louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01222949: A Pharmacokinetic (PK) Trial in Healthy Asian and Caucasian Volunteers Investigating the PK Profile of Eurartesim™
Official title: A Phase I, Pharmacokinetic Trial, in Healthy Asian and Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of Eurartesim™ (40 mg Dihydroartemisinin (DHA)/320 mg Piperaquine (PQ) Phosphate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria, Falciparum
Lead sponsor: sigma-tau i.f.r. S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: CPR Pharma Services Pty Ltd, Australia
First posted: 2010-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Study was designed to evaluate the pharmacokinetics of DHA and PQ in healthy volunteers and to assess the effect of ethnicity (Asian vs Caucasian), gender and body weight on the relative bioavailability of DHA and PQ.


Eligibility criteria: Inclusion Criteria:

* Caucasian or Asian healthy subjects, Male or female, aged between 18 and 50 years (inclusive)
* Body Mass Index (BMI) between 19.0 kg/m2 and 27.0 kg/m2 inclusive, with a minimum body weight of 36 kg.
* Agreed to use two approved methods of contraception
* Had given written informed consent to participate in this study in accordance with local regulations

Exclusion Criteria:

* Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing
* Pregnant or lactating (females only)
* Abnormal laboratory test results deemed clinically significant at screening
* Positive urine drug test or alcohol breath test
* Acute therapy for a serious infection within 30 days of study entry
* History of significant drug allergies or significant allergic reactions
* Had participated in a clinical trial or had received an experimental therapy within 30 days or 10 half-lives of the drug
* Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration

Primary outcomes:
measure: PK: tmax, Cmax, AUC0-12(DHA), AUC0-24(PQ), AUC0-inf, λz, t1/2
timeFrame: During the first and last day of drug administration (day 0 and 2) and followed up till Day 90
Secondary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Day 0 till Day 90
measure: Hematology and blood chemistry changes respect to baseline values
timeFrame: Day 0, Day 3, Day 28, Day 90
measure: QTc interval prolongation
timeFrame: Day 0, day 3, day 28, day 90
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, a division of IDT Australia Limited
city: Melbourne
country: Australia
facility: Nucleus Network Limited
Study officials:
References:
Clinical trial NCT06366906: 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma
Official title: Clinicopathological and Prognostic Analysis of Oral and Maxillofacial Squamous Cell Carcinoma: a Single-center 10-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HNSCC
AI
Radiomic
MRI
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 319
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The radiomics features that affects the prediction of OCLNM in OC and OP SCC. A total of 319 patients with early-stage OC or OP SCC from the hospitals

Brief summary: Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.

Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.

Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed, previously untreated oral and oropharyngeal squamous cell carcinoma with radical resection;
2. MRI examination was performed two weeks before surgery;
3. All patients with neck dissection and the status of regional lymph nodes was confirmed via pathological examination;
4. All patients had no clinical evidence of nodal involvement.

Exclusion Criteria:

1. Other malignant tumor, such as adenoid cystic carcinoma;
2. a lack of complete MRI imaging or poor MRI imaging quality;
3. patients had undergone neck dissection or treated non-surgically;
4. patients with metastatic disease.

Primary outcomes:
measure: AUC(the area under the curve) values of the model
timeFrame: 10 years（This is a retrospective research，we collect 10 years patients, but the project we implement data collection and analysis is 9 months）
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun yat-sen memorial hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun yat-sun memorial hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02169206: Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Official title: Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Keywords: Frozen shoulder
scapulothoracic angle
scapulohumeral angle
acromiohumeral distance
center equator distance
shoulder radiography
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.

Detailed description: Adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions will be included. Patients with bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.

Eligibility criteria: Inclusion Criteria:

* adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions

Exclusion Criteria:

* bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.

Primary outcomes:
measure: Radiographic parameter (scapulothoracic angle) measured in angle
timeFrame: one year
Secondary outcomes:
Other outcomes:
measure: Center equator distance
timeFrame: one year
measure: Scapulohumeral angle
timeFrame: one year
measure: Acromiohumeral distance
timeFrame: one year
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Khorasan-Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Mohammad H Ebrahimzadeh, M.D.
role: STUDY_DIRECTOR
affiliation: Mashhad University of Medical Sciences
name: Amir R Kachooei, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02381106: The ADRB3 Receptor in Pregnancy
Official title: The ADRB3 Adrenergic Receptor - a Possible New Target for Controlling Pre-eclampsia and Hypertension in Pregnancy and Uterine Contractions in Non-pregnant and Pregnant Myometrium
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Pregnancy Complications
Keywords: arterial contractility
Uterine contractility
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregant women undergoing cesarian section.

Brief summary: The primary overall objective of this study is to characterize the levels of and compare levels of the ADRB3 receptor in human non-pregnant myometrium, pregnant myometrium at different time points in pregnancy, in normal and dysfunctional labor and also to measure levels and expression of these receptors in placental arteries at different maturation statuses of placenta and in pre-eclampsia/hypertension


Eligibility criteria: Inclusion Criteria:

* Women undergoing cesarian section

Exclusion Criteria:

* Interkurrent diseases

Primary outcomes:
measure: characterization of the levels of the ADRB3 receptor in human pregnant myometrium
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Danderyd Hospital
Study officials:
References:
Clinical trial NCT00584506: Computer Aided Evaluation of Orbital Volume
Official title: Computer Aided Evaluation of Orbital Volume
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Fractures
Keywords: orbital fractures
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with complex maxillofacial and orbital trauma that underwent operative repair of orbital fractures. Computer tomography scans from a cohort of patients with normal CT data sets will also be collected to assess "normative" orbital volumes.

Brief summary: A retrospective review to assess the performance and clinical predictive value of a novel software program (Maxillo) designed to perform complex volumetric analysis with application in the field of orbital trauma.

Detailed description: The concept of open reduction and internal fixation of large and complex traumatic orbital deformities is well established. It is known that successful orbital reconstruction hinges upon restoration of native orbital volume in order to establish pre-morbid function and avoid long-term complications. To date, a facile, reliable, and reproducible method to measure orbital volume has not been rendered, despite numerous approaches. The objective of this study is to assess the performance and clinical predictive value of a novel software program designed to perform complex volumetric analysis with application in the field of orbital trauma.

Eligibility criteria: Inclusion Criteria:

* Chart reviews of patients at UCDMC with orbital trauma and having operative repair of the orbital fractures with post-reduction imaging included.

Exclusion Criteria:

* Absences of post-operative imaging

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Edward B Strong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04524806: Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
Official title: Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Temporomandibular Joint Disorders
Orofacial Pain
Keywords: stabilization splint
temporomandibular disorders
RDC/TMD
temporomandibular joint
orofacial pain
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.

Detailed description: Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.

Eligibility criteria: Inclusion Criteria:

* No need for orthodontic treatment
* Maximum 2 teeth have been extracted
* Having efficient occlusal contacts
* Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Exclusion Criteria:

* Treated with stabilization splint before
* Partial edentulous patients
* Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Primary outcomes:
measure: Presence of myofascial pain
timeFrame: Up to 6 months
measure: Presence of intra-capsular temporomandibular disorders
timeFrame: Up to 6 months
Secondary outcomes:
measure: Presence of TMJ sounds
timeFrame: Up to 6 months
measure: Limitation of jaw movements
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Medipol University
name: Halenur Bilir, DDS
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Hanefi Kurt, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03457506: Intra-individual Comparison of Conventional and Digital PET/CT Scanners
Official title: Intra-individual Patient-based Comparison of Conventional and Digital PET/CT Scanners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Esophageal Cancer
Miscellaneous Neoplasm
Keywords: Cancer
Digital pet
Conventional pet
Lead sponsor: Isala
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2018-03-07
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All included patients will have two PET scans, one on the conventional PET (Ingenuity TF, Philips Healthcare) and one on the digital PET (Vereos, Philips Healthcare). The order of the two PET scans will differ per patient.
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators will analyze the impact of digital PET/CT on the final diagnostic conclusion of the scan in patients with lung cancer, breast cancer, esophageal cancer and a group of mescellaneous cancers.

Detailed description: There will be a single injection of the PET radiopharmaceutical FDG, followed by a conventional PET/CT scan and a digital PET scan, in this order or vice versa.

Eligibility criteria: Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* referred to Isala for a clinically indicated FDG-PET/CT scan
* suspected or proven lung cancer, esophageal cancer, breast cancer or miscellaneous cancer, either as a primary diagnosis or follow-up study
* signed informed consent

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* age \< 18 years
* incapacitated adults
* prisoners
* pregnant patients
* unable to undergo two consecutive PET/CT scans

Primary outcomes:
measure: Diagnostic outcome of the PET/CT study
timeFrame: approximately 2 hours
Secondary outcomes:
measure: PET image quality
timeFrame: approximately 2 hours
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
Study officials:
affiliation: p.l.jager@isala.nl
name: Pieter L Jager, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koopman D, Jager PL, Slump CH, Knollema S, van Dalen JA. SUV variability in EARL-accredited conventional and digital PET. EJNMMI Res. 2019 Dec 10;9(1):106. doi: 10.1186/s13550-019-0569-7.
Clinical trial NCT05302206: Colonic Glucose vs. Saline Infusion
Official title: Colonic Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Hormones
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The distal ileum and proximal colon, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, are important organs in mediating glycemic control. The proximal colon is not easy to access and the correspond in vivo research remains to be difficult. The investigators intend to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion, and quantify the glucose absorption rate within the proximal colon.


Eligibility criteria: Inclusion Criteria:

* Male and postmenopausal females aged 18 - 75 years
* Body mass index (BMI) 20 - 35 kg/m2
* With protective ileostomy due to benign or malignant rectal surgery

Exclusion Criteria:

* History of postoperative adjuvant chemotherapy
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range))
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Females who are pre-menopausal
* Inability to give informed consent
* Vegetarians

Primary outcomes:
measure: serum or plasma GLP-1 changes during colonic infusion
timeFrame: 180 minutes
measure: serum or plasma GIP changes during colonic infusion
timeFrame: 180 minutes
measure: serum or plasma ghrelin changes during colonic infusion
timeFrame: 180 minutes
measure: serum or plasma c-peptide changes during colonic infusion
timeFrame: 180 minutes
measure: serum or plasma insulin changes during colonic infusion
timeFrame: 180 minutes
measure: serum or plasma glucagon changes during colonic infusion
timeFrame: 180 minutes
measure: glucose absorption capacity
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Kexin Wang
role: STUDY_DIRECTOR
References:
Clinical trial NCT02847806: Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.

Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.


Eligibility criteria: Inclusion Criteria:

* Hypogonadism hypogonadotropic or hypergonadotropic
* Man aged 18-60 years
* BMI between 18 and 27.

Exclusion Criteria:

* Other ante-pituitary deficiency
* Chronic treatment modifying carbohydrate metabolism (thiazides, beta 2 mimetics, steroids ...)
* Diabetes
* Obesity diffuse or android
* Hemochromatosis
* osteoporosis
* chronic diseases
* neoplasia
* High blood pressure

Primary outcomes:
measure: GIR (glucose infusion rate) during euglycemic hyperinsulinemic clamp
timeFrame: change between baseline and after 4 weeks of treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
Study officials:
References: