louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01878279: HSV Oral Reactivation in Children
Official title: Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HSV-1
HIV
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children

Brief summary: In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV.

Study Objectives:

1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children

   Secondary Objectives:
2. To determine the acceptability of performing daily oral swabs in children age 3-12


Eligibility criteria: Inclusion Criteria:

* age \> 3 and ≤12 years old
* parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures
* For HIV-infected group: Positive HIV serology by either ELISA x 2, ELISA + WB or PCR testing

Exclusion Criteria:

* age \<3 and \> 12 years old
* Acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment)
* co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted).
* Stable co-administration of other medications is permitted (e.g. bactrim)
* For HIV-infected children; receiving or eligible for antiretroviral (ART) therapy by local standards

Primary outcomes:
measure: HSV detection rate
timeFrame: 14 days
Secondary outcomes:
measure: HSV copy number
timeFrame: 14 days
Other outcomes:
measure: compliance with daily swabs
timeFrame: 14 days
Locations:
city: Dar es Salaam
country: Tanzania
facility: MUHAS
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard Zuckerman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasubi MJ, Nilsen A, Marsden HS, Bergstrom T, Langeland N, Haarr L. Prevalence of antibodies against herpes simplex virus types 1 and 2 in children and young people in an urban region in Tanzania. J Clin Microbiol. 2006 Aug;44(8):2801-7. doi: 10.1128/JCM.00180-06.
citation: Grando LJ, Machado DC, Spitzer S, Nachman S, Ferguson F, Berentsen B, Yurgel LS. Viral coinfection in the oral cavity of HIV-infected children: relation among HIV viral load, CD4+ T lymphocyte count and detection of EBV, CMV and HSV. Braz Oral Res. 2005 Jul-Sep;19(3):228-34. doi: 10.1590/s1806-83242005000300013. Epub 2005 Nov 21.
Clinical trial NCT04608279: Urinary Creatinin/Protein Ratio in Preterms
Official title: Evolution of the Proteinuria / Creatininuria Ratio in the First Month of Life in the Preterm Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Renal Failure
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 124
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature gestational age at birth superior or equal to 32 week of amenorrhea

Brief summary: From the first days of life, the newborn presents a "physiological" proteinuria explained by the coexistence of a glomerular and tubular immaturity, all the more marked as the gestational age (GA) is weak. In the child term, proteinuria decreases the first month and its persistence is the marker of kidney damage. The persistence of proteinuria in preterm infants is also considered a marker of renal impairment; however, neither the "physiological" values nor the pattern of urinary excretion of proteins in the first month of life are known.

The proteinuria / creatininuria ratio is a validated indicator of proteinuria, as it is correlated with 24-hour urine proteinuria.


Eligibility criteria: Inclusion Criteria:

* Premature gestational age at birth superior or equal to 32 week of amenorrhea hospitalized in the intensive care unit or neonatal intensive care unit of the University Hospital of Reunion, southern site, Saint Pierre, in the first 24 hours of life
* Informed consent form Legal representant

Exclusion Criteria:

* Renal malformation known in antenatal

Primary outcomes:
measure: Evolution in time of Ratio of proteinuria / creatininuria
timeFrame: Day 0, Day 2 or Day 3, Day 5 or Day 6, Week 2, Week 3, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Hospitalier de La Réunion
state: La Réunion
Study officials:
References:
Clinical trial NCT05238779: An Integrative Model for Palliative Care in End-Stage Liver Disease
Official title: An Integrative Model for Palliative Care in End-Stage Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Liver DIsease
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 28
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: Hospitalized patients with ESLD and their caregivers

Brief summary: The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD.

Detailed description: Patients with end-stage liver disease (ESLD) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. Palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. While palliative care consults are used in those with ESLD, despite the pain and suffering that accompanies ESLD, palliative care is often used too little and too late.

Eligibility criteria: Inclusion Criteria:

Primary participant:

* admission for decompensated cirrhosis, age ≥ 18
* willingness to sign consent
* able to read and understand English
* presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC

Caregiver:

* identified as the primary caregiver of the participant
* age ≥ 18
* willingness to sign consent
* able to read and understand English

Exclusion Criteria:

Primary participant:

* prior liver transplant
* lack of capacity to provide informed consent (in the judgement of the investigator)
* already in receipt of palliative or hospice care
* those who are likely to receive a LT during the index admission

Caregiver:

• none

Primary outcomes:
measure: Change in symptom intensity
timeFrame: Up to 60 days
measure: Change in liver disease QOL
timeFrame: Up to 60 days
measure: Change in depression
timeFrame: Up to 60 days
measure: Change in anxiety
timeFrame: Up to 60 days
measure: Change in perform ordinary tasks
timeFrame: Up to 60 days
measure: Change in caregiver burden
timeFrame: Up to 60 days
measure: Hospital readmissions and/or Emergency room (ER) visits
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Joel Wedd, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03772379: Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Official title: Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posterior Crossbite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 34
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.

Detailed description: The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.

Eligibility criteria: Inclusion Criteria:

* Female adolescent patients with an age range 11- 14 years.
* Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
* Normal vertical growth pattern.
* Fully erupted maxillary first premolars and first permanent molars.

Exclusion Criteria:

* Previous orthodontic treatment.
* Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
* Active periodontal affection or severe gingival inflammation.

Primary outcomes:
measure: Dental tipping.
timeFrame: an average1 year
measure: Alveolar bending
timeFrame: an average1 year
measure: Dental changes(transverse).
timeFrame: an average1 year
measure: Skeletal changes(transverse, anteroposterior and vertical)
timeFrame: an average1 year
Secondary outcomes:
measure: Pattern of expansion
timeFrame: an average1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06046079: Predictors of Health Service Utilizations Among Key Population in Washington DC
Official title: A Mixed Methods Study of the Association Between LAI PrEP Initiation and Adherence, and Utilization of Health and Social Support Services Among Key Populations in Washington DC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-exposure Prophylaxis
HIV
Health Behavior
Lead sponsor: Us Helping Us, People Into Living, Inc.
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
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: Black sexual minority men, Latino sexual minority men, Black cisgender women, people who inject drugs, and transgender women

Brief summary: The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization. Our primary hypothesis is that the investigators will observe higher utilization of sexual health (STI screenings), psychosocial health (psychotherapy, and substance use treatment) and other social services (emergency cash assistance, food pantry, transportation assistance, clothing,and housing resources) among PrEP users (LAI-PrEP or daily oral) compared to participants who are PrEP naïve over the 12-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* age of 18 years or above;
* confirmed HIV-negative status;
* residence in the Washington, DC metropolitan area;
* one of the following PrEP profiles (PrEP naïve \[no history of any PrEP use in the past\] currently on daily oral PrEP or receiving LAI-PrEP).

Exclusion Criteria:

* being younger than18 years of age
* being unable to speak and/or read English
* a reported residence outside of the defined Washington, DC metropolitan area
* being unable or unwilling to provide written informed consent
* being unable to comply with the requirements of the protocol (i.e. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons)
* evidence of suspected hepatoxicity

Primary outcomes:
measure: The rate of service utilization (sexual health, psychosocial health & other social services) over 12 months as a function of demographic characteristics, mental health, and substance use behavior.
timeFrame: Over 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Us Helping Us, People into Living Inc
state: District of Columbia
Study officials:
References:
Clinical trial NCT03461679: Analgesic Effect of Adding an Adductor Canal Block to a Femoral Triangle Block for Total Knee Replacement
Official title: A Randomised Controlled Trial Investigating the Addition of an Adductor Canal Block to a Femoral Triangle Block for Analgesia After Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacements
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee arthroplasty under spinal anaesthesia
* 45y or older
* ASA 1-3
* BMI 18-35

Exclusion Criteria:

* Unable to consent
* Chronic opioid consumption
* Allergy to study medication
* Lower limb surgery preceding year
* Unable to complete baseline testing, pre-existing neurological deficit
* Contraindication to spinal anaesthesia

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours
measure: Opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Muscle strength
timeFrame: 24 hours
measure: Muscle strength
timeFrame: 48 hours
measure: Time to up and go test
timeFrame: 24 hours
measure: Time to up and go test
timeFrame: 48 hours
measure: 30 Chair stand test
timeFrame: 24 hours
measure: 30 Chair stand test
timeFrame: 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
Clinical trial NCT06127979: A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery
Official title: Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Ki67 Expression
BRCA2 mutation
ER+/HER2-
endocrine therapy
23-311
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+/HER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+/HER2-
* Scheduled to undergo upfront surgery
* Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines

Exclusion Criteria:

* History of breast cancer
* Receipt of ET for risk reduction in the previous 3 months
* Stage IV disease at presentation
* Scheduled to undergo neoadjuvant systemic chemotherapy
* Pregnant

Primary outcomes:
measure: assess the change in Ki67
timeFrame: baseline to at least 2 weeks of endocrine therapy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Minna Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323879: Combined LDR Boost and HDR Whole Gland
Official title: Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma Prostate
Keywords: brachytherapy
LDR
HDR
monotherapy
focal
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sequential dose escalation design
Primary purpose: TREATMENT

Brief summary: This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.

Detailed description: Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal brachytherapy to the DIL using iodine-125, while at the same time have single 19 Gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (HDR). The LDR boost dose will start at 50 Gy, and increase DIL dose in sequential cohorts of patients up until a dose of 80 Gy. Up to 20 patients will be included. Primary endpoint is toxicity at 3 months.

Eligibility criteria: Inclusion Criteria:

* Confirmed Adenocarcinoma of the prostate
* Single PIRADS 4 or 5 lesion on multiparametric MRI
* T1c-T2b on rectal exam
* Gleason 3+3 and PSA \< 20ng/mL
* Gleason 3+4 and PSA \<10ng/mL
* Less than 50% of the cores positive in an untargeted prostate biopsy.
* Prostate volume \< 60 cc

Exclusion Criteria:

* Incapable or ineligible for MRI imaging
* Previous trans-urethral resection of prostate (TURP)
* Previous or current use of androgen deprivation
* Baseline International Prostate Symptom Score (IPSS) \> 15
* Evidence of distant or nodal metastasis
* Disease that contraindicates treatment with radiation (e.g connective tissue disease)
* Unsuitable for anesthesia due to comorbidity

Primary outcomes:
measure: Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
timeFrame: At 3 months
Secondary outcomes:
measure: Late urinary and rectal toxicity using NCI CTCAE v4.0
timeFrame: 3-monthly for first year, then 6-monthly until Year 5
measure: Health related quality of life (HRQOL) changes
timeFrame: 3 monthly for first year, then annually year 1-5
measure: Disease Free Survival
timeFrame: will be reported at 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT06129279: Effect of Emotional Freedom Technique on Symptoms in Dysmenorrhea
Official title: Examining the Effect of Emotional Freedom Technique on Quality of Life and Symptoms in Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Woman
Pain
Keywords: dysmenorrhea
woman
quality of life
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Reducing symptoms with EFT in young women suffering from dysmenorrhea
2. Improving the quality of life of young women suffering from dysmenorrhea
3. Raising women's awareness for EFT
4. Reducing healthcare costs for dysmenorrhea

Detailed description: Primary dysmenorrhea, the most common form of dysmenorrhea, is a problem characterized by pain that begins in the lower abdomen before or with menstruation, lower back pain and pain radiating to the legs. The Emotion Freedom Techniqu has become a manualized method that has led to uniform application research, education, and clinical practice. EFT is a brief intervention that combines exposure, cognitive therapy, and somatic stimulation of acupressure points on the face and body. It has been reported in the literature that EFT, a "needle-free and emotional" form of acupuncture, reduces or eliminates dysmenorrhea symptoms and premenstrual complaints.

Eligibility criteria: Inclusion Criteria:

* • Being a female student at Karabük University Faculty of Health Sciences

  * Being between the ages of 18-25
  * Voluntarily agrees to participate in the study,
  * T.R. to be a citizen,
  * Not having any chronic disease,
  * Those whose symptom complaints are 5 or above according to the VAS scale

Exclusion Criteria:

* • Leaving the study at any time,

  * Having any diagnosed psychiatric disorder.
  * Not having secondary dysmenorrhea pathology

Primary outcomes:
measure: Examining the Effect of Emotional Freedom Technique on Quality of Life and Symptoms in Dysmenorrhea
timeFrame: Preliminary tests will be carried out and then the 1st EFT session will be held. After 30 days, the first final tests will be performed and then the second EFT session will be held. After 30 days, only the 2nd final tests will be performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
state: Karabuk
city: Karabuk
country: Turkey
facility: Karabük University
Study officials:
References: