louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04999631: SADBE for Congenital Melanocytic Nevi
Official title: Neoadjuvant Squaric Acid Dibutylester Treatment of Melanocytes in Congenital Melanocytic Nevi
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Congenital Melanocytic Nevus
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two areas of the subject's nevus will be marked. Study medication will be applied to one area. Placebo ethanol solution will be applied to the other area. Area to be treated will be randomized among subjects. Both areas will be monitored and following surgery, samples will be obtained. Area to be treated vs area that will serve as control will be randomized.
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and efficacy topical squaric acid dibutylester (SADBE) for the neoadjuvant treatment of congenital melanocytic nevi (CMN).

Detailed description: Patients with CMN and plans for elective surgical resection of their nevi will be enrolled in the study. Two clinically similar areas within the planned excision site will be identified, marked and treated with SADBE or the placebo solution. Following surgical resection, samples from the excised nevi will be taken and assessed for number of melanocytes. Incidence of adverse events will also be collected.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Subject or parents willing and able to give informed consent, and assent as appropriate.
* Patients who have a clinical diagnosis of CMN with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of \> 6 cm2.

Exclusion Criteria:

* Immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma).
* History of malignancy.
* History of organ transplantation.
* Known immunosuppressive disease, including infection with HIV.
* Severe medical comorbidities (diabetes mellitus requiring insulin, CHF of any severity, MI, CVA, or TIA within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease)
* Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
* Subjects who have known hypersensitivity to SADBE or any of its components.
* Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.

Primary outcomes:
measure: Number of melanocytes per mm2
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 weeks
Other outcomes:
measure: Clinical appearance of nevi
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Elena B. Hawryluk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029731: Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
Official title: Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia, Sickle Cell
Pneumonia
Keywords: Nitric Oxide
Administration, Oral
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.

Detailed description: Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)

Acute chest syndrome with the following:

* New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
* Fever
* Cough, tachypnea, retractions, rales, or wheezing
* Chest pain

Exclusion criteria:

* Inability to take or tolerate oral medications
* Hepatic dysfunction (SGPT greater than 2 times normal)
* Renal dysfunction (creatinine greater than 2 times normal)
* Mental status or neurological changes
* Allergy to arginine
* History of priapism
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital Oakland
state: California
Study officials:
References:
Clinical trial NCT01823731: A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Keywords: PCI,SOTOC, Ovarian cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2013-04-04
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * ovarian cancer, tubal cancer, primary peritoneal cancer, mesothelioma, pseudomyxoma peritonei
* Debulking operation

Brief summary: objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer

Detailed description: * Informed consent
* Digital photography \& Checking PCI (tumor size\& location )
* Postoperative surveillance(tumor marker, image and physical examination)
* Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern

Eligibility criteria: Inclusion Criteria:

* Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma
* Available preoperative image study (CT and/or MRI and/or PET)
* Patients who gave a written informed consent
* Patients must be surgical candidate considering medical and psychological condition

Exclusion Criteria:

* Patients who refuse to participate or want to withdraw at anytime.

Primary outcomes:
measure: evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01208831: An East Asian Study of LDE225
Official title: An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor Cancers
Medulloblastoma
Basal Cell Carcinoma
Keywords: Advanced tumors
hedgehog
smoothened inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-24
Enrollment: 45
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: The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of advanced solid tumor (including medulloblastoma and basal cell carcinoma)
* blood work criteria

Exclusion Criteria:

* patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
* positive HIV, hepatitis B or C
* impaired intestinal function
* impaired heart function
* pregnant or breast-feeding women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: determine maximum tolerated dose of single agent LDE225
timeFrame: 28 day cycles
Secondary outcomes:
measure: characterize safety and tolerability
timeFrame: 28 day cycles
measure: characterize pharmacokinetics (PK) of single and repeated doses of LDE225
timeFrame: 28 day cycles
measure: assess preliminary anti-tumor activity
timeFrame: 28 day cycles
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Minami H, Ando Y, Ma BB, Hsiang Lee J, Momota H, Fujiwara Y, Li L, Fukino K, Ito K, Tajima T, Mori A, Lin CC. Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors. Cancer Sci. 2016 Oct;107(10):1477-1483. doi: 10.1111/cas.13022. Epub 2016 Sep 24.
Clinical trial NCT01189331: CT Coronary Angiography and Computational Fluid Dynamics
Official title: Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
CT
Computational flow dynamics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University
name: Pauls Stradins Clinical University Hospital
name: Cornell University
name: Ulsan university
name: Indiana University
name: Stanford University
First posted: 2010-08-26
Enrollment: 103
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: Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.


Eligibility criteria: Inclusion Criteria:

* Significant stenosis at CT angiography
* Normal ejection fraction on echocardiography
* Informed consented patient

Exclusion Criteria:

* total occlusion and collateral flow to target vessel
* AV conduction abnormality
* Left ventricular hypertrophy
* significant valvular heart or primary myocardial disease

Primary outcomes:
measure: fractional flow reserve
timeFrame: 1day
measure: target vessel failure
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koo BK, Erglis A, Doh JH, Daniels DV, Jegere S, Kim HS, Dunning A, DeFrance T, Lansky A, Leipsic J, Min JK. Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. Results from the prospective multicenter DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional Flow Reserve) study. J Am Coll Cardiol. 2011 Nov 1;58(19):1989-97. doi: 10.1016/j.jacc.2011.06.066.
Clinical trial NCT05450731: Cardiac Rehab Post-atrial Fib Ablation
Official title: Effect of Cardiac Rehabilitation Exercise on the Recurrence of Atrial Fibrillation in Post-ablation Patients: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: MultiCare Health System Research Institute
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in patients at six- and twelve-months post-ablation procedure.


Eligibility criteria: Inclusion Criteria:

* ● Adult patients 18 years and older.

  * Willing to participate in the study after randomization to either an intervention group (cardiac rehabilitation exercise) or a control group (usual care).
  * Able to attend two pre and post study clinic visits at a local designated Pulse Heart Institute cardiac rehab program.
  * If randomized to the cardiac rehab intervention group can attend exercise rehab visits for 3 x per week for 12 weeks (36 visits) at a designated Pulse cardiac rehab program.
  * Has an active email address and phone number.
  * Documented diagnosis of Paroxysmal and persistent Atrial Fibrillation.
  * Undergone ablation treatment and is at a minimum of 2 weeks post ablation status.
  * Compliant with medication therapy including medications for heart rate control and anticoagulant(s).

Exclusion Criteria:

* ● Does not speak English.

  * Does not have clearance to participate in the study by their attending cardiologist.
  * Documented cardiovascular disease or pulmonary/respiratory disease that would qualify the patient for Cardiac, Pulmonary or Vascular Rehabilitation at a Pulse Heart Institute rehabilitation program.
  * Dementia or cognitive impairment.
  * Unable to participate in rehabilitation exercise due to physical limitations.
  * Greater than one prior ablation procedure
  * Long standing, chronic Atrial Fibrillation
  * Patients who have undergone posterior wall isolation ablation.

Primary outcomes:
measure: The aim of this study is to examine the effect of a 12-week exercise-based cardiac rehabilitation intervention on the recurrence of atrial fibrillation (AF) in 40 patients at six- and twelve-months post-ablation procedure.
timeFrame: 12 months after the first intake appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Tacoma General Hospital
state: Washington
Study officials:
References:
Clinical trial NCT03295331: Assessment of Asthma Control Level in Malaysia
Official title: A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Control Level
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 398
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary Care Centre ( patients seen at outpatient physicians )

Brief summary: A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital Serdang. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

Detailed description: Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

Eligibility criteria: Inclusion Criteria:

* All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016.
* Be at least 18 years of age

Exclusion Criteria:

* Clinical features suggesting emphysema or chronic bronchitis
* Other de-compensated organ failures

Primary outcomes:
measure: Level of GINA-defined asthma control
timeFrame: up to 8 months
Secondary outcomes:
measure: Types of medication prescribed for asthma control
timeFrame: up to 8 months
measure: Asthma control level
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Institut Perubatan Respiratori
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References:
Clinical trial NCT03942731: Penicillin Allergy Testing and Resensitization Rate
Official title: Resensitization Rate After Drug Provocation Test and Challenge in Eighty-three Adult Outpatients With a Distant Penicillin Allergy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penicillin Allergy
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited during the clinical evaluation of labelled penicillin allergy at the regional hospital of Metz, France (Mercy, Centre Hospitalier Régional CHR de Metz - Thioville). All patients were well and had no need of penicillin treatment at the time of evaluation and testing. A detailed history of the probable implicated molecule, the type of the reaction, the age at onset and the received treatment were obtained by Dr SL.

Brief summary: Penicillin is one of the earliest discovered antibiotics and a drug of choice for several infections. Up to 10 to 20% of all patients in clinical trial are labeled as penicillin allergic. Most of these patients do not have a true allergy but few have had it verified. Approximately 80% of patients with IgE-mediated penicillin allergy lose their sensitivity after 10 years. Several studies have been conducted denying the risk of sensitization following negative testing of penicillin allergy. Investigators have not had the same experience and have therefore decided to conduct a retrospective study review of 83 adult outpatients with a distant penicillin allergy label and evaluate outcomes of skin retesting six weeks following Drug Provocation Test and challenge.


Eligibility criteria: Inclusion Criteria:

- 18 years old

Exclusion Criteria:

* Pregnancy
* poorly controlled asthma and cardiovascular disease
* use of drugs that interfere with testing and could not be stopped such as antihistamines, tricyclic antidepressants, antipsychotics, beta blockers, high dose oral glucocorticoids
* Non-IgE mediated type of serious allergic reaction such as Stevens - Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Syndrome.

Primary outcomes:
measure: efficacy of repeated skin testing
timeFrame: week 4
Secondary outcomes:
measure: efficacy of allergy testing
timeFrame: Week 4
Other outcomes:
Locations:
city: Thionville
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
affiliation: CHR Metz Thionville
name: Sebastien Lefevre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02047331: Periarticular Injection Versus Fascia Iliaca Block for Total Knee Arthroplasty
Official title: Multimodal Periarticular Injection Versus Fascia Iliaca Compartment Block for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: periarticular drug injection
fascia iliaca block
knee arthroplasty
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the aim is to compare the efficacy of Periarticular multimodal drug injection(group PI) and Fascia Iliaca Compartment Block ( group FI)for total knee arthroplasty.

Detailed description: Total knee arthroplasty is very painful surgical intervention.Patients were assigned to 2 groups to receive either periarticular multimodal drug injection or fascia iliaca compartment block for postoperative pain.

Eligibility criteria: Inclusion Criteria:

* patients undergoing knee arthroplasty
* \> 18 years of age

Exclusion Criteria:

* obesity
* heart failure
* kidney failure
* liver failure

Primary outcomes:
measure: Postoperative pain scores of periarticular injection and fascia block for total knee arthroplasty
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University School of Medicine Adana Teaching and reserach Hospital
Study officials:
affiliation: Baskent University School of Medicine
name: Anis Aribogan, Prof.,MD
role: STUDY_DIRECTOR
References: