louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02551510: Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
Official title: Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Closure After Port Catheter Implantation
Keywords: Skin Adhesive
Suture
Port Incisions
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Aesculap AG
First posted: 2015-09-16
Enrollment: 128
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: Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.

Detailed description: Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.

Eligibility criteria: Inclusion Criteria:

* Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition

Exclusion Criteria:

* Children and adolescents \< 18 years
* Thrombocytes \< 50/nl
* PTT \<50%
* INR \>1.5
* Systemic or local infection of the interventional location
* Known allergy to used material
* Known allergy to Histoacryl, Cyanoacrylate, D\&C Violett or Formaldehyd
* General contraindication of port catheter implantation

Primary outcomes:
measure: Cosmetic outcome after wound healing
timeFrame: 8 weeks
measure: Cosmetic outcome after wound healing
timeFrame: 8 weeks
measure: Cosmetic outcome after wound healing
timeFrame: 8 weeks
Secondary outcomes:
measure: Infection rate
timeFrame: 8 weeks
measure: Economy of time for wound closure
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
Study officials:
References:
citation: Witting S, Ingwersen M, Lehmann T, Aschenbach R, Eckardt N, Zanow J, Fahrner R, Lotze S, Friedel R, Lenz M, Schmidt C, Miguel D, Ludriksone L, Teichgraber U. Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing. Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324.
Clinical trial NCT02422810: High-Shear Microfluidic Thrombosis Assay
Official title: Characterization of a Novel High-Shear Thrombosis Assay in Normal and Aspirin-treated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Defects, Other and Unspecified
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 16
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are healthy Emory Executive Health patients over the age of 45 with no history of myocardial infarction, ischemic stroke, or other ischemic event

Brief summary: The purpose of this study is to characterize a new test to assess the rate and time it takes to form a blood clot in people who either do or do not take aspirin.

Detailed description: It is estimated that approximately 25% of people are resistant to aspirin, or do not respond to its effect. These individuals have a four fold higher risk of a heart attack or stroke compared to those who respond to aspirin. Current tests for determining those who are aspirin resistant are not reliable. This study is assessing the effectiveness of a new assay in determining the rate and time it takes for people who are or are not on aspirin in forming a blood clot.

Eligibility criteria: Inclusion Criteria for "no aspirin" group:

* have not taken aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel in the previous 10 days
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "aspirin daily" group:

* have taken aspirin daily over the last 10 days or more
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "new to aspirin" group:

* have not previously been prescribed aspirin, but have been prescribed aspirin at their present appointment, e.g. a high calcium plaque score on CT
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Exclusion Criteria:

* a known bleeding or thrombotic disorder

Exclusion Criteria for "new to aspirin" group:

* a known bleeding or thrombotic disorder
* have taken aspirin, other NSAIDs, clopidogrel, or an anticoagulant in the previous 10 days

Primary outcomes:
measure: Thrombotic occlusion time
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Sharon Bergquist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00561210: Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Official title: Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections on
Severe Burn Patients
Keywords: infections
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 57
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune enhancing diet versus polymeric diet)in severe burn hospitalized patients .


Eligibility criteria: Inclusion Criteria:

* Thermic burn from 20% to 80%
* 15 \< age \< 70 years
* written informed consent

Exclusion Criteria:

* diabetes mellitus
* corticoid or immuno-suppressive therapy
* HIV
* evolutive cancers
* pregnancy
* abdominal lesion
* hepatic or renal failure

Primary outcomes:
measure: Number of infections and number of multiple organ failure
timeFrame: 6 months
Secondary outcomes:
measure: digestive tolerance and healing
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin-Unites des brules
city: Lyon
country: France
facility: Hôpital Saint Luc - Service des brûlés
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nantes
country: France
facility: Hopital Hotel Dieu-Service des brules
city: Paris Cedex 12
country: France
facility: Hopital Saint Antoine- Service des Brules
Study officials:
affiliation: Hopital Edouard Herriot - Lyon
name: Cecile Chambrier
role: STUDY_CHAIR
References:
Clinical trial NCT05996510: Suprascapular Notch Cross-sectional Area Measured by Ultrasonography
Official title: Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Shoulder Impingement Syndrome
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Chronic shoulder pain is one of the most common diseases affecting the quality of life today. Although there are multiple causes, one of the most common causes is shoulder impingement syndrome.

Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions that are usually evaluated, the visualization of the Suprascapular notch is usually observed during injection. The connection between the suprascapular notch and the shoulder joint has been demonstrated in different studies.

Detailed description: In this study, the investigation of the relationship between the measurements of the suprascapular nerve and the suprascapular notch, which the investigators observed in our clinical ultrasound applications, and the disease activity intended.

Eligibility criteria: Inclusion Criteria:

* chronic shoulder pain
* 35-65 years
* who agreed to participate in the study

Exclusion Criteria:

* . Lymphoproliferative diseases and other neoplasms
* .Uncontrolled arterial hypertension
* Metabolic syndrome
* Uncontrolled diabetes mellitus
* Mental retardation
* Antidepressant use
* Autoimmune diseases

Primary outcomes:
measure: Suprascapular notch cross-sectional area measurement
timeFrame: baseline
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: baseline
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: korgün ökmen
role: STUDY_CHAIR
affiliation: uludağ university faculty of medicine
name: Lale altan inceoğlu, phd
role: STUDY_CHAIR
affiliation: uludağ university faculty of medicine
name: ugur ertem, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06950710: Mechanisms of Macrophage Polarization in HIRI in Patients With NAFLD
Official title: Mechanisms of Macrophage Polarization in Hepatic Ischemia-Reperfusion Injury in Patients With Non-Alcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatic Ischemia-reperfusion Injury
Non-alcoholic Fatty Liver Disease
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing partial hepatectomy

Brief summary: To better understand the occurrence of hepatic ischemia-reperfusion injury (IRI) in patients with non-alcoholic fatty liver disease (NAFLD) and the role of macrophage polarization in this process, this study will retrospectively collect clinical data from patients who underwent partial hepatectomy at Beijing Tsinghua Changgung Hospital between September 2021 and March 2025. Additionally, clinical information and liver blood samples from patients scheduled for partial hepatectomy from April 2025 onward will be prospectively collected. These samples will include normal liver tissue from the resected portion, as well as 5 mL of venous blood obtained before and after surgery. The investigators will compare the severity of hepatic IRI, the expression of macrophage polarization-related proteins, and macrophage polarization markers in blood samples between NAFLD patients and controls. The study aims to determine whether NAFLD patients experience more severe hepatic IRI and to elucidate the role and mechanisms of macrophage polarization in this context. The findings will provide a theoretical basis for understanding the molecular mechanisms underlying hepatic IRI in NAFLD patients, thereby identifying potential therapeutic targets to prevent IRI and improve prognosis in NAFLD patients undergoing partial hepatectomy.


Eligibility criteria: Inclusion Criteria:

* The vital organ systems (heart, lungs and kidneys) have sufficient functional reserves.

Exclusion Criteria:

* No hepatic inflow occlusion (Pringle maneuver) was applied during surgery.
* American Society of Anesthesiologists (ASA) Physical Status Classification \> Grade III.
* Secondary causes of hepatic steatosis were excluded, including viral hepatitis, drug-induced liver injury, total parenteral nutrition, Wilson's disease, and autoimmune liver diseases.
* Prior chemotherapy or radiotherapy before the planned surgery.
* Use of anticoagulant medications.

Primary outcomes:
measure: Concentration of transaminase
timeFrame: 7 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University
state: Beijing
Study officials:
References:
Clinical trial NCT05372510: Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
Official title: A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Human Immunodeficiency Virus Type I Infection
Keywords: HIV-1, immune responses, cell death, acute
Lead sponsor: MRC/UVRI and LSHTM Uganda Research Unit
Sponsor class: OTHER
Collaborators: name: International AIDS Vaccine Initiative
First posted: 2022-05-12
Enrollment: 100
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: Any females and males between 18years - No limit.

* Able and willing to provide informed consent.
* Willing to undergo HIV testing using GeneX pert Viral Load assay.
* Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff.
* Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.

Brief summary: It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint.

This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.


Eligibility criteria: Inclusion Criteria:

* Females and males.
* Able and willing to provide informed consent.
* Willing to undergo HIV testing using GeneX pert Viral Load assay.
* Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff.
* Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.

Exclusion Criteria:

Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives.

* Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.

Primary outcomes:
measure: To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: MRC/UVRI & LSHTM, Uganda Research Unit,Masaka station
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: ANDREW OBUKU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172510: Mutation Analysis of 17α-Hydroxylase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudohermaphroditism
Congenital Adrenal Hyperplasia
Hypertension
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

Detailed description: 17α-hydroxylase is a rare form of congenital adrenal hyperplasia. Patients with complete 17α-hydroxylase deficiency may come to attention to the doctor at their early adulthood due to hypertension or disordered puberty. 17α-hydroxylase is a form of cytochrome P450 enzyme in the adrenal cortex for the production of cortisol, while 17,20-lyase is required in both adrenal glands and the gonads for the production of androgen precursors of sex hormones. Therefore, patients with 17α-hydroxylase will presented with elevated deoxycorticosterone (DOC) level and decreased aldosterone and cortisol level. Because DOC is the second most important naturally occurring mineralocorticoid hormone, hypertension and hypokalemic alkalosis will be noted in these patients. Besides, deficiency of 17,20-lyase activity will lead to impairment of virilization in 46 XY patients and deficient estrogen production in 46 XX patients.

The P450c17 has both 17α-hydroxylase and 17,20-lyase activity and are encoded by the CYP17 gene. The sequence of CYP17 gene was established in 1987 and more than 40 mutations were identified till now. The purpose of this study is to elucidate the molecular pathology of the 4 families with 17α-hydroxylase/17,20-lyase deficiency.

Eligibility criteria: Inclusion Criteria:

* Patients with 17α-hydroxylase deficiency and their family

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yi-Ching Tung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05839210: Lifestyle Intervention of Food and Exercise for Lymphoma Survivors
Official title: Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Hodgkin Lymphoma
Hodgkin Lymphoma
Keywords: Mediterranean Diet
Exercise Program
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 120
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 purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read or understand English or Spanish
5. Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:

   1. R-CHOP or R-CHOP-like regimen
   2. BR
   3. BV-AVD or ABVD or checkpoint inhibitor+AVD
6. ECOG Performance Status grade of \<2

   a. PI approval needed if ECOG = 2
7. Approval from treating oncologist, confirmed via email or in writing
8. Delivery of chemotherapy treatments at one of the following institutions:

   1. Sylvester Comprehensive Cancer Center (including satellite/network sites)
   2. University of Miami Hospital/UHealth Tower
9. Internet access on a smart phone, tablet, or computer
10. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria:

1. Individuals younger than 18 years of age
2. Unable to provide consent
3. Unable to read or understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
6. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. History of dementia or major psychiatric disease
8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

Primary outcomes:
measure: Percentage of Survivors who participate
timeFrame: Up to 12 months
measure: Percentage of Participants Completing Intervention Sessions
timeFrame: Up to 26 weeks (Post-Intervention)
measure: Change in percentage of participant satisfaction
timeFrame: 4 weeks (post-intervention), up to 30 weeks
Secondary outcomes:
measure: Average Relative Dose Intensity (RDI)
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Tracy E Crane, Phd, RDN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Craig Moskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912210: Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Official title: Higher Protein Diet and Exercise for Optimal Weight Loss in Elderly Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bone and Body Composition
Obesity
Metabolic Syndrome
Physical Function
Quality of Life
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 31
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The broad aim is to determine efficacy of a weight loss diet higher in protein and lower in carbohydrate combined with low intensity exercise to favorably impact body composition, bone health, physical function, metabolic disease and quality of life compared to a conventional higher carbohydrate diet in overweight women over age 60.


Eligibility criteria: Inclusion Criteria:

* Body mass index \> 28 kg/m²
* Clearance of primary physician to participate in diet and mild exercise

Exclusion Criteria:

* Medical condition contraindicating prescribed diet and exercise regimen
* Type 2 Diabetes Mellitus
* Physically active lifestyle (\>30 min moderate physical activity 2+ times weekly)

Primary outcomes:
measure: Bone and body composition: Weight, percent fat, muscle and fat distribution in the thigh and abdomen and bone density and structural quality assessed by DXA and structural MRI
timeFrame: Baseline and post 6 months weight loss
Secondary outcomes:
measure: Physical function: balance, gait, strength and activities of daily living
timeFrame: Baseline and post 6 months weight loss
measure: Quality of life
timeFrame: Baseline and post 6 months weight loss
measure: Metabolic syndrome: insulin resistance, blood pressure, blood lipids, waist circumference
timeFrame: Baseline and post 6 months weight loss
measure: Acid-base balance
timeFrame: Baseline and post 1 and 6 months weight loss
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Ellen M Evans, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Donald K Layman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References: