louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05608902: Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study (DOCTOBA)
Official title: Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Tomography, Optical Coherence
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion

Brief summary: Basal cell carcinoma (BCC) are the most frequent skin cancers. Their incidence is constantly increasing. BCC diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. Surgery is the first-line treatment and some procedures (notably Mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. Such on-site histopathological examination can be time consuming and associated with decreased sensitivity. Skin imaging techniques have already been tested to overcome these limitations and seem promising. Although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of BCC.

The DOCTOBA study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.


Eligibility criteria: Inclusion Criteria:

- patient \> 18 years of age who received skin biopsy or excision of basal cell carcinoma suspected lesion between start study date and primary completion date

Exclusion Criteria:

* inability to perform dynamic full-field optical coherence tomography observation at the moment of skin biopsy
* diagnosis of basal cell carcinoma disproved

Primary outcomes:
measure: Histopathological analysis of basal cell carcinoma with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following skin biopsy or resection
Secondary outcomes:
measure: Histopathological analysis of healthy skin with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following skin biopsy or resection
Other outcomes:
Locations:
city: Chalon sur Saône
country: France
facility: Centre Hospitalier William Morey - Chalon sur Saône
state: Saône-et-Loire
Study officials:
affiliation: Centre Hospitalier William Morey - Chalon sur Saône
name: Thomas Maldiney
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05320302: A Brain Imaging PET Study of [11C]-Lu AF88370 in Healthy Adult Male Participants
Official title: Interventional, Open-Label, Positron Emission Tomography (PET) Study With [11C]-Lu AF88370 Investigating Blood-Brain Barrier Penetration of Lu AF88370 in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 6
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goals of the study are to assess uptake and distribution of Lu AF88370 in the brain when given at tracer levels (microdose) in healthy young men.


Eligibility criteria: Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30.0 kilograms (kg)/square meter (m\^2) at the Screening Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical and neurological examination, vital signs, an ECG, and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the Screening Visit for any medication taken.
* The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
* The participant has had surgery or trauma with significant blood loss \<6 months prior to the first dose of the study drug.
* The participant is exposed to significant levels of ionising radiation at work.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Whole Brain Total Distribution Volume (VT) of [11C]-Lu AF88370
timeFrame: Day 1
measure: VT of [11C]-Lu AF88370 in Regions of Interest (ROI)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Invicro
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT03573102: Effect of Sodium Glucose co Transporter 2 Inhibitor ( SGLT2) on Proteinuria in Diabetic Patients
Official title: Effect of SGLT2 Inhibitor on Proteinuria in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Nephropathies
Keywords: proteinuria , SGLT2 inhibitors , diabetes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 60
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: Diabetes Mellitus is the leading cause of end stage renal disease. As proven by many studies , controlling proteinuria can delay the progression to end stage renal disease.This work will study the effect of sodium glucose co transporter 2 inhibitor , a new antihyperglycemic drug , on proteinuria and to compare its effect with the effect of classic antiproteinuric drugs as angiotensin converting enzyme inhibitor , aspirin and statins.

Detailed description: Diabetic nephropathy involves progressive stages including glomerular hyperfilteration , microalbuminuria , overt proteinuria and a decline in glomerular filteration rate leading to end stage renal disease.

Despite all the available interventions available for diabetic patients including tight glycemic control , and blood pressure control , using angiotensin converting enzyme inhibitors, angiotensin II receptor antagonist renal disease remains prevalent and progress in these patients.

The newer therapy of diabetes is the use of sodium glucose cotransporter 2 inhibitor as it has the potential of renoprotection in patients with diabetic nephropathy just as ACEI and ARBS to reduce glomerular hyperfilteration .This action may reduce albuminuria.

Eligibility criteria: Inclusion Criteria:

* adult patients with type 2 diabetes.
* controlled diabetes.
* patients with proteinuria

Exclusion Criteria:

* patients with proteinuria due to other disease.
* patients with HbA1c \>8%.
* patients with uncontrolled hypertension.
* patients with chronic liver disease.
* patients with type 1 diabetes .
* patients already on the same drug ( dapagliflozine).
* patients with raised serum creatinine.

Primary outcomes:
measure: decrease in proteinuria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Ain Shams University
name: Magdy Sharkawy, MD
role: STUDY_DIRECTOR
References:
citation: Lotfy M, Adeghate J, Kalasz H, Singh J, Adeghate E. Chronic Complications of Diabetes Mellitus: A Mini Review. Curr Diabetes Rev. 2017;13(1):3-10. doi: 10.2174/1573399812666151016101622.
Clinical trial NCT02387502: Comparison of Three Laryngoscopes in Difficult Laryngoscopy
Official title: Comparative Evaluation of Macintosh, MacCoy and Airtraq Laryngoscope in Simulated Difficult Laryngoscopy Using Rigid Neck Collar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Lead sponsor: Government Medical College, Haldwani
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tracheal intubation requires alignment of oro-pharyngeal-laryngeal axes. When these three axes are not aligned, intubation becomes difficult. In the researchers' study, the investigators simulated difficult laryngoscopy situation by using a rigid neck collar. This neck collar renders intubation difficult not only by restricting neck movement, but also reducing mouth opening. The investigators compared the performance of Macintosh, MacCoy and Airtraq laryngoscope in simulated difficult laryngoscopy using a rigid neck collar.

Detailed description: Airtraq laryngoscope is an optical laryngoscope which allows visualization of vocal cord as a reflected image through multiple lenses and prisms. MacCoy laryngoscope is a modification of Macintosh laryngoscope. It has a lever which, when pressed, moves its flexible tip. In the investigators' study, the researchers compared the performances of Airtraq laryngoscope with MacCoy and Macintosh laryngoscopes in simulated difficult laryngoscopy using a rigid neck collar. The researchers recruited 120 patients and randomly divided those patients into three equal groups i.e. 30 patients in each group. These three groups are 1-Airtraq, 2-MacCoy and 3-Macintosh. The researchers compared efficacy and safety in these three laryngoscopes. The researchers compared efficacy in terms of time of intubation, ease of intubation, overall success, Intubation difficulty score, visualization of vocal cord in terms of POGO (percentage of Glottic Opening) score. The researchers compared safety in terms of hemodynamic pressor response and airway trauma.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II.
* Posted for elective surgery requiring general anesthesia and tracheal intubation

Exclusion Criteria:

* patients with anticipated difficult airway
* obese (body mass index (BMI)\>30) patients
* patients with risk of pulmonary aspiration of gastric contents
* pregnant patients
* patients with airway distortion or trauma.

Primary outcomes:
measure: Time of Intubation
timeFrame: up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor, Department of Anesthesiology, G.M.C. Haldwani
name: Geeta Bhandari, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00424502: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Official title: An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 20
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 single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* diagnosed RA for \>=3 months prior to first administration of study medication;
* inadequate response or intolerance to \>=1 anti-TNF therapies, alone or in combination with methotrexate;
* if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for \>=2 weeks prior to start of study.

Exclusion Criteria:

* other chronic inflammatory diseases;
* use of parental corticosteroids within 4 weeks prior to screening;
* severe heart failure, or severe, uncontrolled cardiac disease.

Primary outcomes:
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Day 0 and Week 24
Secondary outcomes:
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores
timeFrame: Day 0 and Week 24
measure: Anti-cyclic Citrullinated Peptide (Anti-CCP)
timeFrame: Day 0 and Week 24
measure: Vascular Endothelial Growth Factor (VEGF)
timeFrame: Day 0 and Week 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Day 0 and Week 24
measure: C-Reactive Protein (CRP)
timeFrame: Day 0 and Week 24
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01958502: Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nonunion of Fracture
Keywords: nonunion
mesenchymal stem cell
scaffold
BMP2
long bone
Lead sponsor: Emdadi Kamyab Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University of Science and Technology
First posted: 2013-10-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. On the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate.

Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. Clinical union consider to relief pain in non union site and be stable in examination.


Eligibility criteria: Inclusion Criteria:

* Every patient with non union in the site of long bone fracture
* Age more than 18 and under 60 years old
* Fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction.
* No infection in site of surgery
* Be able and willing to participate in the study
* Written informed consent

Exclusion Criteria:

* Evidence of malignancy
* Pregnancy or breastfeeding
* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing

Primary outcomes:
measure: clinical and radiological union at 1 month to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Safety of Mesenchymal Stem Cells injection in nonunion fractures. Follow-up for revealing any significant immediate or late adverse effects(infection,malignancy,local or systemic allergic reaction)
timeFrame: 12 months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Emdai Kamyab Hospital
state: Khorasan
Study officials:
affiliation: Emdadi Kamyab Hospital
name: mohammad taghi peivandi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emdadi Kamyab Hospital
name: amin razi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00449202: Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Official title: A Phase 2a Randomized, Double-Blind, Placebo Controlled, Parallel Group, Safety and Efficacy Study of Two 14 Day Cycles of Oral Doses of Oleoyl-Estrone (MP-101) in Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Manhattan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.


Eligibility criteria: Inclusion Criteria:

* Be a male or female between the ages of 18 and 65 years, inclusive
* Female subjects must be either surgically sterile or at least 2 years postmenopausal
* Have a BMI of 27 - 38.9, inclusive
* Have a stable weight for the past 30 days per subject report
* Be otherwise healthy and have an acceptable medical history
* Have negative urinalysis test results for drugs of abuse and alcohol
* Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions
* Exhibit stable behavior patterns with regard to smoking and exercise
* Subject who has at least one factor of the metabolic syndrome

Exclusion Criteria:

* Be pregnant or nursing
* Have taken exclusionary medication in the past 30 days
* Have any clinically significant abnormal laboratory test as determined by the investigator
* Have a clinically significant illness during the 30 days before enrollment
* Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV
* Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer
* Have a previous diagnosis of diabetes
* Be otherwise unsuitable for the study, in the opinion of the investigator
* Have an allergy to safflower seeds or its byproducts (e.g., safflower oil)
* Have any postmenopausal bleeding within the last 6 months
* Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days
* Currently working night shifts
* Have a history of known multiple miscarriages

Primary outcomes:
measure: To evaluate the safety and tolerability
Secondary outcomes:
measure: To evaluate the preliminary efficacy
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research
state: Louisiana
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Basel
country: Switzerland
facility: Swiss Pharma Contract
Study officials:
References:
Clinical trial NCT04682002: Low-back Pain During Pregnancy and Its Psycho-social Implications
Official title: Low-back Pain During Pregnancy and Its Psycho-social Implications. The Role of the Osteopathic Manipulative Treatment Within Its Multi-disciplinary Management. A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Low Back Pain
Pelvic Girdle Pain
Keywords: osteopathic manipulative treatment
pregnancy
pain
low back pain
pelvic girdle pain
psychological factors
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2020-12-23
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnancy-related pelvic girdle pain (PPP) and pregnancy-related lumbar pain (PLBP) are two distinct symptoms, which can occur together as lumbar-pelvic pain.The primary objective is to measure the impact of osteopathic manipulative treatment on pregnancy-related lumbar and pelvic pain. The secondary objective is to study the interaction between pain and psycho-social factors during the gestational period.


Eligibility criteria: Inclusion Criteria:

* Women aged 18-44
* Primiparae
* Single pregnancy
* Spontaneous pregnancy - fisiological pregnancy
* pregnancy \>= 12 weeks
* low-back pain (between the 12th rib and the lumbo-pelvic region) and/or pelvic (in the pubic region and/or in one or both of the sacro-iliac joint and/or of the gluteal region) non specific
* consent to treatment
* absence of linguistic barriers

Exclusion Criteria:

* Women aged \<18 o \>44
* Pathological pregnancy, twins
* Metabolic pathologies
* Obstetrician's emergencies
* Pre-term birth
* Specific lumbar and/or pelvic pain - Genetics disorders
* Major congenital anomalies
* Absence of consent to treatment
* Presence of linguistic barriers

Primary outcomes:
measure: Change in VAS at 6 months
timeFrame: 6 months
measure: Change in ODI at 6 months
timeFrame: 6 months
measure: Change in PMI at 6 months
timeFrame: 6 months
measure: Change in PGQ at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in PWB at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Niccolò Giovanni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05441202: Lung Nodule Intervention Cohort Study
Official title: The Efficacy of Transdermal Therapy for Lung nodule---an Real Word Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incident Lung Nodule
Lead sponsor: Chinese Chronic Respiratory Disease Research Network
Sponsor class: NETWORK
First posted: 2022-07-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any patient with incident lung nodule after health check up

Brief summary: Incident lung nodule is quite common in China. The major treatment method is long-term floolow up without a specific intervention. We aim to investigate the efficacy an safty of a novel transdermal therapy with Chinese herb. The study included two arms: one arm is routine treatment and another arm is routine treatment plus transdermal therapy. The study end point is the change of lung nodule size under CT scan.


Eligibility criteria: Inclusion Criteria:

* incident lung nodule patients

Exclusion Criteria:

* severe baseline conditions

Primary outcomes:
measure: change of lung nodule size
timeFrame: three months minimal
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang An Men Hospital
state: Beijing
Study officials:
References: