (SPADI)
timeFrame: 6 months
measure: SSV
timeFrame: 6 months
measure: General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)
timeFrame: 6 months
measure: Quality of life (utilities) derived using EQ-5D-5L
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Daniel Rikli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.
citation: Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 Jun;29(6):1127-1135. doi: 10.1016/j.jse.2019.11.006. Epub 2020 Feb 10.
Clinical trial NCT02053818: Remifentanil/Sufentanil for CABG+/-AVR Evaluated by Recovery, Cognitive Function, Haemodynamics and Biochemical Markers.
Official title: Fast-track in Cardiac Surgery. Remifentanyl & Sufentanil Anaesthesia for CABG+/-AVR Evaluated by Recovery, Cognitive Dysfunction, Haemodynamics (PAC/TTE) and Cardiac Biochemical Markers (CKMB, TNT, Pro-BNP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischaemic Heart Disease
Aortic Stenosis
Keywords: Cognitive dysfunction
Cardioprotection
Recovery
Renal function
ICU discharge
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 60
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 effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

Detailed description: 1. Haemodynamic effects, evaluated by invasive haemodynamic data (arterial line and PAC) of opioid given as single drug and in combination with Propofol (first 30 patients only).
2. Cognitive dysfunction evaluated by standard test preoperative and postoperative day 1, 4 and 30
3. Recovery quality and time parameters using objective ICU score criteria
4. Cardioprotection effect evaluated by myocardial biochemical markers obtained preoperative and postoperative 4, 9 and 18 hours

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for coronary artery bypass grafting (CABG) +/- aortic valve replacement (AVR)

Exclusion Criteria:

* Ejection Fraction \< 30%
* Previous Myocardial Infarction within 4 weeks
* Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) \> 33% of mean arterial pressure (MAP)
* Arterial hypertension (Sap \> 180, Dap \> 110)
* Diabetes, Non- and Insulin dependent
* Non usable echocardiography windows

Primary outcomes:
measure: Cognitive function score
timeFrame: Postoperative day 4
measure: Fast-track potential
timeFrame: Time ((mean hours) to eligible discharge from ICU (up to 48 hours)
Secondary outcomes:
measure: Eligible time to discharge from ICU
timeFrame: Time (hours) to ICD4
measure: Postoperative cognitive dysfunction
timeFrame: Postoperative day 1 and 30
Other outcomes:
measure: Haemodynamic effects of opioids
timeFrame: From induction anaesthesia until cardiopulmonary bypass
measure: Cardioprotection
timeFrame: 0,4,9,15 and 40 hours after surgery
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
name: Carl-Johan Jakobsen, MD
role: STUDY_DIRECTOR
References: