louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01307254: Association Between Non-alcoholic Fatty Liver Disease and Iron Status
Official title: (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD - Non Alcoholic Fatty Liver Disease
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
Collaborators: name: Prof Doron Zamir
First posted: 2011-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.

Brief summary: The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.

The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.

Detailed description: Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.

This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

Eligibility criteria: Inclusion Criteria:

* age\>18
* BMI\>25

Exclusion Criteria:

* pregnancy
* unable to sign an informed consent (legally)
* known solid/hematological malignancy
* hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
* active or carrier of viral hepatitis
* treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment \> 3 months)
* consumption of \> 120g ethanol per week
* primary liver disease (eg. glycogen storage disease)
* CRP\>20
* acute intoxication
* surgery in previous 7 days

Primary outcomes:
measure: grade of fatty liver disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai medical center
Study officials:
References:
Clinical trial NCT02074254: Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors
Official title: Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tracheostomy Complication
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is being done to evaluate the safety of percutaneous tracheostomy in patients taking antiplatelet agents such as aspirin and/ or clopidogrel or selective serotonin reuptake inhibitors. We will identify all patients age 18 or older who have undergone percutaneous tracheostomy by interventional pulmonology at OSUMC and access their PHI to record variables (see data collection form).

Brief summary: Safety of Percutaneous Tracheostomy in Clopidogrel and Selective Serotonin Reuptake Inhibitors

Detailed description: We propose a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI.

Eligibility criteria: Inclusion Criteria:

* on antiplatelet therapy or selective serotonin reuptake inhibitors(SSRI)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: a retrospective review of our experience with bleeding complication in the presence of antiplatelet and SSRI therapy and compare the complications with those who were not on antiplatelet agents or SSRI
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: OSUMC
state: Ohio
city: Columbus
country: United States
facility: University Hospital, OSUMC 473 W 12th Ave
state: Ohio
Study officials:
affiliation: Ohio State University
name: Shaheen Islam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468154: Efficacy of Leg Casts With Heel Off-loaded in Children
Official title: Efficacy of Leg Casts With Heel Off-loaded in Children: Open Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorders
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assess whether by placing a "custom made" splint with heel in the immediate postoperative period until removal of the cast, the rate of pain, the number of healthcare interventions to maintain the off-loaded heel position and number of pressure sores in children wearing lower limb plaster casts is reduced.


Eligibility criteria: Inclusion Criteria:

* Treated by operations to the lower limbs which require immediate plaster casts that include the foot
* Treated by osteotomy, joint fusion, patella repositioning and fracture fixation
* Children with intact skin at the heel

Exclusion Criteria:

* Caregivers who cannot speak Italian
* Those who refuse to give their consent to take part in the study
* Patients with lower limb casts that are allowed to load the limb

Primary outcomes:
measure: Pain Score on the "Numeric Rating Scale" or "Visual Rating Scale" or "Face, Legs Activity Cry Consolability" According to Age Group
timeFrame: up to the first 2 days during hospitalization and at cast removal (maximum 30 days).
Secondary outcomes:
measure: Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
timeFrame: one time at cast removal (expected average of 30 days).
measure: Health Staff/Caregiver Interventions
timeFrame: up to the first 2 days during hospitalization
measure: Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10
timeFrame: one time at cast removal (expected average of 30 days).
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Luisa Veronesi, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06245954: The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy
Official title: Learning Curve for the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy and the Role of Standardized Training in It
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transbronchial Lung Cryobiopsy
Keywords: transbronchial lung cryobiopsy
standardized training
learning curve
bronchoscopist
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* suspected ILD.
* ≤3 months since HRCT
* Forced vital capacity (FVC) ≥50% of predicted value
* Diffused lung carbon monoxide (DLCO) ≥35% predicted value
* Echocardiography ≤ 12 months
* Estimated pulmonary artery systolic pressure ≤40 mmHg
* Body mass index (BMI) ≤35 kg/m2
* Patient consent for experimentation

Exclusion Criteria:

* Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
* Patients refused to participate in the experiment

Primary outcomes:
measure: Obtain pathologic quality assessment of specimens
timeFrame: 1 month
measure: histopathological pattern diagnosis rate
timeFrame: 1 month
measure: diagnostic rate of multidisciplinary discussions
timeFrame: 1 month
Secondary outcomes:
measure: Occurrence of short-term adverse events
timeFrame: 24 hours or 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02967354: [11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes
Official title: [11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the \[11C\]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers

Exclusion Criteria:

* Ongoing pregnancy
* Renal failure (GFR\<60 ml/min)
* Magnetic metal parts in the body
* Ongoing treatment with selective serotonin receptor inhibitors

Primary outcomes:
measure: [11C]5-hydroxy-tryptophan Uptake in the Pancreas
timeFrame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Secondary outcomes:
measure: Pancreatic Perfusion
timeFrame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
measure: Pancreatic Volume
timeFrame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
measure: Pancreatic Fat Content
timeFrame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
measure: Hepatic Fat Content
timeFrame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
Other outcomes:
Locations:
Study officials:
References:
citation: Carlbom L, Espes D, Lubberink M, Martinell M, Johansson L, Ahlstrom H, Carlsson PO, Korsgren O, Eriksson O. [11C]5-hydroxy-tryptophan PET for Assessment of Islet Mass During Progression of Type 2 Diabetes. Diabetes. 2017 May;66(5):1286-1292. doi: 10.2337/db16-1449. Epub 2017 Feb 28.
Clinical trial NCT00000354: Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3
Official title: Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110954: Fluorescence-guided Resection in Breast Cancer
Official title: Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Tumour
Lead sponsor: photonamic GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Caucasian female postmenopausal patients
* Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2)

Exclusion Criteria:

* Suspicious lymphogenic metastases (cN1-3)
* Acute or chronic hepatic diseases
* Manifest renal diseases with renal dysfunction
* Relevant cardiac disease
* Preceding therapy of breast tumour under investigation
* Patients with multiple attempts of hook-wire placement in preparation of surgery
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment

Primary outcomes:
measure: Fluorescence intensity in breast cancer tissue
timeFrame: 3 h after intake of study medication
Secondary outcomes:
measure: Laboratory data and adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Munich
country: Germany
Study officials:
References:
Clinical trial NCT02747654: Isoniazid Dosage Prediction Model Development
Official title: Development of a Dosing Model Based on Anti-tuberculosis Drug Monitoring NAT2 Genotypes in Tuberculosis Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAT2 Genotype
Keywords: NAT2 genotype guided dosing
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment. However, treatment with INH is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its associated hepatotoxicity. The objective of this study was to develop an individualized INH dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study.


Eligibility criteria: * Eligible participants were patients newly diagnosed with active TB
* Who underwent standard four drug treatment for 6months: isoniazid (5 mg/kg, usually 300 mg), rifampin (450 mg for \<50 kg or 600 mg for 50 kg body weight), ethambutol(15mg/kg), and pyrazinamide (20 - 30 mg/kg)
* Given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months.
* Those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-TB treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to INH at the start of treatment were excluded.

Primary outcomes:
measure: Serum concentrations of INH
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: SMC
name: Soo-Youn Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813954: The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Official title: The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Transient Tachypnea of Newborn
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 184
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. While fetal urine is the major content of AF since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL depends on chloride transport and postnatal clearance of FLL is provided by active reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. Lower genomic expression of Na channels in airways is shown to be associated to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.


Eligibility criteria: Inclusion Criteria:

Accepted to participate with informed consent Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

Primary outcomes:
measure: The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Postdoctoral Fellow of Neonatology
name: Seda Yilmaz Semerci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yilmaz Semerci S, Yucel B, Erbas IM, Gunkaya OS, Talmac M, Cetinkaya M. The utility of amniotic fluid pH and electrolytes for prediction of neonatal respiratory disorders. J Matern Fetal Neonatal Med. 2020 Jan;33(2):253-257. doi: 10.1080/14767058.2018.1488961. Epub 2018 Jul 22.
Clinical trial NCT00583154: A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Official title: A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: constipation
laxative
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 60
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: To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 18 years of age
* Constipated according to ROME I criteria
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
* Subjects who are pregnant or lactating, or intending to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any BLI-801 component.
* Subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Primary outcomes:
measure: Bowel Movement Count
timeFrame: 24 hours
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Cranston
country: United States
state: Rhode Island
city: Cumberland
country: United States
state: Rhode Island
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: