louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00320333: COPD Rehabilitation in Primary and Secondary Health Care
Official title: Comparison of Pulmonary Rehabilitation of Patients With Chronic Obstructive Pulmonary Disease in Primary and Secondary Health Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
rehabilitation
health services research
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Pulmonary rehabilitation of COPD patients are implemented in a non-randomized manner in two settings: primary and secondary health care. The effect on quality of life and hospitalizations will be evaluated


Eligibility criteria: Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* severe concomitant chronic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Internal Medicin, Glostrup University Hospital
state: Glostrup
city: Gladsaxe
country: Denmark
facility: Omsorgscentret Kildegården
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Susanne Vest, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GloustrupUH
name: Allan Linneberg, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01248533: Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo
Official title: Screening for Abdominal Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm, atherosclerosis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 7500
Sex: MALE
Minimum age (years): 65
Maximum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 65 year old males in Oslo

Brief summary: Male subjects, 65 years of age, living in Oslo, Norway will be invited to be screened for abdominal aortic aneurysm.

Detailed description: The invited population will be offered ultrasound investigation of their abdominal aorta. Further information regarding risk factors will be noted and measurement of ankle-brachial index will be measured/calculated. A further step in the future will be to sample blood with focus on different cytokines and genmediators.

Eligibility criteria: Inclusion Criteria:

* Males aged 65 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Abdominal Aortic Aneurysm (AAA)
timeFrame: Yearly the number of patients with AAA among the screened population will be assessed during the inclusion period of 18 years..
Secondary outcomes:
measure: Peripheral Arterial Disease (PAD)
timeFrame: Yearly the number of patients with PAD among the screened poplulation will be assessed during the inclusion period of 18 years.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01937533: Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer
Official title: Diffusion-weighted MRI at 3T Using an Endovaginal Coil: Evaluating the Prognostic Value of the Apparent Diffusion Coefficient Distribution in Stage 1 Cervical Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Magnetic Resonance Imaging
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2013-09-09
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value.

The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).


Eligibility criteria: Inclusion Criteria:

* All patients with presumed early stage cervical cancer being considered for curative surgery

Exclusion Criteria:

* Ferromagnetic metal implants
* claustrophobia (MRI incompatibility)

Primary outcomes:
measure: To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups.
timeFrame: 1-2 months post imaging
Secondary outcomes:
measure: Establish ADC values associated with poor prognosis tumours
timeFrame: Duration of study, 2-3 years
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: ICR
name: Nandita deSouza, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03458533: Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
Official title: Changes in the Hypothalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Metabolic Syndrome
Keywords: Pituitary
Obesity
Overweight
Metabolic syndrome
MRI
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 69
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: Overweight and obese patients come to our attention for weight loss interventions

Brief summary: This study aims to identify new morphological and quantitative magnetic imaging parameters of pituitary gland and sellar region in overweight and obese patient at baseline and after 3 years, dividing patients in 3 groups (weight loss through diet and lifestyle changes, weight loss through bariatric surgery, no weight loss)

Detailed description: This longitudinal prospective study in overweight and obese patients aims to identify and characterize new morphological and quantitative MRI parameters of pituitary gland and sellar region assessed by texture analysis with a specific software (ImageJ©). These parameters will be correlated them to hypothalamic-pituitary-peripheral axis function, metabolism and body composition.

Data will be detected at baseline and at 3 years follow-up to quantitatively identify the different pituitary MRI patterns in 3 groups:

1. patients without weight modifies
2. patients with weight loss obtain through diet and lifestyle changes
3. patients with weight loss obtained through bariatric surgery

Eligibility criteria: Inclusion Criteria:

* BMI \> 25 Kg/m2

Exclusion Criteria:

* Malignant neoplasia;
* Current use of psychotropic drugs;
* Chronic renal failure;
* Pituitary macroadenomas and craniopharyngiomas;
* Contraindications to MRI execution (p. e. pace-maker, metal foreign bodies like slivers, non MRI compatible vascular clips or prosthesis)

Primary outcomes:
measure: Pituitary volume
timeFrame: 0, +3 years
Secondary outcomes:
measure: Evaluation of pituitary mean and standard deviation intensity
timeFrame: 0, +3 years
measure: Correlation of magnetic resonance parameters with anthropometric measurements
timeFrame: 0, +3 years
measure: Correlation of magnetic resonance parameters with pituitary axis function
timeFrame: 0, +3 years
measure: Correlation of magnetic resonance parameters with glyco-metabolic status
timeFrame: 0, +3 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Andrea M Isidori
Study officials:
affiliation: University of Roma La Sapienza
name: Andrea M Isidori, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02409433: Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management
Official title: Prospective, Randomized, Single-blinded Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Seizures
Keywords: lacosamide
phenytoin
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: UCB Pharma GmbH
First posted: 2015-04-06
Enrollment: 3
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: The Investigator plans to perform a prospective, randomized, single blinded, study that will compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident and sub-clinical seizures, and to compare long-term outcomes between patients treated with lacosamide and those treated with Phenytoin.


Eligibility criteria: Inclusion Criteria:

* Traumatic Brain Injury (TBI) or Subarachnoid hemorrhage (SAH)
* Admitted to the hospital less than 48 hours prior to randomization
* Glasgow Coma Scale (GCS) score 3-8 (inclusive), or GCS motor score of five or less and abnormal CT scan showing intracranial pathology
* Hemodynamically stable
* Older than 18 years of age

Exclusion Criteria:

* No IV access
* Spinal cord injury
* History of or CT confirmation of previous brain injury, including brain tumor, stroke, or a spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxia
* Liver failure
* Younger than 18 years of age
* Pregnant
* Allergy to phenytoin or lacosamide
* Inability to obtain consent

Primary outcomes:
measure: Incidence of Clinical Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Jorge Burneo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608633: Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain After Dry Needling
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.


Eligibility criteria: Inclusion Criteria:

* Subjects presenting latent trigger points in the trapezius muscle

Exclusion Criteria:

* Subjects with active trigger points or absence of trigger points.

Primary outcomes:
measure: Pain
timeFrame: 72 hours
Secondary outcomes:
measure: Pain
timeFrame: 48 hours
measure: Psychological factors
timeFrame: 72 hours after needling
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CEU San Pablo University
Study officials:
References:
Clinical trial NCT06993233: A Study With CIT-013 in HS Patients
Official title: A Phase 2a Double Blind, Randomized, Parallel Arm, Placebo-controlled Trial to Investigate the Effects of Two Dose Levels of CIT-013 on Disease Activity in Patients With Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa (HS)
Lead sponsor: Citryll BV
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 96
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: The goal of this clinical trial is to learn if CIT-013 works to treat Hidradenitis Suppurativa in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:

Does CIT-013 lower the disease activity of HS patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of HS.

Participants will:

Take receive 50 or 100 mg CIT-013 or placebo every other week for 12 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period


Eligibility criteria: Inclusion Criteria:

* Male or female participants with HS of more than 6 months duration,
* 18 years of age at screening visit,
* Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III (according to Hurley classification system),
* A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization,
* Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS,
* Total draining tunnel count less than 20

Exclusion Criteria:

* Any current and/or recurrent clinically significant skin condition in the treatment area other than HS,
* Prior treatment with a recombinant therapeutic protein during the 6 weeks before baseline
* Prior treatment with any of the following medications before baseline:

  1. Any other systemic therapy for HS (28 days before baseline)
  2. Any IV anti-infective therapy (14 days before baseline)
* History of malignancy with exception of non-melanoma skin cancer that has been excised and cured,

Primary outcomes:
measure: Proportion of participants with HiSCR75 on CIT 013 versus placebo
timeFrame: week 12
Secondary outcomes:
measure: Incidence of TEAEs as assessed by CTCAE
timeFrame: week 12
measure: Maximum Plasma Concentration of CIT-013 before doses
timeFrame: 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus UMC
Study officials:
affiliation: Citryll BV
name: Maarten Kraan
role: STUDY_DIRECTOR
References:
Clinical trial NCT06254833: Microdosing ICG for Serial Colonic Perfusion Study During Surgery
Official title: Microdosing ICG for Serial Colonic Perfusion Study During Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perfusion; Complications
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: using microdosing of ICG vs regular dosing of ICG for perfusion assessment during surgery

Detailed description: Randomized dosing of 7.5mg or 0.75mg of ICG injection during surgery for bowel perfusion assessment using new imaging equipment

Eligibility criteria: Inclusion Criteria:

* all patient undergoing intestinal resection surgery

Exclusion Criteria:

* pregnancy, renal insufficiency

Primary outcomes:
measure: ability to assess perfusion
timeFrame: up to 30 days post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
Clinical trial NCT01973933: Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR
Official title: A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Pyrimethamine and Metformin IR After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Metformin
Pyrimethamine
Drug interaction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive)
* 100 kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: AUC(area under the plasma concentration-time curve)
timeFrame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
Secondary outcomes:
measure: AUG(total area under the serum concentration-time curve for glucose)
timeFrame: predose and 15, 30, 45, 60, 90, 120, 150, 180min oral glucose tolerance test
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea
name: Jae-Yong Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139333: Blood and Tumor Tissue Samples From Young Patients With Acute Myeloid Leukemia
Official title: Evaluation of Mer and Axl Expression in Acute Myeloid Leukemia Patient Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-08
Enrollment: 52
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying blood and tumor tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To evaluate Mer and Axl expression in samples from pediatric patients with acute myeloid leukemia (AML).
* To determine if abnormal expression of Mer and Axl is associated with poor clinical characteristics (e.g., induction failure or relapse) of AML in these patients.

OUTLINE: This is a multicenter study.

Archived samples from pediatric patients with acute myeloid leukemia are analyzed for Mer and Axl expression by flow cytometry and western blot assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Children Oncology Group (COG) patient samples

PATIENT CHARACTERISTICS:

* Available clinical data

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Expression of Mer and Axl
measure: Association of abnormal expression of Mer and Axl with induction failure or relapse
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Kristen M. Eisenman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353233: Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Official title: Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Primary Total Knee Arthroplasty
Physical Therapy
Pain
Knee Extension
Keywords: iPACK
Interspace between the Popliteal Artery and Capsule of the Knee
Posterior Capsule block
Nerve Block
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 50
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Between 18 and 75 years old
* American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion Criteria:

* ASA 4 or 5
* Revision knee arthroplasty
* Diagnosis of chronic pain
* Daily chronic opioid use (over 3 months of continuous opioid use)
* Inability to communicate pain scores or need for analgesia
* Acute knee dislocation/fracture
* Infection at the site of block placement
* Age under 18 years old or greater than 75 years old
* Pregnant women
* Intolerance/allergy to local anesthetics
* Weight \<50 kg
* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
* Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Primary outcomes:
measure: Number of Participants Able to Hyperextend the Knee After Surgery
timeFrame: Within 8 hours
Secondary outcomes:
measure: Ambulation as Measured by Distance Walked After Surgery
timeFrame: Post-operative Day 0
measure: Pain as Measure by Numerical Rating Scale (NRS) 11
timeFrame: 24 hours
measure: Cumulative Opioid Consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
References: