louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782897: Intravenous Immunoglobulin for Acute Intracranial Hemorrhage
Official title: A Pilot Study of Safety and Efficacy of Intravenous Immunoglobulin Therapy in Patients With Acute Intracranial Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intracranial Hemorrhage, Hypertensive
Keywords: intravenous immunoglobulin
intracerebral hemorrhage
perihematomal edema
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims to investigate whether intravenous immunoglobulin is safe and effective in alleviating perihematomal edema and neurologic deficits in patients with intracranial hemorrhage.

Detailed description: The trial consists of two groups: IVIg group and control group. Thirty patients will be recruited into IVIg group. Thirty Patients who are matched for age, gender, National Institutes of Health Stroke Scale scores, hematomal volumes, and locations of hematomas, will be selected into control group. Patients in control group just receive standard management, while those in IVIg group will receive standard management plus intravenous immunoglobulin therapy. The outcome assessor is blinded to the group assignments.

Eligibility criteria: Inclusion Criteria:

1. The first-ever primary supratentorial intracerebral basal ganglia hemorrhage 5-30ml.
2. 18-80 years old.
3. No longer than 72 hours from the acute ICH to medication.
4. Glasgow Coma Score ≥8.

Exclusion Criteria:

1. Occurrences of secondary intracerebral hemorrhage.
2. Significant past history of disability, modified Rankin Scale（mRS）≥1.
3. Currently taking antitumor drugs, immunosuppressive drugs, or immunomodulatory therapy.
4. Patients with pregnancy, Severe infection, severe heart dysfunction or renal and hepatic injuries.
5. Patients with contraindications for immunoglobulin.

Primary outcomes:
measure: Proportion of the patients with mRS of 3 or more
timeFrame: 90 days after the onset of ICH
Secondary outcomes:
measure: Changes in hematoma volume
timeFrame: At baseline, 7 days, 14 days and 30 days after the onset
measure: Change in peripheral edema volume
timeFrame: At baseline, 7 days, 14 days and 30 days after the onset
measure: All-cause mortality
timeFrame: 90 days after the onset
measure: mRS score
timeFrame: 30 days, 90 days after the onset
measure: mBI score
timeFrame: 30 days, 90 days after the onset
measure: Incidence of severe adverse events
timeFrame: 30 days, 90 days after the onset
measure: Change in the levels of blood CRP, MMP-9, IL-6, TNF-alpha, and C3
timeFrame: At baseline, 5 days after the first administration of immunoglobulin
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Neurology, Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Wei Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481597: Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers
Official title: Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: deuteporfin
safety
tolerability
pharmacokinetics
healthy volunteers
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.


Eligibility criteria: Inclusion Criteria:

* Chinese healthy male and/or female subjects
* 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
* weigh at least 45 kg for female subjects or 50 kg for male subjects
* In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Significant illness or major surgery within four weeks prior to dosing
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
* Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
* Participation in any clinical investigation within 30 days prior to dosing
* Smokers, alcoholics, drug abusers
* Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* pregnancy or lactation for female subjects

Primary outcomes:
measure: number of participants with adverse events
timeFrame: up to 19 days following injection
Secondary outcomes:
measure: Pharmacokinetic profile
timeFrame: predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central-South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Zeneng Cheng, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
name: Jining Tao, Master
role: STUDY_DIRECTOR
affiliation: Xiangya Hospital of Central South University
name: Pingsheng Xu, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06992297: Clinical Evaluation of Long-term Sequelae in Patients With Severe Plasmodium Falciparum Malaria
Official title: Clinical Evaluation of Long-term Sequelae in Patients With Severe Plasmodium Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Falciparum Malaria
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Malaria, endemic in 85 countries, remains a major concern. By 2022, there will be 249 million cases and 608,000 deaths, 94% of them in Africa. In France, 4995 cases of imported malaria were reported in 2021, with 15% of severe forms and a fatality rate of 2.5%. Long-term sequelae, such as kidney failure and neurological disorders, are well documented in children, but few studies have focused on adults.

Our main objective is to describe and estimate the frequency of long-term sequelae of severe imported malaria treated at our centre.

Our aim is to compare long-term neurological sequelae between neuromalaria and severe malaria without neurological disorders. In addition, we aim to identify the clinical, radiological and biological factors associated with sequelae in order to improve post-hospitalisation follow-up. Finally, we aim to describe acute complications arising at diagnosis and during hospitalisation.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years of age
* Have been diagnosed with severe malaria according to WHO criteria and have been treated between 1/1/2018 and 321/12/2024 at the AP-HM
* Have been treated with Artesunate IV (MALACEF®) (at least one dose)
* Patient who has received information about the study and has not expressed opposition
* Patient benefiting or entitled to benefit from a social security scheme

Exclusion Criteria:

* Patients with advanced neurodegenerative pathology pre-existing the malaria attack
* Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patients, patients of legal age under guardianship, curatorship or safeguard of justice, patients deprived of their liberty, pregnant or breast-feeding women),
* Persons who do not understand French

Primary outcomes:
measure: frequency of long-term sequelae of severe malaria
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: APHM
name: Francois CREMIEUX
role: STUDY_DIRECTOR
affiliation: APHM
name: Coralie L'OLLIVIER, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01788397: Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre
Official title: Effect of Comprehensive Rehabilitation at Beitostølen Healthsports Centre. A Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physically Disabled
Keywords: physical disabilities
rehabilitation
Lead sponsor: Beitostølen Health Sports Center
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2013-02-11
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main hypothesis:

The participants receive treatment at Beitostølen within 8 weeks or within 16 weeks. The groups waiting for rehabilitation is compared with the group receiving rehabilitation

Detailed description: nn

Eligibility criteria: Inclusion Criteria:

* Patients with physical disabilities admitted to treatment at BHC

Exclusion Criteria:

* Patients with severe cognitive disorders

Primary outcomes:
measure: Quality of life
timeFrame: Eight weeks
Secondary outcomes:
measure: Pain
timeFrame: 8 weeks
measure: Behavioural Regulation in Exercise Questionnaire (BREQ 2)
timeFrame: 8 weeks
measure: Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
timeFrame: 8 weeks
Other outcomes:
measure: Self efficacy
timeFrame: 8 weeks
Locations:
city: Beitostolen
country: Norway
facility: Beitostolen Healtsports Centre
state: Oppland
Study officials:
affiliation: Beitostolen Healthsports Centre
name: Rolf Stalenget
role: STUDY_DIRECTOR
References:
Clinical trial NCT03543397: MRI in Ductal Carcinoma in Situ (DCIS)
Official title: Relevance of Mammary MRI in the Preoperative Assessment of Ductal Carcinoma in Situ (DCIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ductal Carcinomas
Keywords: ductal carcinomas
ductal carcinoma in situ (DCIS)
MRI
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 74
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: Woman with DCIS

Brief summary: Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size


Eligibility criteria: Inclusion Criteria:

* Age ≥18 ans
* Woman with DCIS

Exclusion Criteria:

* Age ≥18 ans)

Primary outcomes:
measure: The investigators compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size
timeFrame: The period from January 1st, 2017 to December 31st, 2017 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie 1
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Marie Noëlle ROEDLICH, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01658397: The Effect of Calorie Deprivation on Adipose Tissue Distribution
Official title: The Effect of Calorie Deprivation on Adipose Tissue Distribution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy subjects
Fasting
Weight loss
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast) on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will increase after an acute fast.


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 21-45 years
* 101-130% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
* Normal thyroid function
* Regular menses (women)
* Normal liver transaminases

Exclusion Criteria:

* Any disease known to affect bone metabolism, including untreated thyroid dysfunction, Cushing's syndrome, or renal failure
* Any medication known to affect bone metabolism -- including systemic steroids or immunosuppressants -- within three months of the study, excluding estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for six months after their last injections. Bisphosphonates must have been discontinued for at least one year before participation
* Serum potassium \<3.0 meq/L
* Pregnant and/or breastfeeding (women)
* Diabetes mellitus
* Active substance abuse, including alcohol
* Contraindications to MRI: cardiac pacemaker, metal implants, claustrophobia

Primary outcomes:
measure: Change in Bone Marrow Adiposity over 10 day fasting period
timeFrame: Baseline, After 10 day fasting period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Pouneh K Fazeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03799497: Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental
Official title: Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Anorexia nervosa
functional MRI (fMRI)
self body-shape recognition
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 43
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volontary subjects : patients suffering from Anorexia Nervosa and control subjects, matched by age and study level

Brief summary: Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.

Detailed description: Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.

Eligibility criteria: Inclusion Criteria:

* Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
* With medical insurance
* With normal vision
* Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
* Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder

Exclusion Criteria:

* Pregnant or breast-feeding women
* With antecedent or current neurologic disease
* With antecedent or current ophthalmologic disease
* Contraindication for IRMf

Primary outcomes:
measure: Measure of the activation brain areas in self body-recognition network
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU,Hôpital Fontan 2
Study officials:
affiliation: University Hospital, Lille
name: Olivier Cottencin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06836297: Neural and Behavioural Bases of Action Simulation
Official title: Neural and Behavioural Bases of Action Simulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to understand the neural and behavioural bases of action simulation and its links with action execution in healthy volunteers.

Hypotheses: Action simulation recruits neural networks that are largely similar to those activated by action execution, with some differences to avoid executing a movement while observing/imagining it.

Participants will be tested with TMS while doing motor imagery or action observation.


Eligibility criteria: Inclusion Criteria:

* healthy adult volunteers (more than 18 years old)

Exclusion Criteria:

* Participants taking anti-epileptic drugs
* pregnant or breastfeeding women cannot participate in this study
* people with a pacemaker
* people with a cochlear implant
* people with a metal part in the brain or any other medical implant in their body (pump, neurostimulator, valve,) cannot take part in this study.

Primary outcomes:
measure: Motor Evoked Potential (MEP)
timeFrame: For the duration of the participants' visit to the laboratory (max 2h30)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03989297: PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
Official title: Expression and Clinical Significance of PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
programmed death-ligand 1
prognosis
Lead sponsor: Kiang Wu Hospital
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who were pathologically diagnosed with NPC between 2006 and December 2010 at the Kiang Wu Hospital (Macau, SAR China) and for whom fresh-frozen tissue samples were available were included.

Brief summary: The prognostic value of programmed death-ligand 1 (PD-L1) and BRAF expression in nasopharyngeal carcinoma (NPC) is not well-defined. In this study the investigators investigated alterations in PD-L1, BRAF and EGFR by using immunohistochemistry analysis in a cohort of consecutively enrolled NPC patients.

Detailed description: NPC is a common type cancer in Macau and Southern China. The role of PD-L1 in NPC remains controversial. There many reasons behind these inconsistent findings. We used the SP263 antibody with the standard cut off value of 1% and 5%, which is frequently used for lung cancer and other cancer types. We also plan to include over 150 patients, which will be the largest study in NPC. This will help us to gain insights in NPC.

Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Locally advanced (stage IIIB) or metastatic (stage IV) NPC
* Fresh-frozen tissue samples were available were included
* After treatment with curative surgery or radiotherapy in Macau
* With follow up data were available

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study

Primary outcomes:
measure: Response rate
timeFrame: Followed up with 12 months after last patient in
Secondary outcomes:
measure: Survival rate
timeFrame: Followed up with 12 months after last patient in
Other outcomes:
Locations:
city: Macao
country: China
facility: Kiang Wu Hospital
Study officials:
affiliation: Kiang Wu Hospital, Department of Oncology
name: Yabing Cao, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Chan KI, Xiao G, Chen Y, Qiu X, Hao H, Mak SC, Lin T. Expression and clinical significance of PD-L1 and BRAF expression in nasopharyngeal carcinoma. BMC Cancer. 2019 Oct 29;19(1):1022. doi: 10.1186/s12885-019-6276-y.