louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02170688: Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT
Official title: Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IV Contrast Dosing
Keywords: IV contrast
contrast dosing
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There are several different methods that can be used to determine the dose of iodinated contrast material for a CT scan. These include a standard fixed dose, a dose based on total body weight, a dose based on body mass index, a dose based on lean body weight, and a dose based on estimated lean body weight. The fixed dose method uses a predetermined amount of contrast material for all patients having a CT scan of the abdomen regardless of size. This is the standard procedure currently used at Duke. The other methods use the patient's weight, either the total body weight or lean body weight, to determine the amount of contrast necessary for the CT exam. For this study, the investigators will use the fixed dose, total body weight, the lean body weight, and estimated lean body weight methods. The purpose of this study is to evaluate these five methods of determining the IV contrast volume and which may be best for abdominal CT scanning.


Eligibility criteria: Inclusion Criteria:

* male or non-lactating, non-pregnant females
* 18 years or older who are able to give written informed consent

Exclusion Criteria:

* a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver or glycogen storage diseases
* patients with a prolonged cardiac transit time such as those with a congested heart failure, a history of prior cardiac valve replacement, or restrictive/constrictive pericarditis
* patients having undergone any other radiological procedure utilizing iodinated contrast with the 24 hours prior to the CT exam
* patients above a certain total body weight (440 lbs.) due to limitation of the scales themselves (determined by manufacturer)
* any subjects with a history of hypersensitivity to iodine-containing compounds or renal insufficiency (serum creatinine \>1.8)
* subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps, etc.)

Primary outcomes:
measure: Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)
timeFrame: baseline, post-dose imaging (approximately 1hr)
Secondary outcomes:
measure: Difference in Volume of Contrast Used, Measured in Milliliters
timeFrame: baseline, post-dose imaging (approximately 1hr)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Lisa Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196909: Clinical, Biological and NMR Outcome Measures Study for Hereditary Inclusion Body Myopathy Due to Mutation of UDP-N-acetylglucosamine 2-epimerase/N-acetylmannosamine Kinase Gene (GNE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIBM
Keywords: HIBM
GNE
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to identify the best clinical and biological outcome measures for further therapeutics approaches.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age.
* Must be willing and able to provide consent.
* Must have a genetic diagnosis of HIBM, GNE myopathy, Quadriceps Sparing Myopathy (QSM), Inclusion Body Myopathy Type 2, distal myopathy with rimmed vacuoles (DMRV), or Nonaka disease.
* Must be willing and able to comply with all study requirements.
* Affiliated to or a beneficiary of a social security category
* Must take part in the HIBM-PMP UX001-CL401 study

Exclusion Criteria:

* Received ManNAc therapy or other similar substance
* Any unrelated, comorbid disease or condition that, in the view of the investigator, would interfere with study participation or would affect safety.
* Patients with specific contraindication to MRI (i.e. metallic foreign body, claustrophobia...) will be allowed to participate, but MRI will not be performed.
* Pregnant women.

Primary outcomes:
measure: Measure of changes in motor function and muscle strength assessment between 2 time points
timeFrame: baseline, 1 year, 2 years, 3 years
measure: Measure of changes in NMR upper and lower limbs assessment between 2 timepoints(not for controls)
timeFrame: baseline, 1 year, 2 years, 3 years
measure: 24h urine and serum collection, measures at different time points
timeFrame: baseline, 1 year, 2 years, 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institute of Myology
Study officials:
References:
Clinical trial NCT02121509: Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/750 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-04-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.


Eligibility criteria: Inclusion criteria:

- Healthy male or female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition

Primary outcomes:
measure: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Maximum Measured Concentration of Linagliptin in Plasma (Cmax)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: Cmax of Metformin in Plasma
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Secondary outcomes:
measure: Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
measure: AUC0-inf of Metformin in Plasma
timeFrame: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1288.10.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00135109: Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathies
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 654
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: This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.


Eligibility criteria: Inclusion Criteria:

* Diabetic neuropathy

Exclusion Criteria:

* Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.

Primary outcomes:
measure: To investigate the efficacy of 200, 400, and 600mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.
Secondary outcomes:
measure: To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, and quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Shaibani A, Fares S, Selam JL, Arslanian A, Simpson J, Sen D, Bongardt S. Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial. J Pain. 2009 Aug;10(8):818-28. doi: 10.1016/j.jpain.2009.01.322. Epub 2009 May 5.
Clinical trial NCT02705209: Cayenne Pepper Cataplasm - Effect Study
Official title: Cayenne Pepper Cataplasm - Effect Study on Healthy Subjects and Subjects With Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Low Back Pain
Lead sponsor: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
Sponsor class: OTHER
Collaborators: name: Comenius University
First posted: 2016-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The beneficial analgesic effects of Rubefacenciae (redden skin substances), is known since 1830 as a treatment for pain, cramps, and disorders of the musculoskeletal system. Herbal cataplasms containing rubefacient substances, such as Cayenne pepper, are commonly used as natural medications to treat painful or aching areas in the case of acute or chronic back pain, and rheumatisms. In Vienna and lower Austria, a Cayenne Pepper Cataplasm (CPC) application containing Cayenne pepper and Kaolin powder in mixed proportion, is commonly used to treat musculoskeletal conditions of pain especially of the low back.

Therefore, the aim of the present study was to test effects of a series of ten applications of CPC prepared with 5% of pepper, investigating the resulting effect on: skin temperature, skin sensory functions, pain threshold, and proprioception. Placebo control condition (0% cayenne pepper) was also tested. It was hypothesized that a series of 20-minute application of a CPC will have significant effects on the measured parameters.

40 subjects will be randomized into Treatment/control group.


Eligibility criteria: Inclusion Criteria:

* chronic lumbar spine pain \>= 3 months
* pain during activity VAS \>= 4
* Oswestry Disabilty Index \>= 20%

Exclusion Criteria:

* pregnancy
* sensibility disorders (e.g. due to neurological disease)
* injuries, open wounds or rash in intervention area
* known hypersensitivity against the applied substances
* HIV, Hepatitis C and other due blood communicable infectious diseases

Primary outcomes:
measure: Two-point discrimination test
timeFrame: before 1st and 3 weeks later after 10th intervention
Secondary outcomes:
measure: Monofilament Test
timeFrame: before 1st and 3 weeks later after 10th intervention
measure: Skin Temperature
timeFrame: before 1st and 3 weeks later after 10th intervention
measure: Blood Sample
timeFrame: before, 1h and 48h after the first intervention and 3 weeks later before, 1h and 48h after 10 interventions
measure: Range of Motion (thoracic and lumbar spine)
timeFrame: before 1st and 3 weeks later after 10th intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Ludwig Boltzmann Institute of Electrical Stimulation and Physical Rehabilitation
city: Bratislava
country: Slovakia
facility: Facultiy of Physical Education and Sports, Comenius University of Bratislava
Study officials:
References:
Clinical trial NCT04071509: Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device
Official title: Pilot Study on the Prevention of PNX (Pneumothorax) and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Procedures Using the MIPP-Kit Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications in Diagnostic Percutaneous Lung Biopsy Procedures
Keywords: Lung Biopsy, pneumothorax, interventional radiology
Lead sponsor: BetaGlue Technologies spa
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.


Eligibility criteria: Inclusion Criteria:

* Clinical indication for diagnostic percutaneous lung biopsy

Exclusion Criteria:

* Pregnant, or breastfeeding patient (Female)
* actively participating in other clinical trials in the previous 30 days
* known allergies to the investigational device components
* comorbidities that preclude undergoing percutaneous lung biopsy procedure
* concomitant treatments that preclude undergoing percutaneous lung biopsy procedure

Primary outcomes:
measure: Rate of complications associated with percutaneous lung biopsy
timeFrame: 48 hours after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Istituto Tumori Bari Giovanni Paolo II
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
References:
Clinical trial NCT06490809: Minimal Clinically Important Difference of the Box and Block Test in Parkinson
Official title: Examining the Clinical Significance of the Change in Manual Dexterity of Parkinson&#39;s Patients Receiving Conventional Physiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Box and Block Test
Minimal Clinically Important Difference
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.

Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.

Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.


Eligibility criteria: Inclusion Criteria:

* Being Hoehn \&amp; Yahr Stage between 1-3,
* Individuals in the "On" phase,
* Those who were not exposed to any physiotherapy intervention during the initial assessment

Exclusion Criteria:

* Mini-mental status assessment \&lt; 24 points;
* Presence of severe dyskinesia,
* Those who experience fluctuations in the on-off phase,
* Those who have undergone stereotaxic brain surgery for Parkinson's,
* Individuals with changes in dopamine dose within three months,
* Presence of unstable cardiac and respiratory disease
* Those with an orthopedic problem or a history of surgery affecting upper extremity performance.

Primary outcomes:
measure: Box and Block Test
timeFrame: Baseline of the study
measure: Box and Block Test
timeFrame: 6 weeks (5 session days for 6 weeks)
measure: Global Rating of Patient-Perceived Changes (GRP-PC)
timeFrame: 6 weeks (5 session days for 6 weeks)
Secondary outcomes:
measure: Demographic Data Form
timeFrame: Baseline of the study
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Özel Öz İstanbul Tıp Merkezi
Study officials:
affiliation: Karadeniz Technical University
name: Murat Emirzeoğlu, PhD
role: STUDY_CHAIR
affiliation: Bağcılar Education and Research Hospital
name: Tuğba Eyigürbüz, PhD
role: STUDY_CHAIR
affiliation: İstanbul Gelişim University
name: Adem Aktürk, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05047809: The Effect of "Jinchuang Ointment" (JCO) on the Treatment of Wounds in Patients With Hansen's Disease.
Official title: The Evaluation of Treatment of Leprosy Wounds With Traditional Chinese Herbal Medicine Complex "Jingchuang Ointment"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leprosy
Hansen's Disease
Wounds
Keywords: Leprosy
Hansen's disease (HD)
Jinchuang Ointment (JCO)
wounds
anti-inflammation
Lead sponsor: Lo-Sheng Sanatorium
Sponsor class: OTHER_GOV
First posted: 2021-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the effect of a Chinese herb complex "Jinchuang ointment" (JCO) on the treatment of chronic nonhealing wounds in patients with Hansen's disease and its mechanism.

Detailed description: 20 patients who were hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare, were recruited. Ulcers were treated in this study using the four-step wound care guidelines, observation, rinsing, cleaning, and dressing, published by the Taiwan Food and Drug Administration. Besides, JCO was applied once a day on the wounds.

Basic data of each case were collected, and a monthly wound record was used to follow the condition of the wound healing of these patients.

Eligibility criteria: Inclusion Criteria:

* Hanson's patients
* Meet the definition of chronic wound

Exclusion Criteria:

* Kidney disease
* Parathyroid disease
* Malignant tumors.

Primary outcomes:
measure: The size of wound area
timeFrame: Changes in wound size in 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Lo-Sheng Sanatorium
Study officials:
affiliation: Lo-Sheng Sanatorium
name: Wei-Hung Hsu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00583609: A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently treated with PEG3350 powder for treatment of constipation.


Eligibility criteria: Inclusion Criteria:

* Male or female constipated outpatients between the ages of 4 and 16
* Currently taking a dose of PEG 3350 powder up to a maximum of 17g per day that has been consistent for at least 4 weeks, or if less than 4 weeks, the investigator testifies that the patient is stable
* Current treatment is considered successful - defined as greater than 2 bowel movements per week with no accidents
* Are otherwise in good health, as judged by a physical examination
* If female and of childbearing potential, patient must be using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so for the duration of the study
* In the investigator's judgment, patient or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients who are impacted at baseline exam
* Patients with known or suspected perforation or obstruction
* Patients with a history of gastric retention, inflammatory bowel disease, bowel resection, or colostomy
* Patients with a known history of organic cause for their constipation
* Patients currently using medications known to cause constipation (these include opiates, antidepressants, SSRI's, antimotility agents and anticholinergics)
* Patients who are breastfeeding, pregnant, or intend to become pregnant during the study
* Female patients of childbearing potential who refuse a pregnancy test
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedure
* Patients with known allergy to PEG or PEG containing medications
* Patients who, within the past 30 days have participated in an investigational clinical study

Primary outcomes:
measure: Efficacy will be measured by analysis of patient self reported bowel movement (BM) data
timeFrame: 2 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Morristown
country: United States
state: New Jersey
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: