louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00465049: Comparison of Suturing and Packing of Drained Abscesses
Official title: Primary vs. Secondary Closure of Cutaneous Abscesses After I&D: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutanoeus Abscesses
Keywords: abscess, primary closure, secondary closure
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2007-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard treatment for skin abscesses in drainage followed by packing to prevent premature closure and reaccumulation of pus. Studies from the 1950s and later conducted outside of the US suggest that when drained abscesses are drained and sutured closed they actually heal faster without complications. The current study compares the time to healing and scar formation when drained abscesses are packed or sutured.


Eligibility criteria: Inclusion Criteria:

* Non complicated abscesses

Exclusion Criteria:

* Fever,
* Immunocompromise,
* Cellulitis,
* Perianal and
* Pilonidal abscesses

Primary outcomes:
measure: Days to healing.
timeFrame: 1 week
Secondary outcomes:
measure: Need for subsequent drainage, scar appearance.
timeFrame: 1 week
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
affiliation: Stony Brook University
name: Adam J Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ELLIS M. Incision and primary suture of abscesses of the anal region. Proc R Soc Med. 1960 Aug;53(8):652-3. doi: 10.1177/003591576005300819. No abstract available.
citation: Khanna YK, Khanna A, Singh SP, Laddha BL, Prasad P, Jhanji RN. Primary closure of gluteal injection abscess (a study of 100 cases). J Postgrad Med. 1984 Apr;30(2):105-10. No abstract available.
citation: Ajao OG, Ladipo JK, al-Saigh AA, Malatani T. Primary closure of breast abscess compared with the conventional gauze packing and daily dressings. West Afr J Med. 1994 Jan-Mar;13(1):28-30.
citation: Stewart MP, Laing MR, Krukowski ZH. Treatment of acute abscesses by incision, curettage and primary suture without antibiotics: a controlled clinical trial. Br J Surg. 1985 Jan;72(1):66-7. doi: 10.1002/bjs.1800720125.
citation: Edino ST, Ihezue CH, Obekpa PO. Outcome of primary closure of incised acute soft-tissue abscesses. Niger Postgrad Med J. 2001 Mar;8(1):32-6.
citation: Abraham N, Doudle M, Carson P. Open versus closed surgical treatment of abscesses: a controlled clinical trial. Aust N Z J Surg. 1997 Apr;67(4):173-6. doi: 10.1111/j.1445-2197.1997.tb01934.x.
citation: Singer AJ, Taira BR, Chale S, Bhat R, Kennedy D, Schmitz G. Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial. Acad Emerg Med. 2013 Jan;20(1):27-32. doi: 10.1111/acem.12053.
Clinical trial NCT02019849: Post Market Clinical Follow-Up of Plasmafit® Cup
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Hip Arthroplasty
Keywords: THA, Plasmafit®
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-12-24
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: Specialist Clinical Centre

Brief summary: Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.


Eligibility criteria: Inclusion Criteria:

* Minimum age 18 years
* Indication for cementless total hip arthroplasty
* Patient consent for study participation
* Physical and mental willingness to participate at clinical and radiological follow-up

Exclusion Criteria:

* Patient not available for follow-up
* Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
* Tumor
* Alcohol or drug abuse
* Permanent cortisone therapy
* Clinically relevant infection
* Pregnancy or planned pregnancy
* Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip
* Acute fracture at the concerned hip
* Patients needing a cemented hip arthroplasty

Primary outcomes:
measure: Implant Survival Rates
timeFrame: 10 years
Secondary outcomes:
measure: Osteolysis
timeFrame: 3 months, 12 months, 5 years, 10 years
measure: Ossifications
timeFrame: 3 months, 12 months, 5 years, 10 years
measure: Implant Position
timeFrame: 3 months, 12 months, 5 years, 10 years
measure: Migration of Plasmafit®
timeFrame: 3 months, 12 months, 5 years, 10 years
measure: Clinical Outcome
timeFrame: 3 months, 12 months, 5 years, 10 years
Other outcomes:
Locations:
city: Bad Rappenau
country: Germany
facility: Vulpius-Klinik Bad Rappenau
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
Study officials:
References:
Clinical trial NCT02031549: Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation
Official title: Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Fertility Center of Las Vegas
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 40
Sex: MALE
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: Couples who undergoing IVF treatment who have surplus sperm available after oocyte insemination.

Brief summary: We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.

Detailed description: A "SpermComet" assay will be used to characterize DNA fragmentation of surplus sperm samples remaining after in vitro fertilization (IVF) cycles. We will investigate potential correlation between these assay results and the outcomes of IVF cycles that used those sperm samples.

Eligibility criteria: Inclusion Criteria:

* Undergoing IVF
* Surplus sperm available after oocyte insemination
* Consented

Exclusion Criteria:

* Surgical sperm extraction
* Use of donated sperm or oocytes
* No minors may participate

Primary outcomes:
measure: Blastulation rate
timeFrame: 6 days
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Embryo grade
timeFrame: 6 days
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Fertility Center of Las Vegas
state: Nevada
Study officials:
affiliation: Fertility Center of Las Vegas
name: Bruce Shapiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01358149: Trial of Cocoa-based Food in Children
Official title: Double Blind Controlled Trial of Cocoa-based Food in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Today, there is an important lack of knowledge on child metabolism and the effects of phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here, the investigators will monitor the metabolism of children using minimally invasive techniques at rest, and with physical/mental activities and assess the changes associated with the intake of cocoa-based food.


Eligibility criteria: Inclusion Criteria:

All subjects must comply with all the following inclusion criteria:

* Healthy and physically active, and no diabetes or metabolism related disorders in their first degree relatives (as determined by medical and activity questionnaire)
* Caucasian, with English as a first language and an adequate standard of literacy.
* BMI adjusted for age and gender which falls between the 9th and 91st as shown in the Child Growth Foundation BMI growth charts
* 8-13 years of age
* Having obtained his/her informed assent
* Having obtained his/her legal representative's informed consent
* Willing to allow their family doctor (GP) to be informed about their participation in this study

Exclusion Criteria:

Subjects representing one or more of the following criteria are excluded from participation in the study.

* Post-pubertal
* Taking any medication
* Smoker
* Undergoing medical treatment or investigations
* Body mass index \> 24
* Suffer from chronic diseases (with regular intake of drugs, medical history)
* Vegetarians
* Vaccination in the last 4 months
* Any know food allergies or intolerance
* Pregnancy
* Special diet or weight loss program (e.g. Atkins diet)
* Acute illness
* Fever, cold, flu
* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).

Primary outcomes:
measure: Blood glucose concentration
timeFrame: Baseline will be fasting, and monitoring measures up to 7 hours after consumption
Secondary outcomes:
measure: Metabolic monitoring
timeFrame: measured over a 7-8 hours period
measure: physical monitoring
timeFrame: two hours and four hours after concumption
measure: mental monitoring
timeFrame: 3.3 hours after intake
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull York Medical School
Study officials:
affiliation: Hull University
name: Stephen Atkin, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852849: Rapid Build of HIV Related Protective Barriers
Official title: Cohort Study on Appropriate Strategies of The Rapid Build of HIV Related Protective Barriers in Yunnan, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Viral Suppression of HIV Infection
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: Yunnan Center for Disease Control and Prevention
name: Yunnan AIDS Care Center
First posted: 2019-02-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to screen the optimal intervention strategies to rapid establish the protective barriers against HIV-infection by maximally decreasing the viremia among HIV- infected patients.

Detailed description: Sexual transmission became the primary route of HIV transmission in China and heterosexual transmission also contributed greatly to HIV epidemic which was mostly reported in South-west rural areas. In past years, Yunnan has experienced powerful campaign of scaling-up the HIV identification as well as antrertroviral therapy.

This study will investigate how to reach the last two of HIV'90-90-90 targets': to provide antiretroviral therapy (ART) for 90% of who diagnosed HIV infection and to achieve viral suppression for 90% of those treated.

The study population consists of participants who received an newly diagnosed HIV infection within the study period. All rerolled participants will be randomized into different study group. In intervention group, medical institutions will provide patients personal involved intervention strategies which guided by frequent viral load detection, and providing of the dosage form of 400 mg EFV in their antiviral therapy.

Main assessment measures are viral suppression rate of HIV-infected patients and treatment coverage .

Eligibility criteria: Inclusion Criteria:

* HIV-positive participants who received an newly diagnosed HIV infection within the study period
* Having a current residential address inside of pilot site limits
* Eighteen years old or above
* HIV transmission is heterosexual contact

Exclusion Criteria:

* IDU
* Having severe mental disorder

Primary outcomes:
measure: Viral suppression of HIV-infected patients
timeFrame: 12 months
Secondary outcomes:
measure: Treatment coverage
timeFrame: 12 months
Other outcomes:
Locations:
city: Lincang
country: China
facility: Lincang Center for Disease Control and Prevention
state: Yunnan
city: Wenshan
country: China
facility: Wenshan Center for Disease Control and Prevention
state: Yunnan
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention
name: Zhao Yan, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06079749: Risk of Chronic Post-surgical Pain After TKA
Official title: Risk of Chronic Post-surgical Pain After Simultaneous Versus Staged Bilateral Knee Arthroplasty: A Retrospective Study With Propensity Score Matching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bilateral Total Knee Chronic Pain Following Arthroplasty
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 403
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.

Brief summary: Chronic post-surgical pain (CPSP) is a common surgical complication. The role of timing in the development of CPSP after bilateral total knee arthroplasty (BTKA) is not well studied. We aimed to compare the occurrence of CPSP in patients who underwent simultaneous or staged BTKA without discharge between procedures.


Eligibility criteria: Inclusion Criteria:

* From October 12, 2012 to December 2, 2021, patients who underwent bilateral or staged knee replacement surgery during a single hospitalization under Professor Lee Woo-seok at the Department of Orthopedics at Gangnam Severance Hospital due to bilateral knee arthritis.

Exclusion Criteria:

* Patients whose post-operative pain information cannot be confirmed through outpatient visit records 1 year after surgery
* Those who have undergone surgery other than knee arthritis surgery within 1 year after surgery

Primary outcomes:
measure: Chronic post-surgical pain at one year follow up
timeFrame: at one year follow up after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00237406: Interactive Voice Response (IVR) for Methadone Patients
Official title: Interactive Voice Response for Methadone Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-Related Disorders
Keywords: IVR, methadone
methadone maintenance
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who recently enrolled in methadone maintenance for opioid addiction.

Brief summary: This study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program.

Detailed description: Participants will complete a baseline interview and a follow-up interview at 5-weeks post-baseline. Two-thirds of the participants will be randomized into the telephone call-in group, and will be asked to complete daily, 10-minute, telephone interviews. To complete these interviews, participants will call into a toll-free telephone interview system with a unique and private Study ID number, and answers questions by using the telephone key pad. Questions during both the face-to-face interviews and the telephone interviews will assess mood, sleep, treatment utilization and drug-related experiences. Participants will be compensated for their time.

Comparison(s): Participants randomized into the telephone component of the study as compared to participants in the interview-only component of the study.

Eligibility criteria: Inclusion Criteria:

* Recent enrollment in a methadone maintenance program

Exclusion Criteria:

* Enrollment in a methadone maintenance program within the prior 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael D Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00334906: Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)
Official title: An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: memantine
Alzheimer's disease
MRI
moderate Alzheimer's disease
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.


Eligibility criteria: Inclusion Criteria:

* Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)
* A diagnosis of probable AD \[according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria\] of moderate severity \[Mini-Mental State Examination score between 15 and 20, inclusive\]
* On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD
* Previous imaging results not consistent with the diagnosis of AD
* Modified Hachinski Ischemia Score greater than 4
* Evidence of other neurologic disorders
* Inability to participate in MRI testing
* No clinically significant systemic disease
* A known or suspected history of alcohol or drug abuse in the past 10 years
* Taking excluded medication
* Previous treatment with commercial memantine

Primary outcomes:
measure: Efficacy
measure: Total brain atrophy on MRI
Secondary outcomes:
measure: Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency
measure: Safety
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Forest Laboratories
state: New Jersey
Study officials:
References:
Clinical trial NCT00784706: Effect of Combined Therapy on Neglect Syndrome in Stroke Patients
Official title: Effect of Combined Therapy on Neglect Syndrome in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accidents
Keywords: stroke rehabilitation
perceptual deficits
kinematic analysis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2008-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to evaluate motor and neglect recovery of stroke patients produced by CIT using kinematic and oculomotor assessment, together with conventional clinical measures.

Detailed description: This project will be carried out using a short term constraint and training protocol targeting at subacute and chronic patients with motor and perceptual deficits. The outcome measures will include kinematic and oculomotor analyses, which have not been employed yet.

Eligibility criteria: Inclusion Criteria:

* a clinical cerebrovascular of right cerebral accident patients
* the age over 18-year-old
* demonstration of Brunnstrom stage III of the affected upper extremity
* patients with perceptual deficits
* no severe cognitive disorder, could understand and follow orders
* no severe equilibrium problems which will influence the intervention

Exclusion Criteria:

* recurrent of the stroke or epilepsy during the intervention
* patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder
* injected the Botox into the affected upper extremity during the past 6 months
* participate in the other interventional study in the same time
* refuse subscribed the informed consent

Primary outcomes:
measure: Catherine Bergego Scale (CBS)
timeFrame: 2008-2009
Secondary outcomes:
measure: Clinical measures at the impairment, activity, participation levels
timeFrame: 2008-2009
measure: Eye movement analysis
timeFrame: 2008-2009
measure: kinematic variables
timeFrame: 2008-2009
Other outcomes:
Locations:
city: Kwei-shan, Toayuan county
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy, Chang Gung Univ.
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: