louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785850: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Safety.
Official title: Safety Dermatological Evaluation: Genital Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 31
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To prove the safety in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral skin test in the region;
* Use of cosmetic product of the same category;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time;

Exclusion criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory, immunosuppression or anti-histaminic drugs;
* Atopic antecedent or allergic to cosmetic product;
* Active cutaneous disease in the evaluation area;
* Diseases which cause immunology decrease, such as diabetes and HIV;
* Endocrinal pathologies;
* Intense solar exposure 15 days before the evaluation;
* Treatment until four months before the selection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005450: Health Promotion in the Elderly--Prevention of Cardiovascular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Cerebrovascular Disorders
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop an epidemiologic model to estimate the benefits, costs and risks of disease prevention in the elderly.

Detailed description: DESIGN NARRATIVE:

The investigators extended work they had done in modeling the health benefit of reducing risk factors for cardiovascular disease. Their new model incorporating risks of importance in the elderly, including cerebrovascular disease, estimated both morbidity and mortality averted by risk reduction, and estimated the costs and risks of the interventions used to modify risk factors.

The model was designed for the counseling of elderly individuals free of cardiovascular disease, and evaluated strategies for remaining disease free. It was implemented as software running on personal computers, and marketed to physicians and other health professionals who advised the elderly on medical issues. Accompanying documentation was also developed to explain the assumptions and non-quantifiable aspects of the decision to adopt major lifestyle changes to reduce risk.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05503550: Pre-Approval Access Single Patient Request for Talquetamab in Relapsed or Refractory Multiple Myeloma
Official title: Pre-Approval Access Single Patient Request Treatment for Talquetamab for Treating Physician Use in Relapsed or Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-08-16
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access program is to provide talquetamab for the treatment of participants with relapsed or refractory multiple myeloma.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00428350: Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic
Official title: A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian
* Female and/or male, aged between 18 and 60 years (inclusive)
* Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: \[20.1\] paranoid schizophrenia, \[20.2\] hebephrenic schizophrenia, \[20.3\] catatonic schizophrenia, \[20.5\] undifferentiated schizophrenia

Exclusion Criteria:

* CCMD-3 diagnosis of mental retardation
* Psychosis judged to be the direct physiological effect of an abused medication or substance

Primary outcomes:
measure: Change from baseline in PANSS total score at Day 56 (LOCF)
Secondary outcomes:
measure: Change from baseline in PANSS positive scale score at Day 56 (LOCF)
measure: Change from baseline in PANSS negative scale score at Day 56 (LOCF)
measure: Change from baseline in PANSS EC score at day 56 ,
measure: Change from baseline in MADRS total score at Day 56. etc
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Wuhan
country: China
facility: Research SIte
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Huzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijing
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jon Zhu, MD
role: STUDY_DIRECTOR
affiliation: Beijing An Ding hospital
name: Gang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06920550: A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
Official title: A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Length
Weight
Keywords: artificial intelligence
length
weight
algorithm
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 0 to 24 months.

Brief summary: This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young children and b) test the accuracy of the AI algorithm by comparing the AI predicted length with the gold standard measured length. Images and videos will be collected by care givers and healthcare professionals, together with physical length measurements. These data will be used to train the AI algorithm and to explore potential improvements. Other data to be collected is user experience feedback.


Eligibility criteria: Inclusion Criteria:

1. Infants/young children aged 0 to 24 months old at enrolment;
2. Caregiver(s) have access to the internet and a smartphone or tablet to complete questionnaires, take images and videos, and upload these;
3. Written informed consent from one or both caregivers (according to local laws) or legally acceptable representative(s) aged ≥ 18 years at enrolment.

Exclusion Criteria:

1. Children unable to undergo length or weight measurements when applying standardized techniques recommended by the WHO (e.g. infants/children with structural abnormalities of the lower limbs or orthopaedic conditions (e.g. club foot, hip dysplasia)).
2. Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions

Primary outcomes:
measure: Accuracy length AI
timeFrame: Date of enrolment, at baseline
measure: Accuracy caregiver length
timeFrame: Date of enrolment, at baseline
measure: Accuracy caregiver vs AI length
timeFrame: Date of enrolment, at baseline
Secondary outcomes:
measure: Accuracy weight AI
timeFrame: Date of enrolment, at baseline
measure: Accuracy caregiver weight
timeFrame: Date of enrolment, at baseline
measure: Ease of use tool
timeFrame: Date of enrolment, at baseline
measure: Acceptability tool
timeFrame: Date of enrolment, at baseline
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Wrocław
country: Poland
facility: Ginemedica
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Jerez de la Frontera
country: Spain
facility: Hospital Universitario de Jerez dela Frontera
Study officials:
References:
Clinical trial NCT04819750: Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Official title: Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Anxiety
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications.

Pharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery.

Music Care is a "digital treatment" allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia.

The objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia


Eligibility criteria: Inclusion Criteria:

* Cataract surgery with topical anesthesia

Exclusion Criteria:

* Hearing impaired patient

Primary outcomes:
measure: Self-assessed anxiety score between the 2 groups
timeFrame: Baseline day, when entering the operating room
Secondary outcomes:
measure: Self-assessment of the duration of the surgery
timeFrame: Baseline day, when entering the operating room
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04524650: Early Diagnosis of Oxaliplatin-induced Portal Hypertension
Official title: Construction and Evaluation of the Early Identification for Oxaliplatin Induced Portal Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Varices
Colorectal Cancer
Received Oxaliplatin-based Chemotherapy
Keywords: portal hypertension
splenomegaly
colorectal carcinoma
oxaliplatin
hepatotoxicity
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had a history of colorectal cancer and received oxaliplatin-based chemotherapy

Brief summary: Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, the investigators aim to evaluate the values of potential biomarkers in diagnosing patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18-75
* Had a history of oxaliplatin-based chemotherapy for the treatment of colorectal cancer surgery;

Exclusion Criteria:

* Combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
* With colorectal cancer required further anti-tumor treatment

Primary outcomes:
measure: the severity of portal hypertension
timeFrame: 1 day (the same time as diagnosis)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterology and Hepatology
state: Shanghai
Study officials:
References:
citation: Huang X, Li F, Wang L, Xiao M, Ni L, Jiang S, Ji Y, Zhang C, Zhang W, Wang J, Chen S. Endoscopic treatment of gastroesophageal variceal bleeding after oxaliplatin-based chemotherapy in patients with colorectal cancer. Endoscopy. 2020 Sep;52(9):727-735. doi: 10.1055/a-1157-8611. Epub 2020 May 7.
citation: Aloia T, Sebagh M, Plasse M, Karam V, Levi F, Giacchetti S, Azoulay D, Bismuth H, Castaing D, Adam R. Liver histology and surgical outcomes after preoperative chemotherapy with fluorouracil plus oxaliplatin in colorectal cancer liver metastases. J Clin Oncol. 2006 Nov 1;24(31):4983-90. doi: 10.1200/JCO.2006.05.8156.
Clinical trial NCT02435550: iCare for Cancer Patients
Official title: iCare for Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Acute Lymphoid Leukemia
Leukemia, Acute Lymphoblastic
Multiple Myeloma
Myelofibrosis
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Cellworks Group Inc.
name: Gateway for Cancer Research
First posted: 2015-05-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to use genomic information from individual patients to create simulation avatars that will be used to predict novel drug combinations with therapeutic potential.

Detailed description: As part of normal clinical care, subjects will undergo peripheral blood draws and biopsies for disease assessment of their cancer. In cases of hematological malignancies, bone marrow aspiration \& biopsy are routinely performed.

As part of this project, the following will be done to the samples collected and with clinical outcomes data:

* donate peripheral blood specimens whenever blood is already being drawn for clinical purposes.
* donate bone marrow aspiration samples whenever a bone marrow aspiration procedure is already being done for clinical purposes.
* donate saliva whenever blood draw is already being done for clinical purposes.
* allow the investigators to perform gene mutation profiling.
* allow the investigators to study gene mutation results.
* allow the investigators to perform pharmacogenetic profiling.
* allow the investigators to study pharmacogenetic profiles.
* allow the investigators to examine chromosome copy number variations.
* allow the investigators to examine genomic methylation.
* allow the investigators to quantify metabolomics/cytokines.

Eligibility criteria: Inclusion Criteria:

* Individuals known or suspected of having a blood cancer or hematologic disorder
* Individuals with presence of extramedullary disease
* Capable of providing informed consent.

Exclusion Criteria:

* Does not have a blood cancer or a hematologic disorder

Primary outcomes:
measure: Overall Response
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of patients with drug-related Grade 3 and Grade 4 adverse events
timeFrame: Up to 5 years
measure: Progression-free survival after treatment
timeFrame: Up to five years
measure: Overall survival after treatment
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Cancer Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Christopher R. Cogle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907150: Pleurostrain: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax
Official title: Interest of Strain Ultrasound in the Diagnosis of Pneumothorax: Prospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumothorax
Keywords: Pont-of-Care Ultrasound
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Department or critical care patient who had a chest CT within 2 hours

Brief summary: The objective of this study is to investigate whether the use of strain ultrasound can improve the lung ultrasound accuracy for the diagnosis of pneumothorax, particularly for inexperienced physicians.

Detailed description: Prospective multi-centre diagnostic study based on the post-interpretation of recorded ultrasound loops as part of standard patient management.

Eligibility criteria: Inclusion Criteria:

* Age over 17 years old
* Management in an investigative centre
* Presenting a suspicion of pneumothorax
* Having had a pulmonary ultrasound scan
* Having had a CT scan within 2 hours after or before the pulmonary ultrasound

Exclusion Criteria:

* Pregnant or breastfeeding women
* Persons not covered by a social security scheme
* Persons deprived of their liberty
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under the protection of justice, guardianship or curatorship
* Patient refuses to participate
* It is impossible to give informed information about
* The patient does not read French fluently
* Patient with any known pulmonary pathology pre-existing prior to the hospitalization episode
* Patient with a lung condition other than pneumothorax on a scanner

Primary outcomes:
measure: Pneumothorax diagnosis by an inexperienced physician in lung ultrasound
timeFrame: May 1, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital La Timone
city: Marseille
country: France
facility: AP-HM - Hopital Nord
city: Nimes
country: France
facility: Nimes University hospital
city: Nîmes
country: France
facility: CHU Nîmes
Study officials:
References:
Clinical trial NCT02946450: Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
Official title: Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CT Scanning Patients
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CT scanning patients

Brief summary: The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients


Eligibility criteria: Inclusion Criteria:

* subjects in need of CT scanning
* subjects who signed up informed consent

Exclusion Criteria:

* Known allergy or hypersensitivity to the study medication, ingredient of the medication, and Iodine type medication
* severe renal insufficiency patients
* severe hypothyroidism
* severe local infection or bacteremia

Primary outcomes:
measure: adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
References: