louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06225180: Review of Breast Abscess Management
Official title: Review of Breast Abscess Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Abscess
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years of age

• New diagnosis of N61.1 recorded in their EMR

Brief summary: Breast abscesses are an unfortunate pathology that develop in patients, and treatment is often painful and unpleasant. The goal of this study is to identify risk factors associated with failure of aspiration as a primary intervention as opposed to incision and drainage in the hopes of adequately treating patients at initial presentation.

Detailed description: The pendulum has now swung toward minimally invasive aspiration as the primary treatment modality, with multiple studies reporting superior cosmetic results. However, patients in these studies often required repeat breast aspirations, and sometimes ultimately required incision and drainage. Aspiration first for treatment of breast abscess may not be a wise choice for all patients if it results in increased antibiotic days, return to emergency department (ED)/increased cost, or prolonged pain from multiple procedures. Several studies have identified varying risk factors for aspiration failure as primary intervention for breast abscesses. More data is needed to confirm the true risk factors for failure.

Eligibility criteria: Inclusion Criteria:

* • ≥18 years of age

  * New diagnosis of N61.1 recorded in their Electronic Medical Record (EMR)

Exclusion Criteria:

* • \<18 years of age

  * Pregnant
  * Incarcerated

Primary outcomes:
measure: Number of repeat interventions prior to resolution of abscess(s)
timeFrame: 5 years
Secondary outcomes:
measure: Antibiotic days
timeFrame: 5 years
measure: Repeat aspiration
timeFrame: 5 years
measure: Return to Emergency Department ( ED)
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute at Methodist Health System
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Midlothian Medical Center
name: Conner McDaniel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487980: Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants
Official title: The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight
Perinatology
Iron Status
Cord Clamping
Lead sponsor: Stanger Hospital
Sponsor class: OTHER
Collaborators: name: Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
First posted: 2011-12-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.


Eligibility criteria: Inclusion Criteria:

* Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion Criteria:

1. twin pregnancy
2. history of postpartum haemorrhage (PPH)
3. (gestational) diabetes
4. pre-eclampsia
5. abruptio placentae
6. caesarian section
7. necessity of early clamping due to tight nuchal cord
8. need for resuscitation immediately after birth
9. major congenital abnormalities

Primary outcomes:
measure: Haemoglobin level
timeFrame: two months
Secondary outcomes:
measure: Hyperviscosity syndrome
timeFrame: 1 day
measure: Iron status
timeFrame: two months
measure: hyperbilirubinaemia
timeFrame: 2 days
Other outcomes:
Locations:
city: Stanger
country: South Africa
facility: Stanger Hospital
state: KwaZulu-Natal
Study officials:
affiliation: Stanger Hospital
name: Sybrich Tiemersma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02369380: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Metatarsalgia
Official title: Volume Restoration of Plantar Pad With a Hyaluronic Acid Dermal Filler in Treatment of Metatarsalgia of Forefeet Further Use of High Heel Shoes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metatarsalgia
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-02-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this study is to evaluate the decrease of plantar pain of forefeet due to restoration of plantar pad tissue density and of cushioning function with an hyaluronic acid dermal filler as mechanical-supplementation in subjects with metatarsalgia further use of high heel shoes

Detailed description: This will be an open and single center study. There will be 4 study visits in total for each subject. Each subject will participate for a period of maximum 6 months.

Eligibility criteria: Inclusion Criteria:

* Female subject aged 30 years or older,
* Subject with pain sensation under metatarsal heads, further to use of high heels shoes at any moment of the day whatever the onset time,
* Subject with no previous injections under the metatarsal heads of forefeet.

Exclusion Criteria:

* Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid and to Lidocaine or amide local anesthetics
* Subject with cutaneous infection on either foot or with history of autoimmune diseases or auto-inflammatory diseases,
* Subject who wishes to wear orthotic supports (shock-absorbing insoles or arch supports, etc...).
* Subject with history of bleeding disorders or or erysipelas of the lower limbs,
* Subject with chronic inflammatory pain of the feet due to other non-mechanical causes, such as plantar fasciitis, arthritis, gout, Morton's neuroma.

Primary outcomes:
measure: Pain assessment (Time to onset of pain (TInitial) (in hours)
timeFrame: Subject questioning at baseline after injections and change from baseline 1 month after baseline
measure: Pain assessment (Time to maximum pain tolerance (TEnd)
timeFrame: Subject questioning at baseline after injections and change from baseline 1 month after baseline
Secondary outcomes:
measure: Podiatric criteria
timeFrame: Change from baseline 6 months after baseline
measure: Podiatric criteria (Baro Podometric static examinations)
timeFrame: Change from baseline 6 months after baseline
Other outcomes:
measure: Subject overall satisfaction
timeFrame: 6 months after baseline injections
measure: Adverse Events
timeFrame: At each follow up visit:1 month, 3 months and 6 months after baseline
Locations:
city: Cannes
country: France
facility: Dr Foumenteze
Study officials:
name: Jean Paul Foumenteze, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654680: Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury
Official title: A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Traumatic spinal cord injury
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-09
Enrollment: 418
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate efficacy and safety of Vardenafil in patients with spinal cord injury


Eligibility criteria: Inclusion Criteria:

* Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
* Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

* Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to US Product Information or Summary of Product Characteristics

Primary outcomes:
measure: International Index of Erectile Function-Erectile Function domain
timeFrame: 12 weeks
Secondary outcomes:
measure: Sexual Encounter Profile Question 2
timeFrame: 12 weeks
measure: Sexual Encounter Profile Question 3
timeFrame: 12 weeks
measure: Other diary based variables
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00178880: MRI Imaging of Chronobiologic Abnormalities in Depression
Official title: MRI Imaging of Chronobiologic Abnormalities in Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: depression
MRI
imaging
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and depressed patients.

Brief summary: The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

Detailed description: The purpose of the study is to identify and understand patterns of brain activity when people are depressed. The study will use an imaging method called Magnetic Resonance Imaging (MRI) which does not involve any exposure to radioactivity or radioactive substances.

Eligibility criteria: Inclusion Criteria:

* WEIGHT: less than or at 20% over ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical limitations in fitting overweight individuals into the scanner, and the risk of excessive claustrophobic responses if tightly constricted.
* HEALTH: healthy, ambulatory normal or depressed adults

Exclusion Criteria:

* Presence of aneurysm clips, cardiac pacemakers, cochlear implants, metal in the eyes, and implanted insulin pumps.
* Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities.
* Pregnancy.
* Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
* Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
* Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Patients on antidepressants may not be taking any other medication, except at the discretion of the investigator. Untreated depressed or healthy subjects must be free of all medications except as approved by the investigator.
* Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
* Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ronald M Salomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03710980: Accuracy of Pulse Oximeters With Profound Hypoxia
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oximetry
Lead sponsor: Hancock Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult volunteers.

Brief summary: This study to assess the oxygen saturation accuracy of the Beddr SleepTuner in profound hypoxia.


Eligibility criteria: Inclusion Criteria:

1. The subject is male or female, aged ≥18 and \<50.
2. The subject is in good general health with no evidence of any medical problems.
3. The subject is fluent in both written and spoken English.
4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI\>30).
2. The subject has a known history of heart disease, lung disease, kidney or liver disease.
3. Diagnosis of asthma, sleep apnea, or use of CPAP.
4. Subject has diabetes.
5. Subject has a clotting disorder.
6. The subject a hemoglobinopathy or history of anemia, per subject report or the first bloodsample, that in the opinion of the investigator, would make them unsuitable for study participation.
7. The subject has any other serious systemic illness.
8. The subject is a current smoker.
9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
10. The subject has a history of fainting or vasovagal response.
11. The subject has a history of sensitivity to local anesthesia.
12. The subject has a diagnosis of Raynaud's disease.
13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
14. The subject is pregnant, lactating or trying to get pregnant.
15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: SpO2 Accuracy
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Lab
state: California
Study officials:
References:
Clinical trial NCT04172480: HUSH Restriction in HIV Infected Patients
Official title: HUSH Restriction in HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infections
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2019-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population infected either by HIV1 or HIV2

Brief summary: HIV eradication faces a major obstacle that is viral persistence in latent reservoir cells despite antiretroviral therapy. Epigenetic repression plays a central role in viral transgene latency and several epigenetic regulators have been involved in this process. Among them, the "Human Silencing Hub" or HUSH complex, composed of Tasor, MPP8 and periphilin, has been shown to recruit the H3K9me3 methyltransferase "SET domain bifurcated 1" (SETDB1) and is therefore responsible for genes' epigenetic repression. Our recent results highlight the ability of Vpx from HIV-2/SIVsmm to counteract HUSH and to reactivate latent viruses in a latency model. We propose here to study HUSH activity along pathogenesis.


Eligibility criteria: Inclusion Criteria for group 1:

* Symptomatic or asymptomatic acute HIV1 infection
* Age above 15 years old
* No ARV treatment prior inclusion (excepted as prophylaxis pre or post exposure)

Inclusion Criteria for group 2:

* Chronic HIV1 infection
* Age above 18 years old
* No ARV treatment since at least 3 month (regardless the reason)

Inclusion Criteria for group 3:

* HIV2 Infection
* Age above 18 years old
* No ARV treatment since at least 3 month (regardless the reason)

Exclusion Criteria for all groups:

* HIV1 and HIV2 co-infection
* Evolutive intercurrent pathology, in particular active co-infection (i.e. HBV, HCV, tuberculosis, HTLV1)
* Life-threatening pathology

Primary outcomes:
measure: Viremia
timeFrame: Baseline
measure: Total HIV DNA and integrated HIV DNA
timeFrame: Baseline
measure: Hush activity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôtel-Dieu
city: Paris
country: France
facility: Hôpital Necker
Study officials:
References:
Clinical trial NCT03183180: Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Penicillin Secondary Prophylaxis
Official title: Prevalence of Secondary Cardiac Damage in Rheumatic Fever Patients and Adherence to Penicillin Secondary Prophylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Secondary Cardiac Damage in Rheumatic Fever
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 21 years who were diagnosed with RF (before age 18 years) acoording to the computerized database.

Brief summary: According to American Heart Association criteria, patients who have had Rheumatic Fever (RF) should be treated with antibiotic prophylaxis. Continuous prophylaxis is recommended in patients with well-documented histories of RF and in those with evidence of rheumatic heart disease.

There is a limited data regarding adherence of patients to treatment and efficacy of treatment.

In this study, patients with RF who are older than 21 years will be collected from a computerized database of 'Maccabi Healthcare Services', one of the biggest Israeli Health Funds. Patients will be assigned to the study after obtaining informed consent.

Previous adherence to antibiotic prophylaxis will be examined according to computerized database of drugs which were issued to the patient since RF diagnosis.

Past history of cardiac involvement, including past Echocardiograms, will be collected from computerized database. In addition, the current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination.


Eligibility criteria: Inclusion Criteria:

- Patients older than 21 years who were diagnosed with RF (before age 18 years) according to the computerized database.

Exclusion Criteria:

* patients with other rheumatic disease diagnosed before RF diagnosis
* patients with other cardiac disease diagnosed before RF diagnosis
* patients with neoplastic disease diagnosed before RF diagnosis

Primary outcomes:
measure: Cardiac function including vulvar involvement
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03938480: Duration Threstholds of Intraoperative Hypotension
Official title: Duration Threstholds of Intraoperative Hypotension for Postoperative Major Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 37000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The analysis set of this study was adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.

Brief summary: Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the their relationship.

Detailed description: Intraoperative hypotension is common in non cardiac surgery. longer duration of intraoperative hypotension is related with postoperative morbidity and mortality. however, with the change of hypotension criteria, the duration threshold also change. the relationship of different hypotension criteria and its duration is unclear. This study is to explore the relationship between continous difference mean blood pressure criteria and its duration thresholds for postoperative major adverse events, which include acute cardiac infarction, heart failure, cardiac death, stroke and acute kidney injury.

Eligibility criteria: Inclusion Criteria:

adults underwent elective non-cardiac surgery

Exclusion Criteria:

cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year

Primary outcomes:
measure: major adverse events
timeFrame: 30 days postoperatively in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PKU 1st hospital
state: Beijing
Study officials:
References: