louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01784835: Early Exposure to OMT Prevents Long LOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: Osteopathic manipulative treatment
neonatology
neonatal care
prematurity
complementary and alternative medicine
length of stay
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-02-06
Enrollment: 113
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants


Eligibility criteria: Inclusion Criteria:

* preterm infants born at age between 29 and 37 weeks
* osteopathic treatment performed \< 14 days after birth
* preterms born in the same hospital

Exclusion Criteria:

* Gestational age \< 29 weeks
* Gestational age \> 37 weeks
* First OMT performed after 14 days from birth
* genetic disorders
* congenital disorders
* cardiovascular abnormalities
* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction
* pre/post surgery patients
* pneumoperitoneum
* atelectasis
* Newborn from an HIV seropositive/drug addicted mother
* respiratory disorders
* transferred to/from other hospital
* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Primary outcomes:
measure: Number of days of LOS
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: effectiveness of OMT considering different lag time between birth and the first OMT
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: Macerata
country: Italy
facility: Macerata Hospital
Study officials:
References:
citation: Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15.
Clinical trial NCT00639535: Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities
Official title: Comparative Study of the Diagnostic Accuracy of Scintimammography (Fluorine 18-FDG PET Scintigraphic Imaging) and Magnetic Resonance Imaging in Identifying Malignant Breast Lesions, In Subjects With Breast Abnormalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Disease
Keywords: Radiology
MRI
Positron emission tomography
Breast Abnormalities
Dense Breast Tissue
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from Breast Care Clinic and local physicians.

Brief summary: This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. In addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured.

The MRI studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. Multifocal pathology can be challenging in determining site(s) for biopsy.

PET scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. A further drawback of PET is the lack of ability to observe lesions less than 3-4mm in diameter.

In select cases the combination of MR and PET/CT is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.


Eligibility criteria: Inclusion Criteria:

* Woman who have breast volumes allowing utilization of MRI breast coil
* Patients who are considered, by radiologist reading the mammograms, to have non interpretable or difficult to interpret x-ray studies. These patients may or may not have palpable breast lumps and may and may not have suspicious areas on their x-ray mammograms.

Exclusion Criteria:

* Women of child bearing potential not practicing a medically accepted method of birth control
* Women who are pregnant or breast-feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United States
facility: Central New York PET Center
state: New York
city: Syracuse
country: United States
facility: University Radiology Associates
state: New York
city: Syracuse
country: United States
facility: Institute For Human Performance
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: David Feiglin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01627535: Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
Official title: Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Keywords: Brain Tumor
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-25
Enrollment: 4
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 clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally remove brain tumors and minimize damage to normal brain.

Detailed description: PRIMARY OBJECTIVES:

I. To develop the instrumentation to achieve real time processing and display of intraoperative 2-dimensional optical imaging and spectroscopy (i2DOS) maps in the operating arena.

II. To examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS.

OUTLINE: Patients undergo i2DOS.

Eligibility criteria: Inclusion Criteria:

* Neurosurgical patient population in the City of Hope brain and spinal tumor neurosurgical programs that have been diagnosed with a brain tumor.
* Only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study.
* We do intend to enroll subjects with potentially terminal brain tumors. Due to the potential benefit of intraoperative mapping, we are not planning to exclude these subjects.
* Patients with any type of brain tumor will be eligible for participation.
* All subjects must have the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* There are no exclusion criteria except for individuals without a brain tumor and the location of the craniotomy. If the exposed area of brain is not compatible with peripheral stimuli or volitional activity the subject cannot be enrolled.
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Primary outcomes:
measure: Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.
timeFrame: Day 1 post surgery
measure: Intraoperative determination of the location of critical brain functions.
timeFrame: Day 1 post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Neal Prakash, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951235: A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
Official title: A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 315
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: TREATMENT

Brief summary: This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.


Eligibility criteria: Inclusion Criteria:

1. Subject has given written informed consent
2. Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
3. Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
4. HbA1c criteria: ≥ 7% and ≤ 9.5%
5. Creatinine clearance ≥ 50 mL/\[min\*1.73 m2\] at Screening Visit
6. Effective contraception for women of child bearing potential

Exclusion Criteria:

1. Any disease which in the investigator's opinion would exclude the subject from the study
2. Acute cardiovascular event within 3 months before randomization
3. Uncontrolled high blood pressure
4. Impairment of hepatic function
5. History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
6. Pregnancy or lactation
7. Use of any non-permitted medication
8. Positive screen for viral hepatitis

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)
timeFrame: Baseline to week 24
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
Study officials:
affiliation: P. Stradins Clinical University Hospital
name: Valdis Pirags, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449135: Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Carcinoma
Official title: Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Carcinoma：Clinical Trial
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Nano drug
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-05-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

Detailed description: By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for pancreatic cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except pancreatic cancer
2. History of coagulation disorders or anemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.
Clinical trial NCT06775535: Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation
Official title: Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Neuropathic Pain
Persistent Spinal Pain Syndrome Type 2
Lead sponsor: AZ Delta
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 12
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: Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.

Brief summary: Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.

Detailed description: The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\&#39; sensation.

Eligibility criteria: Inclusion Criteria:

* Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
* Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
* Subject is ≥ 18 years old.
* Subject is not pregnant or nursing.
* Subject is willing and capable of giving informed consent.

Exclusion Criteria:

* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Subject is incapable of understanding or responding to the study questionnaires.
* Subject is incapable of understanding or operating the patient programmer handset.

Primary outcomes:
measure: Number of participants with change in stimulation sensation
timeFrame: 6-months
Secondary outcomes:
measure: NRS
timeFrame: Baseline, 3-months, 6-months, 12-months post-implant
measure: Number of participants with reduced pain distribution
timeFrame: Baseline, 3-months, 6-months and 12-months post-implant
measure: Paraesthesia mapping
timeFrame: 3-months, 6-months and 12-months post-implant
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
affiliation: AZ Delta
name: Karel Hanssens
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491735: Patterns of Glaucoma in Glaucoma Subspecialty Clinics in Egypt and India in the Year 2018
Official title: Patterns of Glaucoma in Glaucoma Subspecialty Clinics in Egypt and India in the Year 2018
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Determining Patterns of Glaucoma in Glaucoma Sub-specialty Clinics in Two Countries: Egypt and India
Keywords: patterns
glaucoma
egypt
india
2018
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
Collaborators: name: Sadguru Netra Chikitsalaya, Post Graduate Institute Of Ophthalmology (New SNC)
First posted: 2018-04-09
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to and following up in the glaucoma sub-specialty clinics in the year 2018 in two centres: Kasr Al-Aini Hospital in Cairo and Sadguru Netra Chikitsalaya Postgraduate Institute of Ophthalmology in India

Brief summary: In this study, we are aiming to identify the patterns of glaucoma observed and treated at Glaucoma Subspecialty Clinics of Kasr Al-Aini Hospital, Cairo University in Cairo, Egypt and corresponding clinics in Sadguru Netra Chikitsalaya Post Graduate Institute of Ophthalmology in Mumbai, Maharashtra, India during the year 2018. We are hoping that this study would provide an update on current statistics available on Indian population as well as provide novel numbers on the prevalence of glaucoma and its patterns in one of the largest tertiary care hospitals in Egypt. These results will then be compared to patterns observed in other epidemiological studies done in other countries.


Eligibility criteria: Inclusion Criteria:

* All patients referred to glaucoma sub-specialty clinics in the year 2018 in two centres: Kasr Al-Aini Hospital in Cairo and Sadguru Netra Chikitsalaya Postgraduate Institute of Ophthalmology in India

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with incomplete examination data

Primary outcomes:
measure: Patterns of Glaucoma
timeFrame: 12 months starting january 1st, 2018 til December 31st, 2018
measure: Demographic data
timeFrame: 12 months starting january 1st, 2018 til December 31st, 2018
Secondary outcomes:
measure: Anti-glaucoma treatment
timeFrame: 12 months starting january 1st, 2018 til December 31st, 2018
measure: Positive family history
timeFrame: 12 months starting january 1st, 2018 til December 31st, 2018
measure: Management decisions
timeFrame: 12 months starting january 1st, 2018 til December 31st, 2018
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al-Aini Hospital, Cairo University
city: Mumbai
country: India
facility: two centres: Kasr Al-Aini Hospital in Cairo and Sadguru Netra Chikitsalaya Postgraduate Institute of Ophthalmology
Study officials:
References:
Clinical trial NCT04210635: Management of Anxiety in Intensive Care Unit Including Olfactotherapy
Official title: Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Lead sponsor: Laboratoires Arkopharma
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 35
Sex: ALL
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: The target population is made up of adult patients (aged over 18) hospitalized in the intensive care unit and expressing a complaint or presenting a state of anxiety during their hospitalization.

Brief summary: The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.

Detailed description: The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).

Eligibility criteria: Inclusion Criteria:

* Hospitalized in one of the departments participating in the study
* Presenting moderate to high intensity anxiety (Digital scale ≥ 5);

Exclusion Criteria:

* Having already benefited from the "ZEN cart"
* Having taken an anxiolytic during the past 48 hours
* Patient (s) intubated and / or sedated
* Allergy or known intolerance to one of the essential oils used
* Respiratory allergies, asthma, or a history of seizures
* Unable to understand the information note (linguistic reason, or related to his medical condition)
* Pregnant or lactating woman.

Primary outcomes:
measure: measurement of the evolution of anxiety
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Laurent du Var
country: France
facility: Institut Arnault Tzanck
Study officials:
References:
Clinical trial NCT00630058: A Phase 1 Study of MP-424, Peginterferon Alfa 2b, and Ribavirin in Hepatitis C
Official title: A Phase I, Open-Label, Two-Arm Study of MP-424 in Combination With Peginterferon Alfa 2b and Ribavirin in Patients With Genotype 1b Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Protease Inhibitor
Telaprevir
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the safety, pharmacokinetics, HCV RNA kinetics, and other viral characteristics after administration of two arms of MP-424 in combination with Peginterferon Alfa 2b (PEG-IFN-a-2b) and Ribavirin (RBV) to patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs antigen in the test

Primary outcomes:
measure: Cmax (Maximum Observed Concentration in Plasma) of MP-424
timeFrame: Data were collected at Day1 to Day85
measure: Tmax (Time of Maximum Concentration in Plasma) of MP-424
timeFrame: Data were collected at Day1 to Day85
measure: AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424
timeFrame: Data were collected at Day1 to Day85
measure: Ctrough (Minimum Observed Concentration in Plasma) of MP-424
timeFrame: Data were collected at Day1 to Day85
measure: T1/2(Time of Half-Life) of MP-424
timeFrame: Data were collected at Day1 to Day85
Secondary outcomes:
measure: Antiviral Effects of TVR on HCV Were Assessed by Measuring Plasma HCV RNA Levels
timeFrame: 37 weeks
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suzuki F, Suzuki Y, Sezaki H, Akuta N, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Mineta R, Watahiki S, Kobayashi M, Nakayasu Y, Tsuda H, Aoki K, Yamada I, Kumada H. Exploratory study on telaprevir given every 8 h at 500 mg or 750 mg with peginterferon-alpha-2b and ribavirin in hepatitis C patients. Hepatol Res. 2013 Jul;43(7):691-701. doi: 10.1111/hepr.12009. Epub 2012 Nov 29.