louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06049602: TDF and Entekavir - Hepatitis B Reactivation
Official title: Efficacy of TDF and Entekavir Prophylaxis at Hepatitis B Reactivation: Multi Center Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B Reactivation
Lead sponsor: Viral Hepatitis Society
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who used entekavir or TDF for Hepatitis B prophylaxis

Brief summary: This is a non-interventional retrospective multi-center study for the patients received Entekavir or TDF for Hepatitis B prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Patients used entekavir or TDF for Hepatitis B prophylaxis

Exclusion Criteria:

* Patients lower then 18 years old.

Primary outcomes:
measure: Reactivation Rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
Study officials:
affiliation: Sentez CRO
name: Ilker Kurkcu
role: STUDY_DIRECTOR
References:
Clinical trial NCT04776902: Effects of Ovarian Reserve on Sexual Satisfaction
Official title: Effects of Ovarian Reserve on Sexual Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex Behavior
Ovarian Failure
Keywords: Ovarian Reserve
Sexual Satisfaction
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Survey Study
Primary purpose: DIAGNOSTIC

Brief summary: This is a survey study. The primary aim of the study is to investigate the relationship between the ovarian reserve and sexual satisfaction. All the patients who underwent ovarian reserve assessment for any reason will fill a questionnaire about sexual satisfaction. And the survey results will be compared with patients' ovarian reserve.


Eligibility criteria: Inclusion Criteria:

* Patients who admitted to the gynecology clinic for any reason
* Patients with ovarian reserve tests
* 18-45 years

Exclusion Criteria:

* Mental disorders
* Anatomic genital malformations
* Patient' Decline to fill the survey
* Presence of malignancy
* Without any sexual activity

Primary outcomes:
measure: Sexual Satisfaction Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University ART Center
Study officials:
References:
citation: Kulahci Aslan E, Aslan K, Gurluler J, Uyaniklar O, Kilik T, Turk P, Ozden O, Kasapoglu I, Uncu G. EROSS study: effect of ovarian reserve on sexual satisfaction. J Obstet Gynaecol. 2022 Oct;42(7):3055-3060. doi: 10.1080/01443615.2022.2081798. Epub 2022 Jun 6.
Clinical trial NCT02927002: Effects of Non-invasive Brain Stimulation in Impulse Control Disorders
Official title: Effects of Non-invasive Brain on Decision-making in Impulse Control Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impulse Control Disorder
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to study the effect of noninvasive brain stimulation on decision-making and on brain activity in impulse control disorders.


Eligibility criteria: Inclusion Criteria:

* Impulse control disorders according to DSM-IV criteria

Exclusion Criteria:

* Other psychiatric disorders
* Contraindication to Non-invasive brain stimulation and MRI

Primary outcomes:
measure: Change in decision-making from pre to post stimulation assessed with the Balloon Analogue Risk Task
timeFrame: 10 minutes before and immediately after the 30 minutes of non invasive brain stimulation
Secondary outcomes:
measure: Changes in brain activity assessed between before and during stimulation measured with functional magnetic resonance (fMRI)
timeFrame: 20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
measure: Neural metabolites concentrations measured with magnetic resonance spectroscopy (MRS)
timeFrame: 20 minutes before and immediately after the 30 minutes of non invasive brain stimulation
measure: Change in Craving from pre to post stimulation assessed with a single standardized scale
timeFrame: 7 minutes before and 3 minutes after the end of the 30 minutes of non invasive brain stimulation
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration
state: Quebec
Study officials:
References:
Clinical trial NCT05744102: Improve MRI Diagnosis
Official title: Evaluation of Advanced and New MRI Techniques to Improve Patient Diagnosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: New MRI Techniques
Keywords: Advanced MRI
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 2016
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the research is to compare by two blind evaluators new MRI techniques with routinely used sequences.

Detailed description: "The main evaluation criterion will be the choice of the two (or three) evaluators as to the best sequence between the new sequence and the standard sequence.

The decision criterion for considering a new sequence as superior to the standard sequence will be based on two measures:

1. The proportion of patients for whom the new sequence was preferred, which must be greater than or equal to 75%;
2. Inter-observer agreement (Cohen's Kappa coefficient), which must be greater than or equal to 0.8; When these two criteria are met, the new sequence will be considered superior to the standard sequence"

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient who signed a consent to participate in the study
* Affiliated patient or beneficiary of a social security scheme
* Patient having an MRI scheduled as part of their care pathway
* Absence of prohibition of participation in another research

Exclusion Criteria:

* Patients under guardianship or curators
* Pregnant or breastfeeding patients
* Patients responding to a contraindication to performing an MRI
* Patient under state medical aid (AME)
* Adult patients protected by law

Primary outcomes:
measure: Image quality
timeFrame: 7 years
Secondary outcomes:
measure: Acquisition period
timeFrame: 7 years
measure: Apnea
timeFrame: 7 years
Other outcomes:
Locations:
city: Villejuif
country: France
facility: CHU Paul Brousse
Study officials:
affiliation: APHP
name: Maïté LEWIN, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06035302: Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Official title: Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholecystolithiasis
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Aswan University Hospital
First posted: 2023-09-13
Enrollment: 90
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 aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure


Eligibility criteria: Inclusion Criteria:

* age . 18 years
* eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

* refused to participate

Primary outcomes:
measure: closure time
timeFrame: 1 day
measure: rate of closure failure
timeFrame: 1 day
Secondary outcomes:
measure: incidence of port site infection
timeFrame: 1 month
measure: incidence of port site hernia
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Mohie El-Din M Madani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05369702: Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes
Official title: Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes- A Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: ABO blood group system
Lewis negative phenotype
coronary artery disease
Lead sponsor: Jubilee Mission Medical College and Research Institute
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 210
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 cases attending the Cardiology department who satisfy the inclusion and exclusion criteria were taken as cases.

140 (age and gender-matched) healthy blood donors who were eligible to donate blood as per the inclusion and exclusion criteria of Drugs and Cosmetics Rules, 1945 were taken as controls.

Brief summary: Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala.

The secondary objective-To find the association of Lewis antigen and A, B, O blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia.

A case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease. This may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.


Eligibility criteria: Inclusion Criteria:

- Patients in the age group of 30-55 years at the time of data collection diagnosed with coronary artery disease based on positive changes in coronary angiogram (more than 70% coronary stenosis)

Exclusion Criteria:

* Patients with other systemic illnesses like malignancy, autoimmune diseases.
* Patients who were not willing to participate in the study.

Primary outcomes:
measure: Prevalence of Lewis and ABO blood group phenotypes in cases and controls.
timeFrame: Lewis and ABO phenotype of the study participants was determined immediately after sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Thrissur
country: India
facility: Jubilee Mission Medical College & Research Institute
state: Kerala
Study officials:
References:
Clinical trial NCT01071902: Safety and Efficacy of Moxidex Otic
Official title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Otitis Media
Keywords: ear tubes
ear drainage
ear infection
ear drops
acute otitis media
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility criteria: Inclusion Criteria:

* 6 months to 12 years of age
* Ear tubes in one or both ears
* Ear drainage visible by parent/guardian
* Ear drainage less than 21 days
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
* Ear tube with antimicrobial activity; ear tube longer than 2.5mm
* Non-tube otorrhea
* No otic surgery other than tube placement in the last year
* No menarchial females; no diabetic patients
* No patients with any disease or condition that would negatively affect the conduct of the study
* No patients taking any other systemic antimicrobial therapy during the study
* Patient must meet certain medication washouts to be eligible
* Analgesic use (other than acetaminophen) is not allowed
* Patients may not be predisposed to neurosensory hearing loss
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Clinical Cure at End of Treatment
timeFrame: Day 8
Secondary outcomes:
measure: Time to Cessation of Otorrhea
timeFrame: From First Dose
measure: Microbiological Success at End of Treatment
timeFrame: Day 8
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: 1-888-451-3937
name: Contact Alcon Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00889902: Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis
Official title: Molecular Markers in Cervical Cancer Screening in the Feasibility of the Mathematical Markov Model Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: Molecular Markers
Cervical Cancer
Screening
Makov
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: residents of a certain town

Brief summary: The purpose of this study is to:

1. make p16INK4A as a cervical cancer screening of tumor markers, cytology improve existing diagnostic sensitivity, specificity, repeatability and validity, so as to effectively prompted the early discovery and diagnosis of cervical cancer.
2. reduce screening costs, screening and benefits into quantitative evaluation, for our country to develop cervical cancer prevention and control strategy to provide a reliable theoretical basis.

Detailed description: 1. To carry out large-scale prospective randomized controlled clinical study to evaluate the "cytological molecular markers Detect + P16INK4A" methods of screening accuracy and reliability, as well as the screening method of the biological effects.
2. Markov set up mathematical model of screening tests to quantify the inputs and the evaluation proceeds. With a view to optimize and perfect a simple, convenient, practical and efficient program of cervical cancer screening.

Eligibility criteria: Inclusion Criteria:

* Married women aged 25 to 65-year-old with risk factors
* No tumor and pelvic radiation therapy history
* Non-pregnant women at present

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wufeng county
country: China
facility: People'S Hospital
state: Hubei
Study officials:
affiliation: gynecologic oncology department, Zhongnan Hospital of Wuhan University
name: Hong B Cai, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04883502: Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Official title: Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Loss
Keywords: Masquelet technique
Induced membrane technique
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 80
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: The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.

Brief summary: Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient with traumatic bone loss
* Patient eligible for the induced membrane technique

Exclusion Criteria:

* Patients with post-tumor bone loss
* Patients who are immunocompromised or under immunosuppressive treatment
* Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
* Patients with collagenosis
* Patient with a contraindication to sampling
* Pregnant or breastfeeding women

Primary outcomes:
measure: Histological profile of induced membrane fragments
timeFrame: Through study completion, an average of 6,5 years
measure: Cellular profile of induced membrane fragments
timeFrame: Through study completion, an average of 6,5 years
measure: Secretory profile of induced membrane fragments
timeFrame: Through study completion, an average of 6,5 years
measure: Gene expression profile of induced membrane fragments
timeFrame: Through study completion, an average of 6,5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
Study officials:
References:
Clinical trial NCT06832202: A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
Official title: A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HER2-low Hormone Receptor Positive Breast Cancer
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Detailed description: experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).

Eligibility criteria: Inclusion Criteria:

1. Male/female who are at least 18 years of age on the day of signing the informed consent.
2. With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
3. HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
4. Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
5. ECOG PS: 0-1.
6. Expected survival ≥ 6 months.
7. Had adequate organ function

Exclusion Criteria:

1. Patients with other malignant tumors within 3 years before the randomization
2. Previous treatment with any HER2-target therapy
3. Uncontrolled or significant cardiovascular disease or infection
4. Lung-specific intercurrent clinically significant illnesses
5. Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
6. Patients with spinal cord compression or clinically active central nervous system metastases

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
measure: Objective response rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: PFS
timeFrame: Up to 5 years
measure: ORR
timeFrame: Up to 2 years
measure: Aderse events (AE)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: