louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06032858: Efficacy and Safety of Apremilast in Psoriasis
Official title: Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.


Eligibility criteria: Inclusion Criteria:

* Diagnosed patients of chronic plaque psoriasis
* patients applicant for oral or parenteral treatments and for light therapy
* patients not responding to topical treatments

Exclusion Criteria:

* Patients who show hypersensitive reactions to apremilast to any of its inactive component
* Pregnancy
* Lactating mothers

Primary outcomes:
measure: Psoriasis area and severity index
timeFrame: 16 weeks
measure: body surface area
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki Hospital
state: Punjab
Study officials:
affiliation: Professor Department of Dermatology LMDC
name: Prof. Dr. Haroon Nabi
role: STUDY_DIRECTOR
affiliation: Department of Dermatology Ghurki Hospital
name: Dr. Saira Muaaz
role: PRINCIPAL_INVESTIGATOR
affiliation: Senior Registrar Department of Dermatology Services Hospital
name: Dr. Hira Tariq
role: STUDY_CHAIR
affiliation: Senior Registrar Department of Dermatology LMDC
name: Dr. Sumera Hanif
role: STUDY_CHAIR
affiliation: Associate Professor, Dermatology, LMDC
name: Dr. Talat Akbar
role: STUDY_CHAIR
affiliation: Head of Department Dermatology SIMS/ Services Hospital
name: Prof. Dr. Faria Asad
role: STUDY_CHAIR
References:
citation: Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.
citation: Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.
Clinical trial NCT05323058: The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy
Official title: The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomatitis
Keywords: oral mucositis
tulsi extract
benzydamine hydrochloride
radiotherapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation ratio (1:1)
Primary purpose: TREATMENT

Brief summary: After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.

Detailed description: the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days

Eligibility criteria: Inclusion Criteria:

* Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV)
* Patient should be able to read and/or understand and sign the consent form.

Exclusion Criteria:

1. Patients with HIV infections or hyperthyroidism.
2. Karnofsky performance status (KPS) less than 60%
3. Patients having an allergy to tulsi or benzydamine HCL
4. Patients who are pregnant and/or nursing.

Primary outcomes:
measure: Severity of mucositis
timeFrame: up to 15 days
Secondary outcomes:
measure: Pain and burning sensation
timeFrame: up to 15 days
Other outcomes:
measure: Oral Assessment Guide (OAG)
timeFrame: up to 15 days
measure: Patient-Reported Oral Mucositis( PROMS scale)
timeFrame: up to 15 days
Locations:
Study officials:
References:
Clinical trial NCT01567358: Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
Official title: A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Nichi-Iko Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-30
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months
2. Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg\~16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit

Exclusion Criteria:

1. History of following diseases

   * Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment
   * Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.）
   * Severe infectious disease（hepatitis, pneumonia、sepsis）
   * History of demyelinating disease or multiple sclerosis
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * History of malignancy
   * Interstitial lung disease
2. Patients with active or latent tuberculosis or history of tuberculosis

Primary outcomes:
measure: Safety : Incidence of Adverse Events
timeFrame: 14 weeks
Secondary outcomes:
measure: PK : Area under the serum concentration versus time curve(AUC)
timeFrame: 14 weeks
measure: Efficacy : ACR core-set
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: 392001001
state: Miyagi
Study officials:
References:
Clinical trial NCT00948558: Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT
Official title: Citrate Pharmacokinetics in Healthy Individuals and Critically Ill Patients and the Application of Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy(RCA-CRRT).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Failure With or Without:
MODS
Sepsis
Hepatic Insufficiency
Keywords: citrate anticoagulation
pharmacokinetic
critically ill
acute kidney failure
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Scientific and technology committe
First posted: 2009-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the subjects will be selected from a university teaching hospital in Shanghai, China.

Brief summary: 1. To compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors.
2. To validate a pharmacokinetic model which has been established in a formal paper.
3. To create a safe and effective RCA-CRRT protocol.


Eligibility criteria: Inclusion Criteria:

* healthy individuals, none-pregnant
* diagnosed with acute renal failure according to RIFLE criteria
* ARF with hepatic insufficiency
* ARF with MODS or sepsis
* within informed consent

Exclusion Criteria:

* used drugs with citrate within one week
* infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours
* serious alkalosis with PH\>7.55
* serious lactic acidosis
* not in resuscitation state

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital
Study officials:
References:
citation: Zheng Y, Xu Z, Zhu Q, Liu J, Qian J, You H, Gu Y, Hao C, Jiao Z, Ding F. Citrate Pharmacokinetics in Critically Ill Patients with Acute Kidney Injury. PLoS One. 2013 Jun 18;8(6):e65992. doi: 10.1371/journal.pone.0065992. Print 2013.
Clinical trial NCT00623558: Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title: A Randomized, Multicenter, Open Phase II Study of Cetuximab With Docetaxel, Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasm
Keywords: head and neck neoplasm
cetuximab
docetaxel
cisplatin
radiotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Research Center for Solid Tumor, Korea
First posted: 2008-02-26
Enrollment: 92
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: The aim of the study is to investigate the efficacy and safety of cetuximab, docetaxel, cisplatin combination as induction therapy in locally advanced head and neck squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

* Unresectable, locally advanced (cT4b \&/or cN2-3) HNSCC
* ECOG performance status 0-1
* Age 18 or older than 18 years
* Measurable disease by RECIST criteria
* Having signed informed consent
* ALT and AST\<2.5 times ULN
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Bilirubin level \< 1.5mg/dL
* Serum creatinine \<1.5 times ULN
* WBC\>3000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>75,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous cytotoxic chemotherapy for HNSCC
* Radiotherapy for targeted lesions within six months
* Previous EGFR pathway-targeting therapy
* Prior surgery for cancer (excluding diagnostic biopsy within 4 weeks prior to study entry)
* Distant metastatic disease
* Heart failure, coronary artery disease, myocardial infarction within the last 6 months
* Known allergy to any study treatment
* Pregnancy or lactation period
* Any investigational agent within the past 28 days
* Other previous malignancy within 5 year, except adequately treated in situ cervical cancer, or non-melanoma skin cancer
* Legal incapacity

Primary outcomes:
measure: Response rate
timeFrame: after induction treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Clinical Research Center for Solid Tumors, Korea
name: Dae Seog Heo, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee KW, Koh Y, Kim SB, Shin SW, Kang JH, Wu HG, Sung MW, Keam B, Kim DW, Kim TM, Kim KH, Kwon TK, Hah JH, Kim IA, Ahn SH, Yoon DH, Lee SW, Kim SY, Nam SY, Jung KY, Baek SK, Hong SH, Lee SH, Heo DS. A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer. Oncologist. 2015 Oct;20(10):1119-20. doi: 10.1634/theoncologist.2015-0208. Epub 2015 Aug 24.
Clinical trial NCT01407458: The Impact of a Structured Physical Activity Program on Bone Strength and Psycho-Motor Learning of Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Strength
Bone Density
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-08-02
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the impact of a structured physical activity program focused on bone strength in elementary school children in the framework of their physical education classes on:

1. Bone strength of children participating in the activity.
2. Physical variables and psycho-motor capabilities: vertical jumping strength, horizontal jumping strength, static balance, dynamic balance and coordination.


Eligibility criteria: Inclusion Criteria:

* First and second grade pupils
* Healthy

Exclusion Criteria:

* Medical condition does not permit participation in physical education class

Primary outcomes:
measure: Bone strength
timeFrame: One year
measure: Bone density
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02758158: Tri-modal Imaging Instrument for Thyroid Cancer
Official title: Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasms
Thyroid Cancer
Thyroid Nodule
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using ultrasound imaging and surgery is the most common treatment. However, most nodules are benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound imaging is very sensitive for localizing nodules, but does not differentiate between cancerous and benign ones. To address this limitation of US imaging, investigators have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic (PA)) that could potentially help diagnose nodules without the need for biopsy and unnecessary surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients with thyroid nodules (cancerous, benign or undetermined)
2. 18 years of age or older
3. Have been consented to their standard-of-care surgery for resection of the thyroid (partial or complete) and lymph nodes (if applicable)
4. Have had pre-surgical US imaging of the thyroid and lymph nodes

Exclusion Criteria:

1. Inability to provide informed consent
2. Pre-operative therapy for current thyroid cancer (including chemotherapy, endocrine therapy and radiotherapy)
3. History of photosensitivity or skin disease (exposure to laser light is involved in PA imaging)
4. Pregnancy

Primary outcomes:
measure: Detect/localize thyroid nodules and lymph nodes in vivo by using tri-modal imaging
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02513758: Penetration and Compartimentation of HIV
Official title: Penetration and Compartimentation of HIV in Genital Mucosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV patients
Genital HIV penetration
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 200
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: HIV patients

Brief summary: Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial cells, Langerhans cells) and antibodies may also play a critical role. The investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.

Detailed description: At inclusion, men will have a two blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm and women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

Eligibility criteria: Inclusion Criteria:

* Adults (\> 18 year-old) HIV positive,
* HIV-CV\> 1000 cp/ml,

Exclusion Criteria:

* children

Primary outcomes:
measure: Viral tropism of HIV
timeFrame: Inclusion
Secondary outcomes:
measure: Genetic polymorphism for HIV strains
timeFrame: Inclusion
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: LUCHT
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Frédéric LUCHT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03818958: Seric Calprotectine in Spondyloarthritis
Official title: Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylarthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary clinic care, rheumatology patients at the CHU de NICE

Brief summary: To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology.


Eligibility criteria: Inclusion Criteria:

* Patients in the active line of the rheumatology department with one of the following criteria:

  * active spondyloarthritis (BASDAI \>4),
  * or spondyloarthritis in low activity (BASDAI\<4),
  * or fibromyalgia without associated inflammatory rheumatism,
  * or healthy subjects (without inflammatory rheumatism and without fibromyalgia.
* Patients who have not objected to the use of their samples

Exclusion Criteria:

* Minor patient
* Subject not affiliated to the social security system
* Subject deprived of liberty
* Patient under guardianship or curatorship

Primary outcomes:
measure: calprotectine rate
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice Hospital
Study officials:
References:
Clinical trial NCT02528058: Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy
Official title: Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopic Traction Maculopathy
Keywords: Myopic traction maculopathy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who underwent vitrectomy with internal limiting membrane peeling for myopic traction maculopathy

Brief summary: The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months

Primary outcomes:
measure: Visual acuity before and after surgery
timeFrame: 6 months
Secondary outcomes:
measure: Retinal reattachment
timeFrame: 6 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Akito Hirakata, MD
role: PRINCIPAL_INVESTIGATOR
References: