louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03572270: HIV and Ovarian Reserve
Official title: Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Infertility
Keywords: HIV
Ovarian reserve
Fertility preservation
Anti HIV agents
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Recent evidence suggests a decline in fertility of persons living with HIV (PLWH) (delayed pregnancies, sponteanous abortions, especially when patients receive an antiretroviral therapy, early menopause, amenorrhea and anovulatory cycles) with a possible decrease in ovarian reserve. However, indications of fertility preservation by freezing oocytes are nevertheless not clearly identified.

The objective of this study is to evaluate the ovarian reserve before and after the implementation of antiretroviral treatment in PLWH for whom the diagnosis of HIV has just been made.

Detailed description: This is a monocentric prospective cohort study with minimal risk and constraints. Ovarian reserve is compared between two groups: 30 PLWH, at time of diagnosis and 6, 12 and 18 months after initiation of an antiretroviral therapy, and 30 HIV negative women attending medically assisted procreation consultation for male infertility, age, BMI and smoking habits matched.

Eligibility criteria: Inclusion Criteria:

* For every participant :
* woman aged 18 to 37
* covered by social security
* able to give an informed consent

Case group only :

* diagnosis of HIV infection during the 3 months before inclusion
* concomitant initiation of an antiretroviral therapy with integrase inhibitors and nucleoside analogues

Control group only :

* assisting medically assisted procreation consultation for male infertility
* matching case subjects with age, BMI and smoking habits

Exclusion Criteria:

* For every participant :
* current pregnancy
* condition or associated treatment that may have an impact on fertility
* premature ovarian failure
* polycystic ovary syndrome
* endometriosis

Control group only :

- suspected HIV infection

Primary outcomes:
measure: change from inclusion visit AMH level at 18 months
timeFrame: M0 (inclusion visit) and M18 (after 18 months)
Secondary outcomes:
measure: antral follicle count
timeFrame: Month 0 (inclusion visit), Month 6 (after 6 months), Month12 (after one year), Month18 (after 18 months)
measure: estradiol, lutenizing hormone and follicle-stimulating hormone test
timeFrame: Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Florence BRUGNON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03271970: The Anatomic Determinants of Perforation Induced Hearing Loss
Official title: The Anatomic Determinants of Perforation Induced Hearing Loss
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Conductive Hearing Loss
Perforated Tympanic Membrane
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with conductive hearing loss due to tympanic membrane perforation.

Brief summary: The purpose of this study is to identify factors that may contribute to conductive hearing loss. Conductive hearing loss is a type that is due to a problem with the outer or middle ear. Because of this, sound does not travel through the ear normally. Perforated tympanic membranes of study patients will be photographed during the patient's routine visit using a digital otoscope. These pictures will be used to analyze perforation size as an absolute value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of temporal bone (reports and images) collected as standard of care will be evaluated. Images of CT scans will be imported into a medical imaging software for creation of anatomically realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be recorded, and data points will be correlated with perforation size and location to audiogram results.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 89 years of age
* Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane perforation
* Treated for the above condition by a Duke physician
* Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry at a Duke-based facility (both tests performed within four weeks of each other), as part of standard pre-operative workup

Exclusion Criteria:

* Temporal CT scan with inadequate resolution as per determination of study staff
* Unable to provide written informed consent
* Unable to read and understand English

Primary outcomes:
measure: presence of perforation
timeFrame: Day 1
measure: absence of perforation
timeFrame: Day 1
measure: change in audiometric measurements
timeFrame: Baseline, up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Dennis Frank-Ito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023670: Lung Protection and Pediatric Cardiac Surgery
Official title: Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Injury, Acute
Keywords: Lung
Cardiopulmonary Bypass
Pediatric
Cardiac surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system

Detailed description: The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery
* Ventricular septal defect (VSD).
* Atrial septal defect (ASD)

Exclusion Criteria:

* Cyanotic heart disease.
* Patients with preoperative chest problems.
* Patients with known renal or hepatic dysfunctions.
* Planned off-pump cardiac surgery.
* Emergency cardiac surgery.

Primary outcomes:
measure: Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
timeFrame: preoperative and within the first 7 days postoperative
Secondary outcomes:
measure: Mechanical ventilation
timeFrame: Within the first 7 days postoperative
measure: Intensive care unit stay
timeFrame: Within the first 7 days postoperative
measure: Intubation time
timeFrame: Within the first 7 days postoperative
measure: Arterial blood gases
timeFrame: Within the first 7 days postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate profossor of Anesthesiology and critical care
name: Sayed Abd-Elshafy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05818670: Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia Long Term Study
Official title: Comparison Between Tamsulosin and Tadalafil in Management of Benign Prostatic Hyperplasia A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: BPH
Keywords: tamsulosin
tadalafil
BPH
Randomised trial
longterm
discontinuation rate
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 160
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Comparison between tamsulosin and Tadalafil in management of benign prostatic hyperplasia A Randomised Trial

Detailed description: Assessment of the discontinuation rate of tamsulosin and tadalafil after 12 months follow up either and evaluate the changes in urinary parameters and sexual parameters in patients with lower urinary tract symptoms due to BPH concomitant with erectile dysfunction. We tried to overcome the limitations of the previous studies by designing a prospective randomized controlled trial as the present study is the first randomized controlled trial that evaluate the safety, discontinuation rate and efficacy of tadalafil compared with tamsulosin for long term follow up (12 months).

Eligibility criteria: Inclusion Criteria:

* patients with Lower Urinary Tract Symptoms
* married and sexually active
* age more than 50 years
* IPSS more than 12
* Q max less than 15 ml/s
* Post voiding residual less than 150 ml

Exclusion Criteria:

* prostatic adenocarcinoma
* cardiac patients on nitrates, patient with unstable angina or recent history of myocardial infarction
* vesical stones
* active Urinary Tract Infection
* patient refused participation in the study

Primary outcomes:
measure: drug discontinuation rate
timeFrame: 12 months
Secondary outcomes:
measure: changes in urinary parameters
timeFrame: 12 months
measure: changes in uroflowmetry
timeFrame: 12 months
measure: changes in post voiding residual urine
timeFrame: 12 months
measure: changes in sexual parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ahmed Atta Elqaffas
state: Dakahlia
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center at Mansoura University
state: Dakahlia
Study officials:
affiliation: Mansoura urology and nephrology center (UNC)
name: ahmed A elqaffas, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759070: Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Official title: Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV Infections
Keywords: Treatment Naïve
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Germans Trias i Pujol Hospital
name: Hospital Universitari Joan XXIII de Tarragona.
name: Hospitales Universitarios Virgen del Rocío
First posted: 2008-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.


Eligibility criteria: Inclusion Criteria:

* Chronic HIV-1 infection
* Age 18 or above
* Antiretroviral-naive
* Criteria for antiretroviral therapy in accordance with current guidelines
* Plasma LDL-cholesterol below 190 mg/dL
* Not receiving lipid-lowering agents
* Written informed consent

Exclusion Criteria:

* Use of phytosterol-enriched food previous month.
* Pregnancy or breastfeeding
* Cardiovascular disease
* Secondary Hypercholesterolemia
* Plasma creatinine above 1,2 mg/dL)
* Aminotransferases above 5 times ULN
* Current treatment for hepatitis C coinfection
* Diabetes mellitus (fasting glycemia \> 124 mg/dL)
* Illegal drug use or alcohol abuse
* Active AIDS-defining opportunistic disease

Primary outcomes:
measure: Changes in total cholesterol and HDL and LDL fractions
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
References:
citation: Leyes P, Cofan M, Gonzalez-Cordon A, de Lazzari E, Trabal J, Domingo P, Negredo E, Vidal F, Forga MT, Gatell JM, Ros E, Martinez E. Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia. AIDS. 2018 Jun 19;32(10):1309-1316. doi: 10.1097/QAD.0000000000001837.
citation: Egana-Gorrono L, Martinez E, Domingo P, Lonca M, Escriba T, Fontdevila J, Vidal F, Negredo E, Gatell JM, Arnedo M. Differential subcutaneous adipose tissue gene expression patterns in a randomized clinical trial of efavirenz or lopinavir-ritonavir in antiretroviral-naive patients. Antimicrob Agents Chemother. 2014 Nov;58(11):6717-23. doi: 10.1128/AAC.03481-14. Epub 2014 Aug 25.
Clinical trial NCT05263570: The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
Official title: The Efficiency for Patient With Stage II-III HR+/HER2+ Early Breast Cancer With Standard Neoadjuvant Therapy: a Retrospective, Multicenter Study in Real World Settings.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: standard Therapy （TCbHP/THP/EC-THP/AC-THP）
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 200
Sex: FEMALE
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 diagnosed with stage II-III HR+/HER2+ early breast cancer.

Brief summary: To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.

Detailed description: This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years or older
* HR+/HER2- breast cancer diagnosis based on local standards
* Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
* Standard Therapy, determined at the discretion of the investigator, including （TCbHP/THP/EC-THP/AC-THP）
* Complete medical history was available
* Karnofsky Performance Status (KPS) Scale score ≥ 70

Exclusion Criteria:

* Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
* Pregnant or breast-feeding women
* Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
* Those who have stage IV breast cancer

Primary outcomes:
measure: Total pathological complete response (tpCR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment
timeFrame: through study completion, an average of 1 year
measure: Residual cancer burden (RCB)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Overall survival (OS)
timeFrame: Within 5 years after surgery
measure: Disease-free survival (DFS)
timeFrame: Within 5 years after surgery
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT04722770: Clinical Development of Deep Learning for the OtoSight
Official title: Clinical Development and Evaluation of a Deep Learning Approach to Improve Diagnostic Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media Acute
Keywords: Ear Infection
Otitis Media
Otitis Media with Effusion
Machine Learning
Lead sponsor: PhotoniCare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-01-25
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children presenting to the pediatric clinic with suspected ear infection

Brief summary: The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients presenting for an office visit with ear-related complaints

Exclusion Criteria:

* Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)

Primary outcomes:
measure: PhotoniCare OtoSight imaging exam
timeFrame: 1-5 minutes; at first and only study visit
Secondary outcomes:
measure: Adverse events
timeFrame: 15-30 minutes; at first and only study visit
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: PhotoniCare, Inc.
name: Ryan Shelton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03568370: Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
Official title: Effects of Olive Oil on Nipple Cracking, Nipple Pain and Maternal Satisfactions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cracked Nipple During Lactation
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to Tri-Service General hospital postpartum unit. Eligible patients were randomized to olive oil group or breast milk group and evaluate the effect of olive oil for nipple pain, nipple trauma, and maternal satisfaction.

Detailed description: Previous studies have shown that olive oil, applied to the skin, has analgesic and anti-inflammatory properties. It is proposed in this study that olive oil may also help prevent cracked nipple and sore nipple in breastfeeding mothers. The aim of the study is to evaluate the effectiveness of olive oil in the prevention of nipple cracking, nipple pain and ascension of maternal satisfaction in lactating women. It's a prospective, randomized study of 80 lactating women, admitted to TSGH postpartum unit. Eligible patients were randomized into two groups of 40 women. In Group 1 Olive oil will be applied on the nipple after breastfeeding, and in Group 2 drops of breast milk were applied to the nipple after feeding. Clinical evaluations were made during the first 3 days of treatment and the 7th and 10th day after delivery. Furthermore, we will check the 1month breastfeeding rate data, which collected by the hospital nurse for baby-friendly hospital policy.

Eligibility criteria: Inclusion Criteria:

* Normal spontaneous delivery.
* Pregnancy weeks between 37-42.
* Single birth.
* Initiated breastfeeding.

Exclusion Criteria:

* Presence of crack in the nipple.
* Medication applied to the nipple
* The maternal health condition that may interfere with breastfeeding.
* The infant with congenital abnormalities that would impair breastfeeding.
* The infant attained low birth weight or other criteria to intensive care unit.

Primary outcomes:
measure: Nipple pain change
timeFrame: Change from baseline nipple pain at 10 days
measure: Nipple sore change
timeFrame: Change from baseline nipple pain at 10 days
measure: Nipple trauma change
timeFrame: Change from baseline nipple trauma at 10 days
measure: breastfeeding duration
timeFrame: 30 days
Secondary outcomes:
measure: Maternal satisfaction
timeFrame: baseline from Baseline nipple sore at 10 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Lin
state: Neihu
Study officials:
affiliation: lin050027@hotmail.com
name: Chen-Xi Lin
role: STUDY_CHAIR
References: