louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006427: Chronic Pain After Amputation
Official title: Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Amputation, Traumatic
Pain
Postoperative Pain
Keywords: Amputation
Chronic Pain
Amitriptyline
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2000-11-02
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

Detailed description: This double-masked placebo controlled trial will randomize patients (n=125) who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks. Patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment. Study participants will also be interviewed by telephone to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain, at the beginning and end of the six-week trial and four months later.

Eligibility criteria: Inclusion Criteria:

* Amputation six months ago or longer
* Pain for 3 months or longer

Exclusion Criteria:

* History of cardiovascular disease, seizures, or glaucoma
* Currently taking antidepressant medications
* Currently hyperthyroid or taking thyroid medication
* Currently pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Department of Rehabilitation Medicine
state: Washington
Study officials:
affiliation: University of Washington, Department of Rehabilitation
name: Lawrence Robinson, MD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis RW. Successful treatment for phantom pain. Orthopedics. 1993 Jun;16(6):691-5. doi: 10.3928/0147-7447-19930601-10.
citation: Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.
citation: Philipp M, Fickinger M. Psychotropic drugs in the management of chronic pain syndromes. Pharmacopsychiatry. 1993 Nov;26(6):221-34. doi: 10.1055/s-2007-1014359.
Clinical trial NCT05470127: Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Official title: Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Disease
Prostate CA
Keywords: Prostate CA
Needle biopsy
Lead sponsor: Uro-1 Medical
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two biopsy needle sets will be used in the same patient during the procedure.
Primary purpose: DIAGNOSTIC

Brief summary: Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.

Detailed description: The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.

Eligibility criteria: Inclusion Criteria:

* Adult male scheduled for prostate biopsy
* Able to provide informed consent
* Able and willing to provide verbal assessment of his condition 5 days post-procedure

Exclusion Criteria:

* Unwilling to provide consent

Primary outcomes:
measure: Procedure Success
timeFrame: 1 Day of the procedure
measure: Core length of tissue in the sample
timeFrame: 1 Day of the procedure
measure: weight of tissue in the sample
timeFrame: 1 Day of the procedure
measure: Tissue Sample Preparation
timeFrame: 1 Day of the procedure
Secondary outcomes:
measure: Ease of use of the biopsy needle
timeFrame: 1 Day of the procedure
Other outcomes:
Locations:
city: Cartersville
country: United States
facility: Georgia Urology
state: Georgia
Study officials:
affiliation: Lawson & Associates
name: Thomas Lawson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04730427: Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19
Official title: A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.

Detailed description: This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.

Study design: prospective, randomized, placebo-controlled, single-blind, single-center

Eligibility criteria: Key Inclusion Criteria:

1. Subjects who have been confirmed to be COVID-19 corresponding to mild cases of severity categorization classified by FDA through polymerase chain reaction (PCR) test or virus gene test (sequencing) and who can be available to be administered within seven days from the date of manifestation.
2. Subjects who are or will be inpatient.

Key Exclusion Criteria:

1. Patients with symptoms of moderate or higher in the severity classification presented by FDA have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc)
2. Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration

Primary outcomes:
measure: Incidence rate, characteristics, and severity of adverse reactions
timeFrame: up to 52 weeks
measure: Shift from baseline of vital sign
timeFrame: up to 52 weeks
measure: Shift from baseline of physical examination
timeFrame: up to 52 weeks
measure: Shift from baseline of hematology
timeFrame: up to 52 weeks
measure: Shift from baseline of blood chemistry
timeFrame: up to 52 weeks
measure: Dose limiting toxicity (DLT)
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Absolute lymphocyte count (ALC)
timeFrame: up to 3 weeks
measure: RT-PCR for COVID-19
timeFrame: up to 52 weeks
measure: Assessment of clinical improvement by modified early warning score (MEWS)
timeFrame: up to 52 weeks
measure: Ordinal scale for clinical improvement (WHO) in each visit
timeFrame: up to 52 weeks
measure: The proportion of subjects who have progressed to death or a critical illness
timeFrame: up to 52 weeks
measure: Immune repertoire
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
Study officials:
affiliation: Genexine_Clinical Development Dept.
name: Minkyu Heo
role: STUDY_DIRECTOR
References:
Clinical trial NCT04497727: Gut Organoid Study
Official title: Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gut Inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypertensive and normotensive patients who routinely undergo scheduled elective colonoscopy (for different, not selected reasons)

Brief summary: The study will compare basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study will determine if there are fundamental differences in the gut epithelium in hypertension compared to normotension.


Eligibility criteria: Inclusion Criteria:

* Inclusion/exclusion criteria for hypertension participants
* Ages: 18-80 years old with a weight greater than or equal to 110 lbs
* Diagnosis of hypertension or without hypertension for the reference cohort. 2017 ACC/AHA (American College of Cardiology/American Heart Association) definition for hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be used.
* Scheduled elective colonoscopy

Exclusion Criteria:

* Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions.
* Pregnant or have been pregnant in the last six months.
* Antibiotic treatment within two months of study enrollment
* Currently taking a medication (e.g. antibiotic, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitor drugs like Prilosec) known to modify gut microbiota.
* Unwilling to discontinue using probiotics for at least two weeks before scheduled biopsy.
* History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
* History of blood transfusion within 4 weeks.
* Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures

Primary outcomes:
measure: Samples with DNA
timeFrame: Visit 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Carl Pepine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04963127: Prospective Study of Diagnostic Accuracy of Spectral CT for the Detection of Bone Marrow Edema
Official title: Prospective Observational Study of Diagnostic Accuracy of Dual-Energy-/Multi-Energy-CT for the Detection of Bone Marrow Edema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fractures, Bone
Bone Marrow Edema
Keywords: Spectral CT
Multi-Energy CT
Dual-Energy CT
Bone Marrow Edema
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are at least 18 years of age who are referred by the emergency department for a CT scan with the suspicion of a fracture.

Brief summary: Dual-Energy/Multi-Energy/Spectral-CT can visualize bone marrow edema associated with fractures, however, current scientific evidence is mostly derived from to retrospective analyses. Our prospective study systematically analyzes the diagnostic accuracy of the visualization of bone marrow edema by including patients who are scheduled for a CT scan to exclude or further characterize a fracture. After giving informed consent, the CT scan will be performed using a dose-neutral Dual-Energy-/Multi-Energy-/Spectral-CT acquisition technique. If the patient undergoes MRI of the same region within 7 days, this scan will be used as a gold-standard for bone marrow edema. This will allow the quantification of diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

* clinical suspicion for a fracture AND
* indication for CT confirmed by board-certified radiologist ('justified indication' according to German/European radiation protection law) AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* cardiorespiratory instability (as judged by the referring physician)
* age \< 18 years
* known or suspected pregnancy
* known bone metastases of a malignant disease
* known rheumatic disease
* metal implants in the region to be scanned
* surgical intervention over the last 12 months in the region to be scanned
* contraindications for MRI

Primary outcomes:
measure: Diagnostic Accuracy of Dual-Energy/Multi-Energy/Spectral CT to detect bone marrow edema in comparison with MRI as the goldstandard.
timeFrame: MRI of the same region can be used for comparison if performed within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
state: Bavaria
Study officials:
affiliation: University Hospital Augsburg
name: Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302127: County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Official title: County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes Mellitus Type 2
Cardiovascular Diseases
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 2560
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.


Eligibility criteria: Inclusion Criteria:

1. Aged between 40 and 70 years old;
2. Patients with hypertension or diabetes;
3. Permanent residents of the county where the research is conducted;
4. Already signed up with the family doctor team in the township where the research is located.

Exclusion Criteria:

1. Unable to independently carry out the interventions required for the study;
2. Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits;
3. Patients who refuse to participate;
4. Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects;
5. Pregnant or lactating women

Primary outcomes:
measure: CVD 10-year risk
timeFrame: 12 months
Secondary outcomes:
measure: CVD incidence rate
timeFrame: 12 months
measure: systolic blood pressure
timeFrame: 12 months
measure: total cholesterol
timeFrame: 12 months
Other outcomes:
Locations:
city: Sanming
country: China
facility: Shaxian County General Hospital
state: Fujian
city: Liuzhou
country: China
facility: Luzhai County People's hospital
state: Guangxi
city: Liuzhou
country: China
facility: Luzhai County Traditional Medicine hospital
Study officials:
References:
Clinical trial NCT04623827: Retrospective Study of Psychoattitudinal Patterns in Patients With Fibromyalgia Receiving Antalgic Therapy
Official title: A Retrospective Study Concerning the Psycho-attitudinal Classification of Patients Suffering From Fibromyalgia Undergoing a Specialized Analgesic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Fibromyalgia
Pain, Chronic
Pain Syndrome
Keywords: Fibromyalgia
Pain, Chronic
Analgesia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of fibromyalgia who come to the pain therapy service over the age of 18 between January 2018 and January 2019..

Brief summary: Fibromyalgia (FM) is a widespread and invalidating disease that requires a multidisciplinary approach. Particularly, the psychiatric component seems to influence the algological management of these patients. Since January 2018, the HADS, SF-36, IMSA, TCI psycho-attitudinal questionnaires have been introduced in the Pain Therapy unit of Policlinico Sant'Orsola-Malpighi in an attempt to improve the care of patients diagnosed with FM.

The aim of the study is to identify, through retrospective evaluation of TCI tests and its subdomains, compiled by patients with FM diagnosis, Pain Avoidance and Pain Persistance personality patterns, indicated in the literature. Anxiety and Depression incidence is also observed through retrospective evaluation of HADS tests.

Patients in the Antalgic Therapy Outpatient Clinic diagnosed with FM, aged ≥18 years, who have completed selfadministered psychoattitudinal tests from January 2018 to January 2019 were considered. The data were collected in aggregate and extrapolated anonymously.


Eligibility criteria: Inclusion Criteria:

* diagnosis of fibromyalgia
* years ≥ 18

Exclusion Criteria:

* not present

Primary outcomes:
measure: Psycho-attitudinal Pattern
timeFrame: 1 year
Secondary outcomes:
measure: Anxiety and depression
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Andrea Fanelli
Study officials:
References:
Clinical trial NCT04665427: Factors Influencing Occurrence of Bile Leaks in Surgery
Official title: Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bile Leak
Anastomotic Leak Biliary
Biliary Tract Fistula
Keywords: hepatobiliary surgery
Morbidity
leak
anastomosis
Lead sponsor: University of Oran 1
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.

Detailed description: The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.

Eligibility criteria: Inclusion Criteria:

* Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.

Exclusion Criteria:

* Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
* Subjects under the age of 18. Years.
* Subjects who refused to participate in this study.
* Cases of biliary and pancreatic anastomoses performed during the same surgery.

Primary outcomes:
measure: The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
timeFrame: From (day 0) of surgery to (day 90)
Secondary outcomes:
measure: Postoperative hospital stay
timeFrame: From (day 0) of surgery to (day 90)
measure: Mortality
timeFrame: From day 0 to day 90
Other outcomes:
Locations:
city: Oran
country: Algeria
facility: Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.
Study officials:
affiliation: University Oran1
name: Benali Tabeti, Pr
role: STUDY_CHAIR
References:
Clinical trial NCT01067027: Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Official title: Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colic
Keywords: Colic
Colic in Breast-fed Infants
Lead sponsor: Children's Investigational Research Program, LLC
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is believed that probiotic Lactobacillus reuteri will improve the symptoms of breast-fed infants with colic.


Eligibility criteria: Inclusion Criteria:

* Ifants aged between 14 and 60 days
* Breast fed, exclusively during length of trial
* Diagnosis of infantile colic according to Wessel's criteria i.e paroxysmal fussing in infancy for more than three hours per day, at least three days per week.
* Debut of colic symptoms 6+/-1 days before randomization
* Gestational age between 37 and 42 weeks
* Apgar score higher than 7 at 5 minutes
* Mothers willing to follow a cows mild-free diet (free from mild, yoghurt, cheese etc) during the study period
* Written informed consent from one or both parents
* Stated availability throughout the study period

Exclusion Criteria:

* Major chronic disease
* Gastrointestinal disease but controlled GERD with or without medication is not an exclusion criteria
* Administration of anitbiotics the week before randomization
* Administration of probiotics the week before randomization
* Participation in other clinical trials

Primary outcomes:
measure: * Reduction of daily average crying time to less than 3 hours from baseline to the end of the study period as measured using a daily reporting of crying time by the parents.
timeFrame: 7, 14 and 21 days
Secondary outcomes:
measure: Number of responders versus non-responders with L. reuteri versus placebo at end of the study.
timeFrame: 21 days
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Children's Investigational Research Program
state: Arkansas
Study officials:
affiliation: Children's Investigational Research Program
name: Bryan M Harvey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: