louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05845619: Enhanced Virologic Monitoring for Pregnant and Postpartum Women With HIV
Official title: Implementing a Risk Score to Facilitate Enhanced Adherence Support for Pregnant and Postpartum Women at Risk of Viremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Viremia
Pregnancy Related
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2023-05-06
Enrollment: 550
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study participants will be compared to historical controls.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to learn about supporting pregnant and postpartum women living with HIV with treatment adherence. The investigators will conduct a pilot study of an intervention that includes peer counseling about viral load levels and rapid delivery of viral load results. The investigators will evaluate the feasibility of the intervention, and will assess whether it improves viral suppression 6 months following the intervention, compared to historical controls.

Detailed description: The investigators will examine the use of more frequent virologic monitoring with enhanced communication around low-level viremia as a strategy to identify and support pregnant and postpartum women at risk of virologic failure. Virologic monitoring itself can reinforce adherence in stable patients, and more frequent monitoring can detect potential adherence challenges early. Notably, low-level viremia is a strong predictor of subsequent virologic failure, and the lowest level associated with perinatal transmission is not known.

The pilot study will run for 6 months at 4 Ministry of Health facilities in Kisumu County, Kenya; 275 participants will be enrolled. Prior to the pilot study, 125 controls will be enrolled prospectively, and 150 controls will be abstracted from records from the prior year.

Eligibility criteria: Inclusion Criteria:

* Women living with HIV
* On antiretroviral treatment
* Either pregnant in the 3rd trimester, OR, postpartum within 6 months of delivery

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Virologic suppression
timeFrame: Within 6 months after study engagement (i.e., after pilot study participation; after the enrollment visit for prospectively enrolled controls; after the date of eligibility for controls from records)
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Lumumba Sub County Hospital
city: Nyakach
country: Kenya
facility: Nyakach County Hospital
city: Nyando
country: Kenya
facility: Ahero County Hospital
city: Nyando
country: Kenya
facility: Rabuor Sub county Hospital
Study officials:
affiliation: University of California, San Francisco
name: Pamela Murnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637819: Leflunomide in Systemic Lupus Erythematosus
Official title: A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Lupus Eythematosus (SLE)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide


Eligibility criteria: Inclusion Criteria:

* Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)

Exclusion Criteria:

* Patients who are pregnant or nursing women, or those with life threatening disease
* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
timeFrame: 52 weeks
Secondary outcomes:
measure: number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Iris Chan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03510819: Evaluation of Knowledge- Attitude- Practice (KAP) of Intern Dentists in Emergency Management of Traumatic Dental Injuries in Permanent Anterior Teeth
Official title: Evaluation of Knowledge- Attitude- Practice (KAP) of Intern Dentists in Emergency Management of Traumatic Dental Injuries in Permanent Anterior Teeth: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatized Permanent Anterior Teeth
Keywords: Dental trauma
Emergency management
Tooth avulsion
Knowledge
Practice
Traumatic injuries
Attitude
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 500
Sex: ALL
Minimum age (years): 22
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dentists attending their internship in Cairo University and another private university (Modern Science and Arts University- MSA).

Brief summary: This study aims to evaluate knowledge, Attitude and Practice of intern dentists in emergency management of traumatic dental injuries in permanent anterior teeth in children aged from 6 to 12 years old. A questionnaire survey will be designed to evaluate Knowledge - Attitude - and practice (KAP) of intern dentists who met the eligibility criteria.


Eligibility criteria: Inclusion Criteria:

* Intern dentists attending their internship in Faculty of Dentistry- Cairo University, other private university (Modern Science and Arts University- MSA).
* The intern dentists who agree to participate.
* Intern dentists who did not attend Pediatric Dentistry round, Endodontic round, Emergency round and Surgery round at Cairo University.
* Intern dentists irrespective of age and sex.

Primary outcomes:
measure: Knowledge, attitude and practice (KAP) of intern dentists.
timeFrame: 1 year
measure: Knowledge, attitude and practice (KAP) of intern dentists.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05658419: Immediate Implant vs.Socket Shield Technique in Esthetic Zone
Official title: Evaluation of Immediate Loaded Implants Placed Using the Socket Shield Technique in the Esthetic Zone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Keywords: socket shield
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study group (socket shield) vs. Control group (immediate implants)
Primary purpose: OTHER

Brief summary: immediate implant placement versus socket shield approach

Detailed description: This study was a randomized controlled clinical trial; patients were randomly allocated to two groups: the study group: ten dental implants were placed in the maxillary esthetic zone, implants were placed using the socket shield technique with immediate loading; and the control group: ten implants were placed immediately with immediate loading. Preoperative and 6 months postoperative CBCT were performed for both groups to assess the dimensional changes in the labial bone plates. Implant stability quotients (ISQs), pink esthetic scores and attachment loss were measured at the time of implant placement and 6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

Patients of 20-45 years of both sexes. Good oral hygiene Demonstrating non-restorable maxillary anterior single rooted teeth in the esthetic zone with as far diagnosable.

Fairly intact buccal periodontal tissues. Patients' acceptance to sign the informed consent. Labial bone plates less than 1.5 mm in thickness or cases with labial root curvatures.

Intact root with no mobility in the tooth and no sub-gingival caries.

Exclusion Criteria:

Patients with systemic diseases that would interfere with the normal healing such as uncontrolled diabetes mellitus.

History of radiation therapy to the head and neck. No history of bruxism/ para-functional habits. (119) Teeth with periodontal disease, vertical root fracture, horizontal fracture at or below the bone level, and teeth with local pathologic incidents that affect the labial part of the root as external or internal root resorption were also excluded.

Maxillary 1st and 2nd premolars. Pregnant and lactating females.

Primary outcomes:
measure: radiographic bone level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Mohamed Mohamed Shehata Elsayed
Study officials:
References:
Clinical trial NCT05315219: A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach
Official title: A Follow-up Study on the Long-term Treatment Effect and Quality of Life of Thyroid Cancer After Total Endoscopic Thyroidectomy Bilateral Areola Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 295
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced. However, these studies are generally with small sample size and short follow-up duration. The lack of long-term follow-up on oncological outcomes makes it inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA versus OT.


Eligibility criteria: Inclusion Criteria:

* 1) Female patients under 55 years old; 2) no lateral cervical lymph node or distant metastasis were detected before the operation; 3) postoperative pathology confirmed the diagnosis of papillary thyroid carcinoma.

Exclusion Criteria:

* 1) Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in the operation; 3) past or current history of underlying diseases including hyperthyroidism, hypertension, diabetes, coagulation dysfunction.

Primary outcomes:
measure: Quality of life
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05059119: Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
Official title: Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 2
Sex: FEMALE
Minimum age (years): 54
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To present cases who developed rectovaginal fistulas after radiotherapy

Brief summary: To investigate the associated risk factors of rectovaginal fistula

Detailed description: To investigate the associated risk factors of rectovaginal fistula in cervical caner patients after radiotherapy

Eligibility criteria: Inclusion Criteria:

Rectovaginal fistula Cervical cancer

Exclusion Criteria:

Nil

Primary outcomes:
measure: Rate of associated comorbidity or intervention
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT05932719: Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators
Official title: Multicentric Evaluation of COVID-19 Impact on Cancer Patients' Diagnostic and Management: Set-up of Indicators to Follow-up the Activities of Different Cancer Pathologies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Peritoneal Carcinoma
Keywords: COVID-19
Cancer
Health Care Quality Indicators
hepatocellular carcinoma
peritoneal carcinosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.

Brief summary: The COVID-19 pandemic has deeply and globally impacted usual procedures and patients management in cancer centers. The aim of this study is to set-up and collect indicators to follow-up the activities of different cancer pathologies before and during the pandemic. Patients loss' of chance will be analysed in term of diagnosis and access to care (surgery, antineoplastic treatments).

Data collection will focus on the analysis of 2 specific pathologies for French patients in the "Auvergne-Rhône Alpes" Area: peritoneal carcinosis and hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in France for peritoneal carcinosis or hepatocellular carcinoma between 2017 and 2020.

Exclusion Criteria:

* Patients who did not allow the reuse of their medical data for research

Primary outcomes:
measure: Measure of patient loss of chance when comparing a set of activity indicators between 2020 and the average activities of previous periods (2017-2019)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hopital Lyon sud, Hospices civils de Lyon
Study officials:
References:
Clinical trial NCT01962519: Early Oral Feeding After Total Gastrectomy for Cancer
Official title: A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adenocarcinoma of the Stomach
Keywords: gastrectomy
gastric cancer
oral feeding
complications
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).


Eligibility criteria: Inclusion Criteria:

* Total gastrectomy for cancer
* Age 18 - 80 years
* Informed consent

Exclusion Criteria:

* Numerous hepatic and peritoneal metastases
* Extended resections (pancreas, colon)
* Preoperative malnutrition requiring total parenteral nutrition
* Emergency surgery

Primary outcomes:
measure: Postoperative hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary outcomes:
measure: Morbidity
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Other outcomes:
measure: Re-admissions
timeFrame: 30 days after discharge
measure: Effective oral feeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: Quality of life
timeFrame: Preoperatively, postoperative day 7, 14 days after discharge
measure: Laboratory parameters
timeFrame: Preoperatively, postoperative day 1 and 8
Locations:
city: Kraków
country: Poland
facility: First Department of Surgery, Jagiellonian University Medical College
state: Malopolska
Study officials:
affiliation: First Department of Surgery, Jagiellonian University Medical College, Krakow, Poland
name: Jan Kulig, prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01880619: Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms
Official title: A Randomized Clinical Trial Comparing Alpha Blacker (Tamsulosin) and Anticholinergic (Solifenacin) in Treatment of Ureteral Stent Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relieve of Ureteral Stent Symptoms
Keywords: Double J
Ureteral stents
Symptoms
Alpha blockers
Anticholinergic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 131
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the effectiveness of alpha blocker (Tamsulosin) and Anticholinergic (Solifenacin) in relieving lower urinary tract symptoms caused DJ ureteral stents.

Detailed description: Eligible patients who signed the informed consent will randomly assigned to one of 3 groups; group 1 (control), group 2 (tamsulosin) and group 3 (Solifenacin). Ureteral stent symptom questionnaire (USSQ) will be used to compare health related quality of life scores.

Eligibility criteria: Inclusion Criteria:

Patient who will undergo unilateral ureteral stent fixation:

1. To relieve upper urinary tract obstruction caused by ureteric calculi
2. After ureteroscopic lithotripsy for ureteral calculi.

Exclusion Criteria:

1. Patients who had LUTS before stent fixation.
2. Ureteral stent fixation after open or laparoscopic surgery.
3. Bilateral ureteral stents.
4. Patients who developed complications related to the primary endoscopic procedure
5. Patients who developed stent related complications such as hematuria, acute pyelonephritis or stent displacement

Primary outcomes:
measure: The Efficacy of tamsulosin and solifenacin in relieving ureteral stent symptoms will be evaluated by comparing the scores of ureteral stent symptoms questionnaire in the studied groups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
affiliation: Urology and Nephrology Center, Mansoura University
name: Ahmed R EL-Nahas, A. Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: El-Nahas AR, Tharwat M, Elsaadany M, Mosbah A, Gaballah MA. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms. World J Urol. 2016 Jul;34(7):963-8. doi: 10.1007/s00345-015-1704-3. Epub 2015 Oct 9.
Clinical trial NCT02521519: Short Terms Effects of Medial Branch Block vs Para-spinal Muscle Injection in Patients With Non-specific CLBP
Official title: Short Term Effects of Medial Branch Block vs Para-spinal Injection in Muscle Patients With Non-specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain, Mechanical
Keywords: Facet induced pain
Myofascial pain
Trigger points
Low back pain
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study compares the efficacy of medial branch block (MBB) vs. paravertebral deep intramuscular (PDI) injection for pain relief in chronic low back pain. Based on randomization in first intervention session, one side receives MBB and the other side takes PDI and in second session the pattern reverses.

Detailed description: Pain relief following medial branch block (MBB) might be due to facet joints desensitization and/or myofascial trigger points' desensitization. Patients will be randomized to two groups. The first group receives MBB in one side and paravertebral deep intramuscular (PDI) injection in the other side of the back. Next week the pattern of injection will be reversed so the side which had received MBB will take PDI injection and PDI side will take MBB. Second group takes the intervention in reverse order.

Eligibility criteria: Inclusion Criteria:

* CLBP of non-malignant origin fulfilling the following criteria:

  * Pain lasting for at least three months
  * Pain in both the left and right sides of the back
  * Pain below the L2 vertebral body
* Lumbar spine CT scan or MRI done in the last 2 years
* Average visual analogue scale (VAS) for pain ≥4/10 on each side for the 3 days
* Cognitive and physical ability to provide informed consent in English or French

Exclusion Criteria:

* Neurologic signs or symptoms suggesting nerve root involvement
* Strictly unilateral Low Back Pain (LBP)
* CT scan or MRI findings suggestive of pain etiology beyond degenerative spine disease

  * Vascular malformations
  * Tumor
  * Infection
  * Fractures
  * DISH (Diffuse idiopathic skeletal hyperostosis)
* Patients who have received injections of any type or acupuncture therapy to the low back in the last 3 months
* Prior spine surgery
* Local or systemic infection
* Bleeding disorder or the use of anticoagulation medications but for low-dose aspirin
* Known allergy to amid local anesthetics
* Active insurance claim (CSST, SAAQ)
* Uncontrolled psychiatric condition

Primary outcomes:
measure: Change in Chronic Low Back Pain (CLBP) measured by VAS
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Alan Edwards Pain Management Unit - Montreal General Hospital
state: Quebec
Study officials:
References: