louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00244803: Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
Official title: Redistribution and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
FRAM 1
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-27
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men or women 18-65 years old, previous FRAM 1 participant, HIV positive

Brief summary: The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.

Detailed description: This research is being done to learn whether HIV-infected patients have abnormalities in their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis), in how fat is distributed in their body and in how their body handles fat and sugars. If there are abnormalities, this study will also try to find out what factors may contribute to those abnormalitites.

People who participated in FRAM 1 may join FRAM 2.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* previous FRAM 1 participant
* HIV positive

Exclusion Criteria:

* Artificial knee or hip replacement or Harrington rod
* Metal objects in the body.Pregnancy
* Breastfeeding or less than 3 months after breastfeeding
* Weight more than 300 pound
* On insulin, pancreatic enzymes, or thioridazine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, The Clinical Trials Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph Cofrancesco Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lake JE, Wohl D, Scherzer R, Grunfeld C, Tien PC, Sidney S, Currier JS. Regional fat deposition and cardiovascular risk in HIV infection: the FRAM study. AIDS Care. 2011 Aug;23(8):929-38. doi: 10.1080/09540121.2010.543885. Epub 2011 Jun 24.
Clinical trial NCT05589103: Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.
Official title: Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head Trauma Injury
Keywords: Head Trauma Injury
Head Trauma
Traumatic Intracranial Hemorrhage
Antiaggregants, Platelet
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 1692
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) victim of mild head trauma visiting the emergency room of the Strasbourg University Hospital during 2017.

Brief summary: The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.

The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.

The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.


Eligibility criteria: Inclusion criteria

* Adult patient (≥18 years old)
* Visit to the emergency room of the Strasbourg University Hospital during 2017
* Victim of mild head trauma
* Patient who has given their consent to the reuse of their data for the purposes of this research.

Non-inclusion criteria

* Patient who expressed their opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or curatorship
* Patient on anticoagulant
* Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)

Primary outcomes:
measure: Propensity score on the factors influencing the taking of antiplatelet agents.
timeFrame: Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'accueil des urgences - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00935103: The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior
Official title: The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Addiction
Risk Reduction Behaviour
Keywords: Addiction
Psychoeducation
Risk reduction behaviour
Drop in center (DIC)
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk behavior


Eligibility criteria: Inclusion Criteria:

Age more than 18 years old Dependency to opioid drugs (Positive result of Urin addiction test)

Exclusion Criteria:

suicide attempt not tendency for including to the study receiving treatment for addiction in recent months.

Primary outcomes:
measure: IV usage of opioid
timeFrame: 12 months
Secondary outcomes:
measure: Usage of condom and safety syringe
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00185003: Blockade of Vascular Potassium Channels During Human Endotoxemia
Official title: Blockade of Vascular Potassium Channels During Human Endotoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endotoxemia
Keywords: Endotoxemia
vascular potassium channels
cytokine
norepinephrine
regional blood flow,
inflammation,
ion channels,
nitric oxide synthase,
pharmacology.
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* drug, alcohol, nicotine abuse

Primary outcomes:
measure: Hemodynamics
timeFrame: 24 hrs after LPS administration
measure: Markers of Inflammation
timeFrame: 24 hrs after LPS administration
measure: Cytokines
timeFrame: 24 hrs after LPS administration
measure: Markers of Renal Injury
timeFrame: 24 hrs after LPS administration
measure: Inducible NO synthase expression
timeFrame: 24 hrs after LPS administration
measure: NO-metabolites
timeFrame: 24 hrs after LPS administration
measure: Mediators of Vascular reactivity
timeFrame: 24 hrs after LPS administration
measure: Sensitivity to norepinephrine
timeFrame: 24 hrs after LPS administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Peter Pickkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickkers P, Dorresteijn MJ, Bouw MP, van der Hoeven JG, Smits P. In vivo evidence for nitric oxide-mediated calcium-activated potassium-channel activation during human endotoxemia. Circulation. 2006 Aug 1;114(5):414-21. doi: 10.1161/CIRCULATIONAHA.105.590232. Epub 2006 Jul 24.
Clinical trial NCT03598803: The Prevalence of Urinary Incontinence in Women and Men With Respiratory Diseases: a Questionnaire Survey
Official title: The Prevalence of Urinary Incontinence in Women and Men With Respiratory Diseases: a Questionnaire Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Respiratory Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with respiratory disease

Brief summary: Study the prevalence of the urinary incontinence among adults with respiratory diseases.


Eligibility criteria: Inclusion Criteria:

* Adults
* Patients with chronic respiratory diseases
* Age: 18-90

Exclusion Criteria:

* Minors
* Patients with cystic fibrosis
* Cognitive disorders
* Patients who do not speak French

Primary outcomes:
measure: Urinary Incontinence
timeFrame: five minutes
Secondary outcomes:
measure: Pulmonary Function
timeFrame: five minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Universitaire Saint-Luc
Study officials:
References:
Clinical trial NCT01136603: TIGR vs Polypropylene (Permanent) Mesh: Randomised Trial
Official title: Abdominal Wall Closure After TRAM / DIEP Flap - Comparison of TIGR Mesh vs Polypropylene Mesh.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hernia
Keywords: Abdominal wall defects
Inflammation reactions
Amount of tissue ingrowth
Adhesion formation
Shrinkage profiles of the implant
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: TIGR mesh as a reconstruction material is a more effective mesh for the repair of the abdominal wall post lipectomy, transverse rectus abdominis myocutaneous (TRAM) / deep inferior epigastric perforator (DIEP) flap.

Detailed description: In this study we will be conducting a randomized trial to study the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap.

Aims -

1. Investigating the efficacy of TIGR as a preferred reconstruction mesh for the repair of the abdominal wall post lipectomy, TRAM / DIEP flap. Efficacy of TIGR will allow us to determine the stability of the material in the abdominal wall reconstruction.
2. Study the absorption characteristics of TIGR implant as compared with a non absorbable polypropylene mesh. Absorption characteristics can be determined by the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant and it can be detect using ultrasound.
3. To determine whether any reactions to the implant will occur. These reaction if any will manifest as inflammation reactions which may be evident on clinical followup and can be detect by ultrasound.

Patients to be recruited :

80 randomized equally into the 2 groups Age range: 21 - 80 All patients undergoing lipectomy, TRAM / DIEP flap reconstruction will be recruited into the study.

Trial Duration: July 2010 - July 2015

Follow up:

Postoperative 1 week, 1 month, 3 months, 6 months, and 12 months Ultrasound will be done to determine the amount of tissue ingrowth, adhesion formation and shrinkage profiles of the implant in all these follow up appointments. Complications if any can also be detected by the Ultrasound.

Eligibility criteria: Inclusion Criteria:

* Age 21 - 80 years
* Both Male, Female
* all patients undergoing Lipectomy, TRAM / DIEP flap reconstruction
* patients with abdominal wall defects

Exclusion Criteria:

* patient refusal
* infection of the abdominal / generalised infection

Primary outcomes:
measure: Shrinkage profiles of the implant
timeFrame: 1 year
Secondary outcomes:
measure: Amount of tissue ingrowth
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Thiam Chye Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604603: The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regular Menstrual Cycle
Irregular Menstrual Cycle
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 470
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.

Brief summary: Background: Menstrual disturbance is the major complain in reproductive age women, the clinical and biochemical characteristics of women with different menstrual disturbance had not been well-understood. Objective: To study the clinical and biochemical characteristics of women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective study, medical records reviewed in patients who visited to outpatient clinic of Reproductive Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31. Including criteria: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who experienced menarche \<3 years before the beginning of the study; (2) Women who received hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or ovarian tumors, uterine abnormality; (4) Women who were \>45 years old.


Eligibility criteria: Inclusion Criteria:

* Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.

Exclusion Criteria:

1. Women who experienced menarche \<3 years before the beginning of the study;
2. Women who received hormones or drugs for major medical diseases;
3. Women who presented ovarian cysts or ovarian tumors, uterine abnormality;
4. Women who were \>45 years old.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: WanFang Medical Center at Taipei Medical University
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ming I Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06367803: Cost Analysis of Vascular Surgical Techniques
Official title: Cost Analysis of Vascular Surgical Techniques: Comparing Limb Revascularisation and Amputation in Patients With CLTI at University Hospital Limerick
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with CLTI and are under the care of a Vascular Surgeon at University Hospital Limerick

Brief summary: Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available.

Detailed description: Surgical interventions for patients with CLTI include endovascular revascularisation, by-pass revascularisation and amputation.

Clinical outcomes vary greatly for each intervention. The 5-year mortality rate for major amputations i.e., below knee (BKA) and above knee (AKA), is reported to range from 30% to 70%, with AKA having the higher rate of mortality. Concomitant Type II diabetes increases these rates of mortality for both AKA and BKA.

Whilst mortality rates are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention.

Eligibility criteria: Inclusion Criteria:

1. Cases where CLTI was treated surgically by a Vascular Consultant at UHL will be included in this analysis. That being individuals who underwent revascularisation procedures and/or lower limb amputation.
2. This analysis will look at cases from a set time frame, that being 1st March 2022 to 1st March 2023.

Exclusion Criteria:

1. Cases where CLTI was treated conservatively/without surgical intervention will not be included.
2. Surgical intervention outside of UHL.
3. Cases that occurred outside of the set timeframe.

Primary outcomes:
measure: A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
state: Munster
Study officials:
References:
Clinical trial NCT00814203: A Registry of COPD Patients to be Used for Future Studies
Official title: The Ohio State University COPD Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Lung Disease
Keywords: COPD
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-12-24
Enrollment: 9
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: primary care clinic

Brief summary: To develop a cohort of COPD participants to assist study staff in determining the most likely candidates for future studies.

Detailed description: To develop a cohort of COPD participants for study staff to determine the most likely candidates for future studies and to develop a repository of blood from subjects with COPD for future studies.

Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years of age and older who have been diagnosed with COPD by at least one of the following:

  * clinical history-a documented history of COPD, emphysema, or chronic bronchitis;
  * pulmonary function results (defined as an FEV1/FVC less than 0.7;
  * radiographic results (high-resolution CT findings of emphysema

Exclusion Criteria:

* in ability to give informed consent
* prisoners
* pregnancy

Primary outcomes:
measure: This is a registry protocol to determine factors contributing to the development of chronic obstructive lung disease.
Secondary outcomes:
measure: To develop a repository of blood from subjects with COPD for future studies. These studies may include evaluation of biologic markers of disease severity and progression.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05814003: Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites
Official title: The Clinical Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Tissue Infections
Gingival Recession
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 30
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: Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .

Detailed description: After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.

Eligibility criteria: Inclusion Criteria:

* insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders

Exclusion Criteria:

* smokers insufficient palatal donor sits un realistic expectations

Primary outcomes:
measure: post operative pain (VAS scale)
timeFrame: first day postoperative to 30 days (days)
Secondary outcomes:
measure: Number of analgesic and anti inflammatory pills consumed
timeFrame: first day postoperative to 30 days (days)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Ahmed Mortada, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolantonio M, De Ninis P, Secondi L, Femminella B. The Full-Thickness Palatal Graft Technique: Description of an Original Surgical Technique and 15 Case Reports. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):267-277. doi: 10.11607/prd.3741.
citation: Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.
citation: Wyrebek B, Gorski B, Gorska R. Patient morbidity at the palatal donor site depending on gingival graft dimension. Dent Med Probl. 2018 Apr-Jun;55(2):153-159. doi: 10.17219/dmp/91406.
citation: Tseng ES, Tavelli L, Wang HL. Palatal Pedicle Flaps for Soft Tissue Augmentation. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):581-588. doi: 10.11607/prd.4561.