louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05449717: Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis in South Sudan
Official title: A Prospective Cohort Study on the Incidence of Relapse and Post-Kala-Azar Dermal Leishmaniasis After Treatment for Primary Visceral Leishmaniasis in South Sudan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leishmaniasis
Leishmaniasis, Visceral
Post-kala-azar Dermal Leishmaniasis
Keywords: Leishmaniasis
Leishmaniasis, Visceral
Post-Kala-Azar Dermal Leishmaniasis
South Sudan
Kala-Azar
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Drugs for Neglected Diseases
name: Medecins Sans Frontieres, Netherlands
First posted: 2022-07-08
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Successfully treated and discharged primary cases of visceral leishmaniasis from the Médecins Sans Frontières-Operational Center Amsterdam (MSF-OCA)-run hospital in Jonglei State, South Sudan

Brief summary: This study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis.

Detailed description: This prospective, observational cohort study aims to describe the burden of Post-Kala-Azar Dermal Leishmaniasis and visceral leishmaniasis relapse in a cohort of patients discharged after successful treatment of primary visceral leishmaniasis from a hospital in Lankien, South Sudan.

Eligibility criteria: Inclusion Criteria:

* Primary visceral leishmaniasis patients who had a confirmed (serological and/or parasitological) diagnosis at admission, and who were discharged after successful treatment
* Availability for follow up visits
* Provision of informed consent, and in the case of minors 12 to 17 years of age, assent as well

Exclusion Criteria:

* Unavailability for follow-up visits due to distance, inaccessibility, or refusal to participate
* Diagnosis of prior primary visceral leishmaniasis done only on clinical basis

Primary outcomes:
measure: Incidence of post-kala-azar-dermal leishmaniasis (PKDL)
timeFrame: 12 months
measure: Incidence of VL relapse
timeFrame: 12 months
Secondary outcomes:
measure: Time of onset of visceral leishmaniasis (VL) relapse or post-kala-azar-dermal leishmaniasis (PKDL)
timeFrame: 12 months
measure: Characterize PKDL lesions
timeFrame: 12 months
measure: Risk factors for the development of VL relapse or PKDL
timeFrame: 12 months
measure: Rate and time period to self-healing of PKDL
timeFrame: 12 months
Other outcomes:
Locations:
city: Lankien
country: South Sudan
facility: Lankien Hospital
state: Jonglei
Study officials:
affiliation: Epicentre
name: Rebecca M Coulborn, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Medecins Sans Frontieres, Netherlands
name: Margriet den Boer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011017: Sexual Health of Sub-Saharan African Migrant Women Recently Diagnosed With HIV in Île-de-France: Missed Opportunities for Prevention
Official title: Sexual Health of Sub-Saharan African Migrant Women Recently Diagnosed With HIV in Île-de-France: Missed Opportunities for Prevention
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Sexual Health
Migrants
Women's Health
Health Services Accessibility
Sub-Saharan Africa
Risk-Taking
Vulnerable Populations
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of Sub-Saharan African migrant women living in Île-de-France who were newly diagnosed with HIV on French territory from 2021 onward. Participants will be selected from two infectious disease departments: the SMIT at the Centre Hospitalier Sud Francilien (CHSF) and the SMIT at the hospital in Melun. Eligible participants must be at least 18 years old and meet the inclusion criteria. This population is particularly vulnerable due to social, economic, and structural barriers that may limit access to sexual health services and HIV prevention.

Brief summary: This study looks at the sexual health of women from Sub-Saharan Africa who recently found out they have HIV after arriving in Île-de-France. It aims to understand their risk factors and identify missed chances for HIV testing and prevention. The goal is to improve care and support for these women by learning more about their experiences and the challenges they face.


Eligibility criteria: Inclusion Criteria:

* Sub-Saharan African migrant women recently diagnosed with HIV (from 2021 onward)
* HIV diagnosis made on French territory
* Aged 18 years or older

Exclusion Criteria:

* Inability to inform the patient about the study due to a language barrier or other obstacle
* HIV diagnosis made before 2021
* HIV diagnosis made in the country of origin
* Under 18 years of age

Primary outcomes:
measure: Description of sexual health characteristics (e.g., history of sexually transmitted infections, contraceptive use, number and type of sexual partners, presence of transactional sex, and access to sexual health services) in Sub-Saharan African migrant wom
timeFrame: enrollment - 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT05435417: Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT
Official title: Effect of Segmentation Techniques (Manual Versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle Using CBCT(A Diagnostic Accuracy Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Segmentation Techniques
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Effect of Segmentation Techniques (Manual versus Semiautomatic) on the Accuracy of the Reconstructed Mandibular Condyle using CBCT

Detailed description: It will be used to segment the mandibular condyle and asses its volumetric and linear measurements. Therefore, the accuracy of the segmentation techniques of the mandibular condyle will be determined

Eligibility criteria: Inclusion Criteria:

* Intact dry human skulls and mandibles.

Exclusion Criteria:

* Presence of fracture, pathological lesions, or skeletal deformities in the condylar area.

Primary outcomes:
measure: Linear assessment of the condyles
timeFrame: one month
Secondary outcomes:
measure: Volumetric assessment of the condyles
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
Study officials:
References:
Clinical trial NCT06216717: Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients
Official title: Study of the Location of Motor Cortical Stimulation Electrodes in Chronic Neuropathic Refractory Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuropathic Pain
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults who were implanted with a motor cortical stimulation system for treatment of chronic neuropathic refractory pain between 2003-2023

Brief summary: Cortical stimulation has been used since 1991 to treat neuropathic pain. However, the underlying mechanisms are still incompletely understood and under-studied. In this protocol, the investigators aim to study the myeloarchitectonic and functional characteristics of areas activated by cortical epidural electrodes and to determine their relation to therapy response in chronic neuropathic refractory pain patients.


Eligibility criteria: Inclusion Criteria

* adults
* patient implanted with a motor cortical stimulation system for chronic neuropathic refractory pain,
* patient with available postoperative scanner

Exclusion Criteria: None

Primary outcomes:
measure: Pourcentage of pain relief
timeFrame: 1 year
Secondary outcomes:
measure: location of leads on the postoperative imaging
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Petru ISAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769517: PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES
Official title: PREDICTION OF GERMLINE BRCA 1/2 GENES PATHOGENETIC VARIANTS FROM HEALTHY OVARIES ULTRASOUND IMAGES: RADIOGENOMICS AS AN INNOVATIVE TOOL TO PREVENT BRCA-RELATED CANCERS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BRCA Mutation
Ovarian Cancer
Ultrasound Therapy; Complications
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 1300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will conduct a retrospective multicenter observational study aimed at collecting US images of healthy ovaries with known BRCA status.

Brief summary: The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases:

Retrospective phase

AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis;

Prospective phase

AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.


Eligibility criteria: Inclusion Criteria:

Availability of gBRCA1/2 test results

Transvaginal pelvic US performed providing at least one picture of one healthy ovary

US images stored in .dicom format.

Exclusion Criteria:

Personal diagnosis of OC

Ovarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour...) with the exception of functional cysts at pelvic US

gBRCA1/2 testing results nor provided by an ISO 1589 accredited laboratory

Refusal to provide written informed consent

Primary outcomes:
measure: Radiogenomics model for predicting germline breast cancer.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT01098617: Antihemostatic Therapy and Endoscopic Biliary Sphincterotomy Induced Bleeding
Official title: The Effect of Antiaggregant, Anticoagulant and Nonsteroidal Antiinflammatory Therapy on Endoscopic Biliary Sphincterotomy Induced Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Biliary Sphincterotomy
Bleeding
Keywords: endoscopic sphincterotomy
hemorrhage
nonsteroidal antiinflammatory agents
antiaggregants
anticoagulants
Endoscopic biliary sphincterotomy induced bleeding
Lead sponsor: Yuksek Ihtisas Hospital
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 350
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who had undergone endoscopic sphincterotomy

Brief summary: The aim of the study is to observe the effects of antihemostatic therapy including nonsteroidal antiinflammatory, anticoagulant and antiaggregant therapy and other patient and procedure related factors on the risk of endoscopic biliary sphincterotomy induced bleeding.


Eligibility criteria: Inclusion Criteria:

* Hospitalization
* Endoscopic sphincterotomy
* The patients whose warfarin treatment was stopped and INR was normalized prior to examination

Exclusion Criteria:

* The patients who had undergone endoscopic cholangiography with no sphincterotomy
* Outpatient procedures

Primary outcomes:
measure: Bleeding induced by endoscopic biliary sphincterotomy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Hospital
Study officials:
affiliation: Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
name: Meral Akdoğan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
name: Ibrahim Koral Onal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Turkiye Yuksek Ihtisas Hospital Gastroenterology Department
name: Erkan Parlak, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02407717: Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer
Official title: Venous Thromboembolism and Bleeding in Hospitalized Medical Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Vein Thrombosis
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 330
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: Patients with cancer hospitalized for an acute medical illness

Brief summary: Patients with cancer hospitalized for an acute medical illness have an increased risk of venous thromboembolic events. Although international guidelines suggest the use of thromboprophylaxis in these patients, the recommendations are based on studies which included a percentage of patients with cancer without primarily focusing on this high risk group.

Since patients with cancer present an increased risk of bleeding complications it is critical to evaluate the safety of thromboprophylaxis in the cancer group. Recent studies suggest a limited use of thromboprophylaxis in these patients.

The aim of this study is to evaluate the use, efficacy and safety of thromboprophylaxis in medical cancer patients hospitalized for an acute medical disease.

Design: observational, prospective study Primary end-point: incidence of major and clinically relevant non major bleeding during hospitalization Secondary endpoints: frequency of use, doses and contraindications for pharmacological thromboprophylaxis; venous thromboembolic events up to three months after discharge


Eligibility criteria: Inclusion Criteria:

* all patients with cancer hospitalized for an acute medical illness

Exclusion Criteria:

* current use of oral or parenteral anticoagulant treatment
* no informed consent to participate

Primary outcomes:
measure: Major bleeding and clinically relevant non major bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Venous thromboembolism
timeFrame: Participants will be followed up to 3 months after discharge, an expected average of 13 weeks
measure: Minor bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Universita degli Studi G. d'Annunzio Chieti e Pescara
Study officials:
References:
Clinical trial NCT00910117: Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title: Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: HNSCC
induction chemotherapy
nimotuzumab
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.

Detailed description: Induction chemotherapy followed by radiotherapy is the standard treatment for patients with unresectable HNSCC. However, the role of induction chemotherapy remains uncertain for resectable disease. Therefore, we plan to perform a phase II study to evaluate it, focusing on radiographic and pathologic response after induction chemotherapy. Moreover, a new EGFR monoclonal antibody (nimotuzumab) is incorporated with PF regimen. The hypothesis is the addition of nimotuzumab would improve the response without remarkably increase the toxicity.

Eligibility criteria: Inclusion Criteria:

* Age range 18-70 years old
* ECOG performance status 0-1
* Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC
* Adequate organ function

Exclusion Criteria:

* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* Previous serious cardiac disease

Primary outcomes:
measure: overall response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: pathologic complete response
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346317: Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Official title: Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Asherman syndrome
hysteroscopy
Uterine stent
Estrogen
Amnion
Hysteroscopic Adhesiolysis
Lead sponsor: Beijing Obstetrics and Gynecology Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can improve clinical outcomes? Therefore, this study was conducted.

Detailed description: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention

Eligibility criteria: Inclusion Criteria:

* age 20-40 years；
* previously diagnostic hysteroscopy confirmed adhesion score \>5， according to the American Fertility Society （AFS）classification of IUA；
* complains of menstruation disorder and reproductive dysfunction；
* informed consent.

Exclusion Criteria:

* premature menopause,
* presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
* presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
* adhesions limited to the lower uterine cavity or the cervical canal.

Primary outcomes:
measure: Incidence of adhesion information
timeFrame: Within the first 3 months after surgery
Secondary outcomes:
measure: Menstruation pattern
timeFrame: Within the first 3 months after surgery
measure: The change of AFS score
timeFrame: Within the first 3 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital，Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Duan Hua, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00777517: Bioequivalence Study On Pediatric Appropriate Formulation
Official title: An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A Pediatric Appropriate Formulation To A 10 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Cardiovascular Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

Detailed description: Determination of Bioequivalence

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening

Primary outcomes:
measure: Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data.
timeFrame: 5 months
Secondary outcomes:
measure: Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin.
timeFrame: 5 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: